Global Medical Device Podcast powered by Greenlight Guru

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.

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.

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

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.

At greenlight.guru, we would like to continue our series on the new breed of medical device companies who are getting more done with less. Newer companies and entrepreneurs can have a lot of insight for all of us on what works, what doesn’t work, and what’s important to the people new to the industry. Today we are talking to Alexei Molodinow from Surgical Innovation Associates. He’s on his first journey through the medical device product development process, and today he is going to share some of the stories and challenges that comes along with tackling the process for the first time. Some of the topics we will discuss today include: ●Alexei’s background and some information about Surgical Innovation Associates and what they’re working on. ●What led Alexei to take the step from being a surgeon to becoming a medical device developer and inventor. ●How Alexei’s approach to solving problems and looking for direction might be different than the typical approach, and his best tips for entrepreneurs who want more than just “the common startup.” ●Alexei’s thoughts on quality vs Quality when it comes to medical device development and production. ●One of Alexei’s biggest frustrations (that turned into one of his biggest surprises) about the process of medical device development. ●What Alexei is hoping to see and accomplish in the future as he continues to work with Surgical Innovation Associates on medical device development.

Today we will be talking about a topic that seems to be an area of continual concern and, in some cases, struggle – CAPA. CAPA is an acronym for corrective action, preventative action. When there’s a problem with a process or a product, certain steps need to be taken so we can identify the issue, find a way to correct it, then determine how to prevent it from happening again. The process can be overwhelming, and today we’re going to go into in exactly what CAPA is, what the intent is, and some advice for medical device companies who aren’t sure where to start. Our guest is Mike Drues, who has been on the show frequently. He’s the president of Vascular Sciences and an expert on medical device technology and regulatory affairs. You won’t want to miss today’s show, because it’s chock-full of insights on CAPA. Some of the highlights of the show include: ● The mechanics of a CAPA investigation or system, and what the results of addressing the problems in a product or process should be. ● Advice for new and existing medical device companies who aren’t sure if their CAPA systems are going to meet FDA requirements. ● Some common mistakes that companies make when developing their CAPA systems and criteria. ● An overview of the CAPA process, including what might trigger a CAPA investigation, ways to get to the root cause of the issue, and the case study approach. ● Why being proactive (rather than reactive) is so important when it comes to CAPA. ● Thoughts on whether CAPA is being overused or underused, with data from the FDA. ● Why the thought and intent behind CAPA is more important than a set of checkboxes on a form.

How Phagenesis Is Using Regulatory Affairs as They Develop a Treatment for Dysphagia with Rebecca Sheridan What if regulatory affairs were not only viewed as a necessary burden, but actually help a medical device company? Our guest today thinks that is exactly the case. Phagenesis, a greenlight.guru customer, is a new type of medical device startup company with a fascinating story. Their products are transforming the lives of people with dysphagia by restoring neurological control of swallowing. Nestlé recently struck a deal to acquire Phagenesis as reported by The WSJ. Today Jon is talking with Rebecca Sheridan, Head of Quality Assurance and Regulatory Affairs at Phagenesis. Join us as Rebecca shares more about her background, the Phagenesis story and the role of regulatory affairs in the medical device industry. Some of the topics discussed today include: ● Rebecca’s professional background ● Differences between large and small medical device companies and joining Phagenesis ● Involving the whole team in regulatory affairs to make it work for everyone ● Using greenlight.guru as a tool at Phagenesis ● Advice for medical device startups ● Overview of Phagenesis and dysphagia treatments