Today Jon Speer and Mike Drues are going to be discussing general wellness devices. Mike is the president of Vascular Sciences, and he’s a guru on all things regarding compliance and medical device development. General wellness device development is relevant right now because they’re so popular and widely used in today’s health-conscious population. It’s important to understand what a general wellness device is, when it becomes a regulated medical device, and how the two are different when it co...
Nov 07, 2019•31 min•Season 1Ep. 45
Today on the Global Medical Device Podcast, we’ll be talking to Mike Drues, who is a frequent guest on our show. He’s the president of Vascular Sciences and a guru on all things related to regulatory compliance for medical device companies. We’ll be chatting about a new program that’s just been announced. It’s a pilot program on accrediting test organizations. The potential is that test compliance will be more consistent and that the process will be streamlined. Some of the highlights of the sho...
Nov 07, 2019•32 min•Season 1Ep. 46
Today, we are talking to Mike Fisher, who is the director of product development at the Global Center for Medical Innovation (GCMI). He deeply understands process and product development and has worked with some great companies both giant and small throughout his career. Mike is going to share some pearls of wisdom on process excellence and how it leads to product excellence. If you're involved in bringing new products to market, you won’t want to miss today’s show. Some of the highlights of the...
Nov 07, 2019•31 min•Season 1Ep. 47
My guest today is Juan Carlos Serna, the co-founder of Right Submission. If you have been in the medical device business very long you know that 510k submissions for the FDA are a long, tedious, frustrating, and all round painfully experience. Juan Carlos and his team are medical device professionals who spent the late nights writing and formatting 510k submissions just like the rest of us. The hours lost creating submissions for the FDA inspired Juan Carlos to build a software that makes 510k s...
Nov 07, 2019•31 min•Season 1Ep. 50
It can be confusing to know which submission type is the correct one for your particular development situation. Today we’re going to talk to Mike Drues, president of Vascular Sciences and regulatory guru, about what to keep in mind as you decide whether to use the 510(k), De Novo, 513(g), or Pre-Sub process. Some of the highlights of the show include: ● The difference between the 510(k) and the De Novo submissions and how to decide between them. ● An explanation of why the 510(k) submission proc...
Nov 07, 2019•32 min•Season 1Ep. 48
Have you ever considered the pros and cons of a PMA vs a 501(k)? Some of the considerations you must keep in mind are related to the path to market, but have you ever thought about competitive regulatory strategy? Going with the PMA approach might be a better business strategy than using the 510(k), despite the entrenched mentality that it’s a longer, more difficult road. Today we’re going to talk to regulatory guru, Mike Drues. Mike is the president of Vascular Sciences and he is well-versed on...
Nov 07, 2019•29 min•Season 1Ep. 49
Something that you might find surprising is the number of medical device companies that are simply not prepared for an FDA inspection. The bottom line is that you should expect to be inspected. Today we’re going to be talking to Mike Drues, the president of Vascular Sciences, about the lessons that companies have learned from their not-so-successful FDA inspections. You can learn from them, too! Some of the highlights of the show include: ● Jon’s story of a situation where a company was complete...
Nov 07, 2019•37 min•Season 1Ep. 51
Do you know the percentage of 510(k)s that are rejected by the FDA the first time? Shockingly, it’s 75%. The vast majority are rejected for poor substantial equivalence, which, as you know, defeats the purpose of the submission in the first place. Today we’re going to talk to Mike Drues, president of Vascular Sciences and regulatory guru, about some common mistakes that can sink your 510(k) submission. Some of the highlights of the show include: ● Jon’s motivation for writing an article about co...
Nov 07, 2019•37 min•Season 1Ep. 53
The topic of Real-World Evidence is generating a lot of discussion lately, especially after the draft guidance was issued last summer and the final guidance was issued in August. So what does Real-world Evidence mean for you and from a regulatory perspective? Today we speak with Mike Drues, President of Vascular Sciences, about how real-world evidence can help you develop products that will improve and save lives. Some of the highlights of the show include: ● Why medical device companies should ...
Nov 07, 2019•36 min•Season 1Ep. 52
Today we’re going to be taking the topic of risk management to the next level. We are talking to Jim Gianoutsos with Regality Consulting. We are going to explore some of the challenges with a company’s approach to manufacturing processes as they apply to risk management. Some of the highlights of the show include: ● Information about Jim’s background and about Regality Consulting. ● Thoughts on how risk is sometimes a box to check rather than an integral part of every discussion and every decisi...
Nov 07, 2019•21 min•Season 1Ep. 54
The topic of human factors can be confusing: How does it relate to design factors and risk? Why is it included in the regulations and how can this factor be handled? On today’s episode, we have Bryant Foster, the Vice President of Research & Design at Research Collective. Bryant applies the principles of cognitive psychology to the design of new technologies and is a great resource on the topic. Some of the highlights of the show include: ● What Bryant does as the VP of Research & Design...
Nov 07, 2019•36 min•Season 1Ep. 55
This past month, the FDA drafted a guidance on a quick path to approval as an alternative to the 510(k). The question is, is this really anything new? Today, we’ll be talking to Mike Drues, president of Vascular Sciences, and he’s going to help us all understand what’s different about this fast track and how it might benefit you. Some of the highlights of the show include: ● What the new draft is about and how long this fast track has really been around. ● Some thoughts on the ramifications for ...
Nov 07, 2019•29 min•Season 1Ep. 56
Do you have a firm grasp and understanding of what substantial equivalence means in regards to the 510(k)? Many don’t understand it; the evidence is the large percentage of submissions that are rejected due to a lack of demonstrating substantial equivalence. Today we’re talking with Mike Drues, President of Vascular Sciences about demonstrating substantial equivalence, so if you’re not rock-solid on the concept, you won’t want to miss this episode. Some of the highlights of the show include: ● E...
Nov 07, 2019•34 min•Season 1Ep. 57
What are the most common problems with the CAPA process? Today, frequent guest Mike Drues, president of Vascular Sciences and Jon are going to dive into that question and get you the answers you need and want. SOME OF THE HIGHLIGHTS OF THE SHOW INCLUDE: ● Why the CAPA process is such a big issue within the industry and why Jon wrote a column on it. ● What businesses are doing instead of focusing on CAPA and why this is one of the major problems with the process, as well as why a cross-functional...
Nov 07, 2019•40 min•Season 1Ep. 59
Are you ready for audits? ISO? FDA? Is your quality management system working the way you want it to? Is it still just a checkbox activity? Or, are you ready to elevate yourself to be a true quality professional? A quality management system should help us run our business better and produce safer medical devices. It should be built well and run well - effective and efficient. On today’s episode, we have Larry Mager, a senior advisor for UL EHS Sustainability. He shares a tool he developed called...
Nov 07, 2019•25 min•Season 1Ep. 58
When it comes to 13485:2016, are you scrambling to meet requirements? Are you trying to figure out the how, what, or when regarding its timeline? Or, maybe you just don’t know what you need to do. You are not alone because a lot of companies are behind. Don’t wait until it is too late. Now is the time to take action. Today’s guest is Kyle Rose, president of Rook Quality Systems, which helps companies achieve 13485 certification by using the Greenlight Guru’s Quality Management Software platform....
Nov 07, 2019•28 min•Season 1Ep. 62
When developing a new medical device, do you try to figure out the fastest and simplest way to get your product to market? As a product developer, do you explore a regulatory path? Or, are you afraid that may kill your idea? Mike Drues, president of Vascular Sciences, is with us today to do some premarket approval (PMA) myth busting and describes why a PMA path may not be as scary as you think. Some of the highlights of the show include: ● PMAs are reserved for the highest risk devices (Class II...
Nov 07, 2019•40 min•Season 1Ep. 63
Students offer hope for our future. They will be developing products that can save our lives, or at least improve our quality of life. We need to give them as much guidance and advice as possible. On today’s episode, we have Associate Professor Andrew DiMeo, who shares his mission and what he is trying to do with the biomedical program at the University of North Carolina and North Carolina State University. Some of the highlights of the show include: ● Andrew’s biomedical product development cou...
Nov 07, 2019•33 min•Season 1Ep. 61
