How to Overcome Three of the Biggest Challenges in Medical Device Development

Kevin Smith

Medical Device Development

The landscape of medical device development is shifting rapidly. And it’s not just balancing innovative gains with safety that medical device companies must worry about anymore.

In our opinion, there are three main challenges medical device companies will be facing in the coming years (if they aren’t already):

  • The rise of connected, software-driven medical devices
  • Increasingly strict medical device regulation
  • New market entrants making a disruptive splash

Given that the medical device industry is slated to skyrocket to $800 billion by 2030, there’s obviously a lot at stake. Luckily though, there are some antidotes that we explain in our eBook, “Overcoming the Three Biggest Challenges in Medical Device Development,” which is available to download here.

Here’s a closer look at some of those big problems that need to be accounted for in modern medical device development.

Challenge One: The Rise of Connected, Software-Driven Medical Devices

Until fairly recently, software embedded within medical devices had limited functionality. Gradually, like so many products, software came to dominate the core features and functionalities of medical devices.

That combination of quality hardware and sophisticated software has made medical devices a lot more complex, which equates with increased development work for those building the products.

Add to that the element of connectivity which, while extremely powerful and convenient, can introduce a variety of risks — including malware and hackers — and the landscape of medical device development has expanded significantly.

Teams building modern medical devices must not only keep pace with the rapid rate of innovation and demands of the market, but also manage risk that only grows with the complexity of the product design. Managing the development of medical devices through documents and spreadsheets isn’t a path to long-term success, and companies must find new ways to develop their products or get left behind.

Read our eBook, How to Overecome Three of the Biggest Challenges in Medical Device Development

Challenge Two: Increasingly Strict Medical Device Regulation

The increasing complexity of medical devices is forcing regulators to take another look at existing rules and guidance, and for good reason. In the first quarter of 2019, the average size of a medical device recall was 823,126, which was the highest quarter since 2006, according to Stericycle’s Recall Index. And, among all recalls, quality issues were the main cause.

Whether it’s ISO 14971 or ISO 13485, compliance with government and industry regulations remains a constant weight for medical device developers, as regulatory bodies struggle to stay current speed of the market.

This is making medical device compliance increasingly costly and making regulatory standards harder to interpret. For instance, one of the most difficult and time-consuming aspects of proving medical device compliance is sorting through the documentation produced by the design and development teams, including outputs from multiple software tools. Even in a best-case documentation scenario, determining the right documentation to show FDA compliance and systematic management of risks is tricky.

Learn more about how Jama Connect helps teams improve medical device development.

Challenge Three: New Market Entrants Making a Disruptive Splash

When names like Apple and Amazon decide to start competing within your industry, there is ample reason to worry. These sorts of household names benefit from instant brand recognition, quick distribution, and seemingly unlimited resources.

For instance, Apple’s Watch Series 4 received a Class II de novo clearance from the FDA for both its electrocardiogram (EKG) and notification of irregular heart rhythm clearances.

Despite the intimidating nature of goliath companies getting into the medical device space, it’s important to remember most of them are still somewhat new to FDA regulation. This introduces new risks for those tech companies with nontraditional FDA-regulation backgrounds and creates fresh challenges for the FDA’s evaluation of each software solution, which has prompted an overhaul of that system.

For medical device companies, this situation sharpens the focus on an ongoing business problem: Evaluating how your processes are being executed and making sure you’re getting your product right the first time.

To see more information specific to the medical device development industry, we’ve compiled a handy list of valuable resources for you!


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