The rapid pace of medical innovation has increased the need for medical device companies to incorporate software and new technologies into their products to keep up with market demand.
As medical device manufacturers have adapted their products to incorporate software, tech companies have also seen the market opportunity and entered the medical device landscape.
These developments have led to changes in the FDA’s regulatory processes. For example, the proposed creation of a “Center of Excellence for Digital Health (CoE)” would modernize the FDA’s regulatory approach to meeting the needs of the growing digital health market.
Whether you’re an established medical device company or a new player, every stakeholder faces numerous challenges to keep up with the pace of the market while delivering compliant products that ensure patient safety.
Complexity and Connectivity are on the Rise
In the past, medical device software was generally used to display readings and manually turn equipment on and off. Complexity in requirements and customer needs, however, has made medical device software far more complex.
As with consumer electronics, patients and healthcare professionals expect today’s medical devices to be better, faster, safer and cheaper than their predecessors.
While these market drivers create new, exciting opportunities to innovate, they also carry inherent complexity and risk.
Small teams building simple products can get by with spreadsheets, documents and emails to track product requirements, testing and risk. However, with larger, more distributed teams and the rise of software-driven medical devices, traceability quickly becomes too convoluted to be handled manually: There are far too many scope changes, remote team members, reviewers and requirements.
By automating traceability into a live system of record, medical device developers can establish consistent, accurate links throughout each step of the development process.
In Jama Connect, you can create relationships to link everything together and map out interdependencies among different items and decision makers.
Automating traceability not only organizes your product development process; it also saves time and gives you confidence in your compliance.
New Entrants into the Medical Device Market
On the flip side of traditional medical device organizations incorporating more sophisticated software into their releases, some of the world’s biggest tech companies are increasingly incorporating health data and functionality into their products.
Big tech healthcare is a rapidly growing segment. In fact, major tech companies have participated in 27 rounds of healthcare financing within the first eight months of 2018, equal to the total amount of rounds in 2014 alone, according to a CB Insights research brief.
Look no further than Apple’s Watch Series 4, which recently received a Class II De Novo clearance from the FDA for both its electrocardiogram (EKG) and notification of irregular heart rhythm clearances. While the letters clearly stated the watches were “not intended to replace traditional methods of diagnosis or treatment,” solutions like these are changing the way consumer electronics companies like Apple think about and develop products.
Compliance today requires a deep level of organization, document and information management, and detailed communications previously unseen in either the medical device or tech industries. This introduces new risks for tech companies with non-traditional FDA regulated backgrounds and creates fresh challenges for the FDA’s evaluation of each software solution.
The good news is being a new entrant into the healthcare market doesn’t automatically put you at a disadvantage. And you shouldn’t have to start from scratch when trying to create a process that satisfies FDA auditors.
Jama Software can help you get up and running quickly with Jama Connect and our Medical Device Services, based on a process tightly aligned to governing regulations ISO13485:2016 & 21 CFR 820.30. The approach is designed to accelerate time to value from Jama Connect and give teams confidence that the products they are developing adhere to FDA and ISO regulations.
Accelerate Medical Device Development While Reducing Risk Now
Despite these changes in the digital healthcare market, the goal remains the same: release high-quality, market-driven products that ensure patient safety.
While the changes and regulations can be overwhelming for new entrants into the market, creating a streamlined development process that balances innovation and compliance is a solid starting point that will only lead to greater product success.
Software and hardware teams need to collaborate now more than ever to produce an innovative product that complies with FDA regulations and gets you that 510k clearance letter faster.
Jama Software guides cross-functional medical device teams through the development of their Class II and Class III medical devices.
Every day, our powerful platform helps hundreds of customers manage device requirements, risks and testing. Our tailored services allow our customers to focus more on innovation and less time navigating compliance.
Learn more by registering for our expert-led webinar specifically designed for medical device product and engineering teams, “Balancing Compliance & Innovation in the Medical Device Industry.”