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Global Medical Device Podcast powered by greenlight.guru

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The Global Medical Device Podcast powered by greenlight.guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

The Global Medical Device Podcast powered by greenlight.guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
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Location:

United States

Description:

The Global Medical Device Podcast powered by greenlight.guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Language:

English


Episodes

Regulatory Tips & Observations from a Former FDA Reviewer

10/10/2018
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What are some recent trends and observations in the medical device industry regarding regulatory affairs and strategies? On today’s episode, we have Allison Komiyama of Acknowledge Regulatory Strategies. She shares her perspective on them, especially as a former FDA reviewer, current consultant who helps companies with regulatory strategies and submissions, and patient of life-saving medical devices. Some of the highlights of the show include: ● The regulatory path to get devices approved...

Duration:00:31:58

Questions to Ask Before Hiring Your QA/RA Consultant

10/3/2018
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Do you work with regulatory consultants to implement a quality system or 510(k), or perform other tasks? Are you asking your consultants the right questions? On today’s episode, Jon Speer talks to Allison Komiyama of AcKnowledge Regulatory Strategies about tips, pointers, and key questions to consider before hiring consultants to help you with quality and regulatory work. Many companies ask the wrong questions. Allison offers them the right questions to ask multiple consultants to find the...

Duration:00:43:37

What You Need to Know About The FDA CDRH Experiential Learning Program

9/26/2018
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FDA has a new program called, The Experiential Learning Program, which involves CDRH going to medical device companies, manufacturers, and service providers to discuss biocompatibility, in vitro diagnostics, clinical trials, and other areas. On today’s episode, Mike Drues of Vascular Sciences and Jon talk about the advantages and disadvantages of this program that encourages reviewers and companies to spend more time together. The better the reviewers understand the development processes...

Duration:00:31:12

Latest Updates on CDRH Standards Program & IEC 60601

9/19/2018
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Medical device standards seem to change and evolve all the time. Is it impossible to keep up with them? Do you know the latest and greatest when it comes to IEC 60601? FDA’s CDRH standards program? Consensus standards database? FDA’s ASCA pilot program? On today’s episode, we have Scott Colburn of the FDA and Leo Eisner of Eisner Safety Consultants to discuss what’s currently happening in the medical device industry when it comes to standards. SOME OF THE HIGHLIGHTS OF THE SHOW INCLUDE: ●...

Duration:00:45:11

15 Habits of Highly Effective Quality and Regulatory Professionals

9/12/2018
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Quality and regulatory professionals in the medical device industry have to deal with a lot. In this episode, Mike Drues of Vascular Sciences shares 15 of his highly effective habits and tips to help you lead your organization. You have an opportunity and obligation to explain the current regulatory structure in the industry - embrace it, don’t resist it! SOME OF THE HIGHLIGHTS OF THE SHOW INCLUDE: ● Poker Game: Relationship between a company and the FDA is like a poker game; even if someone...

Duration:00:42:44

Common Mistakes That Can Tank Your FDA 510(k) Submission

11/16/2017
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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...

Duration:00:37:17

Understanding How to Use Real-World Evidence for Medical Device Regulatory Decisions

11/8/2017
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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...

Duration:00:35:44

Lessons to Be Learned From Recent FDA Inspections

10/18/2017
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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...

Duration:00:36:27

Why the 510(k) Process Is So Stressful & How You Can Help Streamline It

10/11/2017
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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...

Duration:00:30:34

How Competitive Regulatory Strategy Differs from Regular Regulatory Strategy

8/30/2017
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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...

Duration:00:29:05

Comparing FDA Submission Types: 510(k) vs. De Novo vs. 513(g) vs. Pre-Submission

8/18/2017
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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...

Duration:00:32:24

How Process Excellence Leads to Product Excellence

8/2/2017
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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...

Duration:00:30:55

Understanding FDA’s Proposed Conformity Assessment Pilot Program

7/21/2017
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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...

Duration:00:32:17

Understanding the Difference Between a General Wellness Device and a Regulated Medical Device

5/31/2017
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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...

Duration:00:31:21

Understanding the Connection Between Complaints, CAPAs, and MDRs

5/24/2017
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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...

Duration:00:37:03

When Design Inputs Go Wrong + Design Your Label Like You Design Your Device

5/17/2017
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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...

Duration:00:28:04

The Intersection of Medical Device Usability and Risk Management

4/27/2017
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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. ●...

Duration:00:31:13

How FDA Interacts with Medical Devices When They Are Imported into the US

4/5/2017
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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...

Duration:00:30:54

How SimplicityMD Is Leveraging Technology to Help Get Their Devices to Market Faster

3/29/2017
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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...

Duration:00:20:42

An Overview of What Device Makers Need to Know About CAPA

3/15/2017
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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...

Duration:00:37:44