{"id":8869,"date":"2021-03-11T15:30:29","date_gmt":"2021-03-11T15:30:29","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=8869"},"modified":"2023-04-10T12:35:42","modified_gmt":"2023-04-10T12:35:42","slug":"medical-device-design-the-essential-step-by-step-guide","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/medical-device-design-the-essential-step-by-step-guide\/","title":{"rendered":"Medical Device Design: The Essential, Step-by-Step Guide"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_45_1 counter-flat ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" area-label=\"ez-toc-toggle-icon-1\"><label for=\"item-69f186b92b46c\" aria-label=\"Table of Content\"><span style=\"display: flex;align-items: center;width: 35px;height: 30px;justify-content: center;direction:ltr;\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/label><input  type=\"checkbox\" id=\"item-69f186b92b46c\"><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-design-the-essential-step-by-step-guide\/#Medical_Device_Design_IEC_ISO_regulations_and_compliance\" title=\"Medical Device Design: IEC &amp; ISO regulations and compliance\">Medical Device Design: IEC &amp; ISO regulations and compliance<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-design-the-essential-step-by-step-guide\/#Medical_Device_Design_ISO_Standards\" title=\"Medical Device Design: ISO Standards\">Medical Device Design: ISO Standards<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-design-the-essential-step-by-step-guide\/#Medical_Device_Regulations_and_Design_Control\" title=\"Medical Device Regulations and Design Control\u00a0\">Medical Device Regulations and Design Control\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-design-the-essential-step-by-step-guide\/#Medical_Device_Design_Why_Traceability_is_Important\" title=\"Medical Device Design: Why Traceability is Important\u00a0\">Medical Device Design: Why Traceability is Important\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-design-the-essential-step-by-step-guide\/#Medical_Device_Design_Verification_and_Validation\" title=\"Medical Device Design: Verification and Validation\">Medical Device Design: Verification and Validation<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-design-the-essential-step-by-step-guide\/#Medical_Device_Design_Risk_Management\" title=\"Medical Device Design: Risk Management\">Medical Device Design: Risk Management<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-design-the-essential-step-by-step-guide\/#Risk_migration_strategy_vs_Risk_management_plan\" title=\" Risk migration strategy vs. Risk management plan\"> Risk migration strategy vs. Risk management plan<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-design-the-essential-step-by-step-guide\/#Conclusion\" title=\"Conclusion\">Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<p><em><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/shrinidh-joshi\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDDesign\">Shrinidh Joshi<\/a>, <a href=\"https:\/\/www.kolabtree.com\/industry\/medical-device\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDDesign\">medical device expert<\/a>\u00a0on Kolabtree, provides a comprehensive guide to <a href=\"https:\/\/www.kolabtree.com\/blog\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">medical device<\/a> design, design controls, validation &amp; verification, regulatory requirements and risk management.\u00a0 \u00a0<\/em><\/p>\n<p>In the <a href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-development-3-tips-for-success\/\">previous article<\/a>, we took a look at the overview of the medical device development process from the ideation to the discovery phase. In this article, we will focus more on <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device-design\" target=\"_blank\" rel=\"noopener\">medical device design<\/a>, design controls, and compliance.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Medical_Device_Design_IEC_ISO_regulations_and_compliance\"><\/span><b>Medical Device Design: IEC &amp; ISO regulations and compliance<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">By now you know that for market entry your medical device needs to qualify certain regulatory requirements and standards. Medical device standards such as the International Electrotechnical Commission (IEC) or the International Organization for Standardization (ISO) allow medical device manufacturers, designers, laboratories and all other medical device development service providers such as CDMO to inspect, assess and maintain their devices and equipment to certain quality and usability standards.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The (IEC published the first of its kind medical devices standard in 1970,<\/span><a href=\"https:\/\/webstore.iec.ch\/publication\/22261\"> <span style=\"font-weight: 400;\">IEC 60601<\/span><\/a><span style=\"font-weight: 400;\">-1. IEC 60601-1, Medical electrical equipment \u2013 Part 1: This is the internationally recognized standard that addresses general requirements for medical electrical equipment and devices covering standards for basic safety and essential performance <\/span><b>[4]<\/b><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The IEC 60601-1 document has been revised periodically to stay in alignment with the latest medical development and technological breakthroughs in the medical device field. Most recent change came into fruition in 2012 (Amendment 1 to IEC 60601-1). This revised standards contains the requirements for human factor consideration, essential performance evaluation of medical devices, usability and commands. It also includes software as a medical device and specifies its adoption of a formal development life cycle. Also included in the scope of revised IEC 60601-1 are newer and revised technical specifications for hazards (both electrical and mechanical), medical device labeling requirements (including new labeling standards) and documentation.<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Medical_Device_Design_ISO_Standards\"><\/span><b>Medical Device Design: ISO Standards<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">The International Organization for Standardization also has specifications for medical device standards.<\/span><a href=\"https:\/\/www.iso.org\/files\/live\/sites\/isoorg\/files\/store\/en\/PUB100377.pdf\"> <span style=\"font-weight: 400;\">ISO 13485<\/span><\/a><span style=\"font-weight: 400;\"> and<\/span><a href=\"https:\/\/www.iso.org\/standard\/72704.html\"> <span style=\"font-weight: 400;\">ISO 14971<\/span><\/a><span style=\"font-weight: 400;\"> are widely used standards across the world for medical device quality management. Other than these international standards, certain standards are region-specific and all of them are adopted from international standards with little modification and limitation.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">If a medical device company is manufacturing or selling medical devices in the US, the medical device will be regulated by the FDA. American National Standards Institute (ANSI) is the representative of ISO standards in the US.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">There are two more similar organizations: the Association for the Advancement of Medical Instrumentation (AAMI) and the American Society for Quality (ASQ) that defines standards for the US.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">If a medical device company had designed a device considering ISO standards, there is also a possibility that the FDA may not approve the device. As FDA has its own set of procedures for risk management derived from both international and regional standards, which includes:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.iso.org\/standard\/38193.html\"><span style=\"font-weight: 400;\">ISO 14971:2007, Medical devices \u2013 Application of risk management to medical devices<\/span><\/a><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">(international standard.)<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/my.aami.org\/aamiresources\/previewfiles\/149711010_preview.pdf\"><span style=\"font-weight: 400;\">ANSI\/AAMI\/ISO 14971:2007 (R2010), Medical devices \u2013 Application of risk management to medical devices<\/span><\/a><span style=\"font-weight: 400;\"> (A regional standard with additions and modifications from the referred international standard.) <\/span><b>[5].<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">In the case of quality management standard, it does not follow the international or regional version of the ISO 13485 standard. This is because the FDA has different guidelines for quality management in medical devices for the US market.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Whereas, if the medical device company is considering the European Union, the European Committee for Standardization (CEN) is the standardization adopted from ISO and the European Committee for Electrotechnical Standardization (CENELEC) is the regional standard inspired by IEC.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">CEN is a bit modified as per requirement from ISO and written with an \u201cEN\u201d prefix. E.g.:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/ec.europa.eu\/eip\/ageing\/standards\/healthcare\/other-healthcare\/en-iso-134852012_en\"><span style=\"font-weight: 400;\">EN ISO 13485:2012, Medical devices \u2014 Quality management systems \u2014 Requirements for regulatory purposes.<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/standards.cen.eu\/dyn\/www\/f?p=204%3A110%3A0%3A%3A%3A%3AFSP_PROJECT%2CFSP_ORG_ID%3A38201%2C581003&amp;cs=14A047C9499FD595C91B9A9B53DFF1311\"><span style=\"font-weight: 400;\">EN ISO 14971:2012, Medical devices \u2014 Application of risk management to medical devices<\/span><\/a><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">National members adopt these standards from the EU while adding their prefix. For Switzerland, Swiss Standards publishes standard with \u201cSN\u201d as a prefix such as SN EN ISO 13485:2012 and SN EN ISO 14971:2012.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">In the case of Canada, the Canadian Standards Authority (CSA) is the representative organization for ISO.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Medical_Device_Regulations_and_Design_Control\"><\/span><b>Medical Device Regulations and Design Control\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Medical device manufacturers need to follow Design Control guidelines since the regulatory bodies like FDA, European Commission, Health Canada, and others want to ensure that the medical devices are safe for potential users before manufacturers start to market the devices. As I have mentioned in the above section, the FDA doesn\u2019t follow ISO 13485 as it has different requirements for quality management. Design controls are defined under<\/span><a href=\"https:\/\/www.fda.gov\/files\/drugs\/published\/Design-Controls---Devices.pdf\"> <span style=\"font-weight: 400;\">FDA 21 CFR 820.30<\/span><\/a><span style=\"font-weight: 400;\"> which has a similar intent to section 7.3 Design and Development described under the guidelines for ISO 13485. Additionally, FDA incorporates Current Good Manufacturing Practice (cGMP) requirements into the quality system regulation to follow good quality practices for medical device designs <\/span><b>[6]<\/b><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The regulation provides a framework to implement the design control to a wide variety of devices. The framework delivers flexibility for both regulatory compliances as well as the internal design and development process.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">To successfully implement design control of medical devices, professionals with both technical and non-technical backgrounds, such as business administration, life science, engineering, computer science, and the arts are required.<\/span><\/p>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone size-full wp-image-8875\" src=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-science-cycle.png\" alt=\"\" width=\"1066\" height=\"674\" srcset=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-science-cycle.png 1066w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-science-cycle-300x190.png 300w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-science-cycle-1024x647.png 1024w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-science-cycle-768x486.png 768w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-science-cycle-326x205.png 326w\" sizes=\"(max-width: 1066px) 100vw, 1066px\" \/><\/p>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone size-full wp-image-8877\" src=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-regulatory-cycle.png\" alt=\"\" width=\"1102\" height=\"684\" srcset=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-regulatory-cycle.png 1102w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-regulatory-cycle-300x186.png 300w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-regulatory-cycle-1024x636.png 1024w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-regulatory-cycle-768x477.png 768w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-regulatory-cycle-1080x670.png 1080w\" sizes=\"(max-width: 1102px) 100vw, 1102px\" \/><\/p>\n<p><b>Figure 1: <\/b><span style=\"font-weight: 400;\">Total product life cycle. The science cycle and the regulatory cycle (Adapted from <\/span><b>[7]<\/b><span style=\"font-weight: 400;\">).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">It is noteworthy that the medical device life-cycle starting from innovation to regulatory approval and commercialization is a series of interconnected steps which drives the device development (see Figure 1: Total product cycle). In the beginning, prototypes designed by your engineers are bench tested to optimize the design, tested for biocompatibility, extractables, leachables, flexibility or overall strength of your device. Role of your company\u2019s regulatory advisor is to browse through the regulatory database to suggest to you a guidance document that can help you determine if your product will be regulated as a medical device or not. Intended use of your medical device and its mode of operation or action will guide you in the device design and will also decide your regulatory pathway whether 510(k), PMA, De Novo, Pre-sub, IDE, HDE, master files etc.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">As illustrated in Figure 1, both the scientific and regulatory processes are intertwined throughout the product life cycle. Just as different parts of the science life cycle are interconnected, the science and the regulatory requirements are intertwined, each informing and determining the other. There is an opportunity to build connections, both at the FDA and in manufacturers, so parts of the life cycle do not risk only being considered in isolation. For example, it is not uncommon for a premarket application to be reviewed without considering the postmarket experience of similar products.<\/span><\/p>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-8873 size-full\" src=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-design-1.png\" alt=\"\" width=\"977\" height=\"628\" srcset=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-design-1.png 977w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-design-1-300x193.png 300w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-design-1-768x494.png 768w\" sizes=\"(max-width: 977px) 100vw, 977px\" \/><\/p>\n<p><b>Figure 2: <\/b><span style=\"font-weight: 400;\">Waterflow design process for medical device design control (Adapted from <\/span><b>[8]<\/b><span style=\"font-weight: 400;\">).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The initial phase from which Design Control starts is Design Input development and approval, which consists of device design and manufacturing processes to be carried out in the production phase. Design control is a holistic approach and doesn\u2019t end with transferring the design to the production phase, once the design is finalized. It also impacts manufacturing processes according to the changes in the design phase or even post-production feedback. It is an ongoing process to develop a product that is usable for a user and thus for the enhanced product, it considers revolutionary changes from usage patterns as well as analyzing failed products. You can see in Figure 2, how Design Control can be performed in the waterfall design process.<\/span><\/p>\n<ol>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>User Needs:- <\/b><span style=\"font-weight: 400;\">Requirements are defined considering the market need and the device is designed to address that need. After a series of evolution, the medical device design is finalized and transferred to production for manufacturing. There is a need for feedback during every step of this process.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Design Input:<\/b><span style=\"font-weight: 400;\"> This is an iterative process. When an organization decides to address the particular need, they review and test the acceptability of design input derived from the need. At that point, the iterative process of converting requirements into device design starts.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Design Process:<\/b><span style=\"font-weight: 400;\"> These design inputs are converted into design output by converting those requirements into high-level specifications (which are Design Output).<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Design Output:<\/b><span style=\"font-weight: 400;\"> The verification process confirms whether the specifications are satisfying requirements or not. And the output becomes the input to revise the requirements and this process goes on until Design Output is aligned with the Design Input.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Medical Device:<\/b><span style=\"font-weight: 400;\"> Once the final design is ready, it is transmitted to the production facility for mass manufacturing. Design control regulation mandates Design History File (DHF), which illustrates the linkages and relationships between all the Design Controls and help to trace all changes throughout the entire product development process.<\/span><\/li>\n<\/ol>\n<p><span style=\"font-weight: 400;\">Medical device companies can take a paper-based or a software-based approach, especially developed for Design Control; design history files must be traceable as well as accessible to all the team members.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The flow chart below shows a case study for medical device design control.<\/span><\/p>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone size-full wp-image-8874\" src=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-design-example.png\" alt=\"\" width=\"983\" height=\"753\" srcset=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-design-example.png 983w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-design-example-300x230.png 300w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-design-example-768x588.png 768w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-design-example-600x460.png 600w\" sizes=\"(max-width: 983px) 100vw, 983px\" \/><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Medical_Device_Design_Why_Traceability_is_Important\"><\/span><b>Medical Device Design: Why Traceability is Important\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Currently in the realm of the medical devices industry, it is an ideal\u00a0 practice to develop a traceability matrix that can illustrate the links and relations between user needs, design inputs and outputs, design verification and validation. When you are in the early phase for your device development you can maintain the device traceability using a spreadsheet or document version but as you move forward, its good idea to use cloud-based project management and document sharing platforms such as Microsoft Teams, Asana, Trello or whichever platform is suitable for your organization. The goal is as your project progresses you need to find an option which can save time because the old-school method of maintaining a traceability matrix might consume a lot of your time which you should rather be focusing on design verification and validation.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">A Design Control traceability matrix is vital to product development teams, and especially for project managers, because traceability shows the relationship and linkages between all of the Design Controls. How do User Needs relate to Design Inputs? How do Design Outputs relate to Design Inputs? How do Design Verifications link to Design Inputs and Design Outputs? How do Design Validations relate to User Needs? A traceability matrix is an invaluable tool to show a high-level view and the flow of medical device product development from beginning to end.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Best practice product developers have relied on Design Controls traceability for many, many years. And now<\/span><a href=\"https:\/\/13485store.com\/medical-device-standards\/what-is-iso-13485\/\"> <span style=\"font-weight: 400;\">ISO 13485:2016<\/span><\/a><span style=\"font-weight: 400;\"> also makes traceability a requirement. As cited in ISO 13485:2016, 7.1 Planning of Product Realization, 1. c) required verification, validation, monitoring, measurement, inspection and test, handling, storage, distribution and traceability activities specific to the product together with the criteria for product acceptance; And 7.3.2 Design and Development Planning, 1. e) the methods to ensure traceability of design and development outputs to design and development inputs <\/span><b>[9]<\/b><span style=\"font-weight: 400;\">.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Medical_Device_Design_Verification_and_Validation\"><\/span><b>Medical Device Design: Verification and Validation<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Every medical device must meet the functionality, usability, and reliability objectives to get a successful share in the market.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">In addition, your stakeholders (patients, prescribers, regulators or end-users) will also pay attention to the safety and effectiveness of your device. It is very likely that your device is designed to address an unmet need which can be critical to life for example a ventilator or a diagnostic device which can detect heart disease. Therefore, iterative testing of your device with verification and validation is crucial. These two steps in the design process are aimed to confirm that your medical device is in alignment with the requirements of users and it is performing as per its intended use. In simple terms, design verification and validation can ensure that your device is actually doing what it is supposed to be doing. Design verification and validation are also to ensure regulatory requirements, standards, product quality, and manufacturing process of your medical device. Design verification can evaluate if your design output is in compliance with the specified requirements, specifications or regulatory requirements that are specified in the design input. On the other hand, design validation is meant to evaluate whether your medical device is delivering benefits based on the need of the end-users.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Design <\/span><b>verification<\/b><span style=\"font-weight: 400;\"> asks: \u201cDid we design the device right?\u201d<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Design <\/span><b>validation<\/b><span style=\"font-weight: 400;\"> asks: \u201cDid we design the right device?\u201d<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Medical devices may consist of different technology shapes, sizes, and different levels of complexity. Verification and validation (V&amp;V) activity is driven by the regulatory environment and must follow international standards. Standardized V&amp;V activities can streamline the manufacturing process as well as enhance the approval process. Additionally, automated testing, diagnostic techniques, and data collection tools can enhance the V&amp;V process <\/span><b>[10]<\/b><span style=\"font-weight: 400;\">.<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Product validation vs. Process validation<\/b><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Medical device design\/product validation:- Conforming to the user and patient needs, i.e. Does the device work right?<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Process validation:- Manufacturing process meets predetermined specifications.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Noteworthy to remember is Design\/Product validation \u2260 process validation. Regulatory agencies require both design\/product validation and process validation individually, so both of them need to be equally taken into account during regulatory submission.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">How early in the development process should we think about validation? A medical device company should understand that it is never too early to start validation work, a company should start validating sooner than later to figure out that it is going on the right path and solving the right problem.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Validation (also V&amp;V) being an iterative process consumes a good investment, when planned poorly. A strongly-defined test strategy can help you optimize cost as well as the test period to make the product market-ready on time.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The complexity of any testing strategy depends on technologies to be used and geographical target markets. The test strategy should cover at least six parameters mentioned below:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Targeted geographies and associated standards;<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Time to market;<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">A standard to be followed with a version;<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Testing Labs \u2013 internal or independent labs;<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Defining the sequence of tests;<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Presenting the test result<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Accordingly, tests used for the verification and validation process also need to be validated. This is to ensure that you measure what you need to measure because a wrong test will deliver wrong outputs of usability and functionality. Medical device companies need an effective and well documented V&amp;V, which complies with associated regulations.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Medical_Device_Design_Risk_Management\"><\/span><b>Medical Device Design: Risk Management<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"Risk_migration_strategy_vs_Risk_management_plan\"><\/span><b> Risk migration strategy vs. Risk management plan<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">Risk management procedures for medical devices are enforced under internationally accepted compliance standard<\/span><a href=\"https:\/\/www.iso.org\/obp\/ui\/#iso:std:iso:14971:ed-2:v2:en\"> <span style=\"font-weight: 400;\">ISO 14971:2007 Medical Devices \u2013 \u201cApplication of Risk Management to Medical Devices<\/span><\/a><span style=\"font-weight: 400;\">\u201d. Apart from this, risk management policies need to be incorporated across all the stages of medical device design and development and should be also associated with design control aspects as well <\/span><b>[10]<\/b><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Risk management never ends (at least in theory!). The philosophy of risk management is that it should not be about a hard and fast set of rules. Risk management and risk migration strategy are about understanding the intent of risk management and approaching the process logically and systematically. In other words, <\/span><b>don\u2019t just follow the rules\u2026think!<\/b><\/p>\n<p><span style=\"font-weight: 400;\">Considering the complexity of medical device design, focused risk management practices help ensure usability, safety, and regulatory compliance. It is a process of identifying, controlling, and preventing the failure that may cause hazards to users. It also mandates identifying associated risks.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Figure 3 shows all the steps involved in the risk management process. The process starts with the identification of hazards and then associated risk is measured based on the consequences of hazards and their possibility of risk.<\/span><\/p>\n<p><span style=\"font-weight: 400;\"> <img decoding=\"async\" loading=\"lazy\" class=\"alignnone size-full wp-image-8880\" src=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-risk-management.png\" alt=\"\" width=\"887\" height=\"491\" srcset=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-risk-management.png 887w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-risk-management-300x166.png 300w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-risk-management-768x425.png 768w\" sizes=\"(max-width: 887px) 100vw, 887px\" \/><\/span><\/p>\n<p><b>Figure 3: <\/b><span style=\"font-weight: 400;\">Risk management process for Medical Device (Adapted from <\/span><b>[11]<\/b><span style=\"font-weight: 400;\">).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">In case if the risk identified during the risk management process for medical devices is above the defined criteria, then you will require to have a risk mitigation. The level of risk is dependent on several parameters including but not limited to your device, technologies, and in some cases to the way your company is handling the risk mitigation process. It is always advisable to conduct hazard analysis for your device to see what standards can be applied to your device. In the recent revision of ISO 14971: International Standard for Risk Management of Medical Devices, risk analysis and Preliminary Hazard Analysis (PHA) are identified as prime requirements for your medical device <\/span><b>[12]<\/b><span style=\"font-weight: 400;\">. In a simplified manner PHA is meant to provide the initial framework for risk assessments and management and PHA covers both risk analysis and risk evaluation. As per definition, PHA comprises a list of hazards, harms, any hazardous situations, formulated from your devices\u2019 materials of construction (MoC), components or raw material used in your devie, and human-device or manual interfaces, use environment, operating principle, and other relevant factors <\/span><b>[13]<\/b><span style=\"font-weight: 400;\">.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span><b>Conclusion<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">In the end, for every medical device startup or a well-established organization, it is important to remember that reading the regulations gains you nothing but understanding the philosophy buys you a lot!<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Bottom line: when comes to risk analysis and planning:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Should be utilized early and throughout the design and development process,<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Often generated new information to feedback into the design and development process (\u00e0 current\/future devices),<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">No amount of planning can eliminate all hazards and risks\u2026but you can mitigate many of them! (Following the design control philosophies described here automatically mitigates risk!)<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Every medical device\u2019s route to market is complex due to the various factors to be taken into consideration such as usage patterns, material, user experience, regulations, and more.<\/span><\/p>\n<p><strong>Need help with <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device-design\" target=\"_blank\" rel=\"noopener\">medical device design<\/a>? Browse experienced <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDDesign\">medtech industry experts<\/a> on Kolabtree or post your project for free to get proposals.\u00a0<\/strong><\/p>\n<p><b>REFERENCES AND RESOURCES<\/b><\/p>\n<ol>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.welldoc.com\/health-plans\/\"><span style=\"font-weight: 400;\">https:\/\/www.welldoc.com\/health-plans\/<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/ec.europa.eu\/docsroom\/documents\/10337\/attachments\/1\/translations\"><span style=\"font-weight: 400;\">https:\/\/ec.europa.eu\/docsroom\/documents\/10337\/attachments\/1\/translations<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">FDA, 2005, Total Product Lifecycle, FDA-CDRH Presentation by CDRH Director Dr. David Feigal, http:\/\/www.fda.gov\/cdrh\/strategic\/presentations\/ tplc.html<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Pietzsch, Jan &amp; Shluzas, Lauren &amp; Pat\u00e9-Cornell, Marie-Elisabeth &amp; Yock, Paul &amp; Linehan, John. (2009). Stage-Gate Process for the Development of Medical Devices. Journal of Medical Devices. 3(2).<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Regulatory Strategies for the Third Edition of IEC 60601-1 Retrieved 9 September 2020.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.meddeviceonline.com\/doc\/an-introduction-to-international-medical-device-standards-0001\"><span style=\"font-weight: 400;\">https:\/\/www.meddeviceonline.com\/doc\/an-introduction-to-international-medical-device-standards-0001<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.fda.gov\/files\/drugs\/published\/Design-Controls---Devices.pdf\"><span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/files\/drugs\/published\/Design-Controls&#8212;Devices.pdf<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Feigal DW. Appendix D. Impact of the Regulatory Framework on Medical Device Development and Innovation. Institute of Medicine (US) Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process; Wizemann T, editor. Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report. Washington (DC): National Academies Press (US); 2010. Appendix D, Impact of the Regulatory Framework on Medical Device Development and Innovation. Available from:<\/span><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK209794\/\"> <span style=\"font-weight: 400;\">https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK209794\/<\/span><\/a><span style=\"font-weight: 400;\">.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/design-control-guidance-medical-device-manufacturers\"><span style=\"font-weight: 400;\">1997, FDA CDRH 1997, Design Control Guidance for Medical Device Manufacturers<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/starfishmedical.com\/blog\/iso-134852016-section-7\/?doing_wp_cron=1599995964.4528369903564453125000\"><span style=\"font-weight: 400;\">https:\/\/starfishmedical.com\/blog\/iso-134852016-section-7\/?doing_wp_cron=1599995964.4528369903564453125000<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Teixeira, M. B., and Bradley, R., 2003, Design Controls for the Medical Device Industry, Marcel Dekker, New York.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.iso.org\/standard\/72704.html\"><span style=\"font-weight: 400;\">ISO 14971:2019 \u2013 Medical devices \u2013 Application of risk management to medical devices<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.iso.org\/standard\/74437.html\"><span style=\"font-weight: 400;\">ISO\/TR 24971:2020 \u2013 Medical devices \u2013 Guidance on the application of ISO 14971<\/span><\/a><\/li>\n<\/ol>\n<p><strong>All articles in this series:<br \/>\n<\/strong><a href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-development-and-design-a-definitive-guide\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDDesign\">Medical Device Development and Design: A Definitive Guide<\/a><br \/>\n<a href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-development-3-tips-for-success\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDDesign\">Medical Device Development: 3 Tips for Success<\/a><br \/>\n<a href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-design-the-essential-step-by-step-guide\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDDesign\">Medical Device Design: The Essential, Step-by-Step Guide<\/a><br \/>\n<a href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-commercialization-9-steps-from-sketch-to-launch\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDDesign\">Medical Device Commercialization: 9 Steps from Sketch to Launch<\/a><br \/>\n<a href=\"https:\/\/www.biotechnologynewsmagazine.infomeddnews.com\/how-to-overcome-medical-device-commercialization-challenges-best-practices\/\">How to Overcome Medical Device Commercialization Challenges<\/a><br \/>\n<a href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-launch-key-steps-when-taking-product-to-market\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDDesign\">Medical Device Launch: Key Steps to Bring Your Product to Market<\/a><br \/>\n<a href=\"https:\/\/www.kolabtree.com\/blog\/a-comprehensive-guide-to-medical-device-post-market-surveillance\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDDesign\">Medical Device Post-Market Surveillance: A Comprehensive Guide<\/a><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Shrinidh Joshi, medical device expert\u00a0on Kolabtree, provides a comprehensive guide to medical device design, design controls, validation &amp; verification, regulatory requirements and risk management.\u00a0 \u00a0 In the previous article, we took a look at the overview of the medical device development process from the ideation to the discovery phase. In this article, we will focus<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-design-the-essential-step-by-step-guide\/\" title=\"Read More\">Read More<\/a><\/div>\n","protected":false},"author":12,"featured_media":8885,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[540],"tags":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.1 (Yoast SEO v20.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Medical Device Design: The Essential, Step-by-Step Guide<\/title>\n<meta name=\"description\" content=\"The ultimate guide to medical device post-market surveillance: what it should include, proactive &amp; reactive actions, and important timelines.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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