Global Medical Device Podcast powered by Greenlight Guru

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 the show include: ● Why the 2016 FDA guidance on MDR is so important to post-market surveillance. ● What types of events are supposed to be reported, including tips on trying to find the relationship between a device and potential adverse effects. ● The relationship between complaints and MDRs: The MDR is a subset of complaints, but not all complaints will lead to MDRs. ● Mike’s thoughts on the timeliness of the reports when it comes to severity and frequency of the adverse events. ● Why the FDA is putting out this new guidance now, even though the process has been around for a long time. ● Who counts as a manufacturer in terms of the FDA guidance. Mike answers whether dentists, hospitals and physicians must report problems according to the letter of the law vs. the spirit of the law. ● How reprocessors fit into the reporting requirements. ● Mike’s thoughts on why medical device reporting might eventually become a moot point.

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 on analyzing, documenting, and finding experts to help you determine whether you are dealing with SR and NSR, as well as tips on notifying the FDA through the pre-submission process. - Information about the Institutional Review Board and how they are involved in the SR vs. NSR differentiation. - Thoughts on running clinical trials outside of the USA: advantages, disadvantages, and practicalities.

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 permission, having the compliance checked, getting a customs broker, and the other logistics of importing a medical device. ● Tips on actions to take when various alerts and letters are received from the FDA. ● Common mistakes that you should try to avoid that importers often make. ● Why QSR inspections can make or break your ability to work with an international company. ● Tips for getting through the customs process, which is an issue separate from FDA approval.

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 while going through the process, as well as the importance of understanding the difference between designing and implementing systems. - How to prioritize the regulations. You don’t want to spend too much or too little time on regulatory tasks. - Thoughts on how to make a company more efficient and lean.

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 complaint should give rise to a CAPA. - How frequent reviews of a product line can help you track the root causes of various issues and see the forest through the trees. - Thoughts on risk management and the importance of having a sound risk management process can mitigate, but not eliminate, risk.

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 importance of thinking ahead to the verification and validation processes during your design process. - Why companies need to spend more time designing their labeling. - What labels need to include and why it’s so important to carefully consider everything that goes on it when you create your design. - Using caution when determining what the FDA says about advertising off-label uses of a product and how a mistake in this area could end up involving the FBI in addition to the FDA.

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 engineer intends is not how the doctor or surgeon will actually use the device. ● The importance of instructions for use and labeling, and how that relates to risk management. ● The relationship between usability and product liability.

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 clearly. - How marketing a wellness device as a 510k can be beneficial for label expansion purposes, as well as how marketing it first as a wellness device can improve the 510k process -- with a caveat as to how to handle the submission. - The importance of prudent engineering with wellness devices; the lack of regulation is not an excuse to cut corners or take shortcuts.

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 pitfalls of putting testing labs into a position where conflict of interest is a real concern.

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 completely unprepared for an FDA inspection years after their product went to market. ● The difference between not having the required information and having the required information in a format that’s unacceptable to the FDA. ● What companies can do to prevent problems with FDA inspections. ● The importance of knowing what you know and knowing what you don’t know and knowing the difference between the two. ● Why it’s so important to consider the root cause of troubles with FDA inspections. Many times, the root cause is a tick-the-box mentality. ● Best practices for being prepared for an inspection. ● Why an independent audit might not be an effective way to know that you’re prepared for an inspection, as well as tips on knowing whether your auditor is beneficial. ● Why it’s good to purposely inject a problem into your process to be sure that your quality control system will detect it. ● The importance of taking a holistic approach rather than only looking at issues one at a time.