Podcast The Life Science Rundown

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Episode #019 Navigating Risk Management in Medical Devices with Brian Dense

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The FDA Group's CEO, Nick Capman sits down with Brian Dense, a medical device consultant with over 30 years of experience across several parts of the industry, to discuss risk management for medical devices, emphasizing key points such as:

  • The importance of risk management in the medical device industry as it forms the basis of regulations and ensures safe and cost-effective products.
  • Different markets, including the European Union, Canada, and the United States, and their specific regulatory requirements.
  • The primary standard for risk management, ISO 14971, with the 2019 version designed to align with the EU MDR regulation.
  • The significance of addressing the EU's 15 General Safety and Performance Requirements (GSPRs) and including usability in risk management.
  • Risk acceptability determination, using ISO 14971's standard ranking system and evaluating products based on safety rather than cost.
  • The importance of usability in risk management, even for lower-class devices, and its integration with design history and risk management files.
  • The role of FMEA in assessing risk by identifying potential failure modes, their effects, and their probability of occurrence.
  • The value of involving a diverse team with backgrounds in engineering, manufacturing, quality, and marketing when conducting FMEA.
  • The use of process FMEA to evaluate each step in the manufacturing process and identify potential failures impacting the device's performance or safety.
  • The importance of reading and understanding ISO 14971 and ISO/TR 24971, as well as the EU MDR regulation and its GSPRs for those entering the European market.

Brian's medical device experience covers a diverse range of products from dental instruments and diagnostic equipment to orthopedics, spine, contact lenses, and urological products. His extensive background spans various company sizes, including working with two startups and three large conglomerate corporations.

Over the course of his career, Brian has developed expertise in several areas of the medical device sector, such as orthopedics and spine, as well as other specialized fields. In the past 13 years, he has transitioned to consulting, where he has been connected with The FDA group for seven years.

Episode #018 The DEA, FDA & Controlled Substances: An Insider's Perspective with Former DEA Agent Dennis Wichern

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The FDA Group's CEO, Nick Capman sits down with former DEA agent Dennis Wichern to discuss the vital role of compliance for pharmaceutical companies dealing with controlled substances and the significance of adhering to DEA regulations. Key discussion points include:

  • The importance of strong compliance programs, record-keeping, and suspicious order monitoring systems, especially in light of the nationwide opioid lawsuits.
  • Common issues faced by DEA registrants, such as poor record-keeping and security, and the need for adequate security measures and compliant record-keeping systems.
  • The process of determining a buyer's legitimacy and the reasonability of their controlled substance purchases, with suggestions for due diligence, background checks, and evaluating the balance between controlled and non-controlled substances.
  • The focus of DEA inspections on large manufacturers and distributors, and Dennis's work with pain providers, pharmacies, hospitals, and small distributors when problems or fears of DEA intervention arise.
  • Mock inspections and tips for interacting with the DEA to help clients prepare for real inspections.
  • Dennis's experience as an expert witness in opioid lawsuits and the interactions between DEA and FDA, highlighting the different authorities of the two agencies and their collaborative efforts in determining drug schedules.

Dennis is the former Special Agent-in-Charge of the Chicago, Illinois regional office of the U.S. Drug Enforcement Administration (DEA). He offers clients over three decades of federal law enforcement experience as well as a keen understanding federal agencies and working relationships with all major federal agencies, the U.S. Sentencing Commission, Assistant U.S. Attorneys, U.S. Attorneys, and other Department of Justice officials.

EPISODE #017 A Deep Dive into Medical Device Regulatory Strategy with Regulatory Attorney Christine P. Bump

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The FDA Group's CEO, Nick Capman, sits down with Regulatory Attorney Christine P. Bump to discuss the current regulatory landscape for medical devices and the importance of developing a thoughtful regulatory strategy. Discussion points include:

  • The three classifications of medical devices and the various regulatory submission types — each with different risk levels, required data, costs, and approval timelines.
  • The costs associated with FDA approval.
  • Why it's important to craft a regulatory strategy early, even at the product concept stage, to determine device functionality and anticipate FDA requirements.
  • The challenges that the rapidly evolving nature of software, algorithms, and AI present for the FDA's traditional device paradigm.
  • The benefits of pre-submission meetings with the FDA, which provide valuable feedback and insights to streamline the submission process.
  • The differences between regulatory attorneys and consultants.
  • The common pitfalls for companies navigating the FDA approval process, such as insufficient budgeting and lack of in-house expertise.
  • The importance of planning well in advance and adjusting operational goals to align with regulatory requirements.
  • The importance of understanding product claims to avoid regulatory complications.

Christine is a regulatory attorney with more than 15 years of experience developing and implementing FDA strategies for cutting-edge technologies. As the founder of Penn Avenue Law & Policy, she focuses on devices, software as a medical device, digital health, diagnostics, wellness, genetics and genomics, and advertising and promotion. She advises CEOs, scientists, and teams of all levels regarding regulatory pathways, clinical investigations, premarket submissions, pre- and postmarket compliance, and promotional issues. She counsels a variety of clients, including start-ups, national and multi-national corporations, venture capital groups, and portfolio companies on navigating the FDA process.

Episode #016 Lessons from a Medtech Entrepreneur: Ram Konduru on Fostering Teamwork and Personal Growth in Leadership

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The FDA Group's CEO, Nick Capman sits down with Ram Konduru, CEO of PrimeSoft Inc (North America & Europe) and Co-Founder of Coherence Health. Ram discusses his experience in leadership and management, highlighting the importance of having a common purpose and goal for a team. Ram and Nick also discuss the need for leaders to create strong bonds within their teams, provide opportunities for team members to bond, and be humble and relatable.

Other discussion points include:

  • Ram’s personal growth journey as a leader, the impact of his mentors on his development, and the importance of self-reflection, practice, and having a genuine belief in the company's mission. 
  • The idea that money is a byproduct of value creation.
  • The challenges of being a modern leader and manager—and the importance of staying curious and maintaining a learning attitude.
  • Life-impacting questions.
  • The importance of personal relationships and reflecting on one’s actions.
  • A few book recommendations.

EPISODE #015 Unlocking Effective Leadership: A Conversation with MetaComet Systems President, David Marlin

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The FDA Group's CEO, Nick Capman sits down with David Marlin, President of MetaComet Systems, a company specializing in royalty automation software. David shares his background, thoughts on leadership and management, and the importance of working towards a common goal. He emphasizes the value of joining peer groups, vulnerability, trust, and using the Entrepreneurial Operating System (EOS). He credits the concept of "letting go of the vine" for reducing stress and improving overall business performance.

David also discusses:

  • His transformation from a charismatic leader to a better listener and the pride he takes in his company's software.
  • Various books on leadership and management.
  • Self-awareness, empathy, and creating positive environments as key aspects of effective leadership and management.

MetaComet was founded in 1999 to revolutionize royalties through automation. More than two decades on, it remains steered by founder and President, technologist and publishing expert David Marlin, and continues to strive for the highest levels of efficiency. MetaComet serves many different industries, and more than 140 companies of all sizes and types trust it to make royalties effortless. 

EPISODE #014 Leadership, Management, and Enhancing Quality of Life: A Conversation with Dan Barker, CEO of Wikimotive

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The FDA Group's CEO, Nick Capman sits down with David Marlin, President of MetaComet Systems, a company specializing in royalty automation software. David shares his background, thoughts on leadership and management, and the importance of working towards a common goal. He emphasizes the value of joining peer groups, vulnerability, trust, and using the Entrepreneurial Operating System (EOS). He credits the concept of "letting go of the vine" for reducing stress and improving overall business performance.

David also discusses:

  • His transformation from a charismatic leader to a better listener and the pride he takes in his company's software.
  • Various books on leadership and management.
  • Self-awareness, empathy, and creating positive environments as key aspects of effective leadership and management.

MetaComet was founded in 1999 to revolutionize royalties through automation. More than two decades on, it remains steered by founder and President, technologist and publishing expert David Marlin, and continues to strive for the highest levels of efficiency. MetaComet serves many different industries, and more than 140 companies of all sizes and types trust it to make royalties effortless.

EPISODE #013 Navigating the 510(k) Process: A Q&A with Regulatory Consultant Trey Thorsen, MS, RAC

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The FDA Group’s CEO, Nick Capman, sits down with Regulatory Consultant Trey Thorsen, MS, RAC, to answer some of the most frequently asked questions about navigating the 510(k) premarket notification process.

Trey brings experience in Class I, II, and III devices, such as active implantables with MRI functionality, external therapeutic devices indicated for pain, devices that have software functionality, transvaginal catheter systems that evaluate fallopian tube patency, sterile and non-sterile wound care devices, compression devices, surgical booms, surgical lights and devices indicated for incontinence. He also has experience with 513(g)s, Pre-Subs and CFGs, UDI/GUDID implementation, as well as EU MDR technical file development and remediation.

Some of the questions Trey tackles include:

  • "I would like to distribute a manufacturer's product under my own company name. Do I need to submit a 510(k)?"
  • "Can foreign companies submit a 510(k)?
  • "Besides the fees for paying a consultant to help me put this together, are there any other fees I should be aware of?
  • "How much does a U.S. Agent typically cost?"
  • "Do I need to register my facility before I submit a 510(k)?"
  • "Do I need to provide documentation that my facility complies with the quality system in my 510(k)?"
  • "Do I need to have my facility inspected to the Quality System Regulations before I submit a 510(k)?"

Need expert 510(k) assistance? At The FDA Group, we help you move through the 510(k) submission process quickly and efficiently. Our regulatory affairs consultants, many of whom are former FDA personnel, have years of experience working with and within the agency.

EPISODE #012 The Future of Life Science Talent Acquisition: Securing In-Demand Skills in a Competitive Market

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Earlier this year, Deloitte released its Global Life Sciences Outlook report, featuring a section devoted to "transforming the talent experience."

The FDA Group's CEO, Nick Capman, sat down with Larry Stevens, RAC, to unpack some of Deloitte's findings and what they might mean for life science teams looking to innovate their workforce strategies and navigate a hyper-competitive specialized labor market.

Read Deloitte's full report here (PDF).

Some key excerpts:

Page 29:

"Life sciences companies are still optimizing virtual ways of working, and other issues of concern for life science leaders in 2022 include:

  • What is our talent acquisition strategy? How do we secure in-demand skills and capabilities in a competitive market?
  • What are the “Great Resignation” effects on our company? How can we create a more meaningful talent experience?
  • How can we become a more agile and adaptable organization?"

"Life sciences companies that want to succeed in the future of work will need to be flexible in how work is done and how talent is sourced, trained, and managed. Human resources is also undergoing a massive transformation. Instead of trying to predict the future, leaders might consider how they can develop an open culture of experimentation, learning, and iteration."

Page 30:

"Throughout the next year, many life sciences companies will continue to grapple with how to solve these issues, and each will land in a different place on the spectrum. The 'Great Resignation' is calling for a 'Great Re-imagination', and a winning strategy includes creating value for workers as whole human beings and key stakeholders—including internal and external workers."

"Successful companies are no longer concentrating on just hiring the smartest people, but rather on having access to the smartest people. New workforce ecosystems include in-house employees combined with a diverse mix of external contributors—e.g., contractors, app developers, other gig workers, external partners and suppliers, and even software bots. According to recent research from MIT Sloan Management Review and Deloitte, only 28% of global managers feel they are sufficiently preparing to manage a workforce that will rely more on external participants."

"One agile strategy is to shift from a hierarchical structure to a more team- and networked-based approach that may combine internal and external workers into specialized or cross-functional teams."

Page 35:

"According to a recent Fortune/Deloitte CEO Survey, attracting and retaining talent in a tight labor market has ascended to the top of CEOs’ list of strategic priorities. Companies should reimagine work as a landscape of tasks and skills that dynamically evolves with business priorities."

EPISODE #011 FDA Revives Its Proposed Quality Metrics Program for Pharma


The FDA Group's Nick Capman discusses the recent news that the FDA is once again returning to its quality metrics program for pharma manufacturers.

EPISODE #010 Inspection Alternatives Are Driving More FDA Enforcement Actions: What It Means for Industry

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Product sampling and remote records requests accounted for most import alerts and drug GMP warning letters over FDA's fiscal year 2021. They may play a key role post-pandemic.  
 
As remote records reviews conducted during the pandemic accounted for a growing share of warning letters, experts have advised the industry to prepare for remote FDA oversight to continue even after routine site inspections resume and the pandemic recedes.  
 
The FDA, which historically relied solely on on-site inspections as a basis for drug adulteration warning letters, only based 28% of warning letters issued in the first 11 months of fiscal year 2021 on-site inspections, with 62% based on sample testing and 10% on remote records reviews.  
In this episode, we sit down with former FDA professional, Larry Stevens, RAC, to talk about how inspection alternatives may become a permanent facet of FDA's oversight program and what companies may want to consider doing to prepare accordingly.  
 
FDA official: Growing number of enforcement actions stem from inspection alternatives: https://www.raps.org/news-and-articles/news-articles/2021/11/fda-official-says-increasing-number-of-enforcement (RAPS)   
 
About Larry Stevens, RAC:
Larry has held almost every field position within FDA during his 21-year career with the Agency. He has over 18 years of experience in the medical device industry, rising from an RA Manager to Vice President of RA/QA/Clinical for major class III device manufacturers. He specializes in planning, creating, and auditing quality systems as well as creating clinical plans, including protocol development, case report form development, and implementing and managing clinical trials. He also assists in design control to meet FDA requirements. Larry is a professional speaker who regularly trains on all aspects of FDA requirements while offering practical, successful solutions to FDA problems.  

EPISODE #009 FDA's Domestic Biopharma Inspections Return to Normal

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From Endpoints News:

For the first time since March 2020, the FDA’s inspections of US-based biopharma sites have returned to normal, according to FDA acting commissioner Janet Woodcock.

“I’m pleased to say that as of this month, we’ve begun transitioning back to standard operations for domestic inspections while continuing to prioritize mission-critical work for foreign inspections,” Woodcock said. The return to normalcy will be welcomed by industry, which has grappled with a growing backlog of mostly surveillance inspections, although some of those delayed inspections have also delayed the approval of new drugs.

According to a report from FDA in May, an estimated 68 applications (including 48 for human drugs) have been delayed due to FDA’s inability to conduct pre-approval, pre-market, or pre-license inspections as of March. The agency said it postponed nearly 8,000 non-mission-critical surveillance inspections in 2020 due to the pandemic.

Surveillance inspections are routine inspections that monitor conformance to FDA requirements to identify quality problems and adverse trends, but unlike others, they’re planned in advance by applying established risk factors and statutory inspection frequency mandates.

Read the full article here.

EPISODE #008 Quality Management Review: Benchmarking Quantitatively!

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The FDA Group’s CEO, Nick Capman, sits down with Tobias Kuners of Koenders, Managing Consultant at Tob Management, to discuss his integrated approach to implementing and interpreting qualitative and quantitative metrics in the GMP and non-GMP sides of a life science business.

Tobias has worked with Biogen, Ipsen, Thermo Fisher, Kite Pharma, and Danone, among other companies, gaining hands-on experience in engineering services, equipment qualification, maintenance, supply chain, warehousing, and distribution. He has led the design, engineering, and construction of multiple facilities to meet cGMP requirements. He performs audits, identifies gaps, and develops remediation plans, working within organizations to assist with deviation investigations and CAPA implementation and to develop scientific, risk-based solutions. 

EPISODE #007 Addressing FDA's Inspection Backlog with Mary Denigan-Macauley, Director of Health Care, GAO

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The FDA Group’s CEO, Nick Capman, sits down with Mary Denigan-Macauley, Director of Health Care in the Government Accountability Office (GAO) to understand the situation the FDA finds itself in with respect to a formidable pandemic-induced inspection backlog, and what measures the agency may take to address it.

Mary joined GAO in 2001, managing a diverse portfolio related to science and animal health for GAO’s Natural Resource and Environment team. This work covered cross-cutting topics such as foreign animal diseases, antibiotic resistance, food safety, and emergency preparedness. Prior to joining GAO, Mary taught various courses in public policy and public affairs at Sam Houston State University, Troy University, and the Georgian Institute of Public Affairs.

Over the past year, Mary and her team at the GAO have published two FDA-focused reports:

EPISODE #006 FDA's Fraudulent Products Task Force and Operation Quack Hack Battle COVID Vaccine Scams

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The FDA Group’s CEO, Nick Capman, discusses the federal effort to thwart COVID-19 vaccine scams.

From FDA.gov:

"The FDA’s dedicated COVID-19 Fraudulent Products Task Force continues to monitor the market, including online, for fraudulent COVID-19 products, and the Operation Quack Hack initiative continues to leverage agency expertise and advanced analytics, resulting in the removal of hundreds of unlawful products from the marketplace. To date, the agency has uncovered nearly 1,300 fraudulent products, sent more than 160 warning letters, issued more than 270 abuse complaints to domain registrars, and sent more than 290 requests to various marketplaces to remove listings for fraudulent COVID-19 products.

The FDA will continue working with its state and federal partners to take appropriate action against bad actors who prey upon people seeking a COVID-19 vaccine in the midst of this global pandemic. The agency has gone to great lengths to ensure that the authorized vaccines available to the public are safe and effective."

Read the full article here.

EPISODE #005 What to Expect for the FDA's Regulation of Medical Devices & Digital Health Under the Biden Administration

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The FDA Group’s CEO, Nick Capman, breaks down the key points in a recent Morgan Lewis article laying out what to expect for the FDA's regulation of medical devices and digital health under the Biden administration.
 
Read the full Morgan Lewis piece here.
 
Need RA/QA/Clinical project or resourcing support? The FDA Group helps thousands of life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more and get the conversation started.

EPISODE #004 Clinical Outsourcing & Insourcing: Selecting the Right Model or Mix

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The FDA Group’s CEO, Nick Capman, sits down with Mark Shapiro, a Partner with biopharmaceutical consulting firm Pharma Initiatives, to discuss outsourcing and insourcing models in the current clinical R&D environment, and what to consider when selecting the right model or mix of models for a project.

Download the corresponding white paper and put these insights into practice: A Modern Guide to Clinical Operations Resourcing.

Mark is widely recognized as an expert on the business of clinical research and is frequently quoted in the press, including Outsourcing Pharma, PharmaVoice, and CenterWatch. His comments have also been featured in the New York Times and Raleigh News & Observer on topics pertaining to the business of drug development. His focus at Pharma Initiatives is growth and innovation strategies in clinical research, development, and medical affairs. He has led strategic planning, growth, and change management initiatives at many pharmaceutical, biotech, and clinical research organizations. 

Prior to joining Pharma Initiatives, Mark was SVP, Operations at a global CRO, where he was responsible for an operations team of about 500 drug development professionals in more than 30 countries, and a portfolio of more than 100 active clinical trials. He was previously a management consultant at Campbell Alliance in the Clinical Development and Medical Affairs Practice, where he worked with many global CROs and biopharma companies on R&D innovation strategy. Mark is a pharmacologist, holds an MBA from Duke University’s Fuqua School of Business, and has received numerous certifications in clinical research, regulatory affairs, and healthcare management.

Need RA/QA/Clinical project or resourcing support? The FDA Group helps thousands of life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more and get the conversation started.

Episode #003 What RA/QA/Clinical Leaders Should Expect From the FDA in 2021

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The FDA Group’s CEO, Nick Capman, sits down with Ben Locwin, Senior Consultant for Public Health Outreach at the CDC, and Executive Advisor for Valeocon Management Consulting, to discuss what life science leaders should expect from the FDA in 2021 as it pertains to quality system management, regulatory approvals, GxP compliance, and more.

Ben has extensive experience working with the FDA and international regulatory officials. His project work includes Pre-IND, NDA, Ph1-3, and marketed/post-market drug products, as well as PMA and 510(k) medical devices. Ben has trained FDA inspectors within their headquarters and has participated in the design of the FDA's Global Quality Metrics Initiative.

Need RA/QA/Clinical project or resourcing support? The FDA Group helps thousands of life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more and get the conversation started.

EPISODE #002 Inside FDA Pre-Approval Inspections with Former FDA Investigator, Christopher Smith

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The FDA Group’s CEO, Nick Capman, sits down with Former FDA Investigator, Christopher Smith to dive deep into FDA Pre-Approval Inspections (PAIs). Chris has more than 40 years of experience having held senior positions at the FDA, large and small pharmaceutical companies, and contract research organizations. 

Learn how PAIs are planned and conducted, how to prepare for them, and where to go to find helpful resources your team can utilize.

Need expert help with PAI preparation? Contact us to schedule a mock PAI or discuss other quality and compliance support. Learn more about our GMP Auditing services here.

Resources:

EPISODE #001 A Look at FDA's Pandemic Inspections Q&A Guidance

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The FDA Group’s CEO, Nick Capman, breaks down the FDA’s Q&A guidance on drug and biologic inspections during the pandemic, pointing out the important takeaways manufacturers should consider and prepare for. Read our blog post for a written breakdown of the key takeaways. We've also written on FDA's more recent guidance outlining its expectations for resuming normal manufacturing operations during the pandemic. Read that post here. Need expert quality system remediation assistance? Learn more and get in touch.

Resources:

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