Achieving Excellence in Medical Device Benefit-Risk Assessments

Medical devices save lives, but they are not without risk. Whether it is a disposable soft contact lens used on a daily basis, or an intraocular lens surgically implanted to treat cataract, use of medical devices can potentially result in serious injury or even death. There are thousands of medical devices on the market, but there are also reports of millions of injuries and thousands of deaths associated with these devices in the last 10 years.

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Regulatory Policy in the Age of Artificial Intelligence

Artificial intelligence (AI) based devices are unique in their ability to learn from real-world use and experience, which can translate to rapid improvement in performance and new applications. In a sign of recognition of this capability, the FDA is proposing a new regulatory framework for review and approval of modifications to these devices after they have been cleared or approved.

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The Real Goal of Medical Device Safety Surveillance

A defibrillator that locks-up after delivering the first shock causes delay in treatment which can result in serious injury or death. A needle-free closed system used to deliver chemotherapy drugs could release tiny plastic particles in a patient’s blood stream which can cause blockage. A pacemaker fails due to an unpredictable circuit error which can result in a life-threatening situation. These are just a few examples of Class 1 recalls recently announced by the FDA in a span of just a few weeks.

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FDA Wants You to Take a STeP in the Right Direction

Recently, the FDA has taken 2 major steps to encourage innovation in medical devices. The first is finalizing guidance on the Breakthrough Device Program, which will enable accelerated approval of innovative medical devices that more effectively diagnose or treat life-threatening or irreversibly debilitating conditions.

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When Compliance Leaves the Customer Stranded

Most air-travelers these days do not have high expectations. Still, when flights are cancelled under questionable circumstances and they have to spend the night away stranded on an airport, the bitterness of the experience lasts a long time!

Aviation is a heavily regulated industry. Customers are used to rules and procedures. Bad weather is always a wild card. When a paper form that needs to be completed before the plane can leave the gate triggers a sequence of events leading to the flight cancellation, the level of frustration is simply too high to ignore.

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5 Signs Your Medical Device Could Become a Target of FDA Scrutiny

Last month, the FDA issued a Medical Device Enforcement and Quality Report, which provides a summary of FDA annual inspections data and a good explanation of their current approach to regulatory compliance. In providing this data and their commentary, the FDA is telling MedTech companies that they have a big stick (i.e. is the number of annual inspections has gone up in the last 10 years), but they are also offering a sweet carrot (i.e. they are taking a “risk-based” enforcement approach) to focus more on quality rather than simple compliance. 

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How Artificial Intelligence is Shaping FDA’s Thinking

Recently, I had an opportunity to hear directly from FDA leaders during a fire-side chat at the Xavier Health AI Summit in Cincinnati, OH. Alonza Cruse, Director, FDA - Office of Regulatory Affairs and Bakul Patel, Associate Director, FDA – Center for Devices and Radiological Health, each shared their views on how AI is shaping FDA’s thinking in nearly all of its operations. It was very encouraging to hear that the FDA wants to build a collaborative relationship with the industry and “stand out of your way” to help realize the true potential of AI in Healthcare.  

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Major Clinical Study Aims to Improve Patient Experience & Outcome of Joint Replacement Surgery

Zimmer Biomet, one of the leaders in the $50 billion global orthopedic medical device industry, is placing a big bet on this idea! They have just announced a large clinical trial to test their mymobilityTMapp working with the Apple Watch® to see if it can be a viable alternative to the current standard of care after hip and knee replacement surgery. They expect to enroll nearly 10,000 patients in this study over a period of two years.

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A Strong Post-Market Surveillance Enables a Strong Risk Management System

The concept of risk-management is not new to Medical Device companies. The challenge, however is to consistently apply risk-management principles throughout the entire product lifecycle. A strong post-market surveillance process is key to building the organizational capability of a strong and holistic risk-management system.

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