Medical Device and Pharmaceutical Product Development and Compliance

Key takeaway: The ability to reuse product data can dramatically reduce the time taken to design, gain regulatory approvals, and ultimately bring new medical devices to market. Time equates to money in any business, and in the world of medical device design and manufacturing, that can mean BIG numbers! Depending on the route taken, following FDA regulations, the average cost to bring a medical device to market through the Premarket Approval pathway is $94 million. The less intensive 510(k) process averages out at $31 million.

Using unstructured tools such as Word and Excel when doing risk management for medical devices could result in harm to a patient. Why? Because many medical devices are complex, with hundreds to thousands of inter-related design inputs/outputs, testing, and risk management data. Managing that amount of data manually is nearly impossible when using tools like Word and Excel...

The delicate balance between investing and cost-saving at a venture-backed startup or SME is challenging. Particularly at pre-revenue, the CEO and leadership team must steward the capital responsibly and make tough decisions about where to invest – decisions that affect the company’s survival and success.

Giving customers more time to focus on developing great products.  If you are part of a product development team, you know how tedious and time-consuming documentation can be to manage in various word or excel files. We set out to solve that problem over 10 years ago when we launched our solution, Cockpit.  Our goal was to provide a unified and scalable environment to enable companies to structure data and automate processes for more efficient and accurate product development.

Imagine developing a medical device or drug that could be claimed to work without any evidence….

Systems engineering should be used more often in medical device product development. This may be a strong statement, but it can be transformative for device development through decreased development costs, streamlining of interactions with the FDA, and reduced time-to-market. We would like to address this through a series of articles on systems engineering role in Medical Device Product Development of which this is the first.

There are many inputs to consider when designing a new medical device product: user needs, regulatory requirements, and internal and external customer requirements, to name a few. Finding harmony and documenting everything is not a simple paperwork exercise. This can be overwhelming to even the most seasoned medical device professional. How do you make sure the user needs are linked to actionable requirements, and ensure that all requirements have been addressed?

Often in medical device product development, functions exist in silos. Risk, requirements, and test management functions often exist separately, on their own - different systems, different teams, different objectives. Yet, the data related to these functions are both continuously changing and highly dependent on one another. Some type of process is needed to (1) manage the effect of changes across all three systems and (2) provide evidence of a process for notified bodies if and when needed.

SEPARATE RISK MANAGEMENT AND FMEA FOR BETTER MEDICAL DEVICE DEVELOPMENT. The below is an excerpt of the article originally published on MDDI. FMEA (Failure Mode and Effects Analysis) is utilized to identify potential failure modes in the design or manufacturing of a product. But risks associated with medical devices are not created by failures alone. A product may never fail, but there are still potentially many other risks.