Medical device developers spend years designing devices that help improve patient outcomes, which leads to millions of dollars invested in product development. If risk and requirements are not managed properly during development, it could result in a recall and organizations could lose everything.

Consider this: If your company is subject to a recall, patient lives are at stake and millions of dollars (or more) of product and inventory may need to be scrapped. If something goes wrong with a medical device in the field—especially if patient safety is compromised—more than just your customer’s brand reputation is at stake. Product recalls may result in heavy fines, crushing lawsuits, and your competitors reaping the benefits of your device no longer on the market.

Whatever requirements management tool or process you’re using should help medical device development teams manage requirements, risk, and testing to ease the path to compliance and keep you from experiencing detrimental setbacks. If it doesn’t, the following five questions are among the most important to consider.

1. Are you getting traceability in your product development process?
Traceability increases efficiency, drives alignment, and mitigates organizational risk. If your requirements solution doesn’t offer end-to-end traceability, you may have chosen incorrectly.

Traceability is a key component of successful requirements management, particularly when developing medical devices. It helps ensure all requirements relate back to tests so you can understand what you’re building, if it’s what you set out to build, and that you’re releasing a product that’s safe for patient use.

It is possible to do this process manually, but the more requirements you have, the higher the risk of error. That’s why many organizations move from a documents-based approach to using a requirements management solution that provides traceability as part of the process.

Building traceability into the development process is a critical step in ensuring regulatory needs are met, requirements hit, and changes managed and communicated along the way.

In heavily regulated markets such as medical device development, it’s crucial to maintain meticulous audit trails. Traceability enables teams to view and analyze all changes made during development—including who made the change, what it was, when it was made, and why it occurred in the first place. With proper traceability, your requirements management tool can be a unified system of record.

2. Does your requirements solution help you mitigate risk?
Proper risk management functionality within your requirements tool helps teams identify risks earlier in development, saving them from frustrating late-stage design changes and supporting the path to regulatory compliance. The better an organization identifies, evaluates, and mitigates its various risks, the more it can ultimately prevent undesired events or even recalls from occurring in the field.

Risk management is an inextricable part of the medical device development process. Your requirements management tool should give you the visibility you need to look at risk mitigation holistically.

Part of mitigating risk is maintaining audit trails and producing reports. It is important to be able to revisit decisions and show what you did and why you did it. And while document-based requirements management tools like Excel may work for smaller projects, they don’t scale well for teams working on projects as complex as medical device development.

3. Is your requirements tool tailored to your industry?
Medical device developers face strict regulations and should not be using a one-size-fits-all requirements tool. In fact, your requirements solution should give your medical device teams confidence that their products will optimize the health and safety of patients by understanding what hazards might occur and how to avoid them.

With so much to lose, medical device developers should choose a requirements solution that is familiar with—or better yet, tailored to—their specific industry. Ask if your requirements tool has the capability to manage risk in accordance with ISO 14971 and FMEA techniques—best practices in medical device risk management.

Developers need a comprehensive approach to risk management that ties risks directly to requirements, giving manufacturers confidence in the safety and compliance of their products. By choosing a solution built for medical device development teams, you can be assured you are adequately identifying, flagging, and mitigating potential risks unique to medical device development.

4. Does your solution provide support past day one?
Once you’ve established your requirements management tool has the capability you need, it’s time to look at factors for success within your organization. Requirements management can be tricky, and some solutions built for that purpose need a bit of hand-holding. That’s why ongoing training and support are key.

When evaluating requirements management tools, ensure you have customer care that’s available to you 24/7. Choose one that has a variety of ways to get questions answered quickly, including a robust knowledge base, tutorials, and a user community.

Device regulations can be confusing and complex. It’s especially important to choose a requirements management tool that offers services to help teams get up and running faster with the product and align it with governing regulations like ISO 13845:2016 and 21 CFR 820.30 in order to ease the path to regulatory compliance.

5. Is your requirements tool easy to use?
Choosing the right requirements management solution ultimately comes down to what’s right for your team. However, one of the most important factors to consider when selecting a tool is ease of use.

It’s important to choose something that’s robust enough to handle your product from start to finish, but easy enough for team members across the product development lifecycle to actually use it. If it’s not easy to use, you’ll likely find your requirements management tool won’t be built into internal processes and critical data will be missing, leaving you at risk for failed audits, recalls, or worse.

A tool that is too complicated for most of your team or company to easily pick up and use, like archaic legacy software, will only slow you down over time.

Conclusion
In fact, the right requirements tool may not be a tool at all—it’s an easy-to-use, robust product development platform capable of mitigating risk, easing the path to regulatory compliance, and launching the next generation of medical devices.

Medical device development is too serious an endeavor to not be using the absolute best in modern technology to manage the development process. And when you start doing that, you can spend more time focusing on improving quality and innovating, and less time worrying about compliance and risk. 

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Kevin Steigerwald is vice president of Product and UX at Jama Software. He drives the integrated platform strategy and roadmap across the Jama product line. Steigerwald works closely with his team of researchers, designers, and product managers to ensure customers are getting the most out of the company’s products. Prior to Jama, he was CPO and co-founder of Portland, Ore.-based Notion, which was acquired by Jama in 2018. Steigerwald first ventured into product management at CrowdCompass, after building the initial user experience team. With a previous career in advertising, he brings over 14 years of experience designing, researching, marketing, planning, and building products.