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 plan for different contingencies. Even then, we have to be prepared to handle surprises along the way.

It is challenging to strike the right balance, but by trusting our teams and building a culture of collaboration we can achieve success.

About Christopher Gehring

Christopher Gehring is currently a Principal Design Quality Assurance Engineer at Insulet Corporation. He has over 15 years of industry experience with core expertise in design controls, risk management, system engineering, quality management systems and continuous improvement. He holds B.S, and M.S. degrees in Mechanical Engineering, a Professional Certificate in System Architecture and Engineering, and a Graduate Certificate in Business Administration. He is also an ASQ Certified Quality Engineer, Certified Quality Auditor and Six Sigma Green Belt. In his spare time, he enjoys running, sailing and music.

About Let’s Talk Risk! with Dr. Naveen Agarwal

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

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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, not simply a document for compliance. The key point here is that we have to start focusing on planning and project management in addition to having a solid understanding of regulatory requirements. There should be connectivity in operations of different departments so everyone is following the same benchmarks and acceptance criteria.

About Florian Tolkmitt

Florian Tolkmitt is the founder and owner of PRO-LIANCE GLOBAL SOLUTIONS GmbH providing consulting services in all aspects of clinical evaluation, regulatory affairs, risk and quality management. He is an expert in clinical evaluation, post-market clinical follow up and post-market reporting compliance. As a co-founder and board member of RAPS Deutshcland e.V., he is very active in the regulatory community sharing his expertise and mentoring industry colleagues.

About Let’s Talk Risk! with Dr. Naveen Agarwal

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

If you enjoyed this episode, consider becoming a free or paid subscriber.

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 devices are becoming more complex.

About Hugo Felix

Hugo Felix has 25 plus years of industry experience in devices, in-vitro diagnostics, pharmaceuticals and combination products, where he has helped build compliant patient-centric solutions by impacting quality cultures through strategy, cross-functional collaboration and organizational design. He has served in leadership roles in both early start-ups and large organizations. Currently, he is a Director of medical device and combination products quality assurance at Pfizer.

About Let’s Talk Risk! with Dr. Naveen Agarwal

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

If you enjoyed this episode, consider becoming a free or paid subscriber.

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 focused on the end user or patients as we build and launch medical devices.

About Dr. Adam Saltman

Dr. Adam Saltman started his career as a clinician practicing heart surgery for about 20 years. Later he joined the US FDA as a medical officer where he developed policy frameworks on post-market benefit-risk considerations and patient perspectives. Most recently he served as the Chief Medical and Regulatory Officer in the medical device industry. Currently, he is a Principal Strategy Consultant at NAMSA, the industry leader in offering coordinated medical device product development consulting activities under one roof to achieve accelerated outcomes. He has published more than 100 peer-reviewed articles, served on editorial boards, conducted competitively funded research projects, completed advanced training in Health Informatics from the University of Illinois at Chicago, and is certified as a Quality Improvement Associate by the American Society for Quality.

About Let’s Talk Risk! with Dr. Naveen Agarwal

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

If you enjoyed this episode, consider becoming a free or paid subscriber.

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 doing the minimum required and check the box, but it also offers an opportunity to compare our current level of performance with what we need to achieve market leadership.

About Raimund Laqua

Raimund Laqua is the founder of Lean Compliance, where he focuses on helping companies in highly-regulated, high-risk environment to transform their approach to compliance using lean thinking. As a professional engineer trained in electrical and computer engineering, he started his career building test systems for integrated circuits. Over the next 30 years, he consulted with many companies across different industries to help them achieve business results through lean management, systems thinking, risk management, accountability and responsibility frameworks, and continuous improvement. He founded Lean Compliance Consulting in 2017 where he currently serves as the Chief Compliance Engineer

About Let’s Talk Risk! with Dr. Naveen Agarwal

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

If you enjoyed this episode, consider becoming a free or paid subscriber.

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 assumptions to find innovative solutions. As an example, hydrogen is a source of energy, but it does not mean a hydrogen-powered car is inherently more dangerous than a gasoline-powered car.

About Andy David

Andy David is an expert in safety critical embedded software development with many years of experience across different industries. He started his career with an internship at IBM followed by full time roles in heavy equipment, aerospace and automotive industries. He is the MD and Principal Consultant at A2D Consultancy, providing high-integrity software engineering, process and compliance consulting services. One of his current project is a hydrogen-powered car at Riversimple, a UK-based automotive startup.

About Let’s Talk Risk! with Dr. Naveen Agarwal

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

If you enjoyed this episode, consider becoming a free or paid subscriber.

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 Patel

Elisha Patel is a qualified dentist with degrees in both biomedical sciences and dentistry. Her clinical experience includes her tenure as a dental surgeon in the National Health Services (NHS) system of healthcare in the United Kingdom. Currently, she is an associate consultant in the medical evidence practice at a leading consulting firm.

About Let’s Talk Risk! with Dr. Naveen Agarwal

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

If you enjoyed this episode, consider becoming a free or paid subscriber.

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 14971.

But risk also means opportunity. “No risk, no reward”, is a often invoked as a mantra to encourage achievement, especially in business. Sometimes the highest risk maybe the one you did not take when it was worth taking! Risk, therefore, can be perceived both as a negative force to be avoided, or as a positive force to be leveraged.

In this episode, Jayet Moon and Arun Mathew remind us to keep the big picture in mind for risk management. Safety is an important business objective, but not the only one. We need to help our organizations manage all types of risks to achieve business success.

About Jayet Moon

Jayet Moon is the author of Foundations of Quality Risk Management, published by the American Society for Quality (ASQ). He is a chartered quality professional in the UK and holds several certifications from the ASQ. In his current role as a Quality Manager at Terumo Medical Corporation, he is helping to integrate best practices in safe design and development of medical devices through is vast experience in engineering and post-market safety surveillance.

About Arun Mathew

Arun Mathew is currently an associate director of quality systems and risk management at AbbVie. He has over 17 years of diverse industry experience in roles ranging across quality, manufacturing and regulatory functions. His expertise includes medical standards, risk management, computer system validation, process validation, CE marking and FDA submissions.

About Let’s Talk Risk with Dr. Naveen Agarwal

Let’s Talk Risk with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

If you enjoyed this episode, consider becoming a free or paid subscriber to Let’s Talk Risk!.

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 lifecycle. In this context, the auditing practices in the industry are moving from an element-based approach to a risk-based approach.

In this episode, Rick Rios explains what risk-based auditing is and shares best practices to conducting a risk-based audit for maximum effectiveness. We also discuss common challenges with the CAPA process in the industry.

About Rick Rios

Rick Rios started his career in the defense industry working as a systems engineer in nuclear programs. Inspired by the Total Quality Management movement, he moved into a Quality and Regulatory role, and later worked in automotive and aerospace industries as an independent auditor. He has been active in the medical device industry as an independent auditor over nearly 15 years. He has successfully developed, integrated, implemented and audited quality systems based on ISO 13485, 21CFR820, MDSAP, EUMDR, DOE QC-1, NQA-1, ISO 9001, ISO 17025, NCSL Z540, and Baldrige Performance Excellence Program.

About Let’s Talk Risk with Dr. Naveen Agarwal

Let’s Talk Risk with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

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, Alexej Agibalow explains how the clinical evaluation process and risk management are interconnected, and recommends a cross-functional, collaborative approach to fully understand various interfaces and synchronize activities between these processes.

About Alexej Agibalow

Alexej Agibalow is a risk management expert at Escentia GmbH and manager of risk and regulatory affairs at Drager.

About Let’s Talk Risk with Dr. Naveen Agarwal

Let’s Talk Risk with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

If you enjoyed this episode, consider becoming a free or paid subscriber to Let’s Talk Risk!.