Global Medical Device Podcast powered by Greenlight Guru

Today on the Global Medical Device Podcast we have a very interesting and highly debated topic for you around research vs. development for medical device companies. We’ll challenge some conventional wisdom on the subject and dig into when ‘R’ should end and ‘D’ begin. Our guest on the show today is David Amor, a medtech/biotech consultant and mobile health entrepreneur. David is the founder of Medgineering, a consultancy specializing in implementing new quality systems, design control processes, and risk management for both startups and larger companies. Recently David also launched QuickConsult, an online consulting platform that pairs up medtech experts with startups or large companies. The online consulting model allows clients to work with the consultants of their choice who will help them understand their specific quality and regulatory needs. The subject of today’s episode is loosely based on a well written and thoughtful article David authored a few months back titled, “When does the ‘R’ end and the ‘D’ begin for medical device companies?” Jon and David touch upon a lot of the points in that post (which I encourage you to go read after listening to today’s episode) and really dig into why the conventional wisdom regarding ‘R’ and ‘D’ in medical device product development is often wrong. Specifically, today Jon and David get into: -Why should you start design controls early in development? -Are your thoughts about research wrong? -Will doing design controls early slow you down? -When do design controls ACTUALLY start? -How to view design controls as more than a paperwork heavy process. -The shift in traditional R&D roles. -What outcomes you should be focused on BEFORE research.

It’s time to break down the how and why of intended use and indications of use statements for your new medical device. On this episode of the Global Medical Device podcast we’ll explain the differences between these two statements and how you can design your labels around them. Mike Drues, Ph.D. is our guest today giving some great examples of these use statements and successful label designs. He’s the President of Vascular Science, consulting for medical devices and regulatory bodies like FDA, and he travels the globe to set everyone straight on medical device regulations. Your intended use and indications of use statements are integral to getting your medical device to market. These statements help insure your device meets regulation when used properly. If you want to bypass any hiccups in your marketing plan, you need to understand the key differences between these two statements: First, intended use is EXACTLY what your product is used for. Don’t focus on what it COULD be used for. Rather, define exactly what it is in as few words as possible. Second, your indication of use statement are the precise situations and reasons where and why you would use this device. Again, being very clear and definitive here is extremely important. “They think they understand what intended use means, but they really don’t…Intended use is all about what we say this device is to be used for, and indications for use is under what circumstances or under what conditions you would use that particular product.” – Mike Drues Mike Drues goes into what he calls “high level labeling” with tips on how to get your label to market with as few words as possible. Little words do matter, and sometimes it may take you 6 different use statements before you find the right ones that work for your device. Breaking down examples, using clear-cut definitions, and using a trick Mike calls “label expansion” are all ways you can use your intended use and indication of use statements to your advantage. “The single most important thing that people should remember is to apply the same concepts and philosophies that we learned as engineers to product design [and] apply that same kind of thinking to label design…and indication of use statements.” – Mike Drues Mike also discusses the reimbursement pathway and how it is often overlooked in the beginning of our development processes. Changing up when you approach regulation can really make it easier to design and write the right kinds of use statements, and focusing on regulation this early on will often make it easier for marketing further down the road. Tune in now to hear how these tips can be applied to you, your team, and your medical device. To get in touch with Mike Drues, find him on LinkedIn.

On today’s episode of the Global Medical Device podcast, we’re talking about the importance of incorporating business elements into your medical device product development process. When firms focus only on design controls, they may not experience the growth expected, which can lead to a surprisingly low bottom line. Today we are discussing this situation with Therese Graff, a partner with Strategy 2 Market, which is a boutique consulting firm located in Chicago specializing in new product development. “Design control is just good engineering practices... engineering common sense... The business case... allows me to define whether it makes economic sense to build the product.” - Therese Graff Therese has an impressive background in project management and project consulting. She earned her Bachelor of Science at the University of Illinois and her MBA at the University of Chicago. She’s a project management professional, certified with the Project Management Institute, and a new product development professional, certified by the Product Development Management Association. Her career history includes working with complex instrument project management, working as a project consultant for design teams, and, most recently, working with a Fortune 200 medical device firm to streamline design control processes. In our interview with Therese, you’ll learn about: - Factors to keep in mind as you begin the product development process. These include questions about your overall marketing strategy, reimbursement, and the regulations and standards of other countries (if you plan to eventually launch outside of the USA). - How to determine whether a particular product or design will make economic sense before you begin investing time and money into the project. - Free or inexpensive resources for small businesses, entrepreneurs or new product developers who might not have a team of experts or unlimited funds. - A sensible approach toward building a business case, including design control, documentation and prototyping.

Getting started in the medical product development process can be a huge undertaking. You might have an excellent idea, but maybe you’re unsure about where to start. Whether you’re just beginning to research, you’re starting to look for development partners, or you’re almost ready to start the manufacturing phase, having someone on your side who can advise you every step of the way is essential. Today we are talking to Meghan Alonso, the CEO of Imua Services, a company devoted to medical device product development firm, and host of the Inspired by Imua podcast. Meghan has a varied background in the medical field. She started out working with injured athletes during the time that she coached gymnastics. She began working at a general orthopedic rehabilitation clinic, and from there, she says she fell in love with medical devices and the impact that they were having on her patients. Since 2012, she’s been helping companies with their innovations. Meghan earned her B.S. from Texas A&M University and her M.Ed. from University of Houston, and she’s currently pursuing her MBA at Auburn University. On today’s podcast, Meghan will talk about: - Some of the “rough waves” that are common during the development process, including tight budgets and a lack of organization. - Tips on how companies can choose development partners. - Her podcast, Inspired by Imua, takes a three-pronged approach to helping those who are designing medical devices. She speaks to industry experts, companies who have already designed devices, and patients whose lives have been changed. - The types of services that Imua Services provides, which include one-on-one meetings with clients to guide them through the product development process. Imua can help a company formulate a slide deck, write up a regulatory plan, design the manufacturing processes, reduce their costs and identify the strategies and logistics that will go into sales. - And last, something special for the Global Medical Devices listening audience: a guide to the most common wipeouts in medical product development.

On today’s episode, we’re introducing the newest addition to the greenlight.guru team, Jessica Lyons. Jessica is a 2007 graduate of Rose-Hulman Institute of Technology and has worked in the medical device product development for nearly 10 years. She worked in custom integration at Beckman Coulter, then worked on getting medical devices transferred to manufacturing at CRI, a medical device contract manufacture. Jon and Jessica are discussing FDA inspections. “It doesn’t matter your size, shape or how long you’ve been around. You’ll go through an FDA inspection.” – Jon Speer No one looks forward to having the FDA come to inspect their facility, but you always need to be ready for it, as you might be subject to an inspection as frequently as every two years. We want to put your mind at ease by giving you information on how to best prepare for FDA inspections, which can take a minimum of five to seven days. “The FDA seems to find the one piece of information you wish they wouldn’t.” – Jessica Lyons Some of the topics you’ll hear about it in today’s podcast include: Jessica talks about her role at greenlight.guru, which is making sure the customers are successful, in whatever form that takes. - Why FDA inspections are high-stress. - How to prepare for an FDA inspection. - What to expect during your inspection? - Why the FDA nearly always finds potentially questionable items. - How to react if you receive a 483 warning letter. - What to do in order to resolve issues found during your inspection. - What FDA data is available to the public. Now if you liked today’s episode, then I know you’re going to find the free webinar we have coming up valuable. It’s titled, “How to Avoid and Respond to FDA 483’s and Warning Letters.” You can register for the webinar here: http://www.greenlight.guru/webinar/fda-483-warning-letter-response

Here’s a question for our listeners: When it comes to making sure your medical devices are safe and effective, is it more important to find the right answers or to ask the right questions? In this episode of the Global Medical Device podcast, we are delving into everything related to design verification and validation, which is often called the V&V. We discuss why V&V is so important, the major differences between verification and validation, how they fit into your approval process and more. Today we’re talking to a familiar guest and medical device expert Mike Drues, president of Vascular Sciences. “We need to focus on asking the right questions. V&V is all about demonstrating what’s safe and effective.” – Mike Drues Mike works for and consults with medical device companies located all over the world. He also works with the US FDA, Canada Health, and other regulatory and government agencies in the US, Canada, Europe and elsewhere in the world. “When working with the FDA, tell, don’t ask. Lead, don’t follow.” – Mike Drues In our discussion about V&V, some of the points you’ll hear about include: - Validation and verification: What do these two words mean, what are the major differences between the two, and how do they both fit into your approval processes? - How to know when you need to go to the FDA with a 510k form and when you can simply use a letter-to-file. - The importance of knowing why you’re running the V&V tests to begin with. - How you can use the Five Whys tool in your V&V process. - Why it might not make sense to go through the V&V process, and how to approach the FDA to come up with a different procedure to satisfy the regulatory requirements. - Advice on which questions to ask the FDA during the pre-submission process with the FDA.

As medical device developers, it is our responsibilities to make sure that our products are safe and effective. Unfortunately, the recent high profile cases of antibiotic-resistant superbugs spread by tainted endoscopes that have sicken many have called into questions whether there needs to be new regulations to prevent future infections. “If you have a device that is designed to be cleaned or reused, should not some of the design inputs include reprocessability requirements?” - Mike Drues Today we are speaking with a familiar guest Michael Drues, Ph.D. about the recently published guidance document released by FDA for reprocessable medical devices. Mike was one of several people who was invited to present at the panel meeting at FDA on this topic last year. “What good is the regulation if it’s not realistic?” - Mike Drues Mike is the president of Vascular Science, as well as a consultant for the FDA, Canada Health and other worldwide regulatory organizations and medical device companies. Due to his work with these organizations, Mike can see the issue from both sides: He understands the regulations and why they must exist, and he also knows that they need to be approached and implemented with real-world scenarios in mind. On today’s podcast, some of the topics we discuss include: - What happened in a landmark endoscope case from UCLA, and how it affects everyone in the medical device industry. - Who must be considered and included as the end users of a product. - The specifics of some of the new regulations, including new rules pertaining to UDI labels. - Thoughts on who should be handling the reprocessing validation. - Why over-complicated reprocessing manuals can do more harm than good. - Best practices for device development companies to keep in mind when following the new regulations.

If you are part of an organization developing or producing Class II medical devices, you should know that on September 24, 2016, your UDI submissions are due to the FDA. “I don’t mean to scare anyone, but we only have 78 working days left.” - Gary Saner UDI stands for “unique device identification,” and the new labeling regulations have been put into place to increase patient safety, reduce medical errors, and provide a foundation for secure global distribution of devices. Today’s guest, Gary Saner, is an expert on UDI submissions and other regulatory topics. As the Senior Manager of Information Solution at Reed Tech, Gary is speaking to us today about the UDI submission procedures and other relevant topics. “The UDI submission is not a one-time effort.” - Gary Saner With over 30 years’ experience in software management and data conversion, Gary is the go-to person if you have questions about UDI, and his company can help medical device companies of any size be sure that their submissions are in order. Some of the topics you’ll hear discussed on today’s podcast include: - What UDI is and what information needs to be included in each of its components. - The timeline of deadlines leading up to now and up to September 2016 as they pertain to different types of devices. - Some of the challenges that apply to larger and smaller companies when it comes to meeting the 9/24/16 deadline, as well as how the Reed Tech tool can help organizations of all sizes. - The importance of knowing and understanding the UDI submission process. - The two submission methods that the FDA has in place. - Tips and pointers to keep in mind as you go through the submission process.

3D printing can impact new product development and manufacturing. It’s a technology that is hot in many different industries, including medical device development. It’s been around for several decades, and now more than 85 devices are on the market that have been 3D printed, including a 3D-printed medication. While it’s not a new technology, there are new guidance considerations from the FDA on this subject. Mike Drues, President of Vascular Sciences, works with overseeing organizations including Health Canada and the FDA and helps people in the medical device industry navigate regulations. He’s worked with 3D printing for a long time, and he has a lot of valuable insight to share. Some of the topics that you’ll hear about on today’s episode include: ● Why 3D printing matters from an FDA standpoint ● Some of the advantages of 3D printing, and how it relates to personalized medicine. ● Some of the potential ramifications of hospitals and other medical providers becoming “medical device manufacturers” by using 3D printing on-site. ● A few common criticisms of 3D printing, along with Mike’s observations on how they can or will be overcome. ● Examples of real-world ways that 3D printing is being used currently. ● Tips for those who are considering using 3D printing technology for creating medical devices.

In order to get your medical device to market, you will need to know about pre-submission and the pre-submission process. The FDA is trying to get the safest medical devices out there. The most common reasons that the FDA makes rejections is within the submission itself. The indications for use statement is not the same as within the submission itself. “There is no bigger fan of communication with the FDA. But, there is a caveat to that. That is, tell don’t ask, lead don’t follow.” - Mike Drues Today’s guest, is Mike Drues from Vascular Sciences. Mike is a professional in medical device industry for 25 years will talk about the importance of the pre-submission of medical devices to the FDA. “We need to be able to go to the FDA with a well thought out development plan.” - Mike Drues Jon and Mike have a great discussion on how to use pre-submission to bring product to market. Here are some of the specific topics you’ll hear discussed today: What is a pre-submission and why is it important. - The power of pre-submission process and going beyond the guidelines. Common reasons why the FDA rejects a submission. - How to properly communicate with the FDA. - How early should you go to talk to the FDA about your medical device. - How to prepare for a pre-submission meeting with the FDA. - What are some other ways that a pre-submission can be useful for companies. If you found today's episode valuable, and need advice on pre-submission, Mike encourages you to get in touch with him. He is a great resource and is happy to give advice on how to use pre-submissions to get your medical device to market.