Global Medical Device Podcast powered by Greenlight Guru

Recruiting top, elite quality assurance and regulatory affairs (QA/RA) talent in the medical device industry is challenging, but vitally important. Today’s guest is Mitch Robbins, managing director of The Anthony Michael Group. As a recruiter, Mitch joins Jon Speer on the show to break down five myths about QA/RA recruiting and discuss the dos and don’ts medical device companies should consider when hiring these professionals. Some of the highlights of the show include: - Myth #1: Recruiting isn’t necessarily the hiring manager’s responsibility, but also involves Human Resources (HR) or Talent Acquisition to own hiring decisions. - Myth #2: No time to invest in recruitment process to hire elite talent because so much time is spent micromanaging average performers. - Myth #3: Trust your gut feeling. It’s never wrong. You know an elite person when you see them. - Myth #4: Elite talent/top performers can’t be hired because our business can’t compete with perks and benefits offered by billion-dollar companies. - Myth #5: Elite talent is expensive. We can’t afford to hire them because money is their top consideration. The best of the best won’t work for peanuts. - Job Posts: Only 32% of people in the employment market are actively looking for a job, but up to 80% are open to opportunities. - Resumes should summarize role and outcomes delivered. Update regularly to create document that conveys a compelling and relevant story of contributions. - All Talk or True Talent: Conduct a test drive scenario to demonstrate and validate candidate’s actual skills. The cost of a mis-hire is 13 times the leader’s salary.

Which medical technology, product, or device are you focused on bringing to market that will positively impact and improve the quality of life? What are the obstacles and challenges you can expect to experience? How will you overcome those? Today’s guest is Devon Campbell, founder of Prodct, LLC, who joins Jon Speer to discuss the value equation for MedTech companies to elevate and escalate quality and improve value. Some of the highlights of the show include: - Data Process: Sooner than later, think through the deployment and infrastructure for a company’s quality management system (QMS) to generate quality data. - Quality Strategy Mindset: Learn to appreciate, understand, and demonstrate the value and purpose of quality data. - Due Diligence: Multiple reasons exist for MedTech companies getting their product or process into the hands of users sooner and serve as revenue source. - Deliver not just data, but extensive confidence in that data and in a way that end users and stakeholders value and trust, as well as reduce risk. - Quality data is not a one-time occurance. Reproduce and repeat data consistently for process validation and scalability. - How does QMS strategy inform and offer value? Provides ability to articulate and appreciate quality by knowing where you are and want to be with your company. - Elements to consider for a value equation include technology, quality infrastructure, go-to-market regulatory strategies, and data integrity.

Effectively managing suppliers, vendors, consultants, and other third party entities that provide products and services can be challenging. How, what, and when do medical device companies manage relationships between those in the company and those outside of the company? Today’s guest is Mike Drues of Vascular Sciences, who joins Jon Speer to review and discuss the details of supplier quality management. Some of the highlights of the show include: - What is supplier quality management? Anybody outside the main company that provides products/services that directly/indirectly go into medical devices. - Why supplier quality management is important? Manufacturers must use good judgement when establishing and meeting quality system (QS) requirements. - Necessary evil or supplier quality management failure? Used for years, Ethylene Oxide (EtO) sterilization for medical devices is now a public health emergency. - EtO is flammable, carcinogenic, and key ingredient in thermobaric weapons. Companies should identify and consider other options for valid sterilization. - Defining critical vs. non-critical is not enough. Use risk-based approach when assessing criticality levels of suppliers for your products and processes.

Do you have a regulatory strategy to help your company prepare for the new European Medical Device Regulation (EU MDR)? With the May 2020 deadline right around the corner, a main area of focus for medical device companies will be transitioning to the new European regulation. Today’s guest is Isabella Schmitt, regulatory affairs consultant with Proxima Clinical Research. Isabella joins Jon Speer in this episode to share what listeners need to do to prepare for EU MDR, despite the recently announced two-year delay of EUDAMED. Some of the highlights of the show include: - Why EU MDR? Effort to address uproar over ruptured implant devices with unknown materials that made some patients sick. - What is EU MDR? The purpose is increased focus on safety and the entire lifecycle approach, not only pre-market approval (PMA). - Compliant Equivalency: Isabella describes biological and technological factors, as well as data and test requirements for clinical use and support. - Preparation - First Step: Assess general safety and performance requirements (GSPRs) via gap analysis of existing, needed, and publicly available data. - Startup vs. Established Products/Companies: Understand compliance of GSPRs, intended use, description of device, standard of care, and alternative options. - EUDAMED: Medical database with access to and reporting of clinical investigation information, post-market surveillance, universal device identifiers (UDIs).

Depending on the level of quality and compliance, medical devices can impact patients’ lives for better or for worse. Fortunately, FDA recently announced plans to open up and expand participation for its Case for Quality Initiative. Today’s guest is Mike Drues of Vascular Sciences. We discuss the benefits and incentives for compliant and noncompliant companies to participate in the Case for Quality program. Compliance doesn’t necessarily ensure quality. Some of the highlights of the show include: ● Pilot Program Premise: Partnership between FDA, MDIC, and CMMI Institute to promote compliance and focus on true quality products and processes. ● Case for Quality is newer program with somewhat skewed participation from larger companies due to incentives favoring PMA Class III products. ● Case for Quality: Advantages for participating include being excused from routine FDA inspections when state of compliance was demonstrated previously. ● Making changes to positively impact PMA products involves challenging process to submit a supplement. Are regulatory requirements for changes necessary? ● Micromanage Case for Quality: Root cause for such regulations is to prevent shortcuts and oversee those that don’t know what or how to be in compliance. ● Why are some companies not in compliance? They should participate in the Case for Quality Initiative to learn what they need to do.

If you're like many in the medical device industry, you've probably had some questions at one time or another around the FDA's Design Control Guidance. And if you're anything like the guests on today's podcast, you've probably gone through a lot of trial and error trying to implementing them. Wouldn't it be nice if some industry vets were willing to sharing with you their proven best practices and top recommendations for implementing design controls at your medical device company, so you can avoid problems later? You know, the kinds of problems that could cost you months of runway or even stop your device from being approved by the FDA altogether? If so, today's inaugural episode of the Global Medical Device Podcast powered by greenlight.guru, is for you. Jon Speer is a medical device expert with over 16 years industry experience who's played a part in getting 40+ devices approved by the FDA, and he is the Co-founder of greenlight.guru. Michael Drues, Ph.D., is a prolific speaker and consultant to the medical device industry as well as being the President of Vascular Sciences. Join in to hear Dr. Drues and Mr. Speer share some perspectives, opinions, and experiences about various interesting aspects of Design Controls for the medical device industry, including the classic discussion about "research" versus "development" and when should Design Controls begin? They'll also cover a range of topics including: - How do larger companies take on acquisitions when there is little to no Design Control documentation? - Examples of how to manage up-classification situations, i.e., class I à class II or III and addressing Design Controls - When should Design Controls begin? - When to make the transition from "R" to "D" Buckle in, these guys really know their stuff about medical device product development and the nuances Design Controls can present.

Risk management for medical devices from a regulatory and product development perspective is the topic of today’s podcast. We take a look at a few tools to help in the process and liability as it relates to on-label vs off-label use (Some really interesting points on this topic). We suggest following the ISO 14971 standard which provides manufacturers with a framework to manage the risks associated with the use of medical devices. Another helpful guidance document is TR 24971 (Yea it’s not free, but probably worth the couple hundred dollar investments). If your product will be released in Europe, then it’s good to know the European version as well. FMEA is another popular risk management project tool and there are others available. We then discuss the on-label use versus the off-label use of a product, and admittedly the whole thing is a dilemma. From a product liability perspective, if legal counsel can show a manufacturer knew a risk associated with a product that they did not mitigate, then the manufacturer can be held to a higher level of liability. We dive deeper into the topic as we discuss: Setting a strategy regarding limiting discussion on use The difference between intentional and unintentional off-label use The meaning of unintentional misuse Staying focused on the intended use of the product When to push back with regulators Risk management can be overwhelming if you let it. Approach it from a process point of view and understand the documentation suggested. greenlight.guru is about to make following risk management so much easier, featuring a module that allows you to conduct risk management activities and integrate with design control activities all in one, cloud-based solution. Your hosts today for the Global Medical Device Podcast, Jon Speer and Michael Drues Ph.D thank you for listening as they continue to share how you can implement their proven strategies at your organization.

With nearly half a century of combine experience performing medical device Design Reviews between them; Michael Drues Ph.D., Jason McKibbin, and Jon Speer have the battle scars they want to help you to avoid. They peel back the lens on what has worked for them over the years and how you can implement their proven strategies at your organization. Design Reviews are clearly a topic that this group has some strong, and at times, counter intuitive thoughts on. In this 24 minutes episode, our experts really get down to sharing actionable tips and advice that your team can start using today to help improve your Design Reviews. They reveal their candid opinions and advice on a range of Design Review related topics including: • Why Design Reviews are important? • How do Design Reviews fit within Design Controls? • Explain the concept of an “independent reviewer” and why this is necessary? • When should Design Reviews take place? And how often? • What should not be included within a Design Review? • How are Design Reviews the same (or different) from a Phase Review? • What actionable tips & advice do you have to improve Design Reviews?

Superbugs. Reprocessing. The White House. And Design Controls. Probably not a combo of topics you see grouped together very often. But we have them all for you on today’s Global Medical Device Podcast. This is the 2nd edition in our series focused on Design Controls and related topics within the Medical Device Industry. During this episode, we’ll surface some interesting and potentially controversial views on the subject with our three industry thought leaders. If you’re like many, you may very well have already heard about the high profile superbug outbreak connected to reprocessing. You may also have already seen some of the industry’s reactions with lawsuits being filed, FDA alerts being issued...and even the White House getting involved. That’s where we kickoff today’s conversation with our amazing guests Mike Drues, Jon Speer and Jason McKibbin along with moderator Bill Loss. All three guests share some very insightful and through provoking responses to Bill’s questions like: 1. What’s the background behind this reprocessing tragedy anyway? 2. How do our experts see the responsibility panning out at the manufacture’s level as well as those ultimately handling the reprocessing? 3. Could better orchestrated design controls have potentially prevented this tragedy? 4. Do existing design controls apply to problems like this, and if they don’t, should they? 5. Was this problem a design control failure or possibly different steps that should have been handled during the design review process? 6. How do you feel the Design Verification and Design Validation process should fall into place? You’re going to want to listen closely because these guys really dive deep on some important and controversial topics.

Medical device design reviews - are more or less better? What about independent reviews? Are they necessary? How do you get one done? These are a few of the topics we touched upon in episode 3 of the Global Medical Device Podcast, How To Improve Your Medical Device Design Reviews. And they seem to have struck a nerve. That’s why today, we’re excited to release our first bonus episode, 3.5, so that we could expand upon these topics for you. One area deals with getting those independent reviews of your product done and the other concerns comments about slowing down during the product development process. Jon Speer and Michael Drues Ph.D felt they owed it to you to explore these topics on a deeper level in this bonus episode of the Global Medical Device Podcast. As we said, Medical Device Design Reviews are critical steps within your design and development process. If you’re a startup strapped for cash it may be difficult to have an independent review done. Getting that review can be challenging, but it still needs to be part of the process. One way to do so may be to have somebody who is part of a medical device incubator/accelerator that shares the same physical space as you assist in doing the review. Although it’s easy to say, but sometimes hard to do, medical device design reviews need to be a part of your planning. The second thing we wanted to further explore is Jon’s comment about slowing down during the product development process. That can be difficult when you are dealing with expectations from senior management or investors. Jon clarifies that his intent is to say, be more deliberate. Don’t be in such a hurry to get to the next milestone. Start with a project mission and keep the end goal in mind. Follow the structured process so that you can find problems early and often and correct them. Eighty percent of medical device companies have fewer than eighty employees. Depending on the nature of your failure, if your product fails, then your company fails, so it’s better to find problems sooner with a deliberate approach. Now grab some pen and paper because you’re going to want to take some notes in this 18 minute bonus episode where Jon & Mike really dive deep on a topic they brought back by your popular demand.