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. Tod...
Nov 07, 2019•31 min•Season 1Ep. 19
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...
Nov 07, 2019•30 min•Season 1Ep. 20
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...
Nov 07, 2019•28 min•Season 1Ep. 21
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 Sa...
Nov 07, 2019•23 min•Season 1Ep. 22
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 ...
Nov 07, 2019•31 min•Season 1Ep. 25
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 consultin...
Nov 07, 2019•30 min•Season 1Ep. 24
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 includin...
Nov 07, 2019•32 min•Season 1Ep. 23
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. ...
Nov 07, 2019•21 min•Season 1Ep. 26
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 Biome...
Nov 07, 2019•27 min•Season 1Ep. 28
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 ...
Nov 07, 2019•32 min•Season 1Ep. 27
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 cu...
Nov 07, 2019•22 min•Season 1Ep. 31
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 pr...
Nov 07, 2019•33 min•Season 1Ep. 29
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 Scienc...
Nov 07, 2019•36 min•Season 1Ep. 30
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...
Nov 07, 2019•34 min•Season 1Ep. 33
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 be...
Nov 07, 2019•39 min•Season 1Ep. 32
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 o...
Nov 07, 2019•34 min•Season 1Ep. 34
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 o...
Nov 07, 2019•30 min•Season 1Ep. 38
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....
Nov 07, 2019•32 min•Season 1Ep. 35
Do you understand the difference between significant risk and nonsignificant risk when it comes to the development and design of your medical devices? It’s important to classify devices properly, and the difference between SR and NSR is not always well-defined. Today, our guest will help medical device companies differentiate between these two classifications. Mike Drues, president of Vascular Sciences, has been a frequent guest on our show. He’s an expert in compliance, medical technology and r...
Nov 07, 2019•34 min•Season 1Ep. 37
Medical device reporting, or MDR: what is it? What isn’t it? Why is it important? The FDA recently released a guidance on medical device reporting, and today we’re talking to Mike Drues, president of Vascular Sciences, about MDR and what it means to medical device companies. Mike is a frequent guest on our show and really knows just about everything there is to know about medical device reporting. Sit back and enjoy today’s episode of the Global Medical Device podcast. Some of the highlights of ...
Nov 07, 2019•32 min•Season 1Ep. 36
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 a...
Nov 07, 2019•38 min•Season 1Ep. 39
Does your medical device company import components, parts, or materials used in the development or manufacturing of new devices? There are specific procedures you must go through to get your imported products through not only the FDA, but also through United States Customs. Today’s guest is John Johnson, a senior associate attorney at FDAImports.com and the Benjamin L. England & Associates law firm. He will talk to us about some of the challenges associated with getting products into the USA. As...
Nov 07, 2019•31 min•Season 1Ep. 41
In today’s episode we continue our series on new breed medical device company stories. We talk with Andrew Hansen founder and managing partner of SimplicityMD, a lean and efficient organization focusing on getting new products to market relatively quickly while also addressing their quality and regulatory compliance. SimplicityMD develops simple medical devices that reduce health care costs and improve patient care. Their products are developed by a small team of creative and collaborative indiv...
Nov 07, 2019•21 min•Season 1Ep. 40
Today we’re going to be talking to our good friend Mike Drues from Vascular Sciences about the intersection of usability and risk management. There are so many tips and great pointers that you will not want to miss this show. Have a pen and paper or your note-taking device available, because this episode is chock-full of information that you won’t want to forget. Some of the highlights of the show include: ● What usability means and how it applies to the medical device production process. ● Wher...
Nov 07, 2019•31 min•Season 1Ep. 42
Today we are going to talk about the connection between complaints, CAPAs, and MDRs. They are all interrelated and they have a big part of developing your company’s culture and affecting your risk management processes. Mike Drues, president of Vascular Sciences and expert on all regulatory matters when it comes to medical device development and production, will be our guest today. Mike is a regular guest on the show, and our listeners know that he really knows his stuff. Be sure to take the time...
Nov 07, 2019•37 min•Season 1Ep. 44
Today’s guest is Mike Drues, the president of Vascular Sciences and a world-renowned expert on all things pertaining to regulatory topics in medical device development and production. Mike is a frequent guest, so I’m sure you’ve heard them talk about various regulatory and design topics in the past. Today they are actually going to be giving you a sneak-peek of subjects that both Jon Speer and Mike Drues will be talking about live at MD&M East in New York on June 14. They'll be talking about whe...
Nov 07, 2019•28 min•Season 1Ep. 43
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
