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In episode 9 of the Global Medical Device Podcast we’re joined by Mike Cremeans. Mike is the Vice President in the Healthcare and Life Sciences practice at Willis (the third best insurance broker in the world). His main function is that of a risk strategist, for FDA regulated organizations worldwide. He also is the man behind Willis’ Life Sciences Twitter accoun,t which is actually how we met, so be sure to check out some of the great content he shares over there at @WillisLifeSci. Mike’s passion is helping leaders of highly regulated organizations to identify and navigate risks so they can focus on strategically growing their businesses. Mike has been doing medical device work for about 20 years. He has some great stories stacked up from all his years in the field, and he was more than happy to share a great deal of it with us, along with some key pieces of knowledge, as well. For instance, he tells us his top two pieces of advice for a company that’s pursuing bringing a product to market, but isn’t currently engaged in some kind of enterprise risk activity. Today’s topics include: An overview of Mike’s role at Willis and what they do for medical device companies -How he helps people identify, quantify and manage their risks -The horror story of a company that didn’t engage in risk management -ISOs you should be checking out and their predecessors -Striving to always put out an amazing product -The importance of a disaster plan -“Common risk language" “The principals involved with product risk management are similar or maybe even the same principles that you’re employing from an enterprise risk management.” – Jon Speer

We’ve got a good one for you today. In episode #8 of the Global Medical Device Podcast we welcome back Michael Drues, president of Vascular Sciences. As many of our listen may recall, Mike does consulting for medical device companies, the FDA, Health Canada and other regulatory bodies. Today Jon and Mike talk about 510(k)s and some of the major mistakes some companies make when they get 510(k) clearance. Specifically, they talk about companies that get 510(k) clearance but don’t have design controls, risk management and don’t have a quality system. And it’s chuck full of actionable advice and takeaways. “70-75% of 510(k) and PMA submissions are rejected the first time.” -Mike Drues The FDA’s mission is to make sure the products we bring to market are safe and effective. The 2 areas of 510(k) submissions that are getting the most scrutiny are the substantial equivalents argument and the risk mitigation strategy. If you don’t have a rock solid argument and a bulletproof strategy you will probably be rejected. Early and frequent communication with the FDA is the key to success. “Design controls are nothing more than a synonym for prudent engineering.” - Mike Drues Today Mike and Jon talk about: When a 510(k) isn’t necessary Reasons for rejection of a 510(k) “Lead don’t follow, tell don’t ask.” Design controls Multiple Predicate Strategy / Split Predicate Strategy Risk Mitigation Regulatory checks Corrective Action/Preventative Action Plan “Physicians can kill patients one at a time but an FDA reviewer can kill patients thousands at a time.” -Mike Drues What can a company do if they’ve been approved for market but aren’t prepared? Conduct a gap analysis, figure out what you have, figure out what’s missing, fill in what’s missing and be upfront about it. Ask for help if you need it. Go to the experts. There is so much more we can do to help before, rather than cleaning up problems later, but, “It’s never too late to do the right thing.” -Jon Speer

On today's episode of the Global Medical Device Podcast, we’re discussing how startup entrepreneurs like you can remove the common regulatory obstacles your business faces and other tips and pointers you can use when developing new medical devices. Our guest today – Mitch Levinson – is the CEO of Cerebrotech Medical, and with over 30 years experience as a startup CEO and executive for companies that have IPO'd like ZELTIQ Aesthetics and Thermage, he knows all about the ins and outs of FDA regulation. His Number One Tip? Mitigating risks as early as possible. We discuss the ways you can reduce your risks and shorten your regulatory audits, and the best way to do that is to pick the right tech. Mitch also says to start early and meet with the FDA board as soon as possible so you know what parameters you need to meet ahead of time. And among these parameters, we also discuss more of Mitch’s insider tips, including… Holding early meetings with FDA to set your parameters right away Growing a quality system organically so you aren’t struggling through auditing later down the road Finding products that financeable so you can be backed by the investors you need Pursuing clearance in the US and the EU at the same time to speed up your approval process Building the right company culture so you have the most supportive employee team and board to keep your start-up running smooth Seeking FDA approval and mitigating risks go hand-in-hand in this industry. Tune in for Mitch Levinson’s insightful tips and tricks so you can start applying his advice to your startup today.

In episode 10 of the Global Medical Device podcast we welcome Matt Romey from the Azzur Group. Matt is a project manager for the Azzur Group and has been involved with many medical device projects. He was a founding employee and executive team member at GluMetrics, a venture-backed startup that raised over $67M. Matt has 20 years experience in the medical equipment design industry and has plenty of knowledge to share with new startups. During today’s conversation Matt and Jon will discuss the importance of Design Controls, which they both share a passion for. "Design controls are yes, required by law, but they also represent good business practices." - Matt Romey Matt believes so much in the importance of design controls that at one of his companies he had a line from the FDA Design Control guidance document taped to his wall that stated, “It is a well established fact that the cost to correct design errors are lower when errors are caught earlier in the design and development process.” "The 1 - 10 -100 rule. That's where if you catch it early in the process it may cost you a dollar to fix, then a little bit later in the process it will be maybe 10 dollars. Once you get into production... 100 dollars." - Jon Speer The most important thing to keep in mind while working on medical device design is user needs. These user needs will guide you to the right questions so that design inputs are effective and relevant. Today’s highlights include: ● Matt explains how good quality design control is just part of good business practices. ● You will hear why the classic “waterfall diagram” may not be the best guideline for a project. ● Why when you find design inputs, they need to be testable. "Design inputs should be a translation of your user needs to some sort engineering specification that can be measurable." - Matt Romey

If you are in the business of medical devices, then you must eat, breathe, and live quality management systems. In order to get to market and sell your products successfully, your quality system needs to be right-sized, and meeting all of the regulations can be one of the hardest hurdles to cross in this business. Our guest today is here to talk about how you can surpass these hurdles, and David’s insight and resources will help you manage your quality system in the best way possible. David Amor is a medtech consultant who’s behind the genius consultation firm at www.medgineering.com. And today he’s talking about exactly that: consultation for your quality management systems. Managing the quality of your products is something that needs to be taken care of when you’re starting your business. “The bigger your company gets, the more scrutiny you’re going to get from the FDA and the higher the expectation is from the FDA.” – David Amor That’s why finding the right-size system for you right now is extremely important. Tune in now to find out how you can build your business and your management systems at the same time. Today’s topics discussed: - What startups should do to succeed in the medical device realm - Understanding where your business fits within the field and the FDA’s regulations - Practical implementation of quality systems and its regulations - Finding the right size for your quality management system - How to manage your quality systems while still focusing on the development of your medical devices Resources mentioned: David built his consultation website – www.myquickconsult.com – exclusively for startups, giving you access to Med Tech execs who can answer your questions and give you reviews on your quality systems. Email David at [email protected] for a discount. And don’t forget to visit greenlight.guru for your quality management system needs.

Did you know ISO 13485 has been revised and approved in 2016? And is going to be published later this month. The quality management standard we’ve all grown to know is now being updated, and we’ll explain more on this episode of the Global Medical Device podcast. Today we’re joined by special guest, Mark Swanson. In addition to being a consultant for H&M Consulting Group, Mark has spent the last 4 years on the working group that wrote the new ISO 13485:2016. He knows all the insider details, and in addition to this podcast we’re doing a detailed webinar with Mark on the changes to ISO 13485:2016 and all the things you need to know it as the standard becomes live. Mark advises companies on quality management systems and business practices, and specifically he advises quality managers and other senior management in meeting industry standards and regulations for medical devices as well as general ISO management requirements. Be sure to check out Mark’s consulting group here. In this episode, Mark tells us the next steps to making the updated ISO 13485 an official published standard. It's important to have some solid info about the changes that are coming so people can get prepared and know the “why’s” about everything it brings. It’s been in the making for 4 years, so we’re obviously expecting this to be the best yet. Today you’ll be learning the single biggest change that people need to know about the new ISO 13485, and why it’s so important for global medical device companies to understand the topic of risk management as it applies to the updated standard. When it comes to ISO 9001:2015, there are no conflict or competing requirements between the two standards. Both ISO 9001:2015 and ISO 13485:2016 have the right hooks to hang additional requirements off of or whatever is necessary within the regulated environment to continue being consistent. They’ve truly been consistent with what the true requirements are. This new ISO 13485 is going to change the way medical device companies think and build products forever. We talk about controlling your processes, the things you need to know from a supplier control standpoint, its differences in structure, and what the timeline is for adoption. Essentially, we tell you all the things you need to know before making the switch. To get in touch with Mark, you can check out his website at hmcg.biz, feel free to shoot him an e-mail at [email protected], or give him a call at (763) 234-0727. In just a few short weeks we’re going to be hosting a webinar with Mark on Feb 9th, 2016 at 1:00pm EST, where we’ll go further in depth on all the topics we’re discussed today and the changes to ISO 13485 you need to be prepared for. You can sign up for the free webinar using this link: http://www.greenlight.guru/webinar/iso-13485-2016-changes

Standards are absolutely critical when you are developing a medical device. You need to understand why these standards are important when developing your product for your regulatory submission. You need to know what they are and understanding how to incorporate them as part of your design and development process at the beginning rather at the end. Today's guest Leo Eisner from Eisner Safety Consultants is a leading expert in medical device safety standards. He even has built a database to help you navigate the process. I encourage you to take a look. “The standards are rigorous and it’s for good reason.” - Leo Eisner Leo has over thirty years of experience in product safety and is a leading speaker and author when it comes to medical device safety. He knows quality systems, knows how to audit and test. He has recently released the “Standards Reconnaissance Database” so that medical companies can leverage his expertise. “Your indications for intended use [of your device] are directly impacted by the markets where you plan for your product to be used.” -Jon Speer Today Leo & Jon discuss: -How Leo’s career in standards began -Why standards are important -Why should I care about standards regarding my medical device -Standard IEC-60601 -Standards Reconnaissance Database -Benefits of standards -Updates to standards -Classifying your product, drafting a test plan, checking against standards "The most important reason you should care about standards is because of your regulatory submissions and your design process." - Leo Eisner Leo’s best recommendation when it comes to standards is to know your product well enough to know what standards apply early in the development process - from there you’ll know how much preparation and testing it will take. To get in touch with Leo please be sure to check out his website at Eisner Safety Consultants or feel free to shoot him an email at Leo at EisnerSafety dot com.

Another brilliant mind joins us today on the Global Medical Device Podcast. Peter Sebelius is the founder of Gantus.com and today we’ll talk medical device product development and project management. Peter is a certified PM and has vast experience in the industry and extensive knowledge of medical device standards. He is also a member of the joint working groups on ISO 13485 and Iso 14971. Today we’ll talk about lean management and agile as it applies to the development of medical devices. Can you be lean and compliant at the same time? “Medical device product development is far from a straight line.” - Jon Speer Knowing when to turn on the design controls is a delicate balance. Design controls should be a framework - they don’t necessarily need to stifle the creative process. It doesn’t have to be restrictive. “It was never intended in product management or design control to be changing technical solutions fundamentally while you’re in that process.” - Peter Sebelius Today we’ll talk about: - Can you be lean? - Finding the right balance with design controls - Using “TBDs” - Project Management and Design Controls as ‘best practices’ - “Guide for the Project Management Body of Knowledge” - “Shared responsibility is no responsibility” “You can’t write something down that you haven’t thought through well.” - Peter Sebelius Peter suggests that project managers should learn more about qualitative management and regulatory affairs. Make sure you know what’s good enough. Peter provides online training on risk management, project management and design control. You can find him and learn more at gantus.com.

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.

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 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.

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.