The Life Science Rundown

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.

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.

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 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.

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:

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.

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.  

The agency’s focus on quality metrics began in 2015 and continued with a heavily revised draft guidance on submitting metrics data, including quality-related complaints. The guidance led to two FDA pilot projects in 2018.  

In a new update, FDA stressed that additional quality data can help both the FDA and the supply chain, which needs to have a better understanding of which manufacturers are going above and beyond the status quo.

Current GMP compliance “does not necessarily indicate” whether a manufacturer is investing in improvements and striving for consistent control over its manufacturing performance and quality, FDA said.  

“To provide flexibility to manufacturers, FDA would focus less on standardization of quality metrics and definitions,” the agency said Tuesday. “Instead, FDA would identify practice areas that are critical to ensure sustainable product quality and availability and would permit manufacturers to select a metric(s) from each practice area that are meaningful and enable establishments to identify continual improvement opportunities.”  

Rather than set metric definitions on how establishments calculate particular metrics, the FDA said it will allow reporting establishments (i.e. API and finished dose manufacturers, among others) to select the most appropriate metric(s) from each practice area and inform FDA how the metrics were calculated.  

Based on feedback from the pilot participants, the agency said it identified four general areas as appropriate for its metrics program:  

Examples of quality metrics associated with each of these areas include (for area number 1) a metric on the proportion of lots manufactured without the occurrence of a non-conformance, (for area number 2) a measure of the proportion of recurring deviation measures, (for area number 3) a measure that indicates a lab’s ability to accurately perform tests, and (for area number 4) a measure of the extent to which shipments are delivered to their destination containing the correct quantity and according to the order’s schedule.  

As far as questions for industry, the FDA wants to know if stakeholders agree that reporting should be aggregated at an establishment level, and whether reporting at an establishment level would help facilitate the submission of quality metrics data by contract manufacturers.

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.  

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.  

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 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-specific reports:

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

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.

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.

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 35 years of experience having held senior positions at the FDA, large and small pharmaceutical companies, and contract research organizations.