Let"s Talk Risk! Podcast

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 user in mind and understand their needs for both safety and performance. We also need to challenge our

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 helps us understand a physician’s view on risk. About Dr. Elisha PatelElisha Patel is a qualified dentist

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 is that risk needs to be controlled and minimized for patient safety and regulatory compliance. ISO

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 world to adopt a least-burdensome approach for regulatory decision making throughout the device

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 through a clinical evaluation and appropriately integrated with the risk management system.In this episode,

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 counter (OTC) test, such as a rapid COVID-19 test, the end-user directly receives the test results.How this

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 with this approach is that system level hazards and hazardous situations cannot be easily linked to