Let's Talk Risk! Podcast

Artificial Intelligence (AI) now affects almost every aspect of our personal and professional life. It is also changing the way we work, especially in the knowledge industry.

According to a recent report from McKinsey Global Institute about the generative AI and the future of work, 30% of the hours worked in many professional activities across the US economy could be automated by 2030. But AI will actually enhance the work done by STEM professionals, creative and legal professionals.

If there are new challenges for professionals in many industries due to AI, there are also enormous opportunities for those who embrace it and find creative ways to stand out in this hyper-competitive job market.

In this podcast, Elena Kyria shares insights and tips for career success. She was recently recognized as a Top LinkedIn voice for QA/RA recruiting in the Life Sciences industry.

About Elena Kyria

Elena Kyria is currently the founder an CEO at Elemed, a leading European recruitment firm in the MedTech space, specializing in medical devices, diagnostics, IVD, MDR, IVDR, ISO 13485, CE Marking, 510(k), Regulatory Affairs, Quality, Clinical, and Notified Body consulting services. She is also the host of Career Diaries by Elemed, a podcast dedicated to helping QA/RA professionals learn about the latest insights and tips from seasoned industry executives.

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.

Rapid advancement in digital technologies and cloud computing offer huge opportunities for medical devices, but they are also forcing us to change our approach to design, development and risk management.

In this high energy Let’s Talk Risk! conversation Randy Horton inspires us to take a risk-based approach when building and managing connected devices.

Historically, we have considered medical devices as a “fortress” with a high level of engineering control and a defensive “moat” of change control around them to ensure safety and effectiveness. In the new world of digital technologies and cloud computing, we need to think of them as “container ships” that need to safely reach their destination, but we cannot control the ocean.

That is why, we need to focus on resiliency and not redundancy. In the past, we tried to control every possible variable to the extent possible and minimize potential failures. Now, we have to acknowledge that medical devices operate in a complex environment, and that things will break down. We do have to apply solid engineering principles in design, but we also need to have a robust surveillance system in place to continually monitor data and take timely action when circumstances change without warning.

And we have to make risk-based design choices. As an example, certain software functions of a device involved in real-time decision making and life-saving action cannot be “outsourced” to the cloud. On the other hand, we can use cloud computing to monitor and analyze long-term data to improve our algorithms.

Randy encourages risk practitioners in the industry to get involved and shape this conversation. We don’t have to wait until new regulations are developed and finalized. Even the regulatory agencies are trying to figure out the best way to regulate software-based connected devices without slowing down the pace of innovation.

About Randy Horton

Randy Horton is currently the Chief Solutions Officer at Orthogonal, a product development and consulting firm specializing in Software as a Medical Device (SaMD), digital therapeutics (DTx) and connected devices. With a strong business and analytical acumen, Randy facilitates digital transformations by increasing internal agility, cultivating strategic partnerships, and implementing entrepreneurial ideas. He has over 20 years of experience in product management, business development and consulting. Randy graduated from the University of Michigan with a Bachelors in History and a Masters in Information Studies.

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 increasing adoption of Medical Device Single Audit Program (MDSAP) has led to a major shift in current auditing practices in the medical device industry. MDSAP has forced auditors to apply a process-based audit approach rather than a checklist-based approach. The focus in a process-based audit is on process effectiveness and not just element-by-element compliance with regulatory requirements.

As a seasoned auditor with more than 15 years of industry experience, Rick Rios reminds us that external auditors, such as FDA investigators or Notified Body auditors, are not coming in to look for compliance issues. Rather, they are coming in to look at effectiveness of the system and its processes.

So, how do we focus our efforts on process effectiveness? In this episode, Rick offers an invaluable insight - the purpose statement of a procedure provides its design intent, because it serves to provide a framework for establishing objectives to measure the process. It is a review of performance against those objectives that auditors evaluate process effectiveness. That is why we must write a purpose statement clearly and make sure it is understood well by everyone involved in a given process.

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.

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

When we practice risk management mainly for the purpose of compliance, we are really faking it!

A compliance-focused approach to risk management only leads to an ever increasing number of complex procedures, rules and documentation rather than nurturing a culture of empowerment and customer focus. Risk management in such an environment becomes a check-the-box exercise.

In this episode, Vilma Nasteckiene challenges us to critically examine our current practices and adopt a more customer-centric approach. Drawing on her extensive experience in the banking industry, she advises us to work collaboratively, and to develop processes that aim to serve our customers while staying true to the organization’s core values.

When fear drives our actions just to be in compliance with regulations, we take a check-the-box approach to risk management. On the other hand, when we do the right things right, and with courage, we not only produce business results and serve our customers, we also naturally comply with regulations.

Be brave to ask uncomfortable questions, including what we must stop doing and how we should improve our processes to achieve our objectives.

That is how we start unfaking risk management!

About Vilma Nasteckiene

Vilma Nasteckiene is the co-founder and partner at The Holistic Enterprise, where she helps organizations to embrace a new management philosophy that enables them to adapt to a changing world by transforming old paradigms into holistic value-creating interdependencies interacting with the ecosystem. She holds a Ph.D. in Social Sciences and management from ISM University of Management and Economics, where she also serves as a risk practice researcher on a part-time basis. She has over 10 years of experience in risk management in retail and banking.

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.

Digital technologies are being rapidly deployed in medical applications. Buzzwords such as AI/ML, SaMD and Digital Therapeutics are fast becoming a part of our vocabulary in the medical device and the broader healthcare space. While there is new excitement about the potential to solve some of our most challenging medical problems, there is also a lot of uncertainty in the regulatory approach to devices using based on these technologies.

In this episode, Pascal Werner shares this enthusiasm while also highlighting highlighting challenges associated with their application in medical devices.

About Pascal Werner

Pascal Werner is a freelance consultant advising startups and small/medium enterprises focusing on digital therapeutics, digital health, AI and SaMD in developing a successful regulatory strategy supported by a robust quality management system and technical documentation. His expertise in software development and entrepreneurial thinking, combined with his knowledge of laws and regulations, allows Pascal to offer comprehensive regulatory services. He holds Masters degrees in Biomedical Engineering from Germany and Malaysia.

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.

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 preventable harm in some patients.

In this episode, Lori-Ann Archer highlights that inherent bias in medical devices is a serious issue. She emphasizes the need to formalize a requirement for building equity in medical device design control as part of the Quality System Regulation (QSR).

She inspires all of us to, first be aware of inherent bias in medical devices, and second, to do our part in improving our design control processes. A good place to start is to update the Quality Policy to be intentional about building equity across our key processes.

About Lori-Ann Archer

Lori-Ann Archer is currently the founder and CEO of Qafe, the Quality Academy for Excellence, where she offers comprehensive quality insights and consulting services for the cosmetics, medical device and combination product industries. An alumni of the Cornell University alumni of the Electrical Engineering department, she has over 25 years of experience in medical device and combination products as a quality systems subject matter expert and executive leader. She has been involved in building outstanding quality systems at top companies like Google, Teva Pharmaceuticals, Medtronic and multiple startups. She has now dedicated herself to be an advocate and thought leader for equitable development of medical devices, and collaborated with with the Cornell Biomedical Engineering Medical Devices (CUBMD) team to release a white paper on this critical issue (see link below).

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 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, but also suggests that the “word” practicable may be a part of the manufacturer’s policy for establishing criteria for risk acceptability.

In this episode, Ian Sealey shares that there is not a consolidated view on this topic right now. That is why there is a need for a continued conversation on this topic to understand various regulatory requirements and available guidance.

About Ian Sealey

Ian Sealey is currently a medical device regulatory consultant providing regulatory, quality, technical, policy and training services to multinationals and startups. He has previously held engineering positions in both private and the public sectors. He served as a medical device specialist to the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and was appointed to the position of Assistant Secretary at the Department of Health. He holds a BEng(Hons) in Medical Engineering and is a BSI qualified ISO 13485:2016 Lead Auditor.

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.

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 generally driven by Engineering, with clinical aspects considered only during the final phase prior to seeking regulatory approval.

Bottom line - missing clinical input early in the D&D process results in missing key user needs. Often, it later comes back to haunt us in terms of added time and cost of development, and missing launch timeline.

About Sara Vazda

Sara Vazda is an accomplished expert in the medical device industry, with a focus on guiding startups in medical device development and regulatory adherence. Her unwavering commitment to advancing women's health is exemplified through her strategic partnerships with Femtech companies like Ella and Hormona. As a registered biomedical scientist and specialist in laboratory medicine, Sara has accumulated a wealth of experience in various clinical positions, in both private and public hospitals as well as the medical device industry. This extensive background has cultivated a deep understanding of how clinical considerations can significantly influence the adoption of medical devices by both users and patients, resulting in a comprehensive perspective on how design gaps impact user and patient acceptance.

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.

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 and Regulatory professionals can help bridge the knowledge gap, and in doing so, demonstrate the business acumen needed to advance their careers into senior leadership positions. By analyzing the specific regulatory risks, and translating their potential impact in business terms, they can help achieve business goals.

About Steve Silverman

Steve Silverman is president of The Silverman Group. Steve spent more than a decade at FDA in leadership positions across the Agency. He adds private-sector expertise from consulting and representing industry members. Steve develops strategies that satisfy regulators and promote business needs.

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 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 practitioners to clearly define clinical benefits of their as part of the clinical evaluation and document the benefit-risk evaluation in the context of the State of the Art. Realize that post-market surveillance is an active process of information collection and review, and that it must be tightly integrated with the clinical evaluation process on a continual basis.

About Sarah Panten

Sarah Panten is currently the Co-Founder and Managing Partner at avasis, which provides digitalization services to companies in the medical device and machinery industry. She has worked as a trainer and a consultant for more than 10 years at different organizations including TUV SUD and NSF. In 2014, she initiated the digitalization of the design control process at iThera Medical to manage complexity and traceability of information. Her current focus is to develop medical device specific software solutions based on the Siemens Polarion software platform to help companies efficiently implement regulatory requirements.

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.