{"id":40766,"date":"2021-02-02T03:00:39","date_gmt":"2021-02-02T11:00:39","guid":{"rendered":"https:\/\/www.jamasoftware.com\/?p=40766"},"modified":"2023-01-12T16:49:32","modified_gmt":"2023-01-13T00:49:32","slug":"the-top-trend-for-medical-devices-in-2021-putting-quality-first","status":"publish","type":"post","link":"https:\/\/www.jamasoftware.com\/legacy\/blog\/2021\/02\/02\/the-top-trend-for-medical-devices-in-2021-putting-quality-first\/","title":{"rendered":"The Top Trend for Medical Devices in 2021? Putting Quality First"},"content":{"rendered":"

\"Trend<\/p>\n

Editor\u2019s Note:<\/strong> This post on the top trend for medical devices was originally published here<\/a> by MedTech Intelligence<\/a> on November 17th, 2020, and was written by Josh Turpen, Chief Product Officer at Jama Software.<\/a><\/em><\/p>\n

\n

Let\u2019s face it, even in a world filled with innovations we couldn\u2019t have imagined a decade or two ago, the medical technology industry has struggled to keep pace with some other industries. Now, we are in the midst of a once-in-a-lifetime pandemic that is actually serving as a\u00a0call to action<\/a>\u00a0for many organizations to build faster and build better.<\/p>\n

But faster and better brings challenges for the companies and engineers designing and manufacturing medtech products. Teams feel immense pressure to decrease time-to-market, ensuring their company\u2019s product is first to make an appearance. First to market can mean \u201cdisruptor\u201d status\u2014and the cache that comes with that distinction.<\/p>\n

I\u2019m tired of hearing about faster and better being the only way to get to market. It\u2019s a myth, because it is based on assumptions about what the regulatory requirements management process involves during product development. And it could crush great teams.<\/p>\n

We can all relate to the risk that moving too quickly in the process can lead to mistakes. What\u2019s more: In this industry, or any safety-critical industry, making that mistake can put people\u2019s lives at risk.<\/p>\n

As I look ahead to 2021, the biggest trend for medical devices I see will be a keen focus on quality. Here\u2019s why that\u2019s true \u2014 and what your teams can do to prepare.<\/p>\n

Regulation Is About to Experience an Upheaval<\/h4>\n

In what Deloitte has dubbed the\u00a0most significant change to medical device regulation<\/a>\u00a0in nearly three decades, the new European Medical Device Regulations (EU MDR 2017\/745) \u202fimplementation date is fast approaching. Initially scheduled to go into effect in May of this year, the European Parliament and the Council of the EU adopted a proposal to extend the transitional period to May 26, 2021. And, if this year has taught us anything, \u201cpandemic time\u201d feels two-times faster and May will be here before we know it. The new regulation, which emphasizes patient safety, traceability, and transparency\u2014key aspects under the quality umbrella\u2014will impact all medical device developers as they are required to comply. It will prioritize fundamental changes throughout the entire device lifecycle and is expected to provide better, more comprehensive regulatory guidance.<\/p>\n

A big portion of the MDR will focus on increased traceability and labeling for each device, including keeping detailed records of the unique identification number (UID) card, which is new for all developers. With the process for this becoming more rigorous, it is vital that product development groups have an easy way to capture and call on that information. Manually maintaining these details with a document like an Excel sheet is possible, but makes the process cumbersome, slow and prone to manual error. A better approach is a requirements management platform that lets teams trace data, upward and downward decomposition, and present it in a clean way makes exporting it to a design history file (DHF) simple.<\/p>\n

\n

RELATED:<\/strong> <\/span>Your Guide to Selecting a Medical Device Development Platform<\/em><\/a><\/span><\/b><\/p>\n

\n

Medical Device Recalls on the Rise<\/h4>\n

Medical device recalls are on the rise<\/strong><\/a>\u00a0this year with Stericycle\u2019s latest \u201cRecall Index 2020 Edition 2<\/a>\u201d stating recall activity exceeded \u201c300 recalls for the first time since Q2 2018.\u201d What\u2019s further, is safety issues were noted as the highest contributing source. This demonstrates the growing complexity of device development and risk points, as well as the active regulatory enforcement for failed device testing. For engineering teams under pressure to bring products to market quickly, balancing the inherently intricate regulatory environment, can be a lot to handle. This is where mistakes start to happen\u2014mistakes that are magnified for companies that haven\u2019t modernized their approach to requirements management.<\/p>\n

Medical device compliance is achievable with the right, well-documented product lifecycle and real-time collaboration tools. This is especially true for systems that are already aligned with industry standards, making traceability a simple process. Often they will come equipped with frameworks where industry regulations are inputted, saving precious set-up time and ensuring development can begin right away.<\/p>\n

For any medical device company seeking to improve the development lifecycle of their products, simplify compliance and speed-time-to market in 2021, they can\u2019t dismiss quality. Simply put, there\u2019s too much on the line. From bottom-line impact to potentially life threatening implications, it is time to stop thinking about the next bigger and better thing. Let\u2019s start making the best product possible the first time around.<\/p>\n

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<\/div>\n<\/div>\n
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To see more information specific to the medical device development industry, we\u2019ve compiled a handy list of valuable resources for you!<\/h5>\n

SEE MORE RESOURCES<\/a><\/p>\n

\n

 <\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

In this post, experts explain why a keen focus on quality is the top trend for medical device development in 2021, and how teams can prepare. <\/p>\n","protected":false},"author":127,"featured_media":52006,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[72],"tags":[489,41,612],"industry":[574],"class_list":["post-40766","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-product-development-and-management","tag-developing-a-medical-device","tag-medical-device-development","tag-trend-for-medical-devices","industry-medical-devices"],"acf":[],"yoast_head":"\nThe Top Trend for Medical Devices in 2021? 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