Let's Talk Risk! Podcast

If the US FDA has approved or cleared a medical device as safe and effective, you would expect it to be equally effective across the entire patient population within the scope of its intended use. Well, you may be surprised to learn that current industry practices in design, development, and testing of medical devices inadvertently introduce many inherent biases in these devices that can lead to p...

The term practicable is used in ISO 14971, the International Standard for application of risk management to medical devices, in the context of risk controls and benefit-risk analysis of an individual residual risk. In practice, this “term” causes a lot of confusion! One source of this confusion appears to stem from the fact that the standards uses the “term” practicable as part of a requirement, b...

Why do many medical devices fail to reach their adoption goal after launch? Or, hit roadblocks during the regulatory review process before launch? In this episode, Sara Vazda shares that one reason why medical device manufacturers struggle to achieve their business goals is that clinical input is generally not a natural part of the design and development (D&D) process. Medical device D&D is genera...

M&A has traditionally been a strong driver of revenue growth for medical device companies. The current M&A environment, however, is very challenging for companies because of several factors, including declining capital funding and falling market valuations. In this environment, QA/RA professionals have a unique opportunity to make an impact in their organizations, advises Steve Silverman. Quality...

The current medical device regulation in the European Union (EU-MDR) includes the term clinical evaluation more than 140 times! Clearly, clinical evaluation is now more important than ever under EU-MDR (and IVDR). As a result, a general feeling in the medical device industry is that it is now significantly more challenging to bring innovative new devices to market. Sarah Panten advises practitione...

At first glance, risk management of diagnostic devices, including in-vitro devices (IVD), is not overly complex. After all, you mostly have to consider the effects of false negative results, false positive results, and invalid or delayed results. However, it can be challenging to correctly assign the severity of harm(s) resulting from inaccurate and/or delayed results if we don’t fully understand...

We often think of the post-market surveillance (PMS) process as a regulatory requirement for medical devices, especially because of the revised EU-MDR (and IVDR) regulations now in effect in the European Union. But it is more than compliance. According to Per Maegaard, PMS is not just an exercise in meeting regulatory requirements, but intelligence gathering that can help other functions including...

Why - you may ask - should risk practitioners care about empathy? After all, risk management is about managing uncertainty as objectively as possible. How does exercising the empathy muscle help risk practitioners do a better job than, let us say, focusing more on data analysis and regulatory requirements? In this episode, Christie Johnson reminds us that risk management is a team sport . When wor...

Risk management involves making decisions based on incomplete information at any given time. One area where risk practitioners struggle a lot is in managing risk associated with reasonably foreseeable misuse . We struggle to figure out what type of misuse might be reasonable , and what might be foreseeable, because human behavior often is neither reasonable nor predictable! That is why Rene Drost...

There is a lot of hype around artificial intelligence (AI) and machine learning (ML) these days. That is why Michael Bocchinfuso encourages Quality/Regulatory professionals in this episode to go beyond the hype and understand these rapidly emerging technologies at a deeper level. These rapidly evolving technologies offer unique opportunities in the medical device space. To succeed, QA/RA professio...

In this episode, Becki Hiebert recommends taking a strategic approach to building and implementing a Quality Management System (QMS) in a startup. Unlike a mature, established organization, a startup operates in a fast-paced and rapidly changing environment. That is why you have to think about both speed to support the near term goals, and scalability to support rapid growth in the future. Her adv...

Boston marathon is one of the most prestigious running events in the world. It takes a lot of planning to preparation to even qualify to enter the race. In this episode, Christopher Gehring shares his experience preparing for his first Boston marathon and emphasizes the need for good planning in all our projects, including risk management. We have to be both agile and detailed in our approach, and...

There is a new scrutiny on clinical evaluations in the European Union. At the same time, medical device manufacturers are challenged to satisfy the new regulatory requirements under EU-MDR because they are no longer able to claim “equivalence” to an existing device under revised criteria. In this episode, Florian Tolkmitt emphasizes the need to consider clinical evaluation as an important process,...

Risk management is a team sport. In this episode, Hugo Felix reminds us that takes expertise from different functions to fully understand the nature of risk and identify appropriate risk control options. It is not just engineering or manufacturing or quality or clinical; it is all functions working together. This is more important now than ever as technology is rapidly advancing and medical device...

In this episode, Adam Saltman reminds us to not consider risk as an absolute concept; rather think about it in the context of the end user or the patient who is being asked to take the risk in return for a benefit to their health. There is a disconnect in the medical device industry between patients, manufacturers and regulators. By considering the question “who is taking the risk?”, we can stay f...

The term compliance is generally viewed as a “necessary evil”, or as a “tax on production”. But it doesn’t have to be this way. In this episode, Raimund Laqua encourages us to view compliance as an opportunity to consider compliance requirements as part of the overall performance standards generally expected by our stakeholders, including customers and regulators. Compliance can be seen as just do...

Sometimes it is a good idea to learn from best practices used in other industries! In this episode, Andy David shares risk lessons learned while working with hydrogen-powered cars. He shares how design choices are driven by a central idea, which also greatly influences are approach to safety risk management. In the end, safety is an output of our risk mitigation activities. We have to keep the end...

Risk practitioners, including engineers and quality/regulatory experts, mostly focus on device-related risks to ensure safety and effectiveness. Physicians, on the other hand, have to consider the totality of risks, including those arising from the procedure or patient-related factors. Physician’s have to tailor the overall benefit-risk to an individual patient. In this episode, Dr. Elisha Patel h...

The term risk is generally understood as something to be avoided or minimized. In the medical device and pharma industries, risk is generally associated with harm to patients. Regulatory agencies expect the benefits of a medical product to outweigh the risks associated with its use before it can be considered as safe and effective. As a result, the dominant view of risk in the medical device world...

Medical device manufacturers operate under a heavy load of audits and inspections. Even the regulatory authorities across the world are recognizing the heavy burden of multiple audits and inspections on manufacturers, which take away resources and time that could otherwise be invested in new product development and continuous improvement activities. There is a movement in the regulatory compliance...

The medical device regulation in the European Union (EU-MDR) outlines many new requirements for conducting clinical investigations and clinical evaluation throughout the device lifecycle. The challenge is that the term “clinical risk” is not clearly defined in the EU-MDR. This has created a lot of confusion in the medical device industry about the scope of clinical risks that need to addressed thr...

Unlike a typical medical device, most in-vitro diagnostics (IVD) “do not touch” a patient. IVD-related risks to patient safety are considered to be indirect risks, because the information generated by an IVD is an intermediate step in the sequence of events. In the IVD world, a trained technician will generally run the assay and provide the information to a clinician. In case of an over the counte...

FMEA is a commonly used technique by engineers in the medical device industry to analyze different failure modes, their causes and effects. When used correctly, it is highly effective in identifying and implementing appropriate control measures to improve product quality and reliability. However, FMEAs are also overused in the industry; often almost exclusively for risk analysis. The main problem...