Let's Talk Risk! Podcast

“There is a growing awareness that if you bring in Regulatory at the beginning of designing a product, you will end up with a more robust product.

In this Let’s Talk Risk! conversation, Christine Zomorodian highlights some of the barriers that have traditionally hindered good communication and collaboration between QA/RA and Engineering functions in MedTech. However, she also points out that there is reason to be optimistic about the future.

Gender roles are changing, with more women entering Engineering and an increasing number of men choosing the QA/RA profession due to availability of graduate level academic programs. Company cultures are also adapting to big advances in compliance infrastructure technologies and the rapidly changing regulatory landscape. Together, these really underscore the importance of open communication and cross-functional collaboration.

A good tool to foster collaboration is a Quality Plan, which continues to be under-utilized in our industry. But a Quality Plan can help your entire team come together to figure out how you could efficiently achieve a desired goal, whether it is a remediation project or developing a suitable quality system in a startup environment.

Listen to this Let’s Talk Risk! conversation with Christine Zomorodian, which also includes an open discussion with a live audience. Jump to a section of interest using these timestamps.

00:01:59 Introduction

00:05:06 An example of impact of poor cross-functional collaboration

00:08:36 Traditional barriers to cross-functional collaboration in MedTech

00:12:05 Optimistic trends helping to improve communication and collaboration

00:14:00 Audience Q&A and general discussion

00:29:00 Closing comments and key takeaways

If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.

Suggested links:

Tips for improving collaboration in risk management

Collaboration is the secret sauce for success in risk management

About Christine Zomorodian

Christine Zomorodian is the Founder and Managing Consultant at Gish Consulting, LLC, advising MedTech companies in regulatory strategy, quality assurance, regulatory affairs and engineering process improvement. She also serves as a Person Responsible for Regulatory Compliance (PRRC) for EU-MDR compliance, and a guest lecturer at University of Washington. She has over 25 years of industry experience in various QA/RA roles at multiple global medical device companies. She holds a B.A. degree in International Affairs with concentration in Biology and Communication, and a M.S. degree in Biomedical Regulatory Affairs.

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.

“There is a tendency for human factors to be very closely tied to regulatory requirements and nothing else, but human factors as a core discipline is about user-centered design.”

In this Let’s Talk Risk! conversation, Korey Johnson highlights how the current practice of human factors engineering in the medical device industry is mainly driven by regulatory requirements, which often leads to a check-the-box approach and nothing more.

But human factors is more about applying a user-centered design philosophy starting from early feasibility and throughout the product development process.

“Are we designing the right thing, and how do we design the thing right to be able to used well by people, not just safe and effective, but does it drive satisfaction?”

When viewed as a driver of customer/satisfaction, a user-centered design approach can deliver a sustainable competitive advantage.

Listen to this Let’s Talk Risk! conversation with Korey Johnson, which also includes an open discussion with a live audience. Jump to a section of interest using these timestamps.

00:01:47 Introduction

00:04:25 Regulatory emphasis on human factors in medical devices

00:06:45 Barriers to implementing user centered design philosophy

00:08:20 Connecting with risk management and design controls

00:10:15 Assessing impact of changes in software, AI/ML enabled devices

00:14:30 Why human factors must be integrated throughout product development

00:16:50 Audience Q&A and general discussion

00:37:30 Closing comments and key takeaways

If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.

Suggested links:

AI and UX: Why artificial intelligence needs user experience, Published 2020.

FDA: Applying human factors and usability engineering to medical devices, Published February 2016.

ISO: IEC 62366-1:2015; Application of usability engineering to medical devices, Published 2015.

About Korey Johnson

Korey Johnson is the Managing Partner at Bold Insight, a leading research and consulting agency providing services in UX research, usability testing and human factors engineering. With over 25 years of industry experience, Korey is passionate about transforming the practice of human factors engineering in medical devices through empowerment, creativity and collaboration. He holds a B.S. degree in Psychology and an M.S. in Human Factors Psychology.

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.

“There is a very strong push (in the EU) to look at threshold values and acceptance criteria in the clinical evaluation, and these acceptance criteria for benefit risk have to be based on the state of the art.”

State of the art (SoTA) is a very important topic in the medical device industry, because it is directly connected to risk acceptability and benefit-risk evaluation, which in turn, is directly tied to safety and effectiveness for regulatory purposes.

But what is SoTA and how do you define it for your medical device?

In this Let’s Talk Risk! conversation, Chris Whelan helps us understand the nuances of SoTA and encourages us to consider both the engineering and clinical aspects of SoTA for our devices. Also, remember that it is an iterative process and you may have to review SoTA throughout the development process and even after product launch in the post-market process.

Listen to this Let’s Talk Risk! conversation with Chris Whelan, which also includes an open discussion with a live audience. Jump to a section of interest using these timestamps.

00:02:00 Introduction

00:03:26 Definition of State of the art (SoTA)

00:04:57 Understanding SoTA in the context of intended use and standards

00:06:17 Two aspects of SoTA - engineering and clinical state of the art

00:06:53 How to define the SoTA for your product

00:10:20 When to start defining SoTA during product development

00:11:51 Does clinical SoTA depend on standard of care in different markets?

00:14:13 Audience Q&A and general discussion

00:31:25 Closing comments and key takeaways

If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.

Suggested links:

LTR Podcast: Clinical evaluation is a lifecycle process, not a one-time activity

FDA Guidance: Appropriate use of voluntary consensus standards

ACHIEVE: Risk management fundamentals on-demand training which covers 25 key terms and basic concepts, including state of the art, for medical devices.

About Chris Whelan

Chris Whelan is currently the New Product Development Manager at ITL BioMedical where he leads multiple global engineering teams. He has nearly 20 years of industry experience in medical device design, engineering and project management, as well as teaching experience at a university. Other areas of expertise include design controls, usability engineering and risk management. He holds a B.S. in Industrial Design from the University of Technology, Sydney, Australia.

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.

“You can get a lot of valuable insights from the FDA on what your regulatory pathway is when it comes to risk, and how that impacts not only the risk of the product but how you set up your quality systems and what you need to implement in the long run. ”

In this Let’s Talk Risk! conversation, Amit Guruprasad shares how small medical device manufacturers and startups can take advantage of the free pre-sub program to get early feedback from the FDA to inform their regulatory strategy and plans for collecting data to prove safety and effectiveness in their final regulatory submission.

But it requires a strategic approach and preparation before you meet with the FDA. As an example, you should plan to get FDA feedback on your proposed approach and not seek yes/no answers.

Listen to this Let’s Talk Risk! conversation with Amit Guruprasad, which also includes an open discussion with a live audience. Jump to a section of interest using these timestamps.

00:02:12 Introduction

00:04:20 FDA’s Q-Sub program, pre-submissions and risk determination

00:07:11 How to prepare for a pre-sub meeting with the FDA

00:10:05 Develop a strategic plan for pre-sub meetings with FDA

00:12:05 Plan to get feedback on the approach and not answers to yes/no questions

00:12:50 Lessons learned from a recent pre-sub meeting

00:14:25 Audience Q&A and general discussion

00:31:25 Closing comments and key takeaways

If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.

Suggested links:

The Q-Submission Program: FDA guidance for requesting a meeting for feedback on medical device submissions.

DICE: FDA’s division of industry and consumer education.

LTR webinar on post-market surveillance

About Amit Guruprasad

Amit Guruprasad is the founder of Devan MedTech Solutions, where he provides quality and regulatory consulting services to medical device companies and startups. He has over 10 years of professional experience in R&D, quality and regulatory affairs at various medical device companies. He holds B.S. and M.S. in Biomedical Engineering.

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 reality is that, today, a lot of people are studying medicine to go into industry. But if your curriculum do not include areas like risk management, cross-functional collaboration, dFMEA and all of that, then transition for that position is going to be slower.”

In this Let’s Talk Risk! conversation, Dr. Juan Daccach shares his personal journey of transitioning into a medical safety role in MedTech as a practicing orthopedic joint reconstruction surgeon. He advises clinicians aspiring to transition into a Medical Safety role to proactively bridge gaps in their medical training and experience for success.

As an example, clinicians are trained to focus on the worst case and minimizing its impact on an individual patient. Managing risks of a medical device, on the other hand, is not just about the worst case scenario. It is about striking a positive balance between benefit and risk.

There is no quality without safety, and there is no safety without quality.

That is why broadening your view of a medical device, how it is developed and what it takes to bring it to market, is important for success. There is a need to include these topics into medical curriculum and continuing education.

Listen to this Let’s Talk Risk! conversation with Dr. Juan Daccach, which also includes an open discussion with a live audience. Jump to a section of interest using these timestamps.

00:02:11 Introduction

00:08:32 Overcoming challenges when transitioning as a clinician into MedTech

00:12:18 Learning to speak the language of Quality and Regulatory

00:15:00 Challenges in integrating Medical Safety with QA/RA function

00:18:11 Audience Q&A and general discussion

00:31:25 Closing comments and key takeaways

If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.

Suggested links:

Fundamentals of Risk Management: An introductory on-demand course for medical device risk management on ACHIEVE.

About Dr. Juan Daccach, MD

Juan Dacach, MD is currently the Vice President of Product Safety at Metz Aesthetics. Previously he was in various leadership positions in Medical Safety and Medical Affairs at various leading MedTech companies. He specialized in Orthopedics and trauma during his medical training, residency and fellowship as an MD. As part of his continuing education in the industry, he also acquired certifications in quality, auditing, coaching and leadership communication.

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.

“Show me the indicators, show me the KPIs and I will show you the results.”

Resiliency starts at the top. Misaligned incentives often lead to unintended and disastrous consequences. Recently, the Federal Aviation Administration (FAA) in the US grounded 171 Boeing 737-9 MAX planes following a mid-air incident where a cabin door blew open, exposing hundreds of passengers to a serious hazardous condition. The issue was traced to gaps in quality and inspection of components from suppliers.

Similar to the aviation industry, supply chains in the medical device industry are also complex and fragmented. In this conversation, Marco Felsberger emphasizes the need for focusing on supply chain resiliency, and not just managing individual suppliers. He encourages us to consider a systems view to understand various interactions and constraints, and simulate scenarios to identify potential vulnerabilities.

Listen to this Let’s Talk Risk! conversation with Marco Felsberger, which also includes an open discussion with a live audience. Jump to a section of interest using these timestamps.

00:02:15 Introduction

00:04:35 Why supply chain resiliency is critical in a complex world

00:06:40 How misaligned incentives create supply chain vulnerabilities

00:10:10 What we can learn from the automotive industry

00:12:33 Applying systems thinking to improve supply chain resiliency

00:17:01 Audience Q&A and general discussion

00:31:25 Closing comments and key takeaways

If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.

Suggested links:

On the Edge of Resilience: Marco’s Substack publication

About Marco Felsberger

Marco Felsberger is a resilience and risk manager with over 20 years of experience across diverse industries including banking and consumer products. He is currently a Senior Advisor of Supply Chain Resilience at Prewave, specializing in risk and resilience management, business continuity strategies, crisis management protocols and security management. He holds a B.Sc. degree in Integrated Security & Safety Management.

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.

“As professionals in these areas, we are so versed in regulations that we get so deep into the woods with management that 30 seconds after you start speaking, they are gone! They can’t even think about it anymore.”

Know your audience, prepare your topic and respect your listener.

Victor Mencarelli shares these 3 tips for effective communication in this Let’s Talk Risk! conversation.

Remember, effective communication is about connecting and making sure your message is heard. It is not meant to be an information dump on your audience. That is why, it is important to carefully consider the perspectives and preferences of your target audience. To some, details are important. Others want you to be brief, be quick and be gone!

Listen to this Let’s Talk Risk! conversation with Victor Mencarelli, which also includes an open discussion with a live audience. Jump to a section of interest using these timestamps.

00:02:13 Introduction

00:03:20 New regulation for personal care products as OTC products

00:05:40 Challenges for QA/RA professionals in communicating with senior leaders

00:07:15 An example of effective communication

00:08:35 An example of ineffective communication

00:11:46 Can we learn to be good communicators?

00:14:50 Audience Q&A and general discussion

00:29:20 Closing comments and key takeaways

If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.

Suggested links:

Supercommunicators: How to unlock the secret language of connection, by Charles Duhigg

About Victor Mencarelli

Victor Mencarelli is currently the Director of Regulatory Affairs at Orveon Global where he leads all aspects of international regulatory affairs including registration, documentation and formulation review for new startup venture capital backed businesses in the cosmetics and personal care industry. He has more than 25 years of industry experience specializing in microbiology, toxicology and regulatory affairs. He holds a B.S. degree in Biology and an M.S. in Biotechnology regulatory affairs.

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 first thing I do whenever I am starting design control or risk is that I make sure that the intended use and the indication of the device are as nailed down as they can be.”

Yes, design control and risk management can be challenging, especially in a startup or a small medical device company. Generally, there is just one person, a “team of one”, responsible for setting up the entire quality system and the risk management process.

That is why Becki Hiebert advises practitioners to focus on the intended use first. Get to know what your device is supposed to do, where, on whom, and who interacts with it, to set the framework for your quality system. She recommends following the steps outlined in ISO 14971 for risk analysis, and involving your medical/clinical subject matter experts as early in the design process as possible.

Listen to this Let’s Talk Risk! conversation with Becki Hiebert, which also includes an open discussion with the audience. Jump to a section of interest using these timestamps.

00:02:20 Introduction

00:04:32 How to succeed as a “team of one” in a startup

00:06:24 Getting started with design controls and risk management in a startup

00:08:41 Best practices for following ISO 14971 steps in risk analysis

00:12:31 Connecting risk analysis to design controls

00:14:15 Lessons learned in managing cybersecurity risk

00:17:05 Overcoming challenges in risk management documentation

00:19:57 Audience Q&A and general discussion

00:30:19 Closing comments and key takeaways

If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.

About Becki Hiebert

Becki Hiebert is currently a consultant specializing in implementation and improvement of quality management systems in medical device industry in compliance with ISO 13485, 21 CFR 820 and MDSAP. In her 10+ years of professional experience across both pharmaceutical and medical device industries, she has developed a hands-on expertise in regulatory requirements for current good manufacturing practices. She has served in a variety of roles in quality planning, process improvement, internal audits, quality system training and supplier/purchasing programs.

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 regulatory landscape is changing significantly and it is too hard to keep up.”

That is why Jennifer Mascioli-Tudor advises risk practitioners to be “super proactive” in following these rapid changes, understand the impact, and take a leading role in preparing their organizations.

In this Let’s Talk Risk! conversation, we focus on three big trends in MedTech - the shift from Quality System (QS) regulation to Quality Management System Regulation (QMSR), a new regulatory focus on cybersecurity in medical devices, and shifting regulations of lab developed tests (MDT).

Listen to this Let’s Talk Risk! conversation with Jennifer Mascioli-Tudor, which also includes an open discussion with the audience. Jump to a section of interest using these timestamps.

00:02:30 Introduction

00:04:00 Trend 1: Shift from QSR to QMSR in the US

00:07:40 Trend 2: Regulatory focus on cybersecurity in medical devices

00:10:30 Trend 3: Regulating Lab Developed Tests (LDT) in the US

00:13:10 General discussion: Learning opportunities at universities

00:33:07 Closing comments and key takeaways

If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.

Suggested links:

* UC San Diego: Regulatory Affairs for Medical Devices

* Pathway for patient health

* Drexel University: Doctoral program in Biomedical Engineering

About Jennifer Mascioli-Tudor

Jennifer Mascioli-Tudor is currently the Founder and Principal Consultant at JMT consulting offering advisory services to MedTech startups and small manufacturers in business, regulatory and quality management strategy. She is also an instructor at UC San Diego where she teaches regulatory fundamentals and design controls. Her industry experience includes leading roles at J&J, Boston Scientific, Medtronic and GE. She holds a B.S. degree in Physiology/Chemistry/French, and an MBA in Global Business Management.

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.

“Risk management is inherent to all our roles, whether you are in Regulatory, Quality or R&D, but it is not something we spend a lot of time on”.

Risk management in the medical device industry is often seen as a check-the-box activity for regulatory compliance. In this Let’s Talk Risk! conversation, Carolyn Blandford encourages us to not be satisfied with this status quo and help create a dedicated focus on risk management across all processes of the quality system.

How can you be a better partner? How can you help build your product’s story from start to finish during development, and later during the post-market phase?

This is a leadership opportunity for risk practitioners. It is not enough to build a deep technical knowledge of risk management, but also be mindful of how communication occurs within your organization. Combine your technical know-how with good communication skills to help your team make the best possible decision.

This is the key to success in a risk management role.

Listen to this Let’s Talk Risk! conversation with Devon Campbell, which also includes an open discussion with the audience. Jump to a section of interest using these timestamps.

00:01:58 Introduction

00:04:15 How risk management helps build and sustain the product story

00:05:15 Transitioning into a risk management role

00:08:12 Why we need to create dedicated risk management roles

00:10:35 How to lead change by starting small and showing impact

00:12:50 Our role in shaping a culture of quality

00:15:13 Audience Q&A, general discussion

00:32:30 Closing comments and key takeaways

If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.

About Carolyn (Beres) Blandford

Carolyn (Beres) Blandford is currently a Senior Project Management Consultant at IPM Integrated Project Management Company. She has over 20 years of professional experience in the in-vitro diagnostic (IVD) industry, first in a scientific role, later moving into a Quality Management role. She developed a strong interest in risk management as a Quality Manager, where she also led the charge to create a dedicated focus on risk management in the organization. Using her strong research, communication and project management skills, she currently supports her clients in planning and implementing strategically critical initiatives.

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.