Global Medical Device Podcast Powered By Greenlight.guru

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 regulatory compliances. Mike works regularly with the FDA, Canada Health, and other international regulatory agencies, and today he is sharing his insight on SR vs. NSR, as well as how this affects your development processes for your medical devices. Some of the topics you’ll hear about today include: - The difference between significant and nonsignificant risk, and how you can differentiate between the two. - Who decides whether a device has a significant or nonsignificant risk. (Hint: It’s not the FDA!) - Tips

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 of the stories and challenges that comes along with tackling the process for the first time. Some of the topics we will discuss today include: ●Alexei’s background and some information about Surgical Innovation Associates and what they’re working on. ●What led Alexei to take the step from being a surgeon to becoming a medical device developer and inventor. ●How Alexei’s approach to solving problems and looking for direction might be different than the typical approach, and his best tips for entrepreneurs who want m

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 advice for medical device companies who aren’t sure where to start. Our guest is Mike Drues, who has been on the show frequently. He’s the president of Vascular Sciences and an expert on medical device technology and regulatory affairs. You won’t want to miss today’s show, because it’s chock-full of insights on CAPA. Some of the highlights of the show include: ● The mechanics of a CAPA investigation or system, and what the results of addressing the problems in a product or process should be. ● Advice for new and

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 individuals with diverse backgrounds in medicine, law, engineering, and business. Andrews’s going to talk to us about their company’s story and some ways the organization has been successful going from a startup to where they are today. Some of the highlights of the show include: - How SimplicityMD has been working through the process of getting medical devices to market. - Some insight on how SimplicityMD has been able to accelerate and get products through quickly. - The importance of being deliberate and intentional

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 someone who works carefully with companies comply with pre- and post-market investigations, John is qualified to give some great advice, so you won’t want to miss the interview. Some of the highlights of the show include: ● The FDA’s role after market clearance is obtained and as it relates to imports. John talks about how the FDA interacts with devices after they are imported. ● Some thoughts on what is driving the increase of FDA import inspections. ● How an importer can get through the process of getting p

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. ● Where the FDA stands on the topic of usability and what types of guidance documents are available. ● How the topic is handled by international and world agencies in addition to the FDA, as well as how cultural differences can impact usability studies. ● The difference between a usability study and a clinical trial. A usability study is focused on the user and a clinical trial is focused on the patient, but today, the two are often one and the same. ● Why usability needs to be more “real-world.” Many times, what the engi

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 when design inputs go wrong, as well as designing your labeling like you design your device. Some of the highlights of the show include: - What design inputs are and why they are important. - Who comes up with the design inputs and why it’s a mistake to rely only on the technical people to create the elements of the device. - Why it might be inaccurate to say that a clinician knows exactly what they need in terms of a device design, as well as why it’s vital to ask the right questions of clinicians. - The importan

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 to listen to the show. Some of the highlights of the show include: - The connection between Medical Device Reports (MDRs) and complaints: Does one lead to the other? Sometimes it’s a two-way street. - Whether the current criteria for necessitating a CAPA should be investigated and maybe changed. - Why reframing the negative thought process behind getting a complaint into thinking about it as an opportunity can keep companies thriving and patients safer. - The importance of having a criteria for when an MDR or comp

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 comes to FDA regulation. Some of the highlights of the show include: - The FDA’s definition of a general wellness device, as well as Mike’s simpler definition. - What makes a wellness product low-risk, and what “low-risk” really means when it comes to both causing harm and the potential for providing incorrect information. - How to know if you’ve crossed a line with your wellness device and actually need to classify your product as a regulated medical device. Mike also gives examples to paint the difference more clearl

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 show include: ● The background of the Accreditation Scheme for Conformity Assessment (ASCA): When it came about, when it should be implemented, and what it’s going to be used for. ● How current politics have impacted the development of this new program. ● Some of the challenges that the ASCA will likely bring about. ● The importance of asking the right questions and running the right tests. ● Thoughts on what to do if a regulation or a particular type of test is not appropriate or not possible. ● The potential pitfal