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Health Device Software: Architecture Decisions That Determine Your Regulatory Path","2026-04-21T15:12:38.732Z","2026-04-21T15:25:05.867Z","2026-04-21T15:25:05.914Z",168324131814528,"5b4a2bfa-c4b5-4b43-b524-428ea55ef792",{"seo":464,"_uid":478,"title":457,"Subtitle":479,"authorId":480,"postBody":481,"component":2559,"categoryIds":2560,"postSummary":2565,"featuredImage":2568,"secondAuthorId":92,"pressDescription":92,"replaceRelatedPosts":2574},[465],{"_uid":466,"image":467,"title":457,"noIndex":22,"component":476,"description":477,"canonicalUrl":92},"51a0b5e9-d8ed-4efd-a26e-cd8a2a8a6be5",[468],{"_uid":469,"component":470,"imageLink":471,"imageAltText":474,"mobileImageLink":475,"originalImageWidth":92,"originalImageHeight":92,"originalMobileImageWidth":92,"originalMobileImageHeight":92},"b25b365b-0296-478a-8444-f485158f68bb","externalImage",{"id":92,"url":472,"linktype":473,"fieldtype":95,"cached_url":472},"https://a.storyblok.com/f/202591/2482x1696/86d6be1614/software-architecture-regulatory-path.png","asset","Abstract, minimalist illustration of software architecture and regulatory path for connected health devices.",{"id":92,"url":92,"linktype":140,"fieldtype":95,"cached_url":92},"seo","Ultimately, the biggest challenges in connected health device software do come from proving that the system works safely, reliably, and in compliance with IoMT regulatory requirements.","abe8b03c-2c90-4396-8401-fe94f32af8dd",[],"fa0cb701-255f-4077-a658-bc83fa894e25",[482,2525],{"_uid":483,"content":484,"component":2524},"3a2bee2e-5668-4d78-84eb-e90ba6c32680",{"type":72,"content":485},[486,540,578,600,608,616,624,632,640,646,656,664,672,678,692,697,705,713,783,785,803,811,819,827,835,840,849,854,863,885,893,915,923,932,940,948,989,1003,1017,1025,1033,1041,1049,1057,1065,1087,1096,1104,1112,1117,1125,1133,1345,1350,1358,1366,1374,1382,1390,1510,1515,1523,1531,1539,1547,1556,1589,1591,1596,1853,1858,1866,1874,1924,1932,1937,1946,1951,1960,1968,1977,1985,1994,2002,2011,2019,2024,2032,2054,2062,2070,2078,2092,2100,2108,2116,2124,2146,2154,2162,2170,2178,2183,2191,2199,2207,2215,2249,2257,2265,2273,2295,2303,2311,2345,2353,2361,2427,2432,2440,2448,2500,2508,2516],{"type":487,"content":488},"blockquote",[489,500,509,518,527,532],{"type":75,"attrs":490,"content":491},{"textAlign":19},[492],{"text":493,"type":80,"marks":494},"Key takeaways:",[495,497,498],{"type":83,"attrs":496},{"color":85},{"type":99},{"type":499},"italic",{"type":75,"attrs":501,"content":502},{"textAlign":19},[503],{"text":504,"type":80,"marks":505},"The way you design your IoMT software architecture (medical device firmware and embedded software medical devices rely on, BLE healthcare connectivity or cellular protocols or cloud logic and OTA updates medical devices need in the field) directly determines how your product will be classified, validated, and maintained. ",[506,508],{"type":83,"attrs":507},{"color":85},{"type":499},{"type":510,"attrs":511},"blok",{"id":512,"body":513},"748c0521-3107-48c6-b6dd-e73d10d37a2c",[514],{"_uid":515,"margin":516,"component":517},"i-6d28a426-7095-4fdd-94b6-0e230908c030","12px","BlogSpacer",{"type":75,"attrs":519,"content":520},{"textAlign":19},[521],{"text":522,"type":80,"marks":523},"Decisions about where clinical logic lives, how data flows, and how device security healthcare IoT systems require is built into the stack are not implementation details. They define your regulatory pathway, your risk model, and your ability to scale.",[524,526],{"type":83,"attrs":525},{"color":85},{"type":499},{"type":510,"attrs":528},{"id":512,"body":529},[530],{"_uid":531,"margin":516,"component":517},"i-dc8d2f8f-7c1b-43bd-a6af-9e27d9f865be",{"type":75,"attrs":533,"content":534},{"textAlign":19},[535],{"text":477,"type":80,"marks":536},[537,539],{"type":83,"attrs":538},{"color":85},{"type":499},{"type":75,"attrs":541,"content":542},{"textAlign":19},[543,548,559,564,573],{"text":544,"type":80,"marks":545},"The potential connected medical devices in digital health is a no-brainer by now as market projections from ",[546],{"type":83,"attrs":547},{"color":85},{"text":549,"type":80,"marks":550},"McKinsey & Company",[551,554,557],{"type":98,"attrs":552},{"href":553,"uuid":19,"anchor":19,"target":19,"linktype":94},"https://www.mckinsey.com/~/media/mckinsey/industries/technology%20media%20and%20telecommunications/high%20tech/our%20insights/the%20internet%20of%20things%20the%20value%20of%20digitizing%20the%20physical%20world/unlocking_the_potential_of_the_internet_of_things_executive_summary.pdf",{"type":83,"attrs":555},{"color":556},"#1155CC",{"type":558},"underline",{"text":560,"type":80,"marks":561}," and ",[562],{"type":83,"attrs":563},{"color":85},{"text":565,"type":80,"marks":566},"PwC",[567,570,572],{"type":98,"attrs":568},{"href":569,"uuid":19,"anchor":19,"target":19,"linktype":94},"https://www.pwc.com/us/en/industries/health-industries/library/ai-and-healthcare-emerging-technologies.html",{"type":83,"attrs":571},{"color":556},{"type":558},{"text":574,"type":80,"marks":575}," consistently (and for years) point to connected care as a driver of cost reduction and improved clinical outcomes.",[576],{"type":83,"attrs":577},{"color":85},{"type":75,"attrs":579,"content":580},{"textAlign":19},[581,586,595],{"text":582,"type":80,"marks":583},"That potential is visible in practice with remote ",[584],{"type":83,"attrs":585},{"color":85},{"text":587,"type":80,"marks":588},"patient monitoring",[589,592,594],{"type":98,"attrs":590},{"href":591,"uuid":19,"anchor":19,"target":19,"linktype":94},"https://www.monterail.com/blog/internet-of-medical-things-transforming-healthcare",{"type":83,"attrs":593},{"color":556},{"type":558},{"text":596,"type":80,"marks":597}," programs that reduce hospital readmissions in chronic care. Or wearable cardiac devices enable earlier detection of arrhythmias, and connected respiratory tools that support continuous management of conditions like COPD outside clinical environments.",[598],{"type":83,"attrs":599},{"color":85},{"type":75,"attrs":601,"content":602},{"textAlign":19},[603],{"text":604,"type":80,"marks":605},"But translating the high-level understanding into a product architecture that can be actually built and approved is a constant struggle. Why?",[606],{"type":83,"attrs":607},{"color":85},{"type":75,"attrs":609,"content":610},{"textAlign":19},[611],{"text":612,"type":80,"marks":613},"Because recognizing the value of continuous data and connected care is one thing, while defining a repeatable architectural approach that consistently delivers it in a regulated environment is another. ",[614],{"type":83,"attrs":615},{"color":85},{"type":75,"attrs":617,"content":618},{"textAlign":19},[619],{"text":620,"type":80,"marks":621},"Unlike conventional software, connected medical devices cannot be shaped primarily through iteration at the application layer. They require a system-level design from the outset, defining how firmware, connectivity, data processing, and clinical logic interact, and how each of those components will be verified, validated, and documented.",[622],{"type":83,"attrs":623},{"color":85},{"type":75,"attrs":625,"content":626},{"textAlign":19},[627],{"text":628,"type":80,"marks":629},"In regulated contexts, architecture determines classification, evidence requirements, and the constraints on post-market change. Without a defined architectural pattern early on, teams are forced to reconcile product decisions with regulatory expectations retroactively, typically through system-level rework, where changes are both costly and time-constrained.",[630],{"type":83,"attrs":631},{"color":85},{"type":75,"attrs":633,"content":634},{"textAlign":19},[635],{"text":636,"type":80,"marks":637},"In this article, we break down the core architectural decisions behind connected medical devices. From system layers and software boundaries to connectivity, security, and regulatory implications. We’ll also explain how each of them shapes what can be built, approved, and maintained in practice.",[638],{"type":83,"attrs":639},{"color":85},{"type":510,"attrs":641},{"id":512,"body":642},[643],{"_uid":644,"margin":645,"component":517},"i-a400ca2b-94d1-4003-a667-527ec194653f","24px",{"type":647,"attrs":648,"content":650},"heading",{"level":649,"textAlign":19},2,[651],{"text":652,"type":80,"marks":653},"What are the four layers of a connected health device?",[654],{"type":83,"attrs":655},{"color":85},{"type":75,"attrs":657,"content":658},{"textAlign":19},[659],{"text":660,"type":80,"marks":661},"A connected medical device is not a single product in the sense typically used in software development, where one application, even if internally complex, is delivered, deployed, and versioned as a coherent unit.",[662],{"type":83,"attrs":663},{"color":85},{"type":75,"attrs":665,"content":666},{"textAlign":19},[667],{"text":668,"type":80,"marks":669},"In IoMT, what appears as one product is, in fact, a distributed system composed of multiple interdependent components: software running on constrained hardware, a communication layer that governs how data moves across environments, backend infrastructure that processes and stores regulated data, and an application layer that exposes functionality to users.",[670],{"type":83,"attrs":671},{"color":85},{"type":510,"attrs":673},{"id":512,"body":674},[675],{"_uid":676,"margin":677,"component":517},"i-28073d14-0ce4-459c-a985-bfdb7420fa7d","48px",{"type":75,"attrs":679,"content":680},{"textAlign":19},[681],{"type":682,"attrs":683,"marks":687},"image",{"id":684,"alt":92,"src":685,"title":92,"source":92,"copyright":92,"meta_data":686},21599449,"https://a.storyblok.com/f/202591/1201x694/8b0768b913/healthcare.png",{},[688],{"type":98,"attrs":689},{"href":690,"uuid":221,"anchor":19,"target":691,"linktype":140},"/services/healthcare-software-development","_self",{"type":510,"attrs":693},{"id":512,"body":694},[695],{"_uid":696,"margin":677,"component":517},"i-dc11195a-77f8-4ad5-a1c6-266b9725358f",{"type":75,"attrs":698,"content":699},{"textAlign":19},[700],{"text":701,"type":80,"marks":702},"These components are developed, validated, and, in some cases, regulated under different assumptions.",[703],{"type":83,"attrs":704},{"color":85},{"type":75,"attrs":706,"content":707},{"textAlign":19},[708],{"text":709,"type":80,"marks":710},"For clarity, this architecture can be described as four layers:",[711],{"type":83,"attrs":712},{"color":85},{"type":714,"attrs":715,"content":717},"ordered_list",{"order":716},1,[718,735,751,767],{"type":719,"content":720},"list_item",[721],{"type":75,"attrs":722,"content":723},{"textAlign":19},[724,730],{"text":725,"type":80,"marks":726},"Firmware and embedded software",[727,729],{"type":83,"attrs":728},{"color":85},{"type":99},{"text":731,"type":80,"marks":732}," – code running directly on the device, controlling sensors, actuators, and local processing",[733],{"type":83,"attrs":734},{"color":85},{"type":719,"content":736},[737],{"type":75,"attrs":738,"content":739},{"textAlign":19},[740,746],{"text":741,"type":80,"marks":742},"Edge and gateway layer",[743,745],{"type":83,"attrs":744},{"color":85},{"type":99},{"text":747,"type":80,"marks":748}," – the communication bridge that transfers data from the device to external systems",[749],{"type":83,"attrs":750},{"color":85},{"type":719,"content":752},[753],{"type":75,"attrs":754,"content":755},{"textAlign":19},[756,762],{"text":757,"type":80,"marks":758},"Cloud ingestion and processing",[759,761],{"type":83,"attrs":760},{"color":85},{"type":99},{"text":763,"type":80,"marks":764}," – infrastructure responsible for receiving, storing, validating, and analyzing data",[765],{"type":83,"attrs":766},{"color":85},{"type":719,"content":768},[769],{"type":75,"attrs":770,"content":771},{"textAlign":19},[772,778],{"text":773,"type":80,"marks":774},"Clinical application layer ",[775,777],{"type":83,"attrs":776},{"color":85},{"type":99},{"text":779,"type":80,"marks":780},"– the interface through which clinicians or patients interact with the system",[781],{"type":83,"attrs":782},{"color":85},{"type":75,"attrs":784},{"textAlign":19},{"type":487,"content":786},[787],{"type":75,"attrs":788,"content":789},{"textAlign":19},[790,797],{"text":791,"type":80,"marks":792},"NOTE: ",[793,795,796],{"type":83,"attrs":794},{"color":85},{"type":99},{"type":499},{"text":798,"type":80,"marks":799},"Real-world implementations may collapse or further subdivide these boundaries, but it is a useful model for understanding where critical decisions are made and how they propagate through the system. ",[800,802],{"type":83,"attrs":801},{"color":85},{"type":499},{"type":75,"attrs":804,"content":805},{"textAlign":19},[806],{"text":807,"type":80,"marks":808},"Each layer introduces its own technology stack, failure modes, and regulatory exposure. Crucially, the decisions that define system behavior are not concentrated at the interface level. While application development  in any domain is driven by business logic rather than UI, in connected medical devices the primary constraints sit deeper in the stack.",[809],{"type":83,"attrs":810},{"color":85},{"type":75,"attrs":812,"content":813},{"textAlign":19},[814],{"text":815,"type":80,"marks":816},"Choices made at the level of firmware and connectivity, such as where data is processed, how reliably it can be transmitted, or how the device behaves in failure scenarios, establish the conditions under which higher-level logic can operate. ",[817],{"type":83,"attrs":818},{"color":85},{"type":75,"attrs":820,"content":821},{"textAlign":19},[822],{"text":823,"type":80,"marks":824},"These decisions are typically made early, and they directly influence safety classification, the scope of regulatory review, and the long-term cost and feasibility of maintaining the system.",[825],{"type":83,"attrs":826},{"color":85},{"type":75,"attrs":828,"content":829},{"textAlign":19},[830],{"text":831,"type":80,"marks":832},"The sections below examine each of these layers in turn, what role it plays in the system, and how the decisions made at that level shape the product as a whole.",[833],{"type":83,"attrs":834},{"color":85},{"type":510,"attrs":836},{"id":512,"body":837},[838],{"_uid":839,"margin":645,"component":517},"i-aab25b14-56d2-43a2-85cd-a9be0353b1d4",{"type":647,"attrs":841,"content":843},{"level":842,"textAlign":19},3,[844],{"text":845,"type":80,"marks":846},"What does each layer actually do?",[847],{"type":83,"attrs":848},{"color":85},{"type":510,"attrs":850},{"id":512,"body":851},[852],{"_uid":853,"margin":516,"component":517},"i-c78cf03e-0520-4317-9db4-d20f913cf78d",{"type":647,"attrs":855,"content":857},{"level":856,"textAlign":19},4,[858],{"text":725,"type":80,"marks":859},[860,862],{"type":83,"attrs":861},{"color":85},{"type":99},{"type":75,"attrs":864,"content":865},{"textAlign":19},[866,871,880],{"text":867,"type":80,"marks":868},"This is the code that runs directly on the device’s microcontroller. It controls the hardware itself: photodetectors in a pulse oximeter, motors in an insulin pump, or sensors in a ",[869],{"type":83,"attrs":870},{"color":85},{"text":872,"type":80,"marks":873},"wearable",[874,877,879],{"type":98,"attrs":875},{"href":876,"uuid":19,"anchor":19,"target":19,"linktype":94},"https://www.monterail.com/projects/remedee-labs",{"type":83,"attrs":878},{"color":556},{"type":558},{"text":881,"type":80,"marks":882},". For teams coming from web or mobile development, this layer is often unfamiliar, as it operates under strict constraints (limited memory, processing power, and energy) and is responsible for core functions such as signal acquisition, local processing, and power management.",[883],{"type":83,"attrs":884},{"color":85},{"type":75,"attrs":886,"content":887},{"textAlign":19},[888],{"text":889,"type":80,"marks":890},"Under IEC 62304 (the international standard governing medical device software lifecycle processes), this software is classified by safety: Class A, B, or C, based on the potential for patient harm if it fails. ",[891],{"type":83,"attrs":892},{"color":85},{"type":75,"attrs":894,"content":895},{"textAlign":19},[896,901,910],{"text":897,"type":80,"marks":898},"This is also the layer where the boundary between a ",[899],{"type":83,"attrs":900},{"color":85},{"text":902,"type":80,"marks":903},"general digital health product and a regulated medical device",[904,907,909],{"type":98,"attrs":905},{"href":906,"uuid":19,"anchor":19,"target":19,"linktype":94},"https://www.monterail.com/blog/is-your-digital-health-product-a-medical-device",{"type":83,"attrs":908},{"color":556},{"type":558},{"text":911,"type":80,"marks":912}," often begins to take shape. ",[913],{"type":83,"attrs":914},{"color":85},{"type":75,"attrs":916,"content":917},{"textAlign":19},[918],{"text":919,"type":80,"marks":920},"When software directly controls hardware, influences how physiological signals are captured, or performs clinically relevant processing at the point of measurement, it becomes part of a safety-critical system rather than a standalone digital tool.",[921],{"type":83,"attrs":922},{"color":85},{"type":647,"attrs":924,"content":925},{"level":856,"textAlign":19},[926],{"text":927,"type":80,"marks":928},"Edge and gateway",[929,931],{"type":83,"attrs":930},{"color":85},{"type":99},{"type":75,"attrs":933,"content":934},{"textAlign":19},[935],{"text":936,"type":80,"marks":937},"This layer defines how data leaves the device and reaches the internet.",[938],{"type":83,"attrs":939},{"color":85},{"type":75,"attrs":941,"content":942},{"textAlign":19},[943],{"text":944,"type":80,"marks":945},"In practice, three architectural patterns dominate:",[946],{"type":83,"attrs":947},{"color":85},{"type":75,"attrs":949,"content":950},{"textAlign":19},[951,957,962,971,976,984],{"text":952,"type":80,"marks":953},"Smartphone as gateway (BLE) - ",[954,956],{"type":83,"attrs":955},{"color":85},{"type":99},{"text":958,"type":80,"marks":959},"Leveraging hardware the patient already owns is the most cost-efficient and works well in scenarios where the patient is actively engaged with the device, for example, connected wearables such as the ",[960],{"type":83,"attrs":961},{"color":85},{"text":963,"type":80,"marks":964},"Elvie Pump",[965,968,970],{"type":98,"attrs":966},{"href":967,"uuid":19,"anchor":19,"target":19,"linktype":94},"https://www.monterail.com/projects/elvie-pump",{"type":83,"attrs":969},{"color":556},{"type":558},{"text":972,"type":80,"marks":973}," or ",[974],{"type":83,"attrs":975},{"color":85},{"text":977,"type":80,"marks":978},"Remedee Labs",[979,981,983],{"type":98,"attrs":980},{"href":876,"uuid":19,"anchor":19,"target":19,"linktype":94},{"type":83,"attrs":982},{"color":556},{"type":558},{"text":985,"type":80,"marks":986},"’ therapeutic device. Yet, it also has a severe limitation which is dependency on external variables: Bluetooth can be disabled, mobile operating systems may restrict background activity, and connectivity is tied to user behavior.",[987],{"type":83,"attrs":988},{"color":85},{"type":75,"attrs":990,"content":991},{"textAlign":19},[992,998],{"text":993,"type":80,"marks":994},"Dedicated hub - ",[995,997],{"type":83,"attrs":996},{"color":85},{"type":99},{"text":999,"type":80,"marks":1000},"A separate in-home device aggregates data from one or more sensors and transmits it to the cloud automatically. This model reduces reliance on patient behavior and is particularly effective in elderly care or multi-device monitoring setups, but the trade-off is an increased system complexity: an additional hardware component that must be manufactured, certified, maintained, and supported.",[1001],{"type":83,"attrs":1002},{"color":85},{"type":75,"attrs":1004,"content":1005},{"textAlign":19},[1006,1012],{"text":1007,"type":80,"marks":1008},"Cellular-embedded (LTE-M / NB-IoT) - ",[1009,1011],{"type":83,"attrs":1010},{"color":85},{"type":99},{"text":1013,"type":80,"marks":1014},"Connectivity is built directly into the device, enabling continuous data transmission independent of smartphones or local networks. This approach is the most robust for critical monitoring or use in low-connectivity environments; however it comes at a cost: higher unit economics, ongoing data fees, and increased power consumption, which can significantly impact battery design and device form factor.",[1015],{"type":83,"attrs":1016},{"color":85},{"type":75,"attrs":1018,"content":1019},{"textAlign":19},[1020],{"text":1021,"type":80,"marks":1022},"The choice of gateway architecture determines how consistently data can be transmitted, what happens when connectivity is lost, and which parts of the system are considered safety-critical.",[1023],{"type":83,"attrs":1024},{"color":85},{"type":75,"attrs":1026,"content":1027},{"textAlign":19},[1028],{"text":1029,"type":80,"marks":1030},"From a regulatory perspective, this affects how data integrity is demonstrated (e.g., completeness and continuity of transmitted data), how system dependencies are documented (such as reliance on third-party devices like smartphones), and how failure modes are handled in risk analysis. ",[1031],{"type":83,"attrs":1032},{"color":85},{"type":647,"attrs":1034,"content":1035},{"level":856,"textAlign":19},[1036],{"text":757,"type":80,"marks":1037},[1038,1040],{"type":83,"attrs":1039},{"color":85},{"type":99},{"type":75,"attrs":1042,"content":1043},{"textAlign":19},[1044],{"text":1045,"type":80,"marks":1046},"Unlike a typical application backend, where interactions are discrete and occasional inconsistencies can often be tolerated, in healthcare this layer handles continuous, time-series health data that may carry clinical significance at any given point.",[1047],{"type":83,"attrs":1048},{"color":85},{"type":75,"attrs":1050,"content":1051},{"textAlign":19},[1052],{"text":1053,"type":80,"marks":1054},"As a result, systems must ensure not only availability, but also completeness, correct ordering, and traceability of data across its lifecycle. Gaps, delays, or inconsistencies are not just technical issues; they can affect clinical interpretation and must be explicitly addressed in system design and validation. From the moment data is generated, it is also subject to regulatory frameworks such as HIPAA and GDPR, which require strict controls over security, access, and auditability.",[1055],{"type":83,"attrs":1056},{"color":85},{"type":75,"attrs":1058,"content":1059},{"textAlign":19},[1060],{"text":1061,"type":80,"marks":1062},"This is also where the boundary between infrastructure and regulated software becomes critical.",[1063],{"type":83,"attrs":1064},{"color":85},{"type":75,"attrs":1066,"content":1067},{"textAlign":19},[1068,1073,1082],{"text":1069,"type":80,"marks":1070},"In layer 1, that boundary begins when software directly interacts with hardware, controlling how physiological signals; in the cloud layer, the same boundary is crossed for a different reason. If cloud-side logic goes beyond storage and transmission and begins to interpret data in a clinically meaningful way, it may qualify as ",[1071],{"type":83,"attrs":1072},{"color":85},{"text":1074,"type":80,"marks":1075},"Software as a Medical Device (SaMD)",[1076,1079,1081],{"type":98,"attrs":1077},{"href":1078,"uuid":19,"anchor":19,"target":19,"linktype":94},"https://www.monterail.com/blog/SaMD-Regulation-Global-Standards",{"type":83,"attrs":1080},{"color":556},{"type":558},{"text":1083,"type":80,"marks":1084},", with its own regulatory requirements.",[1085],{"type":83,"attrs":1086},{"color":85},{"type":647,"attrs":1088,"content":1089},{"level":856,"textAlign":19},[1090],{"text":1091,"type":80,"marks":1092},"Clinical application",[1093,1095],{"type":83,"attrs":1094},{"color":85},{"type":99},{"type":75,"attrs":1097,"content":1098},{"textAlign":19},[1099],{"text":1100,"type":80,"marks":1101},"This is the interface exposed to clinicians or patients: dashboards, alerts, reports, and timelines.",[1102],{"type":83,"attrs":1103},{"color":85},{"type":75,"attrs":1105,"content":1106},{"textAlign":19},[1107],{"text":1108,"type":80,"marks":1109},"It is the most visible layer, and typically the most familiar to product teams. Its impact is operational rather than structural, but in practice, its quality directly affects clinical outcomes. Poorly designed alerting systems contribute to alert fatigue, where high volumes of low-priority notifications obscure critical signals. In clinical environments, this is not a usability issue but a safety risk.",[1110],{"type":83,"attrs":1111},{"color":85},{"type":510,"attrs":1113},{"id":512,"body":1114},[1115],{"_uid":1116,"margin":645,"component":517},"i-b8a8db91-d785-4492-a13d-88acb8f556e0",{"type":647,"attrs":1118,"content":1119},{"level":649,"textAlign":19},[1120],{"text":1121,"type":80,"marks":1122},"Firmware, embedded software, and cloud-side logic. What’s the difference?",[1123],{"type":83,"attrs":1124},{"color":85},{"type":75,"attrs":1126,"content":1127},{"textAlign":19},[1128],{"text":1129,"type":80,"marks":1130},"Connected medical devices combine three distinct types of software, each operating under different technical constraints and subject to different regulatory expectations.",[1131],{"type":83,"attrs":1132},{"color":85},{"type":1134,"content":1135},"table",[1136,1195,1245,1295],{"type":1137,"content":1138},"tableRow",[1139,1153,1167,1181],{"type":1140,"attrs":1141,"content":1142},"tableCell",{"colspan":716,"rowspan":716,"colwidth":19,"backgroundColor":19},[1143],{"type":75,"attrs":1144,"content":1146},{"textAlign":1145},"center",[1147],{"text":1148,"type":80,"marks":1149},"Layer",[1150,1152],{"type":83,"attrs":1151},{"color":85},{"type":99},{"type":1140,"attrs":1154,"content":1157},{"colspan":716,"rowspan":716,"colwidth":1155,"backgroundColor":19},[1156],227,[1158],{"type":75,"attrs":1159,"content":1160},{"textAlign":1145},[1161],{"text":1162,"type":80,"marks":1163},"What it does",[1164,1166],{"type":83,"attrs":1165},{"color":85},{"type":99},{"type":1140,"attrs":1168,"content":1171},{"colspan":716,"rowspan":716,"colwidth":1169,"backgroundColor":19},[1170],150,[1172],{"type":75,"attrs":1173,"content":1174},{"textAlign":1145},[1175],{"text":1176,"type":80,"marks":1177},"Example",[1178,1180],{"type":83,"attrs":1179},{"color":85},{"type":99},{"type":1140,"attrs":1182,"content":1185},{"colspan":716,"rowspan":716,"colwidth":1183,"backgroundColor":19},[1184],173,[1186],{"type":75,"attrs":1187,"content":1188},{"textAlign":1145},[1189],{"text":1190,"type":80,"marks":1191},"Maintenance",[1192,1194],{"type":83,"attrs":1193},{"color":85},{"type":99},{"type":1137,"content":1196},[1197,1209,1221,1233],{"type":1140,"attrs":1198,"content":1199},{"colspan":716,"rowspan":716,"colwidth":19,"backgroundColor":19},[1200],{"type":75,"attrs":1201,"content":1202},{"textAlign":19},[1203],{"text":1204,"type":80,"marks":1205},"Firmware",[1206,1208],{"type":83,"attrs":1207},{"color":85},{"type":99},{"type":1140,"attrs":1210,"content":1212},{"colspan":716,"rowspan":716,"colwidth":1211,"backgroundColor":19},[1156],[1213],{"type":75,"attrs":1214,"content":1215},{"textAlign":19},[1216],{"text":1217,"type":80,"marks":1218},"Low-level code running on the microcontroller, directly controlling hardware (sensors, timing, power)",[1219],{"type":83,"attrs":1220},{"color":85},{"type":1140,"attrs":1222,"content":1224},{"colspan":716,"rowspan":716,"colwidth":1223,"backgroundColor":19},[1170],[1225],{"type":75,"attrs":1226,"content":1227},{"textAlign":19},[1228],{"text":1229,"type":80,"marks":1230},"Controls LED emission and signal capture in a pulse oximeter",[1231],{"type":83,"attrs":1232},{"color":85},{"type":1140,"attrs":1234,"content":1236},{"colspan":716,"rowspan":716,"colwidth":1235,"backgroundColor":19},[1184],[1237],{"type":75,"attrs":1238,"content":1239},{"textAlign":19},[1240],{"text":1241,"type":80,"marks":1242},"Rarely updated; designed to be stable and tightly controlled",[1243],{"type":83,"attrs":1244},{"color":85},{"type":1137,"content":1246},[1247,1259,1271,1283],{"type":1140,"attrs":1248,"content":1249},{"colspan":716,"rowspan":716,"colwidth":19,"backgroundColor":19},[1250],{"type":75,"attrs":1251,"content":1252},{"textAlign":19},[1253],{"text":1254,"type":80,"marks":1255},"Embedded software",[1256,1258],{"type":83,"attrs":1257},{"color":85},{"type":99},{"type":1140,"attrs":1260,"content":1262},{"colspan":716,"rowspan":716,"colwidth":1261,"backgroundColor":19},[1156],[1263],{"type":75,"attrs":1264,"content":1265},{"textAlign":19},[1266],{"text":1267,"type":80,"marks":1268},"Processes raw sensor data and executes device-level logic (thresholds, alerts, control logic)",[1269],{"type":83,"attrs":1270},{"color":85},{"type":1140,"attrs":1272,"content":1274},{"colspan":716,"rowspan":716,"colwidth":1273,"backgroundColor":19},[1170],[1275],{"type":75,"attrs":1276,"content":1277},{"textAlign":19},[1278],{"text":1279,"type":80,"marks":1280},"Calculates oxygen saturation and triggers a local alarm",[1281],{"type":83,"attrs":1282},{"color":85},{"type":1140,"attrs":1284,"content":1286},{"colspan":716,"rowspan":716,"colwidth":1285,"backgroundColor":19},[1184],[1287],{"type":75,"attrs":1288,"content":1289},{"textAlign":19},[1290],{"text":1291,"type":80,"marks":1292},"Can be updated (e.g., via OTA), but constrained by device resources",[1293],{"type":83,"attrs":1294},{"color":85},{"type":1137,"content":1296},[1297,1309,1321,1333],{"type":1140,"attrs":1298,"content":1299},{"colspan":716,"rowspan":716,"colwidth":19,"backgroundColor":19},[1300],{"type":75,"attrs":1301,"content":1302},{"textAlign":19},[1303],{"text":1304,"type":80,"marks":1305},"Cloud-side software",[1306,1308],{"type":83,"attrs":1307},{"color":85},{"type":99},{"type":1140,"attrs":1310,"content":1312},{"colspan":716,"rowspan":716,"colwidth":1311,"backgroundColor":19},[1156],[1313],{"type":75,"attrs":1314,"content":1315},{"textAlign":19},[1316],{"text":1317,"type":80,"marks":1318},"Handles data ingestion, storage, analytics, and integrations at scale",[1319],{"type":83,"attrs":1320},{"color":85},{"type":1140,"attrs":1322,"content":1324},{"colspan":716,"rowspan":716,"colwidth":1323,"backgroundColor":19},[1170],[1325],{"type":75,"attrs":1326,"content":1327},{"textAlign":19},[1328],{"text":1329,"type":80,"marks":1330},"Analyzes historical patient data to detect trends or predict events",[1331],{"type":83,"attrs":1332},{"color":85},{"type":1140,"attrs":1334,"content":1336},{"colspan":716,"rowspan":716,"colwidth":1335,"backgroundColor":19},[1184],[1337],{"type":75,"attrs":1338,"content":1339},{"textAlign":19},[1340],{"text":1341,"type":80,"marks":1342},"Continuously updated without touching the physical device",[1343],{"type":83,"attrs":1344},{"color":85},{"type":510,"attrs":1346},{"id":512,"body":1347},[1348],{"_uid":1349,"margin":677,"component":517},"i-09a6e67a-1366-4dc9-99ac-604c94c74d62",{"type":647,"attrs":1351,"content":1352},{"level":842,"textAlign":19},[1353],{"text":1354,"type":80,"marks":1355},"Why does this matter for founders?",[1356],{"type":83,"attrs":1357},{"color":85},{"type":75,"attrs":1359,"content":1360},{"textAlign":19},[1361],{"text":1362,"type":80,"marks":1363},"Software classification under IEC 62304 is driven, as we said, by the potential impact of failure, but how it applies in practice depends on where clinical logic is implemented.",[1364],{"type":83,"attrs":1365},{"color":85},{"type":75,"attrs":1367,"content":1368},{"textAlign":19},[1369],{"text":1370,"type":80,"marks":1371},"If clinical logic (the computation that influences diagnosis, monitoring, or treatment) is implemented on the device, the corresponding firmware or embedded software may be classified at a higher safety level (e.g., Class C). This significantly increases the regulatory burden, requiring detailed traceability, unit-level verification, and rigorous validation of hardware–software interaction.",[1372],{"type":83,"attrs":1373},{"color":85},{"type":75,"attrs":1375,"content":1376},{"textAlign":19},[1377],{"text":1378,"type":80,"marks":1379},"If that same logic is implemented in the cloud, the regulatory focus shifts. The device itself may be simpler, but the cloud component must now demonstrate data integrity, system reliability, and cybersecurity controls consistent with a regulated software system.",[1380],{"type":83,"attrs":1381},{"color":85},{"type":75,"attrs":1383,"content":1384},{"textAlign":19},[1385],{"text":1386,"type":80,"marks":1387},"In practice, the choice defines how the system will be evaluated, what risks must be mitigated, and how the product can evolve over time.",[1388],{"type":83,"attrs":1389},{"color":85},{"type":1134,"content":1391},[1392,1434,1472],{"type":1137,"content":1393},[1394,1406,1420],{"type":1140,"attrs":1395,"content":1396},{"colspan":716,"rowspan":716,"colwidth":19,"backgroundColor":19},[1397],{"type":75,"attrs":1398,"content":1399},{"textAlign":1145},[1400],{"text":1401,"type":80,"marks":1402},"Placement of clinical logic",[1403,1405],{"type":83,"attrs":1404},{"color":85},{"type":99},{"type":1140,"attrs":1407,"content":1410},{"colspan":716,"rowspan":716,"colwidth":1408,"backgroundColor":19},[1409],231,[1411],{"type":75,"attrs":1412,"content":1413},{"textAlign":1145},[1414],{"text":1415,"type":80,"marks":1416},"Advantages",[1417,1419],{"type":83,"attrs":1418},{"color":85},{"type":99},{"type":1140,"attrs":1421,"content":1424},{"colspan":716,"rowspan":716,"colwidth":1422,"backgroundColor":19},[1423],291,[1425],{"type":75,"attrs":1426,"content":1427},{"textAlign":1145},[1428],{"text":1429,"type":80,"marks":1430},"Trade-offs",[1431,1433],{"type":83,"attrs":1432},{"color":85},{"type":99},{"type":1137,"content":1435},[1436,1448,1460],{"type":1140,"attrs":1437,"content":1438},{"colspan":716,"rowspan":716,"colwidth":19,"backgroundColor":19},[1439],{"type":75,"attrs":1440,"content":1441},{"textAlign":19},[1442],{"text":1443,"type":80,"marks":1444},"On-device logic",[1445,1447],{"type":83,"attrs":1446},{"color":85},{"type":99},{"type":1140,"attrs":1449,"content":1451},{"colspan":716,"rowspan":716,"colwidth":1450,"backgroundColor":19},[1409],[1452],{"type":75,"attrs":1453,"content":1454},{"textAlign":19},[1455],{"text":1456,"type":80,"marks":1457},"Works without connectivity; ensures critical functions remain available at all times",[1458],{"type":83,"attrs":1459},{"color":85},{"type":1140,"attrs":1461,"content":1463},{"colspan":716,"rowspan":716,"colwidth":1462,"backgroundColor":19},[1423],[1464],{"type":75,"attrs":1465,"content":1466},{"textAlign":19},[1467],{"text":1468,"type":80,"marks":1469},"Higher regulatory scrutiny on the device; more complex validation, especially at the hardware–software boundary",[1470],{"type":83,"attrs":1471},{"color":85},{"type":1137,"content":1473},[1474,1486,1498],{"type":1140,"attrs":1475,"content":1476},{"colspan":716,"rowspan":716,"colwidth":19,"backgroundColor":19},[1477],{"type":75,"attrs":1478,"content":1479},{"textAlign":19},[1480],{"text":1481,"type":80,"marks":1482},"Cloud-side logic",[1483,1485],{"type":83,"attrs":1484},{"color":85},{"type":99},{"type":1140,"attrs":1487,"content":1489},{"colspan":716,"rowspan":716,"colwidth":1488,"backgroundColor":19},[1409],[1490],{"type":75,"attrs":1491,"content":1492},{"textAlign":19},[1493],{"text":1494,"type":80,"marks":1495},"Easier to update, monitor, and scale; enables advanced analytics and AI",[1496],{"type":83,"attrs":1497},{"color":85},{"type":1140,"attrs":1499,"content":1501},{"colspan":716,"rowspan":716,"colwidth":1500,"backgroundColor":19},[1423],[1502],{"type":75,"attrs":1503,"content":1504},{"textAlign":19},[1505],{"text":1506,"type":80,"marks":1507},"Dependency on connectivity; stricter requirements for data integrity, availability, and security",[1508],{"type":83,"attrs":1509},{"color":85},{"type":510,"attrs":1511},{"id":512,"body":1512},[1513],{"_uid":1514,"margin":677,"component":517},"i-3e423fb0-e07e-47d9-86db-c037937f16c5",{"type":647,"attrs":1516,"content":1517},{"level":649,"textAlign":19},[1518],{"text":1519,"type":80,"marks":1520},"How connectivity protocols compare: BLE, Zigbee, LoRa, and Cellular?",[1521],{"type":83,"attrs":1522},{"color":85},{"type":75,"attrs":1524,"content":1525},{"textAlign":19},[1526],{"text":1527,"type":80,"marks":1528},"Connectivity is not the core of an IoMT product but it is the layer that determines whether data can move reliably between the device, the cloud, and the clinical interface. If that flow is disrupted, the rest of the system, such as analytics, alerts, and decision support, cannot function as intended.",[1529],{"type":83,"attrs":1530},{"color":85},{"type":75,"attrs":1532,"content":1533},{"textAlign":19},[1534],{"text":1535,"type":80,"marks":1536},"In healthcare, this makes protocol choice fundamentally different from other IoT domains. Connectivity is not evaluated only in terms of efficiency or cost, but in terms of how reliably clinically relevant data can be delivered under real-world conditions, and what happens when it is not.",[1537],{"type":83,"attrs":1538},{"color":85},{"type":75,"attrs":1540,"content":1541},{"textAlign":19},[1542],{"text":1543,"type":80,"marks":1544},"This section focuses on the four main connectivity options and their real trade-offs in medical contexts, where the evaluation is shaped by constraints that do not exist in typical IoT systems.",[1545],{"type":83,"attrs":1546},{"color":85},{"type":75,"attrs":1548,"content":1549},{"textAlign":19},[1550],{"text":1551,"type":80,"marks":1552},"In IoMT:",[1553,1555],{"type":83,"attrs":1554},{"color":85},{"type":99},{"type":1557,"content":1558},"bullet_list",[1559,1569,1579],{"type":719,"content":1560},[1561],{"type":75,"attrs":1562,"content":1563},{"textAlign":19},[1564],{"text":1565,"type":80,"marks":1566},"the data path is part of the regulated system",[1567],{"type":83,"attrs":1568},{"color":85},{"type":719,"content":1570},[1571],{"type":75,"attrs":1572,"content":1573},{"textAlign":19},[1574],{"text":1575,"type":80,"marks":1576},"patient behavior becomes a system dependency (e.g., carrying a phone, keeping Bluetooth enabled)",[1577],{"type":83,"attrs":1578},{"color":85},{"type":719,"content":1580},[1581],{"type":75,"attrs":1582,"content":1583},{"textAlign":19},[1584],{"text":1585,"type":80,"marks":1586},"connection loss is not just a technical failure but an issue that can degrade or invalidate clinical value",[1587],{"type":83,"attrs":1588},{"color":85},{"type":75,"attrs":1590},{"textAlign":19},{"type":510,"attrs":1592},{"id":512,"body":1593},[1594],{"_uid":1595,"margin":516,"component":517},"i-f3f022ec-f912-45be-af3c-9442a90dbb2f",{"type":1134,"content":1597},[1598,1654,1704,1754,1803],{"type":1137,"content":1599},[1600,1612,1626,1640],{"type":1140,"attrs":1601,"content":1602},{"colspan":716,"rowspan":716,"colwidth":19,"backgroundColor":19},[1603],{"type":75,"attrs":1604,"content":1605},{"textAlign":1145},[1606],{"text":1607,"type":80,"marks":1608},"Protocol",[1609,1611],{"type":83,"attrs":1610},{"color":85},{"type":99},{"type":1140,"attrs":1613,"content":1616},{"colspan":716,"rowspan":716,"colwidth":1614,"backgroundColor":19},[1615],107,[1617],{"type":75,"attrs":1618,"content":1619},{"textAlign":1145},[1620],{"text":1621,"type":80,"marks":1622},"Power",[1623,1625],{"type":83,"attrs":1624},{"color":85},{"type":99},{"type":1140,"attrs":1627,"content":1630},{"colspan":716,"rowspan":716,"colwidth":1628,"backgroundColor":19},[1629],176,[1631],{"type":75,"attrs":1632,"content":1633},{"textAlign":1145},[1634],{"text":1635,"type":80,"marks":1636},"Best 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activity",[1702],{"type":83,"attrs":1703},{"color":85},{"type":1137,"content":1705},[1706,1718,1730,1742],{"type":1140,"attrs":1707,"content":1708},{"colspan":716,"rowspan":716,"colwidth":19,"backgroundColor":19},[1709],{"type":75,"attrs":1710,"content":1711},{"textAlign":19},[1712],{"text":1713,"type":80,"marks":1714},"Zigbee",[1715,1717],{"type":83,"attrs":1716},{"color":85},{"type":99},{"type":1140,"attrs":1719,"content":1721},{"colspan":716,"rowspan":716,"colwidth":1720,"backgroundColor":19},[1615],[1722],{"type":75,"attrs":1723,"content":1724},{"textAlign":19},[1725],{"text":1726,"type":80,"marks":1727},"Low",[1728],{"type":83,"attrs":1729},{"color":85},{"type":1140,"attrs":1731,"content":1733},{"colspan":716,"rowspan":716,"colwidth":1732,"backgroundColor":19},[1629],[1734],{"type":75,"attrs":1735,"content":1736},{"textAlign":19},[1737],{"text":1738,"type":80,"marks":1739},"Multi-device home monitoring (elder care)",[1740],{"type":83,"attrs":1741},{"color":85},{"type":1140,"attrs":1743,"content":1745},{"colspan":716,"rowspan":716,"colwidth":1744,"backgroundColor":19},[1643],[1746],{"type":75,"attrs":1747,"content":1748},{"textAlign":19},[1749],{"text":1750,"type":80,"marks":1751},"Requires hub; no direct internet access",[1752],{"type":83,"attrs":1753},{"color":85},{"type":1137,"content":1755},[1756,1768,1779,1791],{"type":1140,"attrs":1757,"content":1758},{"colspan":716,"rowspan":716,"colwidth":19,"backgroundColor":19},[1759],{"type":75,"attrs":1760,"content":1761},{"textAlign":19},[1762],{"text":1763,"type":80,"marks":1764},"LoRa",[1765,1767],{"type":83,"attrs":1766},{"color":85},{"type":99},{"type":1140,"attrs":1769,"content":1771},{"colspan":716,"rowspan":716,"colwidth":1770,"backgroundColor":19},[1615],[1772],{"type":75,"attrs":1773,"content":1774},{"textAlign":19},[1775],{"text":1676,"type":80,"marks":1776},[1777],{"type":83,"attrs":1778},{"color":85},{"type":1140,"attrs":1780,"content":1782},{"colspan":716,"rowspan":716,"colwidth":1781,"backgroundColor":19},[1629],[1783],{"type":75,"attrs":1784,"content":1785},{"textAlign":19},[1786],{"text":1787,"type":80,"marks":1788},"Rural, low-frequency data (periodic check-ins)",[1789],{"type":83,"attrs":1790},{"color":85},{"type":1140,"attrs":1792,"content":1794},{"colspan":716,"rowspan":716,"colwidth":1793,"backgroundColor":19},[1643],[1795],{"type":75,"attrs":1796,"content":1797},{"textAlign":19},[1798],{"text":1799,"type":80,"marks":1800},"Not suitable for continuous or real-time data",[1801],{"type":83,"attrs":1802},{"color":85},{"type":1137,"content":1804},[1805,1817,1829,1841],{"type":1140,"attrs":1806,"content":1807},{"colspan":716,"rowspan":716,"colwidth":19,"backgroundColor":19},[1808],{"type":75,"attrs":1809,"content":1810},{"textAlign":19},[1811],{"text":1812,"type":80,"marks":1813},"Cellular (LTE-M / NB-IoT)",[1814,1816],{"type":83,"attrs":1815},{"color":85},{"type":99},{"type":1140,"attrs":1818,"content":1820},{"colspan":716,"rowspan":716,"colwidth":1819,"backgroundColor":19},[1615],[1821],{"type":75,"attrs":1822,"content":1823},{"textAlign":19},[1824],{"text":1825,"type":80,"marks":1826},"Higher",[1827],{"type":83,"attrs":1828},{"color":85},{"type":1140,"attrs":1830,"content":1832},{"colspan":716,"rowspan":716,"colwidth":1831,"backgroundColor":19},[1629],[1833],{"type":75,"attrs":1834,"content":1835},{"textAlign":19},[1836],{"text":1837,"type":80,"marks":1838},"Always-on remote monitoring without gateway",[1839],{"type":83,"attrs":1840},{"color":85},{"type":1140,"attrs":1842,"content":1844},{"colspan":716,"rowspan":716,"colwidth":1843,"backgroundColor":19},[1643],[1845],{"type":75,"attrs":1846,"content":1847},{"textAlign":19},[1848],{"text":1849,"type":80,"marks":1850},"Higher cost and power usage",[1851],{"type":83,"attrs":1852},{"color":85},{"type":510,"attrs":1854},{"id":512,"body":1855},[1856],{"_uid":1857,"margin":677,"component":517},"i-6f41746f-7bde-4166-b0ed-111e5616d2ca",{"type":647,"attrs":1859,"content":1860},{"level":649,"textAlign":19},[1861],{"text":1862,"type":80,"marks":1863},"What does 'Secure by Design' mean at the hardware-software boundary?",[1864],{"type":83,"attrs":1865},{"color":85},{"type":75,"attrs":1867,"content":1868},{"textAlign":19},[1869],{"text":1870,"type":80,"marks":1871},"Security in connected medical devices has moved from a technical concern to a regulatory priority, largely in response to how failures have played out in practice. ",[1872],{"type":83,"attrs":1873},{"color":85},{"type":75,"attrs":1875,"content":1876},{"textAlign":19},[1877,1882,1891,1896,1905,1910,1919],{"text":1878,"type":80,"marks":1879},"The ",[1880],{"type":83,"attrs":1881},{"color":85},{"text":1883,"type":80,"marks":1884},"Change Healthcare ransomware attack",[1885,1888,1890],{"type":98,"attrs":1886},{"href":1887,"uuid":19,"anchor":19,"target":19,"linktype":94},"https://www.techtarget.com/whatis/feature/The-Change-Healthcare-attack-Explaining-how-it-happened",{"type":83,"attrs":1889},{"color":556},{"type":558},{"text":1892,"type":80,"marks":1893}," exposed just how interconnected modern healthcare systems have become. A single compromised entry point disrupted claims processing nationwide, affecting around 190 million individuals and forcing providers to delay care, switch to manual workflows, or absorb financial losses. It is not an isolated case. In 2023 alone, the ",[1894],{"type":83,"attrs":1895},{"color":85},{"text":1897,"type":80,"marks":1898},"HCA Healthcare breach",[1899,1902,1904],{"type":98,"attrs":1900},{"href":1901,"uuid":19,"anchor":19,"target":19,"linktype":94},"https://www.techtarget.com/healthtechsecurity/news/366594261/HCA-Healthcare-Suffers-Data-Breach-11M-Patients-Impacted",{"type":83,"attrs":1903},{"color":556},{"type":558},{"text":1906,"type":80,"marks":1907}," exposed data from over 11 million patients, while the ",[1908],{"type":83,"attrs":1909},{"color":85},{"text":1911,"type":80,"marks":1912},"PharMerica",[1913,1916,1918],{"type":98,"attrs":1914},{"href":1915,"uuid":19,"anchor":19,"target":19,"linktype":94},"https://www.hipaajournal.com/almost-6-million-individuals-affected-by-pharmerica-data-breach/",{"type":83,"attrs":1917},{"color":556},{"type":558},{"text":1920,"type":80,"marks":1921}," ransomware attack affected nearly 6 million individuals. ",[1922],{"type":83,"attrs":1923},{"color":85},{"type":75,"attrs":1925,"content":1926},{"textAlign":19},[1927],{"text":1928,"type":80,"marks":1929},"These are recurring, large-scale failures across different parts of the healthcare system, from providers to infrastructure platforms.",[1930],{"type":83,"attrs":1931},{"color":85},{"type":510,"attrs":1933},{"id":512,"body":1934},[1935],{"_uid":1936,"margin":645,"component":517},"i-fc75e90d-fb7d-4409-8bfb-0520c56e1c76",{"type":647,"attrs":1938,"content":1939},{"level":842,"textAlign":19},[1940],{"text":1941,"type":80,"marks":1942},"Which four security decisions must happen before development starts?",[1943],{"type":83,"attrs":1944},{"color":1945},"#434343",{"type":510,"attrs":1947},{"id":512,"body":1948},[1949],{"_uid":1950,"margin":645,"component":517},"i-5d8a406c-d057-4627-af71-3d162a67df75",{"type":647,"attrs":1952,"content":1953},{"level":856,"textAlign":19},[1954],{"text":1955,"type":80,"marks":1956},"Secure boot",[1957,1959],{"type":83,"attrs":1958},{"color":85},{"type":99},{"type":75,"attrs":1961,"content":1962},{"textAlign":19},[1963],{"text":1964,"type":80,"marks":1965},"Secure boot ensures that a device only runs software from a trusted source. Before any application code is executed, the system verifies that the firmware has not been altered, typically using cryptographic signatures. If the verification fails, the device refuses to start. Without this mechanism, anyone with physical or remote access could replace the firmware with a modified version, for example, one that alters measurements, disables safety checks, or silently transmits data elsewhere. Once malicious firmware is installed, higher-level protections such as encrypted communication become irrelevant, because the system has been compromised at its most fundamental level.",[1966],{"type":83,"attrs":1967},{"color":85},{"type":647,"attrs":1969,"content":1970},{"level":856,"textAlign":19},[1971],{"text":1972,"type":80,"marks":1973},"Encrypted transmission",[1974,1976],{"type":83,"attrs":1975},{"color":85},{"type":99},{"type":75,"attrs":1978,"content":1979},{"textAlign":19},[1980],{"text":1981,"type":80,"marks":1982},"All data in transit must be encrypted both between the device and its gateway (e.g., over Bluetooth) and between the gateway and the cloud. Without encryption, data can be intercepted or modified in transit. In healthcare, this is not just a privacy issue. If physiological data is even slightly altered it can lead to incorrect clinical interpretation. Encryption ensures that data arrives exactly as it was sent, and only to intended recipients.",[1983],{"type":83,"attrs":1984},{"color":85},{"type":647,"attrs":1986,"content":1987},{"level":856,"textAlign":19},[1988],{"text":1989,"type":80,"marks":1990},"Device authentication",[1991,1993],{"type":83,"attrs":1992},{"color":85},{"type":99},{"type":75,"attrs":1995,"content":1996},{"textAlign":19},[1997],{"text":1998,"type":80,"marks":1999},"Each device in the system should have a unique, verifiable identity,  typically implemented using certificates. When devices share credentials, a single compromise can escalate into a system-wide breach. In many IoT deployments, devices ship with identical or default credentials, which attackers can discover and exploit at scale. Once one device is accessed, the same credentials often provide access to others, enabling lateral movement across the entire fleet.",[2000],{"type":83,"attrs":2001},{"color":85},{"type":647,"attrs":2003,"content":2004},{"level":856,"textAlign":19},[2005],{"text":2006,"type":80,"marks":2007},"Minimal attack surface",[2008,2010],{"type":83,"attrs":2009},{"color":85},{"type":99},{"type":75,"attrs":2012,"content":2013},{"textAlign":19},[2014],{"text":2015,"type":80,"marks":2016},"Every exposed interface is a potential entry point, whether it’s a debug port, a communication protocol, or a background service. In fact, many successful attacks take advantage of what was left open unnecessarily: unused interfaces, enabled by default or forgotten during development, create easy entry points. Reducing the attack surface by disabling anything that is not essential limits how an attacker can interact with the device.",[2017],{"type":83,"attrs":2018},{"color":85},{"type":510,"attrs":2020},{"id":512,"body":2021},[2022],{"_uid":2023,"margin":645,"component":517},"i-da446c44-6852-4dd3-a086-6c46b3824473",{"type":647,"attrs":2025,"content":2026},{"level":649,"textAlign":19},[2027],{"text":2028,"type":80,"marks":2029},"What do regulators now expect?",[2030],{"type":83,"attrs":2031},{"color":85},{"type":75,"attrs":2033,"content":2034},{"textAlign":19},[2035,2040,2049],{"text":2036,"type":80,"marks":2037},"Since 2023, the ",[2038],{"type":83,"attrs":2039},{"color":85},{"text":2041,"type":80,"marks":2042},"U.S. Food and Drug Administration",[2043,2046,2048],{"type":98,"attrs":2044},{"href":2045,"uuid":19,"anchor":19,"target":19,"linktype":94},"https://www.fda.gov/medical-devices/digital-health-center-excellence/cybersecurity",{"type":83,"attrs":2047},{"color":556},{"type":558},{"text":2050,"type":80,"marks":2051}," has made cybersecurity a formal requirement in premarket submissions for connected medical devices, codified under Section 524B of the FD&C Act. The shift reflects a specific assumption: devices will evolve over time, vulnerabilities will emerge, and the manufacturer must be prepared to respond.",[2052],{"type":83,"attrs":2053},{"color":85},{"type":75,"attrs":2055,"content":2056},{"textAlign":19},[2057],{"text":2058,"type":80,"marks":2059},"That expectation plays out across three concrete areas.",[2060],{"type":83,"attrs":2061},{"color":85},{"type":647,"attrs":2063,"content":2064},{"level":842,"textAlign":19},[2065],{"text":2066,"type":80,"marks":2067},"Software Bill of Materials (SBOM)",[2068],{"type":83,"attrs":2069},{"color":1945},{"type":75,"attrs":2071,"content":2072},{"textAlign":19},[2073],{"text":2074,"type":80,"marks":2075},"An SBOM is a complete inventory of every software component inside a device: proprietary code, third-party libraries, open-source packages, and system-level dependencies.",[2076],{"type":83,"attrs":2077},{"color":85},{"type":75,"attrs":2079,"content":2080},{"textAlign":19},[2081,2086],{"text":2082,"type":80,"marks":2083},"The reason regulators require it is practical. Modern devices are built on layers of software that the manufacturer does not fully develop or control. When a vulnerability surfaces in one of those underlying components, the first question is always the same: ",[2084],{"type":83,"attrs":2085},{"color":85},{"text":2087,"type":80,"marks":2088},"Do we use this anywhere in our stack?",[2089,2091],{"type":83,"attrs":2090},{"color":85},{"type":499},{"type":75,"attrs":2093,"content":2094},{"textAlign":19},[2095],{"text":2096,"type":80,"marks":2097},"Without an inventory, answering that question means manually searching codebases and coordinating across teams, a process that can take days or weeks. With an SBOM, it takes hours. Log4Shell made this visible at scale: a severe flaw in the Java logging library Apache Log4j affected countless applications, many of which included it indirectly through nested dependencies. Organizations without component-level visibility had no fast way to assess their exposure.",[2098],{"type":83,"attrs":2099},{"color":85},{"type":647,"attrs":2101,"content":2102},{"level":842,"textAlign":19},[2103],{"text":2104,"type":80,"marks":2105},"Cybersecurity management as an operational capability",[2106],{"type":83,"attrs":2107},{"color":1945},{"type":75,"attrs":2109,"content":2110},{"textAlign":19},[2111],{"text":2112,"type":80,"marks":2113},"Regulators also expect a defined cybersecurity management plan, and they evaluate it as a living process instead of a static document. The logic is straightforward: vulnerabilities are inevitable, so the regulatory question is whether the manufacturer can detect, assess, fix, and deploy a response in a controlled way.",[2114],{"type":83,"attrs":2115},{"color":85},{"type":75,"attrs":2117,"content":2118},{"textAlign":19},[2119],{"text":2120,"type":80,"marks":2121},"In practice, this means demonstrating how vulnerabilities are monitored across the device fleet, how their clinical impact is assessed, how patches are developed and validated, and how updates reach devices already in the field. Traceability runs through all of it, because proving that a fix was applied matters as much as applying it.",[2122],{"type":83,"attrs":2123},{"color":85},{"type":75,"attrs":2125,"content":2126},{"textAlign":19},[2127,2132,2141],{"text":2128,"type":80,"marks":2129},"This operational layer also intersects with broader data protection frameworks. HIPAA and GDPR define how ",[2130],{"type":83,"attrs":2131},{"color":85},{"text":2133,"type":80,"marks":2134},"patient data ",[2135,2138,2140],{"type":98,"attrs":2136},{"href":2137,"uuid":19,"anchor":19,"target":19,"linktype":94},"https://www.monterail.com/blog/data-privacy-in-healthcare",{"type":83,"attrs":2139},{"color":556},{"type":558},{"text":2142,"type":80,"marks":2143},"must be processed, stored, and protected in connected systems, and cybersecurity management is where those obligations become technical.",[2144],{"type":83,"attrs":2145},{"color":85},{"type":647,"attrs":2147,"content":2148},{"level":842,"textAlign":19},[2149],{"text":2150,"type":80,"marks":2151},"Why all three security layers depend on each other?",[2152],{"type":83,"attrs":2153},{"color":1945},{"type":75,"attrs":2155,"content":2156},{"textAlign":19},[2157],{"text":2158,"type":80,"marks":2159},"These requirements are interdependent. ",[2160],{"type":83,"attrs":2161},{"color":85},{"type":75,"attrs":2163,"content":2164},{"textAlign":19},[2165],{"text":2166,"type":80,"marks":2167},"Without a clear update mechanism, vulnerability response stays theoretical. Without device-level authentication and software traceability, identifying which devices are affected becomes guesswork.",[2168],{"type":83,"attrs":2169},{"color":85},{"type":75,"attrs":2171,"content":2172},{"textAlign":19},[2173],{"text":2174,"type":80,"marks":2175},"Without auditability, there is no way to demonstrate that a fix was actually delivered. Regulators evaluate the full chain, and a gap in any one area weakens the credibility of the rest.",[2176],{"type":83,"attrs":2177},{"color":85},{"type":510,"attrs":2179},{"id":512,"body":2180},[2181],{"_uid":2182,"margin":645,"component":517},"i-e0bc0ee0-df5e-40c4-852c-b2abcec05d69",{"type":647,"attrs":2184,"content":2185},{"level":649,"textAlign":19},[2186],{"text":2187,"type":80,"marks":2188},"How do these decisions shape your regulatory pathway?",[2189],{"type":83,"attrs":2190},{"color":85},{"type":75,"attrs":2192,"content":2193},{"textAlign":19},[2194],{"text":2195,"type":80,"marks":2196},"The architectural decisions described above, where clinical logic lives, how devices connect, how software is updated, and how the system is secured, are not reviewed in isolation. Regulators evaluate them as a system, and together they determine what must be proven, documented, and maintained over time.",[2197],{"type":83,"attrs":2198},{"color":85},{"type":647,"attrs":2200,"content":2201},{"level":842,"textAlign":19},[2202],{"text":2203,"type":80,"marks":2204},"Where does clinical logic live?",[2205],{"type":83,"attrs":2206},{"color":85},{"type":75,"attrs":2208,"content":2209},{"textAlign":19},[2210],{"text":2211,"type":80,"marks":2212},"Where clinical logic is implemented determines what regulators treat as the medical device, and therefore what must be validated and submitted.",[2213],{"type":83,"attrs":2214},{"color":85},{"type":1557,"content":2216},[2217,2233],{"type":719,"content":2218},[2219],{"type":75,"attrs":2220,"content":2221},{"textAlign":19},[2222,2228],{"text":2223,"type":80,"marks":2224},"On-device (firmware / embedded software):",[2225,2227],{"type":83,"attrs":2226},{"color":85},{"type":99},{"text":2229,"type":80,"marks":2230}," Regulators focus on hardware-software integration and real-time device behavior. Required evidence includes firmware safety classification (IEC 62304 Class A/B/C), validation of sensor accuracy and timing constraints, defined behavior under failure conditions (sensor errors, power loss), and device-level verification through bench testing, integration testing, and hardware validation.",[2231],{"type":83,"attrs":2232},{"color":85},{"type":719,"content":2234},[2235],{"type":75,"attrs":2236,"content":2237},{"textAlign":19},[2238,2244],{"text":2239,"type":80,"marks":2240},"Cloud-side (SaMD):",[2241,2243],{"type":83,"attrs":2242},{"color":85},{"type":99},{"text":2245,"type":80,"marks":2246}," Regulators focus on algorithm performance, data processing, and software lifecycle. Required evidence includes SaMD qualification, clinical validation of algorithms (sensitivity, specificity, false positive rates), version control and change management processes, and traceability of updates and revalidation over time.",[2247],{"type":83,"attrs":2248},{"color":85},{"type":75,"attrs":2250,"content":2251},{"textAlign":19},[2252],{"text":2253,"type":80,"marks":2254},"The difference is structural. On-device logic produces a device-centric submission focused on hardware behavior and embedded software. Cloud-side logic shifts the submission toward algorithm performance, data handling, and lifecycle processes.",[2255],{"type":83,"attrs":2256},{"color":85},{"type":647,"attrs":2258,"content":2259},{"level":842,"textAlign":19},[2260],{"text":2261,"type":80,"marks":2262},"Can the system be updated after deployment?",[2263],{"type":83,"attrs":2264},{"color":85},{"type":75,"attrs":2266,"content":2267},{"textAlign":19},[2268],{"text":2269,"type":80,"marks":2270},"Regulators already assume that vulnerabilities and defects will surface after deployment. What they evaluate is whether the manufacturer can respond in a controlled way.",[2271],{"type":83,"attrs":2272},{"color":85},{"type":1557,"content":2274},[2275,2285],{"type":719,"content":2276},[2277],{"type":75,"attrs":2278,"content":2279},{"textAlign":19},[2280],{"text":2281,"type":80,"marks":2282},"Without OTA capability, updates require physical access to every device. That means slow response times, limited ability to patch vulnerabilities at scale, and potential field recalls for issues that could otherwise be resolved through software fixes.",[2283],{"type":83,"attrs":2284},{"color":85},{"type":719,"content":2286},[2287],{"type":75,"attrs":2288,"content":2289},{"textAlign":19},[2290],{"text":2291,"type":80,"marks":2292},"With OTA, regulators expect version control across the fleet, verification that updates install correctly, rollback mechanisms for failed deployments, and staged rollout across device subsets. This is now the expected standard. Without it, manufacturers cannot demonstrate post-market control.",[2293],{"type":83,"attrs":2294},{"color":85},{"type":647,"attrs":2296,"content":2297},{"level":842,"textAlign":19},[2298],{"text":2299,"type":80,"marks":2300},"How does connectivity shape failure mode evidence?",[2301],{"type":83,"attrs":2302},{"color":85},{"type":75,"attrs":2304,"content":2305},{"textAlign":19},[2306],{"text":2307,"type":80,"marks":2308},"Different connectivity architectures create different failure modes, and regulators evaluate them accordingly.",[2309],{"type":83,"attrs":2310},{"color":85},{"type":1557,"content":2312},[2313,2329],{"type":719,"content":2314},[2315],{"type":75,"attrs":2316,"content":2317},{"textAlign":19},[2318,2324],{"text":2319,"type":80,"marks":2320},"Smartphone gateway (BLE):",[2321,2323],{"type":83,"attrs":2322},{"color":85},{"type":99},{"text":2325,"type":80,"marks":2326}," Failure modes are human-dependent: the app gets closed or backgrounded, Bluetooth disconnects, data is lost or delayed. Regulators expect evidence of data buffering and sync logic, reconnection handling, and mitigation of user-dependent reliability risks.",[2327],{"type":83,"attrs":2328},{"color":85},{"type":719,"content":2330},[2331],{"type":75,"attrs":2332,"content":2333},{"textAlign":19},[2334,2340],{"text":2335,"type":80,"marks":2336},"Embedded cellular:",[2337,2339],{"type":83,"attrs":2338},{"color":85},{"type":99},{"text":2341,"type":80,"marks":2342}," Failure modes are infrastructure-dependent: network latency, packet loss, degraded signal. Regulators expect evidence of transmission reliability, end-to-end security, performance under network degradation, and uptime metrics.",[2343],{"type":83,"attrs":2344},{"color":85},{"type":647,"attrs":2346,"content":2347},{"level":842,"textAlign":19},[2348],{"text":2349,"type":80,"marks":2350},"What security evidence goes into the submission?",[2351],{"type":83,"attrs":2352},{"color":85},{"type":75,"attrs":2354,"content":2355},{"textAlign":19},[2356],{"text":2357,"type":80,"marks":2358},"Regulators evaluate whether security controls can be proven effective and maintained over time. Each decision maps to specific evidence:",[2359],{"type":83,"attrs":2360},{"color":85},{"type":1557,"content":2362},[2363,2379,2395,2411],{"type":719,"content":2364},[2365],{"type":75,"attrs":2366,"content":2367},{"textAlign":19},[2368,2374],{"text":2369,"type":80,"marks":2370},"Secure boot:",[2371,2373],{"type":83,"attrs":2372},{"color":85},{"type":99},{"text":2375,"type":80,"marks":2376}," Documentation of how firmware is signed and verified at startup, plus test results confirming unauthorized software cannot execute on the device.",[2377],{"type":83,"attrs":2378},{"color":85},{"type":719,"content":2380},[2381],{"type":75,"attrs":2382,"content":2383},{"textAlign":19},[2384,2390],{"text":2385,"type":80,"marks":2386},"Encryption:",[2387,2389],{"type":83,"attrs":2388},{"color":85},{"type":99},{"text":2391,"type":80,"marks":2392}," Specification of communication protocols (e.g., TLS), key management description, and test evidence that data cannot be intercepted or altered in transit.",[2393],{"type":83,"attrs":2394},{"color":85},{"type":719,"content":2396},[2397],{"type":75,"attrs":2398,"content":2399},{"textAlign":19},[2400,2406],{"text":2401,"type":80,"marks":2402},"Authentication:",[2403,2405],{"type":83,"attrs":2404},{"color":85},{"type":99},{"text":2407,"type":80,"marks":2408}," Description of how devices are uniquely identified (e.g., certificates), how credentials are provisioned, and how unauthorized devices are blocked.",[2409],{"type":83,"attrs":2410},{"color":85},{"type":719,"content":2412},[2413],{"type":75,"attrs":2414,"content":2415},{"textAlign":19},[2416,2422],{"text":2417,"type":80,"marks":2418},"SBOM:",[2419,2421],{"type":83,"attrs":2420},{"color":85},{"type":99},{"text":2423,"type":80,"marks":2424}," A complete inventory of all software components, including third-party libraries, demonstrating that vulnerabilities can be identified and tracked over time.",[2425],{"type":83,"attrs":2426},{"color":85},{"type":510,"attrs":2428},{"id":512,"body":2429},[2430],{"_uid":2431,"margin":677,"component":517},"i-b451f25a-f8b8-426d-bcb9-9d7c9da88f83",{"type":647,"attrs":2433,"content":2434},{"level":649,"textAlign":19},[2435],{"text":2436,"type":80,"marks":2437},"Conclusion",[2438],{"type":83,"attrs":2439},{"color":85},{"type":75,"attrs":2441,"content":2442},{"textAlign":19},[2443],{"text":2444,"type":80,"marks":2445},"To sum up:",[2446],{"type":83,"attrs":2447},{"color":85},{"type":1557,"content":2449},[2450,2460,2470,2480,2490],{"type":719,"content":2451},[2452],{"type":75,"attrs":2453,"content":2454},{"textAlign":19},[2455],{"text":2456,"type":80,"marks":2457},"IoMT software architecture determines not just how a product works, but how it is regulated and validated",[2458],{"type":83,"attrs":2459},{"color":85},{"type":719,"content":2461},[2462],{"type":75,"attrs":2463,"content":2464},{"textAlign":19},[2465],{"text":2466,"type":80,"marks":2467},"Medical device firmware and embedded software decisions define safety classification and testing scope",[2468],{"type":83,"attrs":2469},{"color":85},{"type":719,"content":2471},[2472],{"type":75,"attrs":2473,"content":2474},{"textAlign":19},[2475],{"text":2476,"type":80,"marks":2477},"Connectivity choices (e.g., BLE healthcare vs. cellular) shape risk models and regulatory expectations",[2478],{"type":83,"attrs":2479},{"color":85},{"type":719,"content":2481},[2482],{"type":75,"attrs":2483,"content":2484},{"textAlign":19},[2485],{"text":2486,"type":80,"marks":2487},"OTA updates in medical devices are now a requirement for post-market control, not an optional feature",[2488],{"type":83,"attrs":2489},{"color":85},{"type":719,"content":2491},[2492],{"type":75,"attrs":2493,"content":2494},{"textAlign":19},[2495],{"text":2496,"type":80,"marks":2497},"Device security in healthcare IoT must be designed into the system and proven through regulatory evidence",[2498],{"type":83,"attrs":2499},{"color":85},{"type":75,"attrs":2501,"content":2502},{"textAlign":19},[2503],{"text":2504,"type":80,"marks":2505},"Connected medical devices are difficult because every architectural decision carries regulatory weight. In other domains, choices about data flow, connectivity, or system behavior are primarily technical trade-offs. In healthcare, those same choices determine how the product will be classified, what evidence must be produced, and how it can evolve after deployment.",[2506],{"type":83,"attrs":2507},{"color":85},{"type":75,"attrs":2509,"content":2510},{"textAlign":19},[2511],{"text":2512,"type":80,"marks":2513},"This is why many teams encounter friction late in development. The system works as designed, yet fails to meet what regulators require. Gaps surface because the architecture was built without accounting for how it would be validated, documented, and maintained under regulatory scrutiny. By that point, resolving them means revisiting assumptions already embedded in both the architecture and the submission.",[2514],{"type":83,"attrs":2515},{"color":85},{"type":75,"attrs":2517,"content":2518},{"textAlign":19},[2519],{"text":2520,"type":80,"marks":2521},"Building a connected medical device that functions correctly and building one that can be approved are two different engineering problems. The second demands domain awareness: an understanding of how design decisions translate into safety classification, regulatory evidence, and lifecycle obligations. Teams that account for this early move faster and avoid the late-stage rework that defines the cost and timeline of most IoMT projects.",[2522],{"type":83,"attrs":2523},{"color":85},"richTextRenderer",{"_uid":2526,"items":2527,"title":2557,"component":2558},"49a3347d-a793-4c86-864f-b11526416517",[2528,2533,2537,2541,2545,2549,2553],{"_uid":2529,"title":2530,"component":2531,"description":2532},"7809de1d-7345-4c9b-93c9-f889ed331681","What is connected health device software?","FaqSectionItem","Connected health device software refers to the full system behind a medical device, including firmware, embedded software, cloud processing, and user-facing applications, all working together to collect, transmit, and analyze health data.",{"_uid":2534,"title":2535,"component":2531,"description":2536},"852e79de-307f-4ddc-9b91-6e42882c0cf1","Why is IoMT software architecture so important?","Because it defines how the system behaves under real-world conditions. In healthcare, architecture determines not just performance, but also safety classification, validation requirements, and IoMT regulatory compliance.",{"_uid":2538,"title":2539,"component":2531,"description":2540},"ffe231d0-5dfc-41f1-8ea2-0df783945562","What is the role of medical device firmware?","Medical device firmware controls the hardware directly – sensors, timing, and power. It is often the most safety-critical part of the system and is subject to strict standards like IEC 62304.",{"_uid":2542,"title":2543,"component":2531,"description":2544},"58da18bc-45c0-4fa1-adfd-921982b438b0","Is BLE suitable for healthcare devices?","BLE healthcare setups work well for wearables and patient-controlled devices, but they depend on user behavior (e.g., phone availability, Bluetooth settings). That dependency must be addressed in both system design and regulatory documentation.",{"_uid":2546,"title":2547,"component":2531,"description":2548},"b3ee6d88-60fe-4db0-9bcc-8ed3acab44bd","Why are OTA updates important in medical devices?","OTA updates in medical devices allow manufacturers to fix vulnerabilities and improve performance after deployment. Regulators now expect a clear update strategy, including version control, verification, and rollback mechanisms.",{"_uid":2550,"title":2551,"component":2531,"description":2552},"d387c544-7408-49bd-89af-07b54f6a2576","How does device security affect regulatory approval?","Device security in healthcare IoT is a core part of regulatory review. You must prove how your system protects data, prevents unauthorized access, and responds to vulnerabilities over time.",{"_uid":2554,"title":2555,"component":2531,"description":2556},"000d2e59-071f-439f-b6a8-ca2ce2ad2ebd","How do you choose the right connectivity protocol in IoMT?","There is no single best option. A healthcare IoT protocol comparison should consider the patient, environment, and clinical impact of connection loss. 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Piotr has demonstrated exceptional ability to build and scale healthcare solutions. Former President of EO Poland, part of the world's largest entrepreneur network. 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As the novelty of LLMs fades, the focus has shifted to the \"boring\" but critical work of making these systems safe, sustainable, and physically useful.",[4579],{"type":83,"attrs":4580},{"color":85},{"type":75,"attrs":4582,"content":4583},{"textAlign":19},[4584,4590],{"text":4585,"type":80,"marks":4586},"The New Default",[4587,4589],{"type":83,"attrs":4588},{"color":85},{"type":499},{"text":4591,"type":80,"marks":4592}," speaker series examines the infrastructure required to support a world where AI agents act on our behalf, and hardware finally catches up to software's intelligence.",[4593],{"type":83,"attrs":4594},{"color":85},{"type":75,"attrs":4596},{"textAlign":19},{"type":510,"attrs":4598},{"id":4599,"body":4600},"aafb9f04-4e3a-4752-9cbd-51fcc8407b65",[4601],{"_uid":4602,"quote":4603,"fontSize":4680,"component":4681,"accentColor":4682},"i-66a34f9e-9d68-4066-8acd-f8a845d7214a",{"type":72,"content":4604},[4605,4614],{"type":647,"attrs":4606,"content":4607},{"level":842,"textAlign":19},[4608],{"text":4609,"type":80,"marks":4610},"Key Takeaways:",[4611,4613],{"type":83,"attrs":4612},{"color":85},{"type":99},{"type":1557,"content":4615},[4616,4632,4648,4664],{"type":719,"content":4617},[4618],{"type":75,"attrs":4619,"content":4620},{"textAlign":19},[4621,4627],{"text":4622,"type":80,"marks":4623},"Security is the new feature.",[4624,4626],{"type":83,"attrs":4625},{"color":85},{"type":99},{"text":4628,"type":80,"marks":4629}," AI agents operating in browsers introduce \"agentic attack\" surfaces that require defensive guardrails and rigorous testing frameworks like Spikee.",[4630],{"type":83,"attrs":4631},{"color":85},{"type":719,"content":4633},[4634],{"type":75,"attrs":4635,"content":4636},{"textAlign":19},[4637,4643],{"text":4638,"type":80,"marks":4639},"Embodiment over Immersion.",[4640,4642],{"type":83,"attrs":4641},{"color":85},{"type":99},{"text":4644,"type":80,"marks":4645}," The future of AI hardware lies in \"AI glasses\" that augment reality through audio and context, rather than VR headsets that replace it.",[4646],{"type":83,"attrs":4647},{"color":85},{"type":719,"content":4649},[4650],{"type":75,"attrs":4651,"content":4652},{"textAlign":19},[4653,4659],{"text":4654,"type":80,"marks":4655},"Open Source is a Spectrum.",[4656,4658],{"type":83,"attrs":4657},{"color":85},{"type":99},{"text":4660,"type":80,"marks":4661}," Open-source AI is rarely a purely altruistic act; it is often a strategic \"national bet\" or a way to commoditize complements.",[4662],{"type":83,"attrs":4663},{"color":85},{"type":719,"content":4665},[4666],{"type":75,"attrs":4667,"content":4668},{"textAlign":19},[4669,4675],{"text":4670,"type":80,"marks":4671},"Data Sovereignty is National Security.",[4672,4674],{"type":83,"attrs":4673},{"color":85},{"type":99},{"text":4676,"type":80,"marks":4677}," AI sovereignty is becoming a core component of digital policy, moving from corporate competition to national interest.",[4678],{"type":83,"attrs":4679},{"color":85},"text-24 md:text-26","quoteBlock","purple",{"type":647,"attrs":4684},{"level":842,"textAlign":19},{"type":75,"attrs":4686,"content":4687},{"textAlign":19},[4688],{"type":682,"attrs":4689,"marks":4693},{"id":4690,"alt":92,"src":4691,"title":92,"source":92,"copyright":92,"meta_data":4692},21599167,"https://a.storyblok.com/f/202591/1200x694/ad054351ad/ai-software-development.png",{},[4694],{"type":98,"attrs":4695},{"href":4696,"uuid":19,"anchor":19,"target":691,"linktype":94},"https://www.monterail.com/services/artificial-intelligence-development-services",{"type":647,"attrs":4698,"content":4699},{"level":649,"textAlign":19},[4700],{"text":4701,"type":80,"marks":4702},"Beyond the Hype: How Security, Hardware, and Geopolitics are Shaping the Next Era of AI",[4703,4705],{"type":83,"attrs":4704},{"color":85},{"type":99},{"type":75,"attrs":4707,"content":4708},{"textAlign":19},[4709],{"text":4710,"type":80,"marks":4711},"The New Default is about the structural integrity of the systems that host the chatbots. As we move away from simple API wrappers and toward deep integration, the conversation has shifted toward the heavy lifting of engineering. We sat down with three experts who are redefining these boundaries: exploring how to secure autonomous agents that navigate the web, how to move AI out of the screen and into wearable hardware, and how the \"national bet\" on open-source models is reshaping global digital sovereignty.",[4712],{"type":83,"attrs":4713},{"color":85},{"type":75,"attrs":4715},{"textAlign":19},{"type":647,"attrs":4717,"content":4718},{"level":649,"textAlign":19},[4719],{"text":4720,"type":80,"marks":4721},"Donato Capitella: The Security Architect of Agentic AI",[4722],{"type":83,"attrs":4723},{"color":85},{"type":75,"attrs":4725,"content":4726},{"textAlign":19},[4727,4732,4738],{"text":4728,"type":80,"marks":4729},"Donato Capitella, a leading voice in AI security, focuses on the \"agentic\" shift, where AI doesn't just talk, but ",[4730],{"type":83,"attrs":4731},{"color":85},{"text":4733,"type":80,"marks":4734},"acts",[4735,4737],{"type":83,"attrs":4736},{"color":85},{"type":499},{"text":4739,"type":80,"marks":4740},". As we give LLMs the power to browse the web and execute code, we open a Pandora's box of browser-based vulnerabilities. Here are the areas Donato expanded in our talks: ",[4741],{"type":83,"attrs":4742},{"color":85},{"type":1557,"content":4744},[4745,4761,4777],{"type":719,"content":4746},[4747],{"type":75,"attrs":4748,"content":4749},{"textAlign":19},[4750,4756],{"text":4751,"type":80,"marks":4752},"LLM Guardrails as Infrastructure:",[4753,4755],{"type":83,"attrs":4754},{"color":85},{"type":99},{"text":4757,"type":80,"marks":4758}," Donato argues that guardrails shouldn't be an afterthought. They are the essential filtering layer that prevents prompt injection and ensures model outputs remain within safe operational bounds.",[4759],{"type":83,"attrs":4760},{"color":85},{"type":719,"content":4762},[4763],{"type":75,"attrs":4764,"content":4765},{"textAlign":19},[4766,4772],{"text":4767,"type":80,"marks":4768},"The Browser-Based Agentic Attack:",[4769,4771],{"type":83,"attrs":4770},{"color":85},{"type":99},{"text":4773,"type":80,"marks":4774}," He warns of a new class of threats where AI agents can be manipulated by the very websites they browse. An agent tasked with \"summarizing a page\" might be tricked by hidden text into \"deleting the user's account,\" requiring a fundamental rethink of web security.",[4775],{"type":83,"attrs":4776},{"color":85},{"type":719,"content":4778},[4779],{"type":75,"attrs":4780,"content":4781},{"textAlign":19},[4782,4788,4793,4799],{"text":4783,"type":80,"marks":4784},"Spikee: Testing for Non-Determinism:",[4785,4787],{"type":83,"attrs":4786},{"color":85},{"type":99},{"text":4789,"type":80,"marks":4790}," To solve this, Donato introduces ",[4791],{"type":83,"attrs":4792},{"color":85},{"text":4794,"type":80,"marks":4795},"Spikee",[4796,4798],{"type":83,"attrs":4797},{"color":85},{"type":99},{"text":4800,"type":80,"marks":4801},", a testing framework designed specifically for the unpredictable nature of LLMs, allowing developers to stress-test agentic workflows before they hit production.",[4802],{"type":83,"attrs":4803},{"color":85},{"type":75,"attrs":4805},{"textAlign":19},{"type":510,"attrs":4807},{"id":4808,"body":4809},"e6d2c75f-e4bd-4688-b739-7d088e28afee",[],{"type":510,"attrs":4811},{"id":4808,"body":4812},[],{"type":510,"attrs":4814},{"id":4808,"body":4815},[],{"type":510,"attrs":4817},{"id":4808,"body":4818},[],{"type":510,"attrs":4820},{"id":4599,"body":4821},[4822],{"_uid":4823,"component":4824,"videoTitle":92,"isFullWidth":22,"isAutoplayed":22,"videoTagSource":4825,"placeholderText":92,"placeholderImage":4826},"i-e48320dc-1f65-414f-9288-f6a049ca4168","embededVideoSection","https://www.youtube.com/embed/6mixCpOp3YI?si=HIgBX4wpHtIuqBiJ",[4827],{"_uid":4828,"component":470,"imageLink":4829,"imageAltText":4831,"mobileImageLink":4832,"originalImageWidth":92,"originalImageHeight":92,"originalMobileImageWidth":92,"originalMobileImageHeight":92},"ede1074c-e6e0-4f28-a2ce-48cc84743777",{"id":92,"url":4830,"linktype":473,"fieldtype":95,"cached_url":4830},"https://a.storyblok.com/f/202591/1280x720/62f326ddbc/llm-applications-guardrails-donato.png","llm applications guardrails",{"id":92,"url":92,"linktype":140,"fieldtype":95,"cached_url":92},{"type":487,"content":4834},[4835],{"type":75,"attrs":4836,"content":4837},{"textAlign":19},[4838],{"text":4839,"type":80,"marks":4840},"\"The output of the LLM is untrusted input into your system. You need to treat the output of any LLM as if it came from an untrusted source.\" ",[4841],{"type":83,"attrs":4842},{"color":85},{"type":647,"attrs":4844,"content":4845},{"level":649,"textAlign":19},[4846],{"text":4847,"type":80,"marks":4848},"Bobak Tavangar: Hardware, Software, and the Vision of Embodied AI",[4849],{"type":83,"attrs":4850},{"color":85},{"type":75,"attrs":4852,"content":4853},{"textAlign":19},[4854],{"text":4855,"type":80,"marks":4856},"Bobak Tavangar, Co-founder and CEO of Brilliant Labs, brings a contrarian perspective to the \"AI in a box\" trend. His vision centers on how AI can finally bridge the gap between digital intelligence and physical experience. Here’s what you can lear from Bobak:",[4857],{"type":83,"attrs":4858},{"color":85},{"type":1557,"content":4860},[4861,4877,4893],{"type":719,"content":4862},[4863],{"type":75,"attrs":4864,"content":4865},{"textAlign":19},[4866,4872],{"text":4867,"type":80,"marks":4868},"AI Glasses vs. VR:",[4869,4871],{"type":83,"attrs":4870},{"color":85},{"type":99},{"text":4873,"type":80,"marks":4874}," While the tech world chases high-fidelity VR graphics, Bobak makes the case for AI glasses. His argument? We don't need to be transported to another world; we need our current world to be smarter. AI glasses provide a \"heads-up\" interface where intelligence is felt through context and audio rather than just pixels.",[4875],{"type":83,"attrs":4876},{"color":85},{"type":719,"content":4878},[4879],{"type":75,"attrs":4880,"content":4881},{"textAlign":19},[4882,4888],{"text":4883,"type":80,"marks":4884},"Embodiment and Technical Architecture:",[4885,4887],{"type":83,"attrs":4886},{"color":85},{"type":99},{"text":4889,"type":80,"marks":4890}," Bobak highlights that true AI embodiment requires a tight loop between hardware and software. The \"New Default\" for hardware is a system that isn't just a peripheral but a sensory extension of the AI model itself.",[4891],{"type":83,"attrs":4892},{"color":85},{"type":719,"content":4894},[4895],{"type":75,"attrs":4896,"content":4897},{"textAlign":19},[4898,4904],{"text":4899,"type":80,"marks":4900},"Community-Driven Hardware:",[4901,4903],{"type":83,"attrs":4902},{"color":85},{"type":99},{"text":4905,"type":80,"marks":4906}," He emphasizes that the most resilient technical architectures are those built in collaboration with developer communities, advocating for open-source hardware that allows for rapid iteration and \"embodied\" experimentation.",[4907],{"type":83,"attrs":4908},{"color":85},{"type":75,"attrs":4910},{"textAlign":19},{"type":510,"attrs":4912},{"id":4808,"body":4913},[],{"type":75,"attrs":4915},{"textAlign":19},{"type":510,"attrs":4917},{"id":4808,"body":4918},[],{"type":510,"attrs":4920},{"id":4808,"body":4921},[],{"type":510,"attrs":4923},{"id":4808,"body":4924},[],{"type":510,"attrs":4926},{"id":4808,"body":4927},[],{"type":510,"attrs":4929},{"id":4808,"body":4930},[],{"type":510,"attrs":4932},{"id":4599,"body":4933},[4934],{"_uid":4935,"component":4824,"videoTitle":92,"isFullWidth":22,"isAutoplayed":22,"videoTagSource":4936,"placeholderText":92,"placeholderImage":4937},"i-90610cc7-8560-4516-a25b-2a8369ade72d","https://www.youtube.com/embed/P4qu2gvrMi4?si=tTRcpZem2notgnQn",[4938],{"_uid":4939,"component":470,"imageLink":4940,"imageAltText":4942,"mobileImageLink":4943,"originalImageWidth":92,"originalImageHeight":92,"originalMobileImageWidth":92,"originalMobileImageHeight":92},"c2db670f-9d49-4a74-8c9a-1ad3a258de1c",{"id":92,"url":4941,"linktype":473,"fieldtype":95,"cached_url":4941},"https://a.storyblok.com/f/202591/1280x720/a25c36fb8b/bobak-ai-glasses.png","AI Glasses not vr graphics",{"id":92,"url":92,"linktype":140,"fieldtype":95,"cached_url":92},{"type":487,"content":4945},[4946],{"type":75,"attrs":4947,"content":4948},{"textAlign":19},[4949],{"text":4950,"type":80,"marks":4951},"The glasses don't render new worlds. They try to understand the one you are actually in... it's sort of the best form factor for giving an AI agent a front row seat to that life.",[4952],{"type":83,"attrs":4953},{"color":85},{"type":647,"attrs":4955,"content":4956},{"level":649,"textAlign":19},[4957],{"text":4958,"type":80,"marks":4959},"Elizabeth Seger: The Geopolitics and Economics of Open AI",[4960],{"type":83,"attrs":4961},{"color":85},{"type":75,"attrs":4963,"content":4964},{"textAlign":19},[4965],{"text":4966,"type":80,"marks":4967},"Elizabeth Seger, a specialist in AI ethics and digital policy, shifts the lens toward the macro-scale. She explores why \"open source\" has become the primary battleground for AI dominance. Here are Elisabeth’s insights on the safety and economics of Open AI:",[4968],{"type":83,"attrs":4969},{"color":85},{"type":1557,"content":4971},[4972,4988,5004],{"type":719,"content":4973},[4974],{"type":75,"attrs":4975,"content":4976},{"textAlign":19},[4977,4983],{"text":4978,"type":80,"marks":4979},"The Economics of \"Free\":",[4980,4982],{"type":83,"attrs":4981},{"color":85},{"type":99},{"text":4984,"type":80,"marks":4985}," Elizabeth demystifies the open-source movement, noting that companies often open-source models to commoditize complementary products (like compute or cloud services). It is a strategic play to set the industry standard and prevent vendor lock-in by competitors.",[4986],{"type":83,"attrs":4987},{"color":85},{"type":719,"content":4989},[4990],{"type":75,"attrs":4991,"content":4992},{"textAlign":19},[4993,4999],{"text":4994,"type":80,"marks":4995},"AI Sovereignty and the National Bet:",[4996,4998],{"type":83,"attrs":4997},{"color":85},{"type":99},{"text":5000,"type":80,"marks":5001}," She introduces the concept of AI sovereignty—the idea that nations must own or control their AI infrastructure to ensure economic and security independence. For many countries, investing in open-source AI is a \"national bet\" against the hegemony of a few private tech giants.",[5002],{"type":83,"attrs":5003},{"color":85},{"type":719,"content":5005},[5006],{"type":75,"attrs":5007,"content":5008},{"textAlign":19},[5009,5015],{"text":5010,"type":80,"marks":5011},"Regulation as a Safety Floor:",[5012,5014],{"type":83,"attrs":5013},{"color":85},{"type":99},{"text":5016,"type":80,"marks":5017}," Elizabeth argues that while innovation moves fast, regulation provides the necessary safety floor. The next phase of AI development will be defined by how well we balance the \"democratization\" of open source with the \"guardrails\" required to prevent systemic risks.",[5018],{"type":83,"attrs":5019},{"color":85},{"type":75,"attrs":5021},{"textAlign":19},{"type":510,"attrs":5023},{"id":4808,"body":5024},[5025],{"_uid":5026,"component":4824,"videoTitle":92,"isFullWidth":22,"isAutoplayed":22,"videoTagSource":5027,"placeholderText":92,"placeholderImage":5028},"i-7614efb7-c17c-4378-a90d-967d50adfa3b","https://www.youtube.com/embed/9d29to37eiE?si=KjTrxkTy73mGk5bi",[5029],{"_uid":5030,"component":470,"imageLink":5031,"imageAltText":5033,"mobileImageLink":5034,"originalImageWidth":92,"originalImageHeight":92,"originalMobileImageWidth":92,"originalMobileImageHeight":92},"2d4d6a02-b156-4b86-a969-d6f6ca207817",{"id":92,"url":5032,"linktype":473,"fieldtype":95,"cached_url":5032},"https://a.storyblok.com/f/202591/1280x720/1017708619/the-economics-of-open-ai.png","the economics of open AI",{"id":92,"url":92,"linktype":140,"fieldtype":95,"cached_url":92},{"type":75,"attrs":5036},{"textAlign":19},{"type":487,"content":5038},[5039],{"type":75,"attrs":5040,"content":5041},{"textAlign":19},[5042],{"text":5043,"type":80,"marks":5044},"If there's something you develop that you really want to drive a market demand for, one way to drive that market demand is to make the compliment to that product completely free... You commoditize the compliment to the products you really want to sell.",[5045],{"type":83,"attrs":5046},{"color":85},{"type":647,"attrs":5048,"content":5049},{"level":649,"textAlign":19},[5050],{"text":5051,"type":80,"marks":5052},"Why the AI Advantage Belongs to the Architects",[5053],{"type":83,"attrs":5054},{"color":85},{"type":75,"attrs":5056,"content":5057},{"textAlign":19},[5058,5063,5069],{"text":5059,"type":80,"marks":5060},"The insights from Donato, Bobak, and Elizabeth point to a singular conclusion: the \"New Default\" isn't just about using AI; it's about ",[5061],{"type":83,"attrs":5062},{"color":85},{"text":5064,"type":80,"marks":5065},"owning the architecture",[5066,5068],{"type":83,"attrs":5067},{"color":85},{"type":99},{"text":5070,"type":80,"marks":5071},". We are moving past the era of the \"magic trick\" and into the era of the \"utility.\" The \"New Default\" dictates that the true competitive advantage no longer lies in the ability to write a clever prompt, but in the capability to architect the bedrock beneath it. ",[5072],{"type":83,"attrs":5073},{"color":85},{"type":75,"attrs":5075,"content":5076},{"textAlign":19},[5077],{"text":5078,"type":80,"marks":5079},"Whether it is securing the digital pathways of autonomous agents, weaving intelligence into the physical fabric of our daily wear, or navigating the high-stakes chess match of global AI economics, the focus has shifted from what AI can say to what it can do safely and reliably. In this new epoch, the winners won't be those who merely consume AI, but the architects who build the resilient, embodied, and sovereign systems that allow it to finally inhabit our world.",[5080],{"type":83,"attrs":5081},{"color":85},{"type":75,"attrs":5083,"content":5084},{"textAlign":19},[5085,5091,5100,5108],{"text":5086,"type":80,"marks":5087},"Explore the full interviews and deep dives at",[5088,5090],{"type":83,"attrs":5089},{"color":85},{"type":499},{"text":5092,"type":80,"marks":5093}," ",[5094,5097,5099],{"type":98,"attrs":5095},{"href":5096,"uuid":19,"anchor":19,"target":19,"linktype":94},"https://www.thenewdefault.com/",{"type":83,"attrs":5098},{"color":85},{"type":499},{"text":4585,"type":80,"marks":5101},[5102,5104,5106,5107],{"type":98,"attrs":5103},{"href":5096,"uuid":19,"anchor":19,"target":19,"linktype":94},{"type":83,"attrs":5105},{"color":556},{"type":499},{"type":558},{"text":5109,"type":80,"marks":5110},".",[5111,5113],{"type":83,"attrs":5112},{"color":85},{"type":499},{"type":510,"attrs":5115},{"id":4808,"body":5116},[5117],{"_uid":5118,"margin":645,"component":517},"i-fc427883-b8a2-40e5-ac5c-8c4cca11cb2e",[399,387,2562,381],{"type":72,"content":5121},[5122],{"type":75,"attrs":5123,"content":5124},{"textAlign":19},[5125,5127,5131,5133,5137,5139,5143],{"text":5126,"type":80},"Explore the transition from AI \"wrappers\" to resilient, world-model architectures in this expert-led deep dive. Learn how ",{"text":5128,"type":80,"marks":5129},"Donato Capitella",[5130],{"type":99},{"text":5132,"type":80}," (Security), ",{"text":5134,"type":80,"marks":5135},"Bobak Tavangar",[5136],{"type":99},{"text":5138,"type":80}," (Embodied AI), and ",{"text":5140,"type":80,"marks":5141},"Elizabeth Seger",[5142],{"type":99},{"text":5144,"type":80}," (Digital Policy) are defining the \"New Default\" through security-first engineering, wearable AI hardware, and the geopolitical shift toward AI sovereignty. Discover why the future of competitive advantage lies not in prompting, but in building the physical and secure infrastructure that allows AI to move from the chatbot window into the real world.",[5146],{"_uid":5147,"component":470,"imageLink":5148,"imageAltText":4536,"mobileImageLink":5150,"originalImageWidth":92,"originalImageHeight":92,"originalMobileImageWidth":92,"originalMobileImageHeight":92},"6497a462-5b69-4cfa-890d-a74dec4b38ac",{"id":92,"url":5149,"linktype":473,"fieldtype":95,"cached_url":5149},"https://a.storyblok.com/f/202591/2496x1696/6982f391f4/who-s-defining-the-new-default-speakers-highlights.png",{"id":92,"url":92,"linktype":140,"fieldtype":95,"cached_url":92},[],"who-s-defining-the-new-default-speakers-highlights-part-5","blog/who-s-defining-the-new-default-speakers-highlights-part-5",-7330,[],"782ce54b-5b59-4508-8e23-876950187ab7",[],{"name":5159,"created_at":5160,"published_at":5161,"updated_at":5162,"id":5163,"uuid":5164,"content":5165,"slug":7438,"full_slug":7439,"sort_by_date":19,"position":7440,"tag_list":7441,"is_startpage":22,"parent_id":2579,"meta_data":19,"group_id":7442,"first_published_at":5161,"release_id":19,"lang":26,"path":19,"alternates":7443,"default_full_slug":19,"translated_slugs":19},"How To Create a Product Redesign Scope Template (with templates and examples)","2026-04-14T17:58:51.917Z","2026-04-14T18:06:41.810Z","2026-04-14T18:06:41.839Z",165887721170367,"886c7620-b208-4a0d-afa9-a809dede4503",{"seo":5166,"_uid":5177,"title":5159,"Subtitle":5178,"authorId":5179,"postBody":5180,"component":2559,"categoryIds":7426,"postSummary":7429,"featuredImage":7432,"secondAuthorId":92,"pressDescription":92,"replaceRelatedPosts":7437},[5167],{"_uid":5168,"image":5169,"title":5159,"noIndex":22,"component":476,"description":5176,"canonicalUrl":92},"531da741-6ae5-4022-8fc4-100735ed4f46",[5170],{"_uid":5171,"component":470,"imageLink":5172,"imageAltText":5174,"mobileImageLink":5175,"originalImageWidth":92,"originalImageHeight":92,"originalMobileImageWidth":92,"originalMobileImageHeight":92},"b65e9518-35e4-4472-ba70-ea3fbdf707f5",{"id":92,"url":5173,"linktype":473,"fieldtype":95,"cached_url":5173},"https://a.storyblok.com/f/202591/2482x1696/c6ea32a40a/gemini_generated_image_rfi7gsrfi7gsrfi7.png","Abstract image representing the concept of a redesign project scope document.",{"id":92,"url":92,"linktype":140,"fieldtype":95,"cached_url":92},"A product redesign scope template defines the boundaries, goals, deliverables, and success metrics for a redesign project. ","e483019a-fc60-44e9-ba4a-203f148c99e4",[],"de23d188-a323-4cf3-b0b5-d083b10d094a",[5181],{"_uid":5182,"content":5183,"component":2524},"5a4c76bf-ca6d-4180-bed8-3faf3c4e55b1",{"type":72,"content":5184},[5185,5203,5211,5219,5241,5247,5255,5263,5313,5335,5376,5381,5389,5397,5405,5413,5421,5443,5451,5459,5467,5489,5497,5519,5524,5532,5540,5548,5556,5606,5625,5633,5641,5649,5726,5746,5754,5762,5771,5803,5838,5846,5865,5874,5906,5915,5947,5955,5990,5998,6006,6020,6034,6055,6063,6071,6121,6142,6150,6158,6224,6232,6240,6431,6439,6447,6455,6521,6526,6534,6542,6719,6727,6762,6767,6775,6783,6791,6869,6877,6897,6905,6945,6953,7031,7036,7044,7052,7073,7081,7102,7110,7131,7139,7160,7168,7176,7184,7192,7197,7205],{"type":487,"content":5186},[5187],{"type":75,"attrs":5188,"content":5189},{"textAlign":19},[5190,5197],{"text":5191,"type":80,"marks":5192},"TL;DR: ",[5193,5195,5196],{"type":83,"attrs":5194},{"color":85},{"type":99},{"type":499},{"text":5198,"type":80,"marks":5199},"A product redesign scope template defines the boundaries, goals, deliverables, and success metrics for a redesign project. It keeps teams focused, prevents scope creep, and gives stakeholders the context they need to say \"yes.\" Key sections include: project background, objectives, in-scope and out-of-scope features, deliverables, timeline, risks, and success metrics. ",[5200,5202],{"type":83,"attrs":5201},{"color":85},{"type":499},{"type":75,"attrs":5204,"content":5205},{"textAlign":19},[5206],{"text":5207,"type":80,"marks":5208},"Every product eventually needs a redesign. Maybe your conversion rates are slipping, users are frustrated with the navigation, or your interface just looks like it time-traveled from 2016. Whatever the reason, jumping straight into pixels and prototypes without a clear scope is one of the fastest ways to derail a redesign project.",[5209],{"type":83,"attrs":5210},{"color":85},{"type":75,"attrs":5212,"content":5213},{"textAlign":19},[5214],{"text":5215,"type":80,"marks":5216},"A product redesign scope template is the document that keeps everyone aligned on what you're redesigning, why you're redesigning it, and how you'll know when it's done. Designers and developers, stakeholders and executives, all on the same page.",[5217],{"type":83,"attrs":5218},{"color":85},{"type":75,"attrs":5220,"content":5221},{"textAlign":19},[5222,5227,5236],{"text":5223,"type":80,"marks":5224},"In this guide, we'll walk through everything that goes into a ",[5225],{"type":83,"attrs":5226},{"color":85},{"text":5228,"type":80,"marks":5229},"solid product redesign",[5230,5233,5235],{"type":98,"attrs":5231},{"href":5232,"uuid":19,"anchor":19,"target":19,"linktype":94},"https://www.monterail.com/services/product-design-services/ux-ui-design",{"type":83,"attrs":5234},{"color":556},{"type":558},{"text":5237,"type":80,"marks":5238}," scope document, share free templates you can start using today, and cover practical tips from designers who've been through large-scale redesigns.",[5239],{"type":83,"attrs":5240},{"color":85},{"type":510,"attrs":5242},{"id":5243,"body":5244},"78fadce4-8c3d-4091-8e36-01ef834c4b91",[5245],{"_uid":5246,"margin":645,"component":517},"i-575c2f67-c7db-48ee-ac68-0a55cd2ad6d4",{"type":647,"attrs":5248,"content":5249},{"level":649,"textAlign":19},[5250],{"text":5251,"type":80,"marks":5252},"What is a product redesign scope?",[5253],{"type":83,"attrs":5254},{"color":85},{"type":75,"attrs":5256,"content":5257},{"textAlign":19},[5258],{"text":5259,"type":80,"marks":5260},"A product redesign scope is a document that defines the boundaries of a redesign project. It answers three fundamental questions:",[5261],{"type":83,"attrs":5262},{"color":85},{"type":1557,"content":5264},[5265,5281,5297],{"type":719,"content":5266},[5267],{"type":75,"attrs":5268,"content":5269},{"textAlign":19},[5270,5276],{"text":5271,"type":80,"marks":5272},"What are we changing?",[5273,5275],{"type":83,"attrs":5274},{"color":85},{"type":99},{"text":5277,"type":80,"marks":5278}," Which parts of the product are being redesigned, and which are staying as they are?",[5279],{"type":83,"attrs":5280},{"color":85},{"type":719,"content":5282},[5283],{"type":75,"attrs":5284,"content":5285},{"textAlign":19},[5286,5292],{"text":5287,"type":80,"marks":5288},"Why are we changing it?",[5289,5291],{"type":83,"attrs":5290},{"color":85},{"type":99},{"text":5293,"type":80,"marks":5294}," What business problem, user pain point, or strategic goal is driving the redesign?",[5295],{"type":83,"attrs":5296},{"color":85},{"type":719,"content":5298},[5299],{"type":75,"attrs":5300,"content":5301},{"textAlign":19},[5302,5308],{"text":5303,"type":80,"marks":5304},"What does \"done\" look like?",[5305,5307],{"type":83,"attrs":5306},{"color":85},{"type":99},{"text":5309,"type":80,"marks":5310}," What are the specific deliverables, milestones, and success metrics?",[5311],{"type":83,"attrs":5312},{"color":85},{"type":75,"attrs":5314,"content":5315},{"textAlign":19},[5316,5321,5330],{"text":5317,"type":80,"marks":5318},"Think of it as a contract between ",[5319],{"type":83,"attrs":5320},{"color":85},{"text":5322,"type":80,"marks":5323},"the design team",[5324,5327,5329],{"type":98,"attrs":5325},{"href":5326,"uuid":19,"anchor":19,"target":19,"linktype":94},"https://www.monterail.com/services/product-design",{"type":83,"attrs":5328},{"color":556},{"type":558},{"text":5331,"type":80,"marks":5332}," and the rest of the organization. Without one, redesign projects tend to expand in unpredictable ways -- a homepage refresh turns into a full navigation overhaul, which turns into a design system rebuild, which turns into six months of missed deadlines and frustrated stakeholders.",[5333],{"type":83,"attrs":5334},{"color":85},{"type":75,"attrs":5336,"content":5337},{"textAlign":19},[5338,5343,5349,5354,5360,5365,5371],{"text":5339,"type":80,"marks":5340},"The scope document is sometimes called a ",[5341],{"type":83,"attrs":5342},{"color":85},{"text":5344,"type":80,"marks":5345},"product redesign brief",[5346,5348],{"type":83,"attrs":5347},{"color":85},{"type":99},{"text":5350,"type":80,"marks":5351},", a ",[5352],{"type":83,"attrs":5353},{"color":85},{"text":5355,"type":80,"marks":5356},"design scope statement",[5357,5359],{"type":83,"attrs":5358},{"color":85},{"type":99},{"text":5361,"type":80,"marks":5362},", or a ",[5363],{"type":83,"attrs":5364},{"color":85},{"text":5366,"type":80,"marks":5367},"project scope document",[5368,5370],{"type":83,"attrs":5369},{"color":85},{"type":99},{"text":5372,"type":80,"marks":5373},". The terminology varies across teams and industries, but the purpose is the same: define the work before the work begins.",[5374],{"type":83,"attrs":5375},{"color":85},{"type":510,"attrs":5377},{"id":5243,"body":5378},[5379],{"_uid":5380,"margin":645,"component":517},"i-4ed27a11-7fb1-4b52-9cf0-dab779edb190",{"type":647,"attrs":5382,"content":5383},{"level":649,"textAlign":19},[5384],{"text":5385,"type":80,"marks":5386},"Why you need a product redesign scope document",[5387],{"type":83,"attrs":5388},{"color":85},{"type":75,"attrs":5390,"content":5391},{"textAlign":19},[5392],{"text":5393,"type":80,"marks":5394},"You might be tempted to skip the scoping phase and jump straight into design. After all, the problems are obvious, right? Here's why that almost never works:",[5395],{"type":83,"attrs":5396},{"color":85},{"type":647,"attrs":5398,"content":5399},{"level":842,"textAlign":19},[5400],{"text":5401,"type":80,"marks":5402},"It prevents scope creep",[5403],{"type":83,"attrs":5404},{"color":1945},{"type":75,"attrs":5406,"content":5407},{"textAlign":19},[5408],{"text":5409,"type":80,"marks":5410},"Scope creep is the silent killer of redesign projects. Without clear boundaries, every stakeholder meeting introduces new \"nice-to-have\" features that quietly become must-haves. A well-defined scope gives you something concrete to point to when someone asks, \"Can we also redesign the settings page while we're at it?\"",[5411],{"type":83,"attrs":5412},{"color":85},{"type":647,"attrs":5414,"content":5415},{"level":842,"textAlign":19},[5416],{"text":5417,"type":80,"marks":5418},"It aligns stakeholders early",[5419],{"type":83,"attrs":5420},{"color":1945},{"type":75,"attrs":5422,"content":5423},{"textAlign":19},[5424,5429,5438],{"text":5425,"type":80,"marks":5426},"As ",[5427],{"type":83,"attrs":5428},{"color":85},{"text":5430,"type":80,"marks":5431},"Nick Babich writes on UXPlanet",[5432,5435,5437],{"type":98,"attrs":5433},{"href":5434,"uuid":19,"anchor":19,"target":19,"linktype":94},"https://uxplanet.org/product-redesign-proposal-structure-tips-0aa86aedaacf",{"type":83,"attrs":5436},{"color":556},{"type":558},{"text":5439,"type":80,"marks":5440},", \"When proposing redesign to stakeholders, you should prepare a document that will create a proper context for them and provide answers to the most common questions they likely have.\" A scope document gets everyone on the same page before a single wireframe is drawn.",[5441],{"type":83,"attrs":5442},{"color":85},{"type":647,"attrs":5444,"content":5445},{"level":842,"textAlign":19},[5446],{"text":5447,"type":80,"marks":5448},"It forces you to define success",[5449],{"type":83,"attrs":5450},{"color":1945},{"type":75,"attrs":5452,"content":5453},{"textAlign":19},[5454],{"text":5455,"type":80,"marks":5456},"Vague goals like \"improve the user experience\" or \"make it more modern\" are almost impossible to measure. A scope document requires you to define specific, measurable outcomes -- like reducing checkout abandonment by 15% or cutting support tickets related to navigation by 20%.",[5457],{"type":83,"attrs":5458},{"color":85},{"type":647,"attrs":5460,"content":5461},{"level":842,"textAlign":19},[5462],{"text":5463,"type":80,"marks":5464},"It's a negotiation tool",[5465],{"type":83,"attrs":5466},{"color":1945},{"type":75,"attrs":5468,"content":5469},{"textAlign":19},[5470,5475,5484],{"text":5471,"type":80,"marks":5472},"Project timelines proposed by executives rarely match reality. As one project management expert ",[5473],{"type":83,"attrs":5474},{"color":85},{"text":5476,"type":80,"marks":5477},"explains",[5478,5481,5483],{"type":98,"attrs":5479},{"href":5480,"uuid":19,"anchor":19,"target":19,"linktype":94},"https://www.youtube.com/watch?v=5OkIqlJFCBE",{"type":83,"attrs":5482},{"color":556},{"type":558},{"text":5485,"type":80,"marks":5486},", having a documented scope with a high-level timeline is \"an awesome negotiation tool\" that lets you push back on unrealistic deadlines with evidence rather than opinions.",[5487],{"type":83,"attrs":5488},{"color":85},{"type":647,"attrs":5490,"content":5491},{"level":842,"textAlign":19},[5492],{"text":5493,"type":80,"marks":5494},"It protects the team",[5495],{"type":83,"attrs":5496},{"color":1945},{"type":75,"attrs":5498,"content":5499},{"textAlign":19},[5500,5505,5514],{"text":5501,"type":80,"marks":5502},"Redesign projects can be politically charged. As one experienced designer ",[5503],{"type":83,"attrs":5504},{"color":85},{"text":5506,"type":80,"marks":5507},"put it on Reddit",[5508,5511,5513],{"type":98,"attrs":5509},{"href":5510,"uuid":19,"anchor":19,"target":19,"linktype":94},"https://www.reddit.com/r/UXDesign/comments/1mcpoif/how_do_you_handle_a_full_redesign_after_a_major/",{"type":83,"attrs":5512},{"color":556},{"type":558},{"text":5515,"type":80,"marks":5516},", \"People lose metaphorical limbs in these types of projects because they can be political battles dressed up as 'transformation' and/or 'modernization.' Proceed with caution, do your due diligence, invest in stakeholder management upfront.\" A written scope document is your due diligence.",[5517],{"type":83,"attrs":5518},{"color":85},{"type":510,"attrs":5520},{"id":5243,"body":5521},[5522],{"_uid":5523,"margin":645,"component":517},"i-8d894834-4a4f-42ba-ac0e-adf400145e16",{"type":647,"attrs":5525,"content":5526},{"level":649,"textAlign":19},[5527],{"text":5528,"type":80,"marks":5529},"What to include in your product redesign scope template",[5530],{"type":83,"attrs":5531},{"color":85},{"type":75,"attrs":5533,"content":5534},{"textAlign":19},[5535],{"text":5536,"type":80,"marks":5537},"A comprehensive product redesign scope document covers nine key areas. Here's what each section should contain and why it matters.",[5538],{"type":83,"attrs":5539},{"color":85},{"type":647,"attrs":5541,"content":5542},{"level":842,"textAlign":19},[5543],{"text":5544,"type":80,"marks":5545},"1. Project overview and background",[5546],{"type":83,"attrs":5547},{"color":1945},{"type":75,"attrs":5549,"content":5550},{"textAlign":19},[5551],{"text":5552,"type":80,"marks":5553},"Start with the basics: what is this project, and why does it exist?",[5554],{"type":83,"attrs":5555},{"color":85},{"type":1557,"content":5557},[5558,5574,5590],{"type":719,"content":5559},[5560],{"type":75,"attrs":5561,"content":5562},{"textAlign":19},[5563,5569],{"text":5564,"type":80,"marks":5565},"Project name",[5566,5568],{"type":83,"attrs":5567},{"color":85},{"type":99},{"text":5570,"type":80,"marks":5571}," -- Even a simple working title keeps everyone referring to the same initiative.",[5572],{"type":83,"attrs":5573},{"color":85},{"type":719,"content":5575},[5576],{"type":75,"attrs":5577,"content":5578},{"textAlign":19},[5579,5585],{"text":5580,"type":80,"marks":5581},"Project manager and product owner",[5582,5584],{"type":83,"attrs":5583},{"color":85},{"type":99},{"text":5586,"type":80,"marks":5587}," -- Who's accountable for delivery, and who owns the product decisions?",[5588],{"type":83,"attrs":5589},{"color":85},{"type":719,"content":5591},[5592],{"type":75,"attrs":5593,"content":5594},{"textAlign":19},[5595,5601],{"text":5596,"type":80,"marks":5597},"Background and rationale",[5598,5600],{"type":83,"attrs":5599},{"color":85},{"type":99},{"text":5602,"type":80,"marks":5603}," -- Why are we redesigning? Be specific. \"Low conversion rates on mobile checkout,\" \"user feedback consistently flags confusing navigation,\" or \"brand refresh following acquisition\" are all valid reasons. Avoid vague justifications like \"it's time for a refresh.\"",[5604],{"type":83,"attrs":5605},{"color":85},{"type":75,"attrs":5607,"content":5608},{"textAlign":19},[5609,5614,5620],{"text":5610,"type":80,"marks":5611},"The background section is critical because, as the project management saying goes, it lets people understand ",[5612],{"type":83,"attrs":5613},{"color":85},{"text":5615,"type":80,"marks":5616},"why they're doing what they're doing",[5617,5619],{"type":83,"attrs":5618},{"color":85},{"type":499},{"text":5621,"type":80,"marks":5622},". Without context, team members are just pushing pixels with no sense of purpose.",[5623],{"type":83,"attrs":5624},{"color":85},{"type":647,"attrs":5626,"content":5627},{"level":842,"textAlign":19},[5628],{"text":5629,"type":80,"marks":5630},"2. Current state analysis",[5631],{"type":83,"attrs":5632},{"color":1945},{"type":75,"attrs":5634,"content":5635},{"textAlign":19},[5636],{"text":5637,"type":80,"marks":5638},"Before you can fix something, you need to understand what's broken. This section is especially important when presenting to stakeholders who may not be aware of the current product's shortcomings.",[5639],{"type":83,"attrs":5640},{"color":85},{"type":75,"attrs":5642,"content":5643},{"textAlign":19},[5644],{"text":5645,"type":80,"marks":5646},"Include:",[5647],{"type":83,"attrs":5648},{"color":85},{"type":1557,"content":5650},[5651,5681,5697],{"type":719,"content":5652},[5653],{"type":75,"attrs":5654,"content":5655},{"textAlign":19},[5656,5662,5667,5676],{"text":5657,"type":80,"marks":5658},"UX audit findings",[5659,5661],{"type":83,"attrs":5660},{"color":85},{"type":99},{"text":5663,"type":80,"marks":5664}," -- Summarize insights from heuristic evaluations, usability testing, and user research. ",[5665],{"type":83,"attrs":5666},{"color":85},{"text":5668,"type":80,"marks":5669},"Maze's UX audit framework",[5670,5673,5675],{"type":98,"attrs":5671},{"href":5672,"uuid":19,"anchor":19,"target":19,"linktype":94},"https://maze.co/guides/ux-audit/",{"type":83,"attrs":5674},{"color":556},{"type":558},{"text":5677,"type":80,"marks":5678}," is a helpful starting point.",[5679],{"type":83,"attrs":5680},{"color":85},{"type":719,"content":5682},[5683],{"type":75,"attrs":5684,"content":5685},{"textAlign":19},[5686,5692],{"text":5687,"type":80,"marks":5688},"Pain points",[5689,5691],{"type":83,"attrs":5690},{"color":85},{"type":99},{"text":5693,"type":80,"marks":5694}," -- What specific friction points are users experiencing? Connect these to business impact. \"Users abandon the checkout flow at step 3\" is more persuasive than \"the checkout flow could be better.\"",[5695],{"type":83,"attrs":5696},{"color":85},{"type":719,"content":5698},[5699],{"type":75,"attrs":5700,"content":5701},{"textAlign":19},[5702,5708,5713,5721],{"text":5703,"type":80,"marks":5704},"Competitive analysis",[5705,5707],{"type":83,"attrs":5706},{"color":85},{"type":99},{"text":5709,"type":80,"marks":5710}," -- What are competitors doing differently? This is ",[5711],{"type":83,"attrs":5712},{"color":85},{"text":5714,"type":80,"marks":5715},"especially valuable",[5716,5718,5720],{"type":98,"attrs":5717},{"href":5434,"uuid":19,"anchor":19,"target":19,"linktype":94},{"type":83,"attrs":5719},{"color":556},{"type":558},{"text":5722,"type":80,"marks":5723}," if you're proposing visual design changes or new features.",[5724],{"type":83,"attrs":5725},{"color":85},{"type":75,"attrs":5727,"content":5728},{"textAlign":19},[5729,5733,5741],{"text":5425,"type":80,"marks":5730},[5731],{"type":83,"attrs":5732},{"color":85},{"text":5734,"type":80,"marks":5735},"one designer advises",[5736,5738,5740],{"type":98,"attrs":5737},{"href":5510,"uuid":19,"anchor":19,"target":19,"linktype":94},{"type":83,"attrs":5739},{"color":556},{"type":558},{"text":5742,"type":80,"marks":5743},", \"Focus on UX discovery as the first order of business. What are the key tasks for your users? What are the pain and pleasure points of the existing application? What are your key differentiators and gaps with your competitors?\"",[5744],{"type":83,"attrs":5745},{"color":85},{"type":647,"attrs":5747,"content":5748},{"level":842,"textAlign":19},[5749],{"text":5750,"type":80,"marks":5751},"3. Objectives and success metrics",[5752],{"type":83,"attrs":5753},{"color":1945},{"type":75,"attrs":5755,"content":5756},{"textAlign":19},[5757],{"text":5758,"type":80,"marks":5759},"This is where you define what success looks like, in measurable terms. Use the SMART framework (Specific, Measurable, Attainable, Relevant, Time-bound) or OKRs (Objectives and Key Results) to structure your goals.",[5760],{"type":83,"attrs":5761},{"color":85},{"type":75,"attrs":5763,"content":5764},{"textAlign":19},[5765],{"text":5766,"type":80,"marks":5767},"Examples:",[5768,5770],{"type":83,"attrs":5769},{"color":85},{"type":99},{"type":1557,"content":5772},[5773,5783,5793],{"type":719,"content":5774},[5775],{"type":75,"attrs":5776,"content":5777},{"textAlign":19},[5778],{"text":5779,"type":80,"marks":5780},"Improve checkout conversion rate by 20% within 90 days of launch",[5781],{"type":83,"attrs":5782},{"color":85},{"type":719,"content":5784},[5785],{"type":75,"attrs":5786,"content":5787},{"textAlign":19},[5788],{"text":5789,"type":80,"marks":5790},"Reduce customer support tickets related to navigation by 15% by end of Q3",[5791],{"type":83,"attrs":5792},{"color":85},{"type":719,"content":5794},[5795],{"type":75,"attrs":5796,"content":5797},{"textAlign":19},[5798],{"text":5799,"type":80,"marks":5800},"Achieve a System Usability Scale (SUS) score of 80+ in post-launch usability testing",[5801],{"type":83,"attrs":5802},{"color":85},{"type":75,"attrs":5804,"content":5805},{"textAlign":19},[5806,5811,5820,5825,5833],{"text":5807,"type":80,"marks":5808},"Google's ",[5809],{"type":83,"attrs":5810},{"color":85},{"text":5812,"type":80,"marks":5813},"HEART framework",[5814,5817,5819],{"type":98,"attrs":5815},{"href":5816,"uuid":19,"anchor":19,"target":19,"linktype":94},"https://research.google/pubs/measuring-the-user-experience-on-a-large-scale-user-centered-metrics-for-web-applications/",{"type":83,"attrs":5818},{"color":556},{"type":558},{"text":5821,"type":80,"marks":5822}," (Happiness, Engagement, Adoption, Retention, Task success) is another ",[5823],{"type":83,"attrs":5824},{"color":85},{"text":5826,"type":80,"marks":5827},"excellent tool",[5828,5830,5832],{"type":98,"attrs":5829},{"href":5434,"uuid":19,"anchor":19,"target":19,"linktype":94},{"type":83,"attrs":5831},{"color":556},{"type":558},{"text":5834,"type":80,"marks":5835}," for identifying the right metrics for your redesign.",[5836],{"type":83,"attrs":5837},{"color":85},{"type":647,"attrs":5839,"content":5840},{"level":842,"textAlign":19},[5841],{"text":5842,"type":80,"marks":5843},"4. Product scope: in-scope and out-of-scope",[5844],{"type":83,"attrs":5845},{"color":1945},{"type":75,"attrs":5847,"content":5848},{"textAlign":19},[5849,5854,5860],{"text":5850,"type":80,"marks":5851},"This is the heart of the document. Clearly define what's included in the redesign and, just as importantly, what's ",[5852],{"type":83,"attrs":5853},{"color":85},{"text":5855,"type":80,"marks":5856},"not",[5857,5859],{"type":83,"attrs":5858},{"color":85},{"type":499},{"text":5861,"type":80,"marks":5862}," included.",[5863],{"type":83,"attrs":5864},{"color":85},{"type":75,"attrs":5866,"content":5867},{"textAlign":19},[5868],{"text":5869,"type":80,"marks":5870},"In-scope examples:",[5871,5873],{"type":83,"attrs":5872},{"color":85},{"type":99},{"type":1557,"content":5875},[5876,5886,5896],{"type":719,"content":5877},[5878],{"type":75,"attrs":5879,"content":5880},{"textAlign":19},[5881],{"text":5882,"type":80,"marks":5883},"Redesigning the home page and product listing pages",[5884],{"type":83,"attrs":5885},{"color":85},{"type":719,"content":5887},[5888],{"type":75,"attrs":5889,"content":5890},{"textAlign":19},[5891],{"text":5892,"type":80,"marks":5893},"Implementing a new responsive navigation system",[5894],{"type":83,"attrs":5895},{"color":85},{"type":719,"content":5897},[5898],{"type":75,"attrs":5899,"content":5900},{"textAlign":19},[5901],{"text":5902,"type":80,"marks":5903},"Upgrading the checkout form from 4 steps to 2",[5904],{"type":83,"attrs":5905},{"color":85},{"type":75,"attrs":5907,"content":5908},{"textAlign":19},[5909],{"text":5910,"type":80,"marks":5911},"Out-of-scope examples:",[5912,5914],{"type":83,"attrs":5913},{"color":85},{"type":99},{"type":1557,"content":5916},[5917,5927,5937],{"type":719,"content":5918},[5919],{"type":75,"attrs":5920,"content":5921},{"textAlign":19},[5922],{"text":5923,"type":80,"marks":5924},"Mobile app redesign (web only for this phase)",[5925],{"type":83,"attrs":5926},{"color":85},{"type":719,"content":5928},[5929],{"type":75,"attrs":5930,"content":5931},{"textAlign":19},[5932],{"text":5933,"type":80,"marks":5934},"Backend CRM system changes",[5935],{"type":83,"attrs":5936},{"color":85},{"type":719,"content":5938},[5939],{"type":75,"attrs":5940,"content":5941},{"textAlign":19},[5942],{"text":5943,"type":80,"marks":5944},"Content migration of blog posts older than 2024",[5945],{"type":83,"attrs":5946},{"color":85},{"type":75,"attrs":5948,"content":5949},{"textAlign":19},[5950],{"text":5951,"type":80,"marks":5952},"The out-of-scope list is arguably more important than the in-scope list. It eliminates assumptions and gives you a clear reference when scope creep starts knocking. As one project management practitioner explains, \"The ins and outs become really helpful because it gives you even greater clarity with what exactly you're going to be doing and not doing, and can eliminate some assumptions.\"",[5953],{"type":83,"attrs":5954},{"color":85},{"type":75,"attrs":5956,"content":5957},{"textAlign":19},[5958,5964,5969,5975,5979,5985],{"text":5959,"type":80,"marks":5960},"Pro tip:",[5961,5963],{"type":83,"attrs":5962},{"color":85},{"type":99},{"text":5965,"type":80,"marks":5966}," It's important to distinguish between ",[5967],{"type":83,"attrs":5968},{"color":85},{"text":5970,"type":80,"marks":5971},"project scope",[5972,5974],{"type":83,"attrs":5973},{"color":85},{"type":499},{"text":560,"type":80,"marks":5976},[5977],{"type":83,"attrs":5978},{"color":85},{"text":5980,"type":80,"marks":5981},"product scope",[5982,5984],{"type":83,"attrs":5983},{"color":85},{"type":499},{"text":5986,"type":80,"marks":5987},". Project scope is the work, the meetings, design hours, and review cycles. Product scope is the functionality, the new buttons, new layouts, and new features. Your scope document should address both.",[5988],{"type":83,"attrs":5989},{"color":85},{"type":647,"attrs":5991,"content":5992},{"level":842,"textAlign":19},[5993],{"text":5994,"type":80,"marks":5995},"5. Vision and strategy",[5996],{"type":83,"attrs":5997},{"color":1945},{"type":75,"attrs":5999,"content":6000},{"textAlign":19},[6001],{"text":6002,"type":80,"marks":6003},"Include a clear, concise vision statement that answers: \"Where are we heading and why?\" This should be one or two sentences that the entire team can understand and rally behind.",[6004],{"type":83,"attrs":6005},{"color":85},{"type":75,"attrs":6007,"content":6008},{"textAlign":19},[6009,6015],{"text":6010,"type":80,"marks":6011},"Good vision statement:",[6012,6014],{"type":83,"attrs":6013},{"color":85},{"type":99},{"text":6016,"type":80,"marks":6017}," \"Redesign our checkout experience to be the fastest and most intuitive in the industry, reducing friction and building trust at every step.\"",[6018],{"type":83,"attrs":6019},{"color":85},{"type":75,"attrs":6021,"content":6022},{"textAlign":19},[6023,6029],{"text":6024,"type":80,"marks":6025},"Bad vision statement:",[6026,6028],{"type":83,"attrs":6027},{"color":85},{"type":99},{"text":6030,"type":80,"marks":6031}," \"To be the best eCommerce platform in the world.\" (Too vague, no direction.)",[6032],{"type":83,"attrs":6033},{"color":85},{"type":75,"attrs":6035,"content":6036},{"textAlign":19},[6037,6042,6050],{"text":6038,"type":80,"marks":6039},"The vision statement serves as the ",[6040],{"type":83,"attrs":6041},{"color":85},{"text":6043,"type":80,"marks":6044},"foundation for your strategy goals",[6045,6047,6049],{"type":98,"attrs":6046},{"href":5434,"uuid":19,"anchor":19,"target":19,"linktype":94},{"type":83,"attrs":6048},{"color":556},{"type":558},{"text":6051,"type":80,"marks":6052},". When tough trade-off decisions come up during the project, the vision is what helps the team decide which path to take.",[6053],{"type":83,"attrs":6054},{"color":85},{"type":647,"attrs":6056,"content":6057},{"level":842,"textAlign":19},[6058],{"text":6059,"type":80,"marks":6060},"6. Proposed solution",[6061],{"type":83,"attrs":6062},{"color":1945},{"type":75,"attrs":6064,"content":6065},{"textAlign":19},[6066],{"text":6067,"type":80,"marks":6068},"Now show stakeholders a preview of what you're building. Depending on the type of redesign, this might include:",[6069],{"type":83,"attrs":6070},{"color":85},{"type":1557,"content":6072},[6073,6089,6105],{"type":719,"content":6074},[6075],{"type":75,"attrs":6076,"content":6077},{"textAlign":19},[6078,6084],{"text":6079,"type":80,"marks":6080},"Information architecture improvements",[6081,6083],{"type":83,"attrs":6082},{"color":85},{"type":99},{"text":6085,"type":80,"marks":6086}," -- Updated sitemaps, navigation structures, and content hierarchies.",[6087],{"type":83,"attrs":6088},{"color":85},{"type":719,"content":6090},[6091],{"type":75,"attrs":6092,"content":6093},{"textAlign":19},[6094,6100],{"text":6095,"type":80,"marks":6096},"Interaction design changes",[6097,6099],{"type":83,"attrs":6098},{"color":85},{"type":99},{"text":6101,"type":80,"marks":6102}," -- New user flows, interaction patterns, and journey maps.",[6103],{"type":83,"attrs":6104},{"color":85},{"type":719,"content":6106},[6107],{"type":75,"attrs":6108,"content":6109},{"textAlign":19},[6110,6116],{"text":6111,"type":80,"marks":6112},"Visual design direction",[6113,6115],{"type":83,"attrs":6114},{"color":85},{"type":99},{"text":6117,"type":80,"marks":6118}," -- Color schemes, typography, imagery, and overall aesthetic.",[6119],{"type":83,"attrs":6120},{"color":85},{"type":75,"attrs":6122,"content":6123},{"textAlign":19},[6124,6129,6137],{"text":6125,"type":80,"marks":6126},"One important note from ",[6127],{"type":83,"attrs":6128},{"color":85},{"text":6130,"type":80,"marks":6131},"UXPlanet",[6132,6134,6136],{"type":98,"attrs":6133},{"href":5434,"uuid":19,"anchor":19,"target":19,"linktype":94},{"type":83,"attrs":6135},{"color":556},{"type":558},{"text":6138,"type":80,"marks":6139},": \"When communicating new designs to stakeholders, try to avoid using low-fidelity wireframes because wireframes can easily create an impression of unfinished design. Not all stakeholders understand how grey boxes and arrows will translate into pixel-perfect design.\" Use high-fidelity mockups whenever possible.",[6140],{"type":83,"attrs":6141},{"color":85},{"type":647,"attrs":6143,"content":6144},{"level":842,"textAlign":19},[6145],{"text":6146,"type":80,"marks":6147},"7. Key deliverables",[6148],{"type":83,"attrs":6149},{"color":1945},{"type":75,"attrs":6151,"content":6152},{"textAlign":19},[6153],{"text":6154,"type":80,"marks":6155},"Be explicit about what the project will produce. Typical deliverables include:",[6156],{"type":83,"attrs":6157},{"color":85},{"type":1557,"content":6159},[6160,6176,6192,6208],{"type":719,"content":6161},[6162],{"type":75,"attrs":6163,"content":6164},{"textAlign":19},[6165,6171],{"text":6166,"type":80,"marks":6167},"Research and discovery:",[6168,6170],{"type":83,"attrs":6169},{"color":85},{"type":99},{"text":6172,"type":80,"marks":6173}," User journey maps, competitive audit, stakeholder interview report",[6174],{"type":83,"attrs":6175},{"color":85},{"type":719,"content":6177},[6178],{"type":75,"attrs":6179,"content":6180},{"textAlign":19},[6181,6187],{"text":6182,"type":80,"marks":6183},"Design assets:",[6184,6186],{"type":83,"attrs":6185},{"color":85},{"type":99},{"text":6188,"type":80,"marks":6189}," Wireframes, high-fidelity UI mockups, interactive prototypes, updated design system components",[6190],{"type":83,"attrs":6191},{"color":85},{"type":719,"content":6193},[6194],{"type":75,"attrs":6195,"content":6196},{"textAlign":19},[6197,6203],{"text":6198,"type":80,"marks":6199},"Development and technical:",[6200,6202],{"type":83,"attrs":6201},{"color":85},{"type":99},{"text":6204,"type":80,"marks":6205}," Front-end code, API integrations, QA test results",[6206],{"type":83,"attrs":6207},{"color":85},{"type":719,"content":6209},[6210],{"type":75,"attrs":6211,"content":6212},{"textAlign":19},[6213,6219],{"text":6214,"type":80,"marks":6215},"Documentation:",[6216,6218],{"type":83,"attrs":6217},{"color":85},{"type":99},{"text":6220,"type":80,"marks":6221}," Design specifications for engineers, updated style guide",[6222],{"type":83,"attrs":6223},{"color":85},{"type":647,"attrs":6225,"content":6226},{"level":842,"textAlign":19},[6227],{"text":6228,"type":80,"marks":6229},"8. Timeline and milestones",[6230],{"type":83,"attrs":6231},{"color":1945},{"type":75,"attrs":6233,"content":6234},{"textAlign":19},[6235],{"text":6236,"type":80,"marks":6237},"Map out the major phases and dates:",[6238],{"type":83,"attrs":6239},{"color":85},{"type":1134,"content":6241},[6242,6269,6293,6316,6339,6362,6385,6408],{"type":1137,"content":6243},[6244,6257],{"type":6245,"attrs":6246,"content":6247},"tableHeader",{"colspan":716,"rowspan":716,"colwidth":19},[6248],{"type":75,"attrs":6249,"content":6250},{"textAlign":19},[6251],{"text":6252,"type":80,"marks":6253},"Milestone",[6254,6256],{"type":83,"attrs":6255},{"color":85},{"type":99},{"type":6245,"attrs":6258,"content":6259},{"colspan":716,"rowspan":716,"colwidth":19},[6260],{"type":75,"attrs":6261,"content":6262},{"textAlign":19},[6263],{"text":6264,"type":80,"marks":6265},"Target 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The detailed project plan comes later. The purpose here is to set expectations and give stakeholders a realistic picture of the timeline, which often differs significantly from what executives initially expect.",[6437],{"type":83,"attrs":6438},{"color":85},{"type":647,"attrs":6440,"content":6441},{"level":842,"textAlign":19},[6442],{"text":6443,"type":80,"marks":6444},"9. Risks, assumptions, and approvals",[6445],{"type":83,"attrs":6446},{"color":1945},{"type":75,"attrs":6448,"content":6449},{"textAlign":19},[6450],{"text":6451,"type":80,"marks":6452},"Round out the document with:",[6453],{"type":83,"attrs":6454},{"color":85},{"type":1557,"content":6456},[6457,6473,6489,6505],{"type":719,"content":6458},[6459],{"type":75,"attrs":6460,"content":6461},{"textAlign":19},[6462,6468],{"text":6463,"type":80,"marks":6464},"Assumptions",[6465,6467],{"type":83,"attrs":6466},{"color":85},{"type":99},{"text":6469,"type":80,"marks":6470}," -- Things you're taking for granted that could change. Example: \"The current API will support the new frontend framework.\"",[6471],{"type":83,"attrs":6472},{"color":85},{"type":719,"content":6474},[6475],{"type":75,"attrs":6476,"content":6477},{"textAlign":19},[6478,6484],{"text":6479,"type":80,"marks":6480},"Risks and mitigations",[6481,6483],{"type":83,"attrs":6482},{"color":85},{"type":99},{"text":6485,"type":80,"marks":6486}," -- What could go wrong, and what's your plan? Example: Risk: \"User resistance to the new design.\" Mitigation: \"A/B test with a small user group before full rollout.\"",[6487],{"type":83,"attrs":6488},{"color":85},{"type":719,"content":6490},[6491],{"type":75,"attrs":6492,"content":6493},{"textAlign":19},[6494,6500],{"text":6495,"type":80,"marks":6496},"Constraints",[6497,6499],{"type":83,"attrs":6498},{"color":85},{"type":99},{"text":6501,"type":80,"marks":6502}," -- Hard limits like budget, compliance requirements (GDPR, accessibility standards), or technology restrictions.",[6503],{"type":83,"attrs":6504},{"color":85},{"type":719,"content":6506},[6507],{"type":75,"attrs":6508,"content":6509},{"textAlign":19},[6510,6516],{"text":6511,"type":80,"marks":6512},"Approvals",[6513,6515],{"type":83,"attrs":6514},{"color":85},{"type":99},{"text":6517,"type":80,"marks":6518}," -- List the stakeholders who need to sign off before work begins.",[6519],{"type":83,"attrs":6520},{"color":85},{"type":510,"attrs":6522},{"id":5243,"body":6523},[6524],{"_uid":6525,"margin":645,"component":517},"i-0d90444e-ec88-4096-952f-6747d338d33a",{"type":647,"attrs":6527,"content":6528},{"level":649,"textAlign":19},[6529],{"text":6530,"type":80,"marks":6531},"Product redesign scope VS product redesign brief: what's the difference?",[6532],{"type":83,"attrs":6533},{"color":85},{"type":75,"attrs":6535,"content":6536},{"textAlign":19},[6537],{"text":6538,"type":80,"marks":6539},"You'll often see the terms \"redesign scope\" and \"redesign brief\" used interchangeably. While they overlap significantly, there's a subtle distinction worth noting:",[6540],{"type":83,"attrs":6541},{"color":85},{"type":1134,"content":6543},[6544,6575,6611,6647,6683],{"type":1137,"content":6545},[6546,6551,6563],{"type":6245,"attrs":6547,"content":6548},{"colspan":716,"rowspan":716,"colwidth":19},[6549],{"type":75,"attrs":6550},{"textAlign":19},{"type":6245,"attrs":6552,"content":6553},{"colspan":716,"rowspan":716,"colwidth":19},[6554],{"type":75,"attrs":6555,"content":6556},{"textAlign":19},[6557],{"text":6558,"type":80,"marks":6559},"Product redesign scope",[6560,6562],{"type":83,"attrs":6561},{"color":85},{"type":99},{"type":6245,"attrs":6564,"content":6565},{"colspan":716,"rowspan":716,"colwidth":19},[6566],{"type":75,"attrs":6567,"content":6568},{"textAlign":19},[6569],{"text":6570,"type":80,"marks":6571},"Product redesign brief",[6572,6574],{"type":83,"attrs":6573},{"color":85},{"type":99},{"type":1137,"content":6576},[6577,6589,6600],{"type":1140,"attrs":6578,"content":6579},{"colspan":716,"rowspan":716,"colwidth":19,"backgroundColor":19},[6580],{"type":75,"attrs":6581,"content":6582},{"textAlign":19},[6583],{"text":6584,"type":80,"marks":6585},"Primary audience",[6586,6588],{"type":83,"attrs":6587},{"color":85},{"type":99},{"type":1140,"attrs":6590,"content":6591},{"colspan":716,"rowspan":716,"colwidth":19,"backgroundColor":19},[6592],{"type":75,"attrs":6593,"content":6594},{"textAlign":19},[6595],{"text":6596,"type":80,"marks":6597},"Project team and stakeholders",[6598],{"type":83,"attrs":6599},{"color":85},{"type":1140,"attrs":6601,"content":6602},{"colspan":716,"rowspan":716,"colwidth":19,"backgroundColor":19},[6603],{"type":75,"attrs":6604,"content":6605},{"textAlign":19},[6606],{"text":6607,"type":80,"marks":6608},"Design team (sometimes external agencies)",[6609],{"type":83,"attrs":6610},{"color":85},{"type":1137,"content":6612},[6613,6625,6636],{"type":1140,"attrs":6614,"content":6615},{"colspan":716,"rowspan":716,"colwidth":19,"backgroundColor":19},[6616],{"type":75,"attrs":6617,"content":6618},{"textAlign":19},[6619],{"text":6620,"type":80,"marks":6621},"Focus",[6622,6624],{"type":83,"attrs":6623},{"color":85},{"type":99},{"type":1140,"attrs":6626,"content":6627},{"colspan":716,"rowspan":716,"colwidth":19,"backgroundColor":19},[6628],{"type":75,"attrs":6629,"content":6630},{"textAlign":19},[6631],{"text":6632,"type":80,"marks":6633},"Boundaries, constraints, and success criteria",[6634],{"type":83,"attrs":6635},{"color":85},{"type":1140,"attrs":6637,"content":6638},{"colspan":716,"rowspan":716,"colwidth":19,"backgroundColor":19},[6639],{"type":75,"attrs":6640,"content":6641},{"textAlign":19},[6642],{"text":6643,"type":80,"marks":6644},"Creative direction, brand context, and design goals",[6645],{"type":83,"attrs":6646},{"color":85},{"type":1137,"content":6648},[6649,6661,6672],{"type":1140,"attrs":6650,"content":6651},{"colspan":716,"rowspan":716,"colwidth":19,"backgroundColor":19},[6652],{"type":75,"attrs":6653,"content":6654},{"textAlign":19},[6655],{"text":6656,"type":80,"marks":6657},"Includes",[6658,6660],{"type":83,"attrs":6659},{"color":85},{"type":99},{"type":1140,"attrs":6662,"content":6663},{"colspan":716,"rowspan":716,"colwidth":19,"backgroundColor":19},[6664],{"type":75,"attrs":6665,"content":6666},{"textAlign":19},[6667],{"text":6668,"type":80,"marks":6669},"In/out of scope, timeline, risks, KPIs",[6670],{"type":83,"attrs":6671},{"color":85},{"type":1140,"attrs":6673,"content":6674},{"colspan":716,"rowspan":716,"colwidth":19,"backgroundColor":19},[6675],{"type":75,"attrs":6676,"content":6677},{"textAlign":19},[6678],{"text":6679,"type":80,"marks":6680},"Target audience profiles, visual references, tone of voice",[6681],{"type":83,"attrs":6682},{"color":85},{"type":1137,"content":6684},[6685,6697,6708],{"type":1140,"attrs":6686,"content":6687},{"colspan":716,"rowspan":716,"colwidth":19,"backgroundColor":19},[6688],{"type":75,"attrs":6689,"content":6690},{"textAlign":19},[6691],{"text":6692,"type":80,"marks":6693},"Purpose",[6694,6696],{"type":83,"attrs":6695},{"color":85},{"type":99},{"type":1140,"attrs":6698,"content":6699},{"colspan":716,"rowspan":716,"colwidth":19,"backgroundColor":19},[6700],{"type":75,"attrs":6701,"content":6702},{"textAlign":19},[6703],{"text":6704,"type":80,"marks":6705},"Define what will and won't be done",[6706],{"type":83,"attrs":6707},{"color":85},{"type":1140,"attrs":6709,"content":6710},{"colspan":716,"rowspan":716,"colwidth":19,"backgroundColor":19},[6711],{"type":75,"attrs":6712,"content":6713},{"textAlign":19},[6714],{"text":6715,"type":80,"marks":6716},"Inspire and guide the design direction",[6717],{"type":83,"attrs":6718},{"color":85},{"type":75,"attrs":6720,"content":6721},{"textAlign":19},[6722],{"text":6723,"type":80,"marks":6724},"In practice, many teams combine both into a single document. If you're working with an external design agency, you'll likely need a more detailed brief. If the redesign is handled in-house, a comprehensive scope document usually covers everything you need.",[6725],{"type":83,"attrs":6726},{"color":85},{"type":75,"attrs":6728,"content":6729},{"textAlign":19},[6730,6735,6744,6748,6757],{"text":6731,"type":80,"marks":6732},"For more on writing effective design briefs, ",[6733],{"type":83,"attrs":6734},{"color":85},{"text":6736,"type":80,"marks":6737},"Eleken's guide to creating a design brief",[6738,6741,6743],{"type":98,"attrs":6739},{"href":6740,"uuid":19,"anchor":19,"target":19,"linktype":94},"https://www.eleken.co/blog-posts/design-brief-example-how-it-should-look-like-and-what-it-should-contain",{"type":83,"attrs":6742},{"color":556},{"type":558},{"text":560,"type":80,"marks":6745},[6746],{"type":83,"attrs":6747},{"color":85},{"text":6749,"type":80,"marks":6750},"UXPin's design brief guide",[6751,6754,6756],{"type":98,"attrs":6752},{"href":6753,"uuid":19,"anchor":19,"target":19,"linktype":94},"https://www.uxpin.com/studio/blog/design-brief/",{"type":83,"attrs":6755},{"color":556},{"type":558},{"text":6758,"type":80,"marks":6759}," are both excellent resources.",[6760],{"type":83,"attrs":6761},{"color":85},{"type":510,"attrs":6763},{"id":5243,"body":6764},[6765],{"_uid":6766,"margin":645,"component":517},"i-fe4fa7f7-4c01-4898-a1c0-b84216dac8b3",{"type":647,"attrs":6768,"content":6769},{"level":649,"textAlign":19},[6770],{"text":6771,"type":80,"marks":6772},"Free product redesign scope templates you can use today",[6773],{"type":83,"attrs":6774},{"color":85},{"type":75,"attrs":6776,"content":6777},{"textAlign":19},[6778],{"text":6779,"type":80,"marks":6780},"You don't have to start from scratch. 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managers.",[6924],{"type":83,"attrs":6925},{"color":85},{"type":719,"content":6927},[6928],{"type":75,"attrs":6929,"content":6930},{"textAlign":19},[6931,6940],{"text":6932,"type":80,"marks":6933},"Project proposal template for designers",[6934,6937,6939],{"type":98,"attrs":6935},{"href":6936,"uuid":19,"anchor":19,"target":19,"linktype":94},"https://www.notion.com/templates/projectproposal",{"type":83,"attrs":6938},{"color":556},{"type":558},{"text":6941,"type":80,"marks":6942}," -- A structured proposal template with sections that map well to redesign scoping.",[6943],{"type":83,"attrs":6944},{"color":85},{"type":647,"attrs":6946,"content":6947},{"level":842,"textAlign":19},[6948],{"text":6949,"type":80,"marks":6950},"Other tools",[6951],{"type":83,"attrs":6952},{"color":1945},{"type":1557,"content":6954},[6955,6974,6993,7012],{"type":719,"content":6956},[6957],{"type":75,"attrs":6958,"content":6959},{"textAlign":19},[6960,6969],{"text":6961,"type":80,"marks":6962},"Project scope 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detail.",[6991],{"type":83,"attrs":6992},{"color":85},{"type":719,"content":6994},[6995],{"type":75,"attrs":6996,"content":6997},{"textAlign":19},[6998,7007],{"text":6999,"type":80,"marks":7000},"Website redesign scope of work template",[7001,7004,7006],{"type":98,"attrs":7002},{"href":7003,"uuid":19,"anchor":19,"target":19,"linktype":94},"https://www.wethos.co/scope-of-work-templates/website-redesign",{"type":83,"attrs":7005},{"color":556},{"type":558},{"text":7008,"type":80,"marks":7009}," -- Specifically tailored to website redesign projects, from Wethos.",[7010],{"type":83,"attrs":7011},{"color":85},{"type":719,"content":7013},[7014],{"type":75,"attrs":7015,"content":7016},{"textAlign":19},[7017,7026],{"text":7018,"type":80,"marks":7019},"Product brief 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Resist that urge. As one ",[7058],{"type":83,"attrs":7059},{"color":85},{"text":7061,"type":80,"marks":7062},"experienced designer on Reddit",[7063,7065,7067],{"type":98,"attrs":7064},{"href":5510,"uuid":19,"anchor":19,"target":19,"linktype":94},{"type":83,"attrs":7066},{"color":556},{"type":558},{"text":7069,"type":80,"marks":7070}," advises, \"Focus on UX discovery as the first order of business... Only once these questions are answered can you really start to develop any grounded visual, interaction, or information design concepts.\"",[7071],{"type":83,"attrs":7072},{"color":85},{"type":647,"attrs":7074,"content":7075},{"level":842,"textAlign":19},[7076],{"text":7077,"type":80,"marks":7078},"Don't build the design system first",[7079],{"type":83,"attrs":7080},{"color":1945},{"type":75,"attrs":7082,"content":7083},{"textAlign":19},[7084,7089,7097],{"text":7085,"type":80,"marks":7086},"When tackling a full redesign, teams often want to start by creating a comprehensive design system. This can be a trap. As ",[7087],{"type":83,"attrs":7088},{"color":85},{"text":7090,"type":80,"marks":7091},"another practitioner warns",[7092,7094,7096],{"type":98,"attrs":7093},{"href":5510,"uuid":19,"anchor":19,"target":19,"linktype":94},{"type":83,"attrs":7095},{"color":556},{"type":558},{"text":7098,"type":80,"marks":7099},", \"One of the biggest mistakes people make is starting with a design system and then 3 months later there's a detailed system but no product. Build out a system as you work on core flows.\"",[7100],{"type":83,"attrs":7101},{"color":85},{"type":647,"attrs":7103,"content":7104},{"level":842,"textAlign":19},[7105],{"text":7106,"type":80,"marks":7107},"Prioritize key flows over comprehensive coverage",[7108],{"type":83,"attrs":7109},{"color":1945},{"type":75,"attrs":7111,"content":7112},{"textAlign":19},[7113,7118,7126],{"text":7114,"type":80,"marks":7115},"You can't redesign everything at once. Start with the flows that have the biggest impact on users and the business. A ",[7116],{"type":83,"attrs":7117},{"color":85},{"text":7119,"type":80,"marks":7120},"common approach",[7121,7123,7125],{"type":98,"attrs":7122},{"href":5510,"uuid":19,"anchor":19,"target":19,"linktype":94},{"type":83,"attrs":7124},{"color":556},{"type":558},{"text":7127,"type":80,"marks":7128}," is to \"target key pain points and important flows first to establish the baseline of your system, and then apply it more broadly.\"",[7129],{"type":83,"attrs":7130},{"color":85},{"type":647,"attrs":7132,"content":7133},{"level":842,"textAlign":19},[7134],{"text":7135,"type":80,"marks":7136},"Include a usability testing plan",[7137],{"type":83,"attrs":7138},{"color":1945},{"type":75,"attrs":7140,"content":7141},{"textAlign":19},[7142,7147,7155],{"text":7143,"type":80,"marks":7144},"Stakeholders will inevitably ask, \"How do you know this new design will work better?\" Pre-empt this by including a testing plan in your scope. As ",[7145],{"type":83,"attrs":7146},{"color":85},{"text":7148,"type":80,"marks":7149},"UXPlanet advises",[7150,7152,7154],{"type":98,"attrs":7151},{"href":5434,"uuid":19,"anchor":19,"target":19,"linktype":94},{"type":83,"attrs":7153},{"color":556},{"type":558},{"text":7156,"type":80,"marks":7157},", outline the usability testing methods you'll use, the metrics you'll measure, and how you'll incorporate feedback into iterative improvements.",[7158],{"type":83,"attrs":7159},{"color":85},{"type":647,"attrs":7161,"content":7162},{"level":842,"textAlign":19},[7163],{"text":7164,"type":80,"marks":7165},"Invest in stakeholder management",[7166],{"type":83,"attrs":7167},{"color":1945},{"type":75,"attrs":7169,"content":7170},{"textAlign":19},[7171],{"text":7172,"type":80,"marks":7173},"Don't underestimate the political dimension of redesign projects. Get buy-in early and often. Your scope document is one of the most powerful tools for this -- it shows stakeholders that you've thought through the problem, have a clear plan, and understand the constraints.",[7174],{"type":83,"attrs":7175},{"color":85},{"type":647,"attrs":7177,"content":7178},{"level":842,"textAlign":19},[7179],{"text":7180,"type":80,"marks":7181},"Write for your audience",[7182],{"type":83,"attrs":7183},{"color":1945},{"type":75,"attrs":7185,"content":7186},{"textAlign":19},[7187],{"text":7188,"type":80,"marks":7189},"If your scope document is going to executives, lead with business impact and keep design jargon to a minimum. If it's for your design and engineering team, get technical. 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It's the single most important document for keeping a redesign on track.",[7226],{"type":83,"attrs":7227},{"color":85},{"type":719,"content":7229},[7230],{"type":75,"attrs":7231,"content":7232},{"textAlign":19},[7233,7238,7244],{"text":7234,"type":80,"marks":7235},"Always include ",[7236],{"type":83,"attrs":7237},{"color":85},{"text":7239,"type":80,"marks":7240},"what's in scope and out of scope",[7241,7243],{"type":83,"attrs":7242},{"color":85},{"type":99},{"text":7245,"type":80,"marks":7246},". 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