Global Medical Device Podcast powered by Greenlight Guru

One important piece of documentation that medical device companies rely on to get them through the regulatory process is the premarket notification 510(k). Since the FDA will refuse to accept submissions that are missing the appropriate documentation, it’s vital to understand what this is and when it is needed. Today’s guest, Allison Komiyama, PhD, RAC, is a former FDA reviewer who is an expert in regulatory submissions, quality systems, and biocompatibility evaluation. She started her consulting practice, AcKnowledge Regulatory Strategies, in order to serve clients all over the world, large and small, who manufacture implantable and other patient-contacting medical devices. She received her Ph.D. in Neuroscience from Stanford University and her B.A. in Molecular and Cell Biology from University of California, Berkeley. Jon and Allison have a very insightful conversation on the 510(k) submission process with lots of actionable insights. Here are some of the specific topics you'll hear discussed today: - What happens to new submissions at the FDA, and where the 510(k) fits in - The “Refuse to Accept” policy: What it means and how it can be a positive thing - Where the FDA stands on “I promise” statements - Advice for companies using materials that require biocompatibility testing - Tips for design controls and 510(k) - Biggest mistakes that Allison has seen with 510(k) documents - The timeframe for getting your 510(k) through the FDA, and what factors it depends on If you found today's episode valuable, then you'll definitely get a lot out of the free webinar we're hosting with Allison on this very subject where she will be diving even deeper into this topic of FDA 510(k) submissions. In our free, 60 minute webinar, Allison will be sharing all her 510(k) submission insider tips, tricks and best practices to give you the best chance at receiving your clearance letter faster than your competitors. Go here to sign up for the webinar: http://www.greenlight.guru/webinar/fda-510-k-submission

Internal audits might be inconvenient and a bit nerve-wracking, but they’re also educational. The objective of an internal auditing program is to help you understand your processes and learn about opportunities for improvement. It also protects your company and ensures that your procedures are on par with the regulations. Today’s guest is Kyle Rose, the CEO of Rook Quality Systems. Rook is a company based in Atlanta which helps medical device companies in the pre-marketing and marketing phases. Kyle specializes in structuring internal audit program and today provides tips and pointers to our listeners. Topics you’ll hear about today include: - Best practices for effective internal audits. - Why an audit plan is necessary and helpful. - Things companies can do to make their internal audits more thorough than an FDA audit. - Tips for startups who have not yet implemented an internal auditing procedure. - Why it’s important not to outsource all of the tasks necessary to conduct the internal audit, nor to rely on one person to handle the entire internal audit. - How Rook Quality Systems can help medical device companies with the internal audit process.

When it comes to moving from the conceptual phase of developing a medical device and actually doing first in-human studies, you first need to prove that your device is safe and effective. The documentation that goes along with that can be cumbersome, but, as Michael Drues, today’s guest, says, it’s necessary to prove that what you’re doing is safe. Mike Drues is the president of Vascular Sciences. He consults with FDA, Health Canada and other regulatory bodies and also works with medical device companies to help them get their products ready for approval. He has the unique perspective of seeing medical device issues from both sides, because he works with regulatory agencies as well as development companies. Today we’re discussing the topic of first in-human studies and what needs to go into the development process before devices can be used on and in actual people. Some of the topics that you’ll hear discussed include: -Some of the logistics that go along with those in the proof-of-concept phase: how to meet regulatory and ethical obligations without constructing too many barriers. - The importance of objective evidence that a new device is safe, and how to balance that with the potential burden of documentation. - How to handle offshore trials if you want to submit the data later as part of your FDA regulatory data submission. - Hints on how to choose a country as a place to perform your offshore trials. - Tips on avoiding problems with the first-in-human study process. - How to handle the pre-submission process?

Agreement was reached on the eagerly awaited new EU Medical Device Regulations (MDR) and In-Vitro Diagnostics Regulations (IVDR) earlier this year. This represents the single largest regulatory change in the EU in decades and it will affect ALL device manufactures selling in Europe. The new MDR and IVDR are expected to be formally published any month now, and there will be a three-year transition period to be compliant. Today we’re talking to Richard Young, the managing director of Acclaim Biomedical Consulting. He’s speaking to us today about some of these changes in the EU. With over 20 year in the medical and in-vitro device regulation industry, Richard has good insight on what these changes are, how they came about, and how the new MDR and IVDR will affect medtech companies. Some of the topics you’ll hear about today include: ● An overview of what’s happening in Europe as far as MDR and IVDR. ● How these changes are impacting the burden of clinical evidence. ● How the periodic reporting regulations are changing. ● Richard’s thoughts on whether the EU regulatory processes will become more like the FDA processes. ● Whether there will be changes on how medical and in-vitro devices are classified. ● How software and technology is playing into the decisions made to change some of the regulations. ● Economic influences and impacts that have affected some of the changes.

What happens you need to make a change to a device that’s been cleared via 510(k)? We discuss the importance of decision making during this process and relevant guidance from the FDA. The FDA just released updated guidelines on procedures regarding changes to 501(k) devices and software. Such changes in design or manufacturing are very common in the industry, so it’s important to understand the regulations as it pertains to your device. Our guest today is Mike Drues, president of Vascular Sciences and international regulatory affairs consultant. He works with governmental agencies and medical device companies around the world. Some of the topics discussed today include: - New FDA guidance on changes to 501(k) devices and software - Difference between FDA draft and final guidance - Keeping track of changes to medical devices in a “letter to file” - Limitations to FDA guidance flowcharts - Ways to notify the FDA of a change - Multiple changes made to an existing medical device - Going above and beyond to introduce quality controls for device changes

Zebra Medical Technologies is part of a new breed of medical device companies. They understand the reality that the funding market for truly novel, innovative devices is tight along with a host of other hurdles so they are always looking for advantageous ways to get more done with less resources. Based in the heart of Silicon Valley in Mountain View and hatched out of work done in the Stanford PhD program, Zebra Medical is creating a novel imaging system to permit live cellular pathology with cutting tissue. Their aim is to transform patient care across multiple medical regimes, and their current focus is to improve the diagnostics and treatment of skin cancers. Today we’re join by Gabriel Sanchez, Zebra’s founder and CEO, and Kate Montgomery, their lead R&D scientist who both have quite the impressive backgrounds. Gabriel got his BS in Mechanical Engineering at MIT before getting both his MS and PhD in the same discipline at Stanford. Kate also received her PhD from Stanford, hers being in Bioengineering, and it was there at the Stanford PhD lab that they first met. Having spent the last two years developing their technology at the prestigious Fogarty Institute of Innovation, they’ve also discovered some great business insights, such as the importance of quality management, and how leveraging technology has enabled them to be more efficient and pass a quality audit with flying colors even though they were going through the process for their first time. Specifically, some of the topics you’ll hear about today include: ● Gabriel’s and Kate’s backgrounds that have led them to Zebra Medical Technologies. ● How greenlight.guru has helped Zebra Medical Technologies reach some of their milestones and put off hiring a consult or full time quality resource ● Kate’s experience during an audit: How she prepared, stayed confident and passed with flying colors even though it was their first time going through one ● What to expect to see and hear in the future from Zebra Medical Technologies. ● Some information about the company’s novel imaging system, which provides an alternative to the current method of surgical biopsies for live cellular pathology evaluation.

FDA Pre-submissions: They're a hot, timely topic. We had a recent episode on the pre-submission process, but because there is so much to know, we decided to have our expert speaker, Mike Drues, back to make sure our listeners have the information necessary to properly deal with the FDA. Regulatory non-compliance is one of the biggest risks that medical device companies face, and it’s so important to have a good rapport with the FDA and any other relevant regulatory agencies. Mike Drues is the president of Vascular Sciences. He’s an expert on regulatory topics, as he works with all different types of medical device companies in addition to working with the FDA and other regulatory bodies. Some of the topics that we discuss today include: - Why the pre-submission process has become such a hot topic. - The mechanics of the submission process. - The content of the pre-submission meeting and what questions should be answered. - Why you should not have expectations as to how long the process will take. - How early in the pre-development process you should contact the FDA. - Why the majority of submissions are rejected. - How this process can help you get through changes made post-submission.

Risk management: It’s a topic that needs to be navigated carefully by medical device companies. It’s been gaining a lot of traction in the industry, because some recent standards have focused on risk management. Today’s guest has seen companies take their risk management plan directly from their design controls and paste them into their regulatory submission forms. This is not a correct way to approach risk management, because it gives an incomplete picture. Mike Drues, the president of Vascular Sciences, has been a frequent guest on our show. Not only do we listen to him, but the FDA and Health Canada do, too, because Mike works with these regulatory agencies in addition to working with medical device companies. Today we’re talking about risk management. Mike has a three (plus one bonus) bucket approach to dealing with this important topic. Some of the ideas that we discuss today include: ● Mike’s systematic approach to risk management: three “buckets” he uses when developing his plans. ● How to measure, track and present the probability of harm of not using the device. ● Mike’s thoughts on using FMEA as a tool. ● The problem with equating misuse as off-label use, and what the difference is. ● Mike’s solution for facing the problem of liability pertaining to off-label use of a device. ● Why it’s important not to become a slave to whatever tool(s) your company is using when dealing with risk management.

IEC 60601 is a challenge for companies that are developing electronic medical devices. It’s wise to have a guide to help you understand and work through the process, and today we have a guest who will give you the guidance you need. Leo Eisner, founder and principal consultant of Eisner Safety Consultants, knows IEC 60601 inside and out. Leo has a great background in compliance, quality systems, and more. For nearly two decades, he has been heavily involved in the standards committees and has been working as a consultant. Eisner Safety Consultants helps clients get through the product safety and regulatory processes. Today he shares some great insights on the 60601 approval process. Some of the topics we’ll discuss today include: ● What makes the 60601 process different from the other regulatory compliance processes. ● Some of the details on the differences between creating a device for the ER vs. for home use and for use in other types of facilities. ● Tips on preparing for success when creating a timeline for getting through the 60601 process, as well as some of the steps involved. ● Differences between different types of safety labs and the criteria that’s vital to understand to help you make the right choice. ● What to do early in the process of product design and development to be sure you’re on the right track long before you get to the production phase. ● Why it’s vital to keep the 60601 standard in mind, not only when it comes to meeting the standards, but also when it comes to patient safety.

We’re in the last days of 2016, and it’s a good time to look back as we plan for the future. On today’s episode, Mike Drues and Jon go over the many happenings in the medical device industry over the past year. Mike is a frequent guest on our show, and today we will be talking about the year in review. Some of the topics you’ll hear discussed include: - Some of the significant guidance documents that were new in 2016, including one on medical device reporting for manufacturers. - Two guidances on when to submit a 510K and why these in particular are important. - General wellness devices: What they are and what makes them different from regulated devices. - Thoughts on the Use of Real-World Evidence guidance document. - Why the guidance on 3D printing is so impactful. - What might happen from a regulatory perspective in 2017, including more specific guidances and focusing on usability. - Thoughts on whether the FDA should be in the business of putting out guidance documents.