Global Medical Device Podcast powered by Greenlight Guru

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.

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.

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.

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.

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.

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.

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

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.

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?