Podcasts by Global Medical Device Podcast powered by Greenlight Guru

#327 Understanding the ROI of an eQMS from 2023-07-11T03:25

In this episode with Fran Cruz, Chief Customer Officer at Greenlight Guru, we explore the investment of a purpose-built electronic Quality Management System (eQMS). Some of the topics we explore...

#326 CSA vs. CSV: Modern Validation for Modern MedTech from 2023-07-07T09:00

In this episode, Sandra Rodriguez, an analyst at Axendia, dives deep into the complexities of Computer Systems Validation (CSV) versus Computer Software Assurance (CSA) in the MedTech sector. Sh...

#325 The Role of dFMEAs in Risk Management for Medical Devices from 2023-06-29T20:28

How can dFMEA and ISO14971 work together? This topic is controversial but essential, and today’s guest is more than capable of tackling it. Risk management is one of the top 3 reasons why the FD...

#324 Management Responsibility: The most important part of a QMS from 2023-06-22T19:11

Management responsibility is crucial to the success of a QMS… but what is it? What’s covered by the topic of management responsibility and who’s the responsible party? In today’s episode, you’ll...

#323 The Combination Products Handbook from 2023-06-15T23:05

Combination products are a difficult niche because they combine so many different elements. However, today’s guest literally wrote the book on the topic, and she’s joining the podcast to share h...

Leaning into Lean Documentation from 2023-06-07T17:32:23

What is lean documentation and how can you achieve it? Our guest on today’s live podcast is an expert on quality management systems, audits, and most importantly for today’s conversation, docume...

Cybersecurity and the Future of MedTech from 2023-06-02T14:23:28

The "Consolidated Appropriations Act of 2023" (more commonly referred to as the Omnibus Act) was passed and signed into law on December 29th, 2022. This amendment to the Food and Drug Cosmetic A...

How AI Can Help You Manage Risk from 2023-05-26T17:39:08

With the advent of new Artificial Intelligence (AI) tools, where is risk management headed? How are they affected by the changes? Risk management is essential and becoming more so due to increas...

Ad Promo and The Difference in Regulatory&Legal from 2023-05-24T16:55

What are the 4 buckets of information that MedTech professionals should consider when commercializing their device? Where is the line between perspectives when it comes to regulatory affairs pro...

The Tools that Make Clinical Investigations from 2023-05-12T20:40

What makes a clinical investigation run smoothly?

In today’s conversation, you’ll hear from Jon Bergsteinsson as we speak about electronic data capture for clinical investigati...

Complaint Handling with Medical Device Guru, Brittney McIver from 2023-05-03T16:34:24

What would you think about dealing with complaints all day? Today’s guest has some ideas. Brittney McIver is a Medical Device Guru at Greenlight Guru where she helps guide companies through the ...

Avoiding Potential Issues with your 510(k) Submission from 2023-04-27T19:33:56

When bringing a medical device to the market, it’s important to be aware of the fatal 510(k) flaw. In today’s episode, Mike Drues joins the podcast to discuss the potential issues the 510(k) pro...

Meet a Guru: Brittani Smith from 2023-04-20T18:41:51

What’s it like to become a Medical Device Guru? In today’s episode, you’ll meet one of our newer Gurus, Brittani Smith, and find out more about her role and journey working through UDI implement...

Why Building Supplier Relationships Is So Important from 2023-04-12T18:43:17

How do human relationships impact supplier management in the medical device field? Today you’ll hear from Taylor Brown, a Medical Device Guru and Manager of Onboarding and Implementation for Gre...

Systematic Literature Review for EU MDR from 2023-04-05T17:22:59

What’s involved in a systematic literature review for the EU MDR, and how should companies handle those steps?  In today’s episode, you’ll hear from Co-Founder and Operating Partner of Cite...

Building Your Design Controls (and Pitfalls to Avoid) from 2023-03-29T16:09:31

What do engineers need to understand about manufacturing? How can you apply that knowledge to design controls? On today’s episode, our guest Tom Rish covers the topic of Design Controls. Tom is ...

Most Common Problems Found During FDA Inspections in 2022 from 2023-03-23T19:17:13

Why do the same types of problems show up again and again in FDA medical device inspections? In today’s episode, Mike Drues joins the podcast to talk about the FDA's Fiscal Year Report for 2022 ...

V&V Activities from a Verification Engineer POV - How Hard Could It Be? from 2023-03-15T19:27:17

What’s the difference between design verification and validation, and why are these activities so important?

Today’s guest is Niki Price. Niki is a Medical Device Guru with 15 years of exp...

Understanding the'Compliance Manager'Role from 2023-03-08T21:32:22

What are the challenges in managing compliance and the difference between compliance and quality management positions? You’ll learn more by listening to today’s guest.

In today’s episode, ...

DHF vs. DMR vs. DHR: Understanding the Differences&How They Interact from 2023-03-01T22:41:57

DHF, DMR, and DHR are easy to mix up when you’re just using the abbreviations – they sound a lot alike! And they are connected. But it’s important to understand the differences between them as w...

How Communication Affects the Outcomes of Quality Activities from 2023-02-22T21:13:31

Why do quality professionals struggle with clear communication in writing? What’s the problem with jargon? These are some of the questions explored in today’s podcast.

Joining the show thi...

Part 2: The Theranos Loophole&Lab Developed Tests from 2023-02-15T20:48:45

In a continuation of the previous episode, Mike Drues joins the podcast to further discuss LDTs, IVDs, and how those related to the ongoing Theranos situation.

Mike is the president of Vas...

Part 1: The Theranos Loophole&Lab Developed Tests from 2023-02-09T20:01

What’s the difference between an LDT and an IVD and what does that have to do with the Theranos case? In this episode, we dig deep into this topic.

Mike Drues, a frequent returning guest t...

Implementing an eQMS after Switching from Paper from 2023-02-01T20:12:08

What’s involved in switching from a paper-based QMS to an eQMS? What kinds of difficulties do companies experience when making that change? Today’s guest will explain her experiences with making...

Essentials of Sterilization for Med Device Professionals from 2023-01-25T20:41:09

What tools do sterilization engineers need the most? What’s the difference between sterilization modalities? Those are some of the points that our guest will be talking about in today’s conversa...

UDI: 101 from 2023-01-20T20:55:07

What is UDI? Why is it important, and what does the implementation of UDI look like? If you don’t know, you probably should start learning, and in today’s episode, you’ll hear from two guests wi...

Quality Myths and Lessons Learned from 2023-01-18T21:16:04

What words cause the most problems in MedTech, and what situations should you be ready to handle when you work in Quality? Today’s guest wrote about these issues in his book and will be talking ...

Determining User Needs for Your Medical Device from 2023-01-13T20:21:57

What is a user need, and when should you start working on them? How can you figure out what the user truly needs – and by the way, do you know who the user is? These are some of the topics you’l...

Fraud in the Healthcare Industry&the Role of Whistleblowers from 2023-01-11T20:20:17

What does the False Claims Act do, and when does it involve medical devices? In today’s episode, you’ll hear from Jonathon Tycko, an attorney who represents whistleblowers. Jonathan is a foundin...

Auditing the Auditor from 2023-01-06T21:03:35

For some people, audits are terrifying. But today’s guest says you need to learn to love the audit process, and she shares information that can help you do that.

Sara Adams is a Medical De...

What is MedTech Lifecycle Excellence? from 2023-01-05T18:24:37

Why is the state of MedTech culture and tools the way it is? How should the industry be thinking about moving away from generic compliance and toward MedTech Lifecycle Excellence?

Jon Berg...

The Best of Jon&Mike Through the Years from 2022-12-28T21:39:02

Today’s episode is a little different than usual. This will be Jon Speer’s last podcast for Greenlight Guru, as he’ll be moving on to future ventures as of December 31st.

In honor of many ...

CDRH Proposed Guidance for FY 2023 from 2022-12-21T21:34:02

What are the proposed CRDH guidelines for the 2023 fiscal year, and why do they matter? How should you be thinking about them? Today’s episode covers the newly-released guidelines and addresses ...

Future of the Emergency Use Authorization (EUA): COVID, Monkeypox&Beyond from 2022-12-14T21:07:20

EUAs were less known before COVID than they are now. Between COVID and now Monkeypox, what has been learned about EUA, and where is it going as we move forward? Those are important aspects of to...

The Future of Healthcare&How We Get There from 2022-12-07T20:19:22

What kinds of possibilities exist in the future for healthcare? How can medical devices reach across different fields of medicine and provide a holistic patient experience in collaboration with ...

What"Exempt"Means with Respect to Medical Devices&Regulatory from 2022-11-30T17:54:07

How should you be thinking about 510(k) exemptions for medical devices? Do you know when things do and don’t qualify for exemption and how that intersects with how a device is classed?

Thi...

Developing a Regulatory Strategy from 2022-11-23T16:38:02

What is a regulatory strategy? And for that matter, what do people sometimes think is a regulatory strategy but isn’t? Those are the questions that today’s guest, Mike Drues, discusses as he beg...

We Achieved ISO Certification! Now What? from 2022-11-16T20:36:09

What are ISO 9001 and ISO 27001? Once you have them, what can you do with them? These are the questions you’ll hear Mark Alpert answer in today’s episode.

Mark Alpert is the Director of Qu...

The Future of Reprocessed Used Medical Equipment from 2022-11-10T21:03:06

What’s accelerated the growth of online healthcare device sales, and what’s the future of regulation regarding selling used medical devices? In today’s episode, we spoke with Scott Carson on the...

The Importance of Cervical Cancer Screening in the U.S. from 2022-11-04T15:30

The importance of cervical cancer screening in the U.S.Why is cervical screening so important in the U.S. and globally? And how has the pandemic affected that screening? 

Today’s epis...

Customer Discovery for Medical Device Companies from 2022-11-02T04:00

What is the customer’s ecosystem, and why do you need to know about it? In today’s episode, we spoke with Kari Haab about Customer Discovery for Medical Device companies.

Kari Haab has bee...

EUA and the Impending Transition from 2022-10-26T04:00

There’s a transition underway for devices that are currently under an EUA. People may not realize it, but this EUA, which was put into place under COVID, covers more than just COVID-related devi...

Common QMS Mistakes SaMD Companies Make from 2022-10-20T21:06:35

What pitfalls do SaMD companies run into when they set up their QMS? How can your company avoid making these QMS mistakes? 

Today’s guest, Karandeep Singh Badwal, is a Regulatory Affa...

Design Assurance: The Unsung Heroes of R&D from 2022-10-13T15:42:09

What is design assurance, and what function does it serve in the overall product design process? It’s not a role that gets a lot of upfront credit or name recognition, but it’s an important part...

Lessons from an Industry Leader: Playing the Long Game of MedTech from 2022-10-06T15:13:11

What does it mean to let your values and principles guide you through the challenging times, including the black swan events? Just what is a black swan event anyway? Will you know what it is if ...

7 Common 510(k) Mistakes and How to Avoid Them from 2022-09-29T13:25:48

The 510(k) is the workhorse of regulatory submissions to the FDA from the medical device industry in the United States. However, 510(k)s continue to be the source of problems, delays, and reject...

Best Practices for Clinical Evidence Management from 2022-09-22T18:06:19

How do you bring a medical device through the development process? What are issues that development engineers face during the different phases of the design controls process, especially when res...

Building Your Regulatory Strategy for Commercialization from 2022-09-14T16:57:10

What should early-stage entrepreneurs and medtech companies consider with commercialization in relation to how regulatory strategy affects business roadmap, pitfalls companies fall into, and fun...

Packaging Validation Best Practices from 2022-09-07T19:19:29

The packaging of medical devices, especially sterilized products, is often overlooked and does not make news headlines until it’s done wrong. How can packaging and labeling prevent 510(k) delays...

Overcoming Submission Deficiencies due to Biocompatibility from 2022-08-31T20:38:24

What are submission deficiencies due to biocompatibility and how do medical device companies overcome them in trials, studies, and regulatory post-market surveillance?

In this episode of t...

Does Your CAPA Process Need a CAPA? from 2022-08-24T15:37:24

Have you done Corrective and Preventive Actions (CAPA) on your CAPA process? If not, you need to seriously consider doing so because CAPA is the #1 reason why companies get 483 observations year...

UDI and the Current State of Global Implementation from 2022-08-17T20:10:05

What is the current state of unique device identification (UDI) in the United States versus the European Union (EU)? What are the current deadlines, complexities, and differences, as well as the...

The Changing Job Market&How It Affects Careers for MedTech Quality Professionals from 2022-08-10T18:24:33

How is the changing job market affecting careers for professionals in MedTech? How can video storytelling strategies and techniques impact talent access?   

In this episode ...

Digitizing your SaMD Testing from 2022-08-03T17:19:27

What is software as a medical device (SaMD)? How does one test SaMD? What testing is required? What are the risks related to your SaMD and its testing?  

In this episode of the G...

Examining FDA’s Refusal to Accept (RTA) Policy and Guidance from 2022-07-27T17:13:49

After three “Refusals To Accept” Guidance Documents from the FDA, why are there still so many submission issues? Who’s to blame? Learn from other people’s mistakes.  

In this epi...

Guerilla Tactics for Quality Leadership from 2022-07-20T18:35:31

What are guerilla tactics for quality leadership? How do you implement a lean quality management system (QMS) and put requirements in place that are truly required - especially when there is the...

Preventing the Death of Medical Device Sales from 2022-07-13T18:52:10

The medical device sales industry is slow to change. It’s behind on how hospitals and physicians adopt and adapt to buying, sales strategies are out of date, and increased costs are leading to d...

Shifting Sands of SaMD Cybersecurity Regulations from 2022-07-05T20:11:21

FDA has issued new draft guidance on cybersecurity for software as a medical device (SaMD). If the FDA releases that draft guidance ‘as is,’ it will massively and negatively impact the SaMD indu...

Early Stage Territory Planning for Medical Device Companies from 2022-06-29T18:29:31

Do your field teams still rely on map, spreadsheet, and note apps? How medical device companies have historically generated sales is no longer adequate for selling medical devices in today's mar...

Regulatory&Quality Perspectives of 3D Printing in the Medical Device Industry from 2022-06-22T19:36:10

What are the differences between 3D printing and additive manufacturing? What are the quality and regulatory considerations around 3D printing? What is FDA’s approach to whether or not this tech...

What Impact Does a QMS&Regulatory Have on Fundraising and Pre-money Valuation? from 2022-06-16T17:40:06

How does a quality management system (QMS) and regulatory factors impact fundraising, pre-money valuation, market access, and commercialization for medical device companies?

In this episod...

Early Feasibility Studies in Latin America from 2022-06-08T18:34:51

Colombia represents an untapped destination for early feasibility, first-in-human clinical research for companies to first enter the Latin American market and sell medical devices.   Listen

Software Bill of Materials (SBOMs)&Cybersecurity in the Medical Device Industry from 2022-06-01T19:38:24

In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Ken Zalevsky, Certified CyberSecurity Leader and CEO of Vigilant Ops, about software bill of materials ...

Approaching Cybersecurity&Usability as a SaMD Company from 2022-05-27T20:56:08

How do you balance security and usability of software as a medical device (SaMD)? It’s not easy and trade-offs may need to be made by device companies in order to give users what they want and n...

The Future of Lateral Flow Test Technology from 2022-05-25T17:14:41

How many COVID tests have you taken at home, in hospitals, or at drive-thru clinics? Are you sick and tired of the long wait times to access the tests you need? Do you worry about whether you fo...

Building a Culture of Quality from 2022-05-20T18:11:26

How do you build a company that puts culture before function? Results before profit? Building a culture of quality to improve lives for a better world is more than just a slogan, it's a shared m...

Bringing Medical Devices into the Home from 2022-05-18T19:17:57

Are you passionate about human-centered design and how it relates to health care? Patients deserve a high quality experience when bringing medical devices into their home. They want a product th...

Demystifying the De Novo Process from 2022-05-12T18:37:46

How do you navigate the De Novo process for your medical device? When do you decide to go that route rather than with other FDA submission pathways, such as Q-Sub, 510(k), premarket approval (PM...

Challenges for Regulatory Submission: EU vs. US from 2022-05-06T17:37:48

What are the regulatory pathways used in the United States versus the European Union (EU)? Dealing with regulators can be challenging and emotionally draining. Win in the U.S. and EU marketplace...

From Startup to Industry Leader: LIVE RECORDING AT SCBIO CONFERENCE from 2022-05-04T14:37:54

Have you ever played the game, Operation? The patient’s nose would light up and buzz if your tweezers touched the side. Neurophysiology is a lot like that game.

In this episode of...

The Future of Cybersecurity from 2022-04-29T20:35:34

What will the future be for software as a medical device (SaMD) and cybersecurity? Manufacturers need to identify cybersecurity issues with their medical devices because incidents have become mo...

Achieving Operational Readiness through Good Project Management from 2022-04-27T18:43:42

In this episode of the Global Medical Device Podcast Etienne Nichols talks to Patrick Hayes, Associate Director of Program and Project Management at Commissioning Agents (CAI), about how to achi...

Bridging the Gap between Medical Devices and Clinical Data from 2022-04-20T18:47:01

Selling a medical device in the EU? Understanding the importance of clinical data and what's required will be crucial to your success.

In this episode of the Global Medical Device Podcast ...

Navigating the Medical Device Single Audit Program (MDSAP) from 2022-04-13T15:44:14

Navigating the Medical Device Single Audit Program (MDSAP) may cover most of your regulatory requirements; however, it does not mean that your product will automatically be cleared or approved b...

Bringing Augmented Reality MedTech to Market from 2022-04-06T21:31:47

Today’s innovative medical technology is more like a video game and makes a minimally invasive ablation so easy it could be done by a 12-year-old.

In this episode of the Global Medical Dev...

Making Your Informational Meetings with FDA Valuable & Worthwhile from 2022-03-30T19:20:31

What are informational meetings with the FDA, why should you schedule them, and how should they be conducted to make them valuable and worthwhile? It’s never too early to engage, interact, and c...

Building Your Bill of Materials (BOM) to Accommodate Crossfunctional Needs from 2022-03-23T17:24:37

For many new medical device professionals a bill of materials (BOM) may feel like a big black box. Who owns it? How does it function within a QMS? How is it used differently in design versus in ...

QMSR: The Future of FDA's Quality Management System Regulation for Medical Devices from 2022-03-16T15:50:07

FDA has proposed a new rule to align its Quality System Regulation (QSR) with ISO 13485:2016, the international standard for medical device quality management systems. How will, what's being ref...

How Medical Device Intellectual Property Protection Varies by Sector from 2022-03-09T19:36:03

When developing a product in the medical device space, how does intellectual property (IP) protection work in the private sector versus at an academic institution, like a university? When is a p...

Human Factors & Risk Management: What's Needed & Why? from 2022-03-02T18:35:53

Don’t give up on risk management. It’s the backbone of the product development lifecycle and human factors is one of its most important activities. It serves as a tool to guide development, allo...

What are the Opportunities for Improvement (OFI) for Quality? from 2022-02-23T17:47:58

What are the shortcomings, obstacles, and challenges when it comes to quality? Are there opportunities for improvement (OFIs) for quality? The regulatory and quality landscapes within the medica...

Overcoming Barriers to Receiving 510(k) Clearance: One Company's Go-to-Market Triumph from 2022-02-16T20:38:07

They say eyes are windows to the soul; that studying someone’s gaze can reveal their innermost emotions. But what can the eyes reveal in a neurological sense, particularly when tracking abnormal...

How to Select a Contract Manufacturer from 2022-02-02T18:43:03

What is the best way for medical device professionals, early-stage, and established companies to select and engage with contract manufacturers? One medtech expert has a winning formula that he w...

A Regulatory Gap Analysis of FDA's Systems & Policies from 2022-01-26T19:41:59

What’s missing in the current FDA regulatory framework? Are there areas and opportunities for improvement?

In this episode of the Global Medical Device Podcast Greenlight Guru founder and ...

Greenlight Guru Acquires CanvasGT: A Fire(less)side Chat from 2022-01-19T15:36:44

How can early-stage medical device companies improve product quality, increase creativity, get to market faster, and increase new product introduction success for safer and more effective medica...

Tips for Being Prepared Post-EUA (Emergency Use Authorization) from 2022-01-12T19:13:59

Does your company have products that were granted emergency use authorization to get to market? Assuming you want to keep those products on the market post-EUA, do you know what you need to do n...

Understanding the UDI System for Medical Devices from 2022-01-05T21:06:23

Do you understand how the Unique Device Identification (UDI) system in the medical device industry works? The overall concept can be best understood by learning how it is used and why it exists....

Shaking Things Up: What's Next for the Global Medical Device Podcast from 2021-12-16T15:17:24

Global Medical Device Podcast host and founder of Greenlight Guru, Jon Speer, always says he has the best job in the world. He gets to talk to amazing medical device professionals and hear about...

How Augmented Reality (AR) is Revolutionizing Healthcare from 2021-12-08T22:02:01

Technology can accelerate the transformation of healthcare to improve health, quality of life, safety, and security. Augmented reality (AR) is finding its way into the healthcare ecosystem and t...

Why FDA is Prioritizing Clinical Decision Support Software & Why You Should Care from 2021-12-01T21:31:39

At the top of the FDA’s agenda for the next 12 months is clinical decision support (CDS) software — what is it, why now, and why should those in the medical device and other life science industr...

Why Usability Matters from 2021-11-24T15:12:38

Usability is essential. If you design something, anything used by humans, it needs to be designed for the users. This is especially true for medical devices.

In this episode of the Global ...

A Special Glimpse into Medtronic's Recent Developments in Spine & Biologics Technology from 2021-11-17T19:10:59

Do you want to alleviate pain, restore health, and extend patients’ lifespan? Accelerate the transformation of the spine industry by making outcomes and technologies standardized and reproducibl...

What are the Top Compliance Issues Plaguing Medical Device Manufacturers? from 2021-11-10T18:42:48

Medical device companies must comply with a list of strict requirements throughout the duration of their product's lifecycle. These compliance efforts will be put to the test once an FDA inspect...

Setting the Record Straight on Usability & Human Factors from 2021-11-03T14:45:05

What is usability? Human factors? Are they one and the same or different in the medical device industry? When do each apply? Whatever you call it, both are very important in virtually all medica...

Project Management for Product Development of Medical Devices from 2021-10-27T17:45:08

What is the best way to approach project management (PM) for medical device product development? Don't settle for the trial and error method, turn to the experts with proven best practices for m...

Assessing the Global Regulatory Landscape from 2021-10-20T21:21:13

With medical device regulations tightening around the world, especially in Europe, it's important to assess the changes unfolding across the global regulatory landscape in order to fully underst...

Quality Insights from a 40+ Year Veteran of the Medical Device Industry from 2021-10-13T20:34:07

In this episode of the Global Medical Device Podcast, Jon Speer talks to Herschel “Buzz” Peddicord, founder and CEO of InControl Medical, which designs and manufactures patented devices for the ...

When to Throw the Least Burdensome Flag on FDA from 2021-10-06T16:25:12

What if you submit your 510(k), IDE, or other submission type to FDA only to get an additional information request (AI request)? What do you do for requests that seem overly burdensome? Thanks t...

Past, Present, Future State (and World) of Quality in the Medical Device Industry from 2021-09-22T18:20:37

Quality is a concept that is often overcomplicated in the medical device industry. With complexity comes mistakes, which is why it's so important for manufacturers to simplify!

In this epi...

Focusing on the Intent of the UDI Requirements from FDA's Final Guidance Doc from 2021-09-15T20:22:55

When the Unique Device Identification (UDI) system was first announced by FDA several years ago, the accompanying draft guidance left much ambiguity and confusion among manufacturers who struggl...

Addressing the 'Who, What, When' of Quality in the Medical Device Industry from 2021-09-08T19:40:07

There are many schools of thought when it comes to the 'who, what, and when' of quality management for medical devices.

In this episode of the Global Medical Device Podcast Jon Speer talks...

Meet a Guru: Maryann Mitchell from 2021-09-01T20:42:21

What makes Greenlight Guru unique and sets it apart from other medical device solutions? It’s Guru edge⁠—a team of medical device professionals with a ton of industry experience.

In this e...

Why Storytelling Matters for Medical Device Companies from 2021-08-25T19:19:14

Medical device companies need to tell slightly different versions of their stories depending on the intended audience—investors, suppliers, regulators, clinicians, and patients—and each version ...

A Breakthrough Device that Aims to Prevent Osteoporosis from 2021-08-18T21:50:37

Is your body becoming more frail? Are you worried about fractures? Do you want to improve your bone health? Osteopenia and osteoporosis are very common problems that don’t have completely effect...

Understanding FDA's New Intended Use Rule and its Implications from 2021-08-11T13:42:22

FDA published a final rule, which goes into effect the first of September, to amend its “intended use” regulations.

In this episode of the Global Medical Device Podcast, Jon Speer talks to...

eQMS in Academia: Practical Learning for Biomedical Engineering Students from 2021-07-28T19:03:51

Have you ever thought about the versatility of an eQMS? As it turns out, the use of one medical device eQMS solution in particular is extending across multiple sectors.

In this episode of ...

Tips for Running Better Management Reviews from 2021-07-19T17:30:53

How efficient are your management reviews? Could improvements be made? It might be time to reevaluate and reconfigure your system processes to eliminate burdens and extract utmost value from the...

Meet a Guru: Ryan Behringer from 2021-07-14T15:50:11

Guru Edge. It's what makes Greenlight Guru so unique and particularly valuable to medical device companies. These Gurus form an elite team of medical device experts who serve Greenlight...

Navigating the MedTech Cybersecurity Ecosystem from 2021-07-12T20:02:39

Cybersecurity continues to be a crucial concern for medical device safety and effectiveness in the US, for manufacturers and regulators alike.

In this episode of the Global Medical Device ...

Managing Clinical Data Activities from 2021-07-07T19:57:49

Many medical device companies experience challenges with managing clinical trials even in the most ideal settings, so what happens when big changes occur, like COVID-19 and new regulations, that...

Explaining the Role of Importer under EU MDR from 2021-06-30T20:37:20

What is the role of the importer, according to EU MDR? The requirements for this role have changed since the new regulation went into effect in May 2021 and it's important to understand the exte...

Preparing Your Pre-Submission with the Content FDA Wants to See from 2021-06-23T16:38:06

A Pre-submission can add tremendous value with the feedback given by FDA, which manufacturers can use to guide product developme...

How RADx Tech II Program is Fast-Tracking COVID-19 Technologies to Market in 2021 from 2021-06-21T15:07:23

What can you still do to help in response to the COVID-19 pandemic? The National Institute of Biomedical Imaging and Bioengineering (NIBIB) announced that its Point-of-Care Technology Research N...

How New Training Partnership is Advancing Medical Device Knowledge & Professional Development from 2021-06-16T17:02:10

Hungry for medical device industry knowledge? Greenlight Guru has you covered — now, medical device professionals can enjoy addi...

Top 3 Most Cited Issues in Medical Device Inspections from FDA FY2020 from 2021-06-14T17:29:06

What did FDA report as the most-cited issues during medical device inspections for the fiscal year of 2020? Understanding the data can help you prepare against making these common, avoidable mis...

How Mindset Training Can Help Your Team Operate at Peak Performance from 2021-06-09T19:33:56

Close your eyes, take a deep breath in, and imagine your team operating at peak performance, exceeding goals and each member fee...

Examining the HHS Proposal for Premarket Notification Exemptions from 2021-06-07T15:37:35

What are the pros, cons, and ramifications of the U.S. Department of Health and Human Services’ (HHS) proposal that impacts the ...

Crash Course on Greenlight Guru Academy: How Medical Device Professionals Stay Ahead from 2021-06-02T18:47:36

If you love learning and want to level up your medical device industry knowledge on topics such as audits, document management, design controls, risk management, and more, Greenlight Guru Academ...

Building your Brand as a Medical Device Professional from 2021-05-31T12:45

Have you ever had to “sell” your brand to someone? To do this effectively, you must master the art of networking and selling whatever it is that you bring to the table.

In this episode of ...

Understanding the Value of a Medical Device Guru from 2021-05-26T18:21:30

Have you ever wondered, what does a medical device guru actually do? What role do they play within Greenlight Guru and what valu...

Meet a Guru: Etienne Nichols from 2021-05-24T17:45:45

The Guru edge: it's what makes Greenlight Guru so unique and valuable to the medical device companies it serves. The Guru team is comprised of industry experts with a knack for helping companies...

Meet a Guru: Laura Court from 2021-05-19T16:55:38

What makes Greenlight Guru unique? It’s the Guru edge⁠—a team of medical device professionals with a ton of industry experience....

Regulatory Tips & Pointers from a Former FDA Reviewer from 2021-05-17T15:14:10

As some veteran FDA reviewers leave and new ones are hired, knowledge is not always passed on seamlessly... To that end, regulatory professionals are often left to their own devices to find the ...

Why Demand is so High for Regulatory & Quality Jobs (and should you take advantage?) from 2021-05-12T18:52:31

Great uncertainty brings great opportunities for growth...career growth. Currently, regulatory roles are one of the highest in d...

Comparing FDA’s Breakthrough Devices Program & Safer Technologies Program from 2021-05-11T17:38:37

What are the differences, similarities, and potential benefits of FDA’s Breakthrough Devices Program (BDP) and Safer Technologie...

Why is IVDR Causing Widespread Panic throughout the Medical Device Industry? from 2021-05-06T20:17:26

Is the widespread panic over the EU In-vitro Diagnostics Regulation (IVDR) justified? For many device professionals, the one yea...

Managing Business Risk as a Medical Device Company from 2021-05-03T18:34:13

It's easy to get so wrapped up in the risk management of your medical device that you forget about managing your business risk with the same level of diligence and ongoing attention.

Listen

Waterfall vs. Agile: Battle of the Product Development Methodologies from 2021-04-28T16:51:28

Are you 'Team Waterfall' or 'Team Agile' for your product development methodology of choice?

Listen

For the Love of Internal Auditing from 2021-04-26T19:50:55

Who loves internal auditing? Probably 99.99 percent of medical device professionals answered “not me!” While it may not be every...

Similarities & Differences between In Vitro Diagnostic (IVD) Devices & Medical Devices from 2021-04-21T17:57:39

What are the similarities and differences between an in vitro diagnostic (IVD) device machine and a medical device?  <...

Knowing vs. Doing as Medical Device Professionals from 2021-04-19T19:51:06

For medical device professionals, there are the “knowers” and the “doers.” One group is knowledgeable about quality best ...

Pivoting Operations to Meet PPE Demand during Pandemic from 2021-04-14T12:50:48

Are you on the frontlines of developing new medical devices and technologies during COVID-19? Or, are you a customer who has ben...

Pros & Cons of Being a Physician turned MedTech Inventor from 2021-04-13T13:13:31

Do you fear needles and the associated pain? No one understands this fear more than physicians who see it firsthand with their p...

3 Systems of Risk for Medical Devices from FDA from 2021-04-07T19:50:52

Why does the FDA have three systems in place to address and handle risk related to medical devices? Each system serves a differe...

Quality Management for IVD Devices vs Medical Devices from 2021-04-05T16:07:49

How are in vitro diagnostic (IVD) devices similar and different from medical devices? How should IVD manufacturers approach quality management and other key elements based on these similarities ...

Understanding the Investigational Device Exemption (IDE) Process from 2021-03-31T15:13:50

Does your medical device qualify for an investigational device exemption (IDE)? What does this process involve and what does FDA...

Evaluating, Monitoring & Selecting Suppliers in the Medical Device Industry from 2021-03-30T13:51:14

Are you a medical device professional or company seeking suppliers? Or, are you a supplier yourself? There’s a supplier manageme...

Why the PMA Process is so Dreaded by Manufacturers in the US Market from 2021-03-25T14:03:42

Premarket Approval (PMA) is a FDA regulatory pathway designated for Class III medical devices that has historically been known t...

Learning about the Real-world Impact of Design, Manufacturing, Quality & Culture on Patients from 2021-03-24T14:08

Why is design, manufacturing, quality, and culture so important in the medical device industry? 

These key ele...

What is the Safer Technologies Program (STeP) and Can Your Device Use It? from 2021-03-21T17:00

What do manufacturers need to know about the Safer Technologies Program (STeP) for Medical Devices from FDA? How is STeP differe...

Meet a Guru: Sara Adams from 2021-03-17T12:45

One of the main differentiators that makes Greenlight Guru so unique is its Guru Edge. The medical device gurus ⁠are a team of m...

Building a Startup in the MedTech Industry from 2021-03-10T16:25:10

What does it take to build a successful MedTech startup? It’s a multi-million dollar question and the answer involves strong execution of a highly strategic pl...

Meet a Guru: Karen Schuyler from 2021-03-08T15:25:24

What makes Greenlight Guru unique? It’s Guru Edge⁠ Listen

Visualizing a Medical Device through Illustrations, Animations, and other Artwork from 2021-03-03T21:37:43

Imagine using medical illustrations, animations, and other types of artwork to tell the story of a medical device, its procedure...

Everything you Need to Know about SaMD from an FDA Perspective from 2021-03-01T15:41:54

Software as a Medical Device (SaMD) is a growing sector of the medical device industry. If you are interested in entering the Sa...

Preparing for Remote and On-Site Inspections and Audits from 2021-02-24T18:23:12

How can medical device companies be better prepared for remote and on-site inspections or audits? Practice, practice, practice s...

How does EU MDR impact your Quality Management System? from 2021-02-22T15:41

The new medical device regulation in the European Union (EU MDR) has introduced a host of new challenges for medical device comp...

Virtual Auditing in a Post-COVID World of Digital Compliance from 2021-02-17T21:32:26

What do auditing and compliance protocols look like during a pandemic? Medical device companies continue to adjust to changing circumstances in an attempt to maintain business as close to normal...

Inside Look into ISO 14971:2019 & ISO TR 24971:2020 from the Author's Point of View from 2021-02-10T18:52:08

Keeping a constant pulse on current medical device industry standards for risk management, like ISO 14971:2019 and its companion documents, while also adhering to the recommended guidelines is one ...

Prioritizing Medical Device Reimbursement During Product Development from 2021-02-03T20:13:50

Medical device reimbursement is a key consideration that must be well researched, understood, and managed by companies in order to ensure no money, to which you’re entitled to, is left on the table...

5 Actionable Lessons Learned from the RADx Initiative by NIH from 2021-01-27T18:21:46

Rapid Acceleration of Diagnostics (RADx) is an initiative launched by the National Institutes of Health (NIH) aimed at accelerating the development, commercialization, and implementation of COVID-1...

What are the Strategic Priorities for CDRH in 2021? from 2021-01-20T15:26:06

What are the 2021 strategic priorities for FDA’s Center for Devices and Radiological Health (CDRH) and what impact will these initiatives have on the medical device industry? In this episode of the...

Understanding and Handling Different Types of Feedback from 2021-01-14T14:44:12

What’s the relationship between product feedback, complaints, and adverse events? In this episode of the Global Medical Device Podcast, Jon Speer talks to guest Isabella Schmitt, Director of Regula...

Measuring the Impact of AI/ML Technologies on the Current Medical Device Landscape from 2021-01-06T21:20:51

What impact has artificial intelligence (AI) and machine learning (ML) had on the medical device industry thus far? Have the emergence of these new technologies created new, unanticipated regulator...

Post-Pandemic Readiness: Preparing for the Aftermath of COVID-19 on the Medical Device Industry from 2020-12-23T17:59:50

Are you prepared for the aftermath of the pandemic’s impact on the medical device industry? It may be time for device professionals to start bracing for a new normal. In this episode of the Global ...

Tips to Prepare for EU MDR and IVDR as Deadlines Draw Near from 2020-12-16T21:42:15

The end of 2020 is near, which will close out a year that’s been fraught with challenges and difficulties. However, 2021 will bring its own set of new challenges for those implementing the European...

How will Emergency Use Authorization (EUA) during Pandemic Influence Future FDA Policy Changes? from 2020-12-09T18:55:36

Still seeking guidance to stay in the know when it comes to new and updated FDA requirements related to medical devices, especially during the ongoing pandemic? In this episode of the Global Medica...

Why SaMD Companies Should be Leveraging Pre-Submissions to FDA from 2020-12-02T16:58:40

Software as a Medical Device (SaMD) is one of the fastest growing segments of the medical device industry. How are regulators keeping pace with its growth? FDA has a set of specific requirements un...

What Goes into Designing Devices for Military and Emergency Applications? from 2020-11-25T20:27:10

There’s one niche market within the device industry that rarely gets the attention it deserves: products designed for military applications and use in other emergency settings. In this episode of t...

Are you Spending Enough Time Defining and Managing Requirements for your Medical Device? from 2020-11-18T19:55:54

Some sources claim that one-third of your product development project should be spent on defining good requirements. Why? Requirements are key determinants of success for any new product that’s bei...

Positive and Negative Impacts of EUA on the Medical Device Industry from 2020-11-11T20:07:22

As the COVID-19 global pandemic continues, emergency use authorization (EUA) has become a highly utilized regulatory pathway to market in the United States. In this episode of the Global Medical De...

Why Biocompatibility Should be Addressed by Every Medical Device Company from 2020-11-04T18:10:41

Should your medical device company address biocompatibility? The short answer is, yes. Every single medical device should conduct some level of biocompatibility testing. What’s important is that yo...

Meet a Guru: Erica Loring from 2020-10-27T20:01:19

What makes Greenlight Guru unique? It’s Guru edge⁠—a team of medical device professionals with decades of industry experience whose primary role within the company is to enable customer success. In...

What is a Multiple Function Device? from 2020-09-30T17:20:57

What is a multiple function device? From a high level, it’s a product with at least one portion that meets FDA’s Code of Regulations’ (CFR) definition of a medical device and at least one other por...

Challenges related to Home Use Devices from 2020-09-10T14:45:34

What could go wrong as more medical device products are used at home and in similar non-traditional environments outside of hospitals and healthcare facilities by non-medical professionals? In this...

Submitting a 510(k) using FDA's Safety and Performance Based Pathway from 2020-09-02T17:23:48

What is FDA’s Safety and Performance Based Pathway and how does it relate to the Traditional, Special, and Abbreviated Premarket Notification 510(k) programs? In this episode of the Global Medical...

How Jon Speer Met His Most Frequent Guest: Mike Drues from 2020-08-26T18:38:36

Reminiscing about past and present lessons learned from listening to conversations with this show’s most frequent guest, one important principle emerged: Teach others how to think, not what to thin...

Meet a Guru: Wade Schroeder from 2020-08-19T19:26:33

What sets Greenlight Guru apart from other quality management solutions? It’s Guru edge⁠—a team of medical device professionals with more than seventy years of combined industry experience. In this...

What are the Audit Etiquette Rules I Should be Following? from 2020-08-12T16:21:33

Who looks forward to audits? Not most people except for maybe the actual auditor. Hold yourself accountable and stay audit-ready, so you can remove any pre existing concerns from the equation altog...

Meet a Guru: Tom Rish from 2020-08-05T18:49:43

What makes Greenlight Guru so unique, beyond its medical device QMS (MDQMS) software? Its Guru edge. In this episode of the Global Medical Device Podcast, Jon Speer talks to Tom Rish, a senior medi...

Addressing Clinical Trial Challenges & Concerns during COVID-19 from 2020-07-29T18:56:38

The current COVID-19 pandemic and its impact on clinical trials has created a sense of chaos amongst medical device companies worldwide. Are there creative ways to stay on track while ensuring the ...

Protecting the Intellectual Property of your Medical Device Technology from 2020-07-22T15:33:08

Are you considering patent protection for your software as a medical device? Should you keep your secret sauce via the trade secret route? Perform due diligence to stay ahead of the competition. I...

Meet a GURU: Jesseca Lyons from 2020-07-15T16:15:26

What makes Greenlight Guru unique? It’s Guru edge, composed of a team of medical device experts with over seventy years of combined industry experience. In this episode of the Global Medical Devic...

How to Build a QMS for a Medical Device from 2020-07-08T17:04:31

Where do you begin when building a quality management system (QMS) for a medical device? It’s a task that is often delayed until later stages of development. Don’t wait to implement a QMS; the cons...

Meet a Guru: Taylor Brown from 2020-07-01T16:37:01

What makes Greenlight Guru unique? The Guru Edge⁠—a team of medical device professionals with over eight decades of combined industry experience. Greenlight Guru’s mission is to improve quality of ...

What is Regulatory Due Diligence for Medical Devices? from 2020-06-24T18:49:31

What is regulatory due diligence? Why does it matter, and how does it differ from other regulatory strategies and pathways? In this episode of the Global Medical Device Podcast, Jon Speer talks to...

Mass-Manufacturing a 5-in-1 Ventilator System for COVID-19 Relief from 2020-06-17T19:34:35

Are you discouraged by all of the negative news and sad stories about COVID-19? Let's shift the focus to a story centered on positivity and innovation that will reignite hope for a better, safer ro...

How Being Strategic During A Career Transition Can Yield The Best Opportunities from 2020-06-10T20:03:22

There is a spectrum of feelings someone may experience in the midst of a career transition. For some, however, being laid off can turn out to be one of the best things to ever happen to them. In t...

Identifying the Positive and Negative Effects of COVID-19 on the Medical Device Industry from 2020-06-03T16:26:59

Most of us have read about, observed, participated in, and spoke with healthcare providers and medical device professionals collaborating during the COVID-19 crisis.  Creativity within reason can ...

How to Construct an Effective Regulatory Strategy from 2020-05-27T14:39:52

What is a regulatory strategy? What are the components involved? In this episode of the Global Medical Device Podcast Jon Speer talks to Mike Drues of Vascular Sciences to provide listeners with ...

What you Need to Know about Clinical Evaluation & Validation for Software as a Medical Device (SaMD) from 2020-05-20T19:26:39

Does your software as a medical device (SaMD) function properly? Does it meet the needs of the end user? What are the expectations for post-market clinical surveillance and real world evidence for ...

How to Use Artificial Intelligence & Machine Learning to Produce Better, Smarter, Safer Devices from 2020-05-13T16:23:13

What is artificial intelligence (AI) and machine learning (ML) and how do the two differ in the medical device industry? How can companies leverage AI and ML in their medical devices to improve the...

510(k) Tips and Answers to Frequently Asked Questions for Medical Device Companies from 2020-05-06T16:12:28

What does the 510(k) process involve? How should medical device companies know if this is the right regulatory pathway to market? When should a premarket notification be submitted to FDA and how sh...

Addressing the PPE Shortage with a No Cost Solution for Healthcare Providers from 2020-04-29T14:00:48

Are you a medical provider or caregiver unable to find facemasks as PPE for COVID-19? Get one for free. In this episode of the Global Medical Device Podcast, Jon Speer talks to Sanjay Vakil and D...

[LIVE] How EU MDR Changes are Impacting the Medical Device Ecosystem from 2020-04-22T18:44:09

NOTE: This episode was recorded prior to the EU Commission Proposal and now EU Parliament approval; pending EU Council (member states approval) and publication in the official journal (OJEU) for th...

How to Approach Verification and Validation for Cloud Software from 2020-04-15T17:28:01

Why is verification and validation (V&V) confusing and challenging for many medical device professionals? In today’s new episode of the Global Medical Device Podcast, Jon Speer and his guest Brad...

Fighting COVID-19: How one MedTech Company is Using UV-C Technology to Eliminate Virus & Save Lives from 2020-04-10T17:57:30

In response to the COVID-19 pandemic, medical device companies are improving and saving lives through innovative technologies and methods to combat the virus. In this episode of the Global Medical...

Emergency Use Authorization (EUA) 101: What Medical Device Companies Need to Know from 2020-04-08T13:22:03

What qualifies and what does not for Emergency Use Authorization (EUA)? What is the impact of this rare regulatory pathway during the COVID-19 pandemic? In this episode of the Global Medical Devi...

How to Integrate Usability into your Medical Device from 2020-04-01T16:31:19

Medical device usability is a critical, yet confusing component of medical device design, development, regulatory, marketability, and product success. Although three things are clear when it comes ...

[LIVE] Design Controls, Development & Risk for Software as a Medical Device (SaMD) from 2020-03-26T13:00:20

In this modern digital world, did you know that most medical devices are not connected to the Internet? This episode of the Global Medical Device Podcast is a special live recording from The Green...

How to Leverage IEC 62304 to Improve SaMD Development Processes from 2020-03-18T16:14:58

How can the IEC 62304 standard serve as a framework for your Software as a Medical Device (SaMD) development processes? Today’s guest is Cathy Wilburn, Director of Quality Assurance and Compliance...

What is the eSTAR Pilot Program and How Will it Improve FDA's 510(k) Review Process? from 2020-03-12T14:57:39

The FDA announced another new pilot program to improve the consistency and efficiency of its 510(k) review process. It’s called, eSTAR, or electronic Submission Template And Resource. Today’s gue...

How to Choose the Right FDA Regulatory Pathway for your Device from 2020-02-26T14:13:40

Most medical device professionals and companies are familiar with Premarket Approval (PMA) and 510(k) options. However, there are several other major regulatory pathways along with several sub-path...

How to Establish a Solid Foundation for Fundraising and Product Success by Focusing on Regulatory from 2020-02-19T14:49:16

Regulatory is a big deal for medical device companies. Whether it’s a startup or established business, a strong understanding of regulations and regulatory strategy is vital for product success in ...

4 Parts to Interviewing Candidates for Medical Device Roles from 2020-02-12T20:42:51

Are you looking to hire medical device professionals? Or, are you a professional seeking new job opportunities in the industry? Today’s guest is Mitch Robbins, founder and managing director of Th...

5 Tips for Hiring Medical Device Advisors from 2020-02-05T15:47:16

Everybody seeks advice and opinions from others from time to time, even those in the medical device industry. What are the pros and cons when it comes to hiring industry advisors? Today’s guest is...

2 Key Areas Missing from FDA CDRH's Regulatory Science Priorities for 2020 from 2020-01-29T16:41:38

What top priorities can medical device professionals and patients expect in 2020 from the Center for Devices and Radiological Health (CDRH)? Today’s guest is Mike Drues from Vascular Sciences. We...

Navigating the Twists and Turns of Change Management for Medical Devices from 2019-12-28T15:55:48

Change is constant… Especially in the medical device industry. Medical device change management can be a challenging concept and process for companies, especially during FDA inspections and other a...

What is FDA's ASCA Pilot Program and How Does it Impact Medical Device Manufacturers? from 2019-12-18T20:39:19

FDA announced the launch of a new program for test lab accreditation that will evaluate medical devices for conformity to specific consensus standards recognized by the regulatory agency. The Acc...

5 Myths about QA/RA Recruiting in the Medical Device Industry from 2019-12-11T17:22:17

Recruiting top, elite quality assurance and regulatory affairs (QA/RA) talent in the medical device industry is challenging, but vitally important. Today’s guest is Mitch Robbins, managing direct...

How to Solve the Medtech Value Equation with Quality Data from 2019-12-05T16:47:46

Which medical technology, product, or device are you focused on bringing to market that will positively impact and improve the quality of life? What are the obstacles and challenges you can expect ...

Why Supplier Quality Management Is So Important For Medical Device Companies from 2019-11-27T15:38:25

Effectively managing suppliers, vendors, consultants, and other third party entities that provide products and services can be challenging. How, what, and when do medical device companies manage ...

Preparing for EU MDR from 2019-11-26T15:38:29

Do you have a regulatory strategy to help your company prepare for the new European Medical Device Regulation (EU MDR)? With the May 2020 deadline right around the corner, a main area of focus for ...

FDA is Expanding its Case for Quality Program... Should Your Company Participate? from 2019-11-26T15:38:28

Depending on the level of quality and compliance, medical devices can impact patients’ lives for better or for worse. Fortunately, FDA recently announced plans to open up and expand participation f...

Best Practices for Implementing Design Controls for the Medical Device Industry from 2019-11-07T15:07:39

If you're like many in the medical device industry, you've probably had some questions at one time or another around the FDA's Design Control Guidance. And if you're anything like the guests on to...

Risk Management from a Regulatory & Product Development Point of View from 2019-11-07T15:07:38

Risk management for medical devices from a regulatory and product development perspective is the topic of today’s podcast. We take a look at a few tools to help in the process and liability as it...

How to Improve Your Medical Device Design Reviews Bonus Episode from 2019-11-07T15:07:38

Medical device design reviews - are more or less better? What about independent reviews? Are they necessary? How do you get one done? These are a few of the topics we touched upon in episode 3 of...

How To Improve Your Medical Device Design Reviews from 2019-11-07T15:07:38

With nearly half a century of combine experience performing medical device Design Reviews between them; Michael Drues Ph.D., Jason McKibbin, and Jon Speer have the battle scars they want to help yo...

Should design controls have prevented the recent reprocessing tragedy: Do we need new regulation? from 2019-11-07T15:07:38

Superbugs. Reprocessing. The White House. And Design Controls. Probably not a combo of topics you see grouped together very often. But we have them all for you on today’s Global Medical Devic...

How Proper Design Controls & a Quality System Could Save You $20M With Ronny Bracken from 2019-11-07T15:07:37

What are the most common mistakes a startup medical device company usually make? Hear Ronny Bracken candidly disclose how to avoid some very expensive lessons when starting out in the medical devi...

Sara Naab On Going From Idea to Funding to One of the Bay Area's Most Innovative Life Sciences Co's from 2019-11-07T15:07:37

In today’s episode of the Global Medical Device Podcast Jon Speer welcomes Sara Naab to the show. Sara is the co-founder and director of quality and marketing for Sandstone Diagnostics. Sara sha...

How To Identify, Quantify & Manage Enterprise Risks for Medical Device Companies with Mike Cremeans from 2019-11-07T15:07:36

In episode 9 of the Global Medical Device Podcast we’re joined by Mike Cremeans. Mike is the Vice President in the Healthcare and Life Sciences practice at Willis (the third best insurance broker i...

How To Avoid Major Common Mistakes During the 510(k) Process with Michael Drues from 2019-11-07T15:07:36

We’ve got a good one for you today. In episode #8 of the Global Medical Device Podcast we welcome back Michael Drues, president of Vascular Sciences. As many of our listen may recall, Mike does con...

Tips, Tricks and Pointers for MedTech Startup Entrepreneurs With Mitch Levinson from 2019-11-07T15:07:36

On today's episode of the Global Medical Device Podcast, we’re discussing how startup entrepreneurs like you can remove the common regulatory obstacles your business faces and other tips and pointe...

Why Medical Device Startups Need to Implement a ‘Right-Sized’ QMS with David Amor from 2019-11-07T15:07:35

If you are in the business of medical devices, then you must eat, breathe, and live quality management systems. In order to get to market and sell your products successfully, your quality system ne...

Why Design Inputs Are So Important to the Success or Failure of Your Project with Matt Romey from 2019-11-07T15:07:35

In episode 10 of the Global Medical Device podcast we welcome Matt Romey from the Azzur Group. Matt is a project manager for the Azzur Group and has been involved with many medical device projects....

Why Using the Proper Standards for Your Regulatory Submission is So Important with Leo Eisner from 2019-11-07T15:07:34

Standards are absolutely critical when you are developing a medical device. You need to understand why these standards are important when developing your product for your regulatory submission. Yo...

An Insider’s Look at the Changes Coming in ISO 13485:2016 with Mark Swanson from 2019-11-07T15:07:34

Did you know ISO 13485 has been revised and approved in 2016? And is going to be published later this month. The quality management standard we’ve all grown to know is now being updated, and we’l...

Medical Device Product Development Project Management Best Practices with Peter Sebelius from 2019-11-07T15:07:33

Another brilliant mind joins us today on the Global Medical Device Podcast. Peter Sebelius is the founder of Gantus.com and today we’ll talk medical device product development and project managemen...

The Difference Between Intended Use and Indications of Use with Mike Drues from 2019-11-07T15:07:32

It’s time to break down the how and why of intended use and indications of use statements for your new medical device. On this episode of the Global Medical Device podcast we’ll explain the diffe...

Why the Conventional Wisdom Regarding ‘R’ and ‘D’ in Medtech Product Development Is Wrong from 2019-11-07T15:07:32

Today on the Global Medical Device Podcast we have a very interesting and highly debated topic for you around research vs. development for medical device companies. We’ll challenge some convention...

Integrating Business Elements into Your Product Development Process with Therese Graff from 2019-11-07T15:07:31

On today’s episode of the Global Medical Device podcast, we’re talking about the importance of incorporating business elements into your medical device product development process. When firms focu...

How to Avoid Medical Device Product Development Wipeouts with Meghan Alonso from 2019-11-07T15:07:31

Getting started in the medical product development process can be a huge undertaking. You might have an excellent idea, but maybe you’re unsure about where to start. Whether you’re just beginning...

Tips to Help You Prepare for an FDA Inspection from 2019-11-07T15:07:30

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 medica...

What Device Makers Need to Know About Design Verification and Validation with Mike Drues from 2019-11-07T15:07:30

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...

Preparing Your Class II Device for the UDI Compliance Deadline with Gary Saner from 2019-11-07T15:07:29

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 any...

Dirty Devices and Reprocessing: Are New Design Change Rules On the Horizon? from 2019-11-07T15:07:29

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 sprea...

How to Properly Use the FDA Pre-Submission Process and Why It's So Important with Mike Drues from 2019-11-07T15:07:28

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 c...

Insider Tips and Best Practices Regarding the 510(k) Submission Process from a Former FDA Reviewer from 2019-11-07T15:07:28

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 sub...

Insights Into the New FDA 3D Printing Guidance & How It Impacts Med Device New Product Development from 2019-11-07T15:07:28

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 ...

Preparing for the Changes to the EU Medical Device and In-Virto Diagnostics Regulations from 2019-11-07T15:07:27

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 ch...

Tips for Avoiding Problems with the First-In-Human Study Process with Mike Drues from 2019-11-07T15:07:27

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 docu...

Tips & Pointers for Effective Internal Quality Audits with Kyle Rose from 2019-11-07T15:07:27

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...

Zebra Medical Technologies: How a New Breed of Medical Device Companies Is Leveraging Technology from 2019-11-07T15:07:26

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 ...

Understanding the New FDA Guidance on Changes to 510(k) from 2019-11-07T15:07:26

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 jus...

What Devicemakers Need to Know about the FDA Pre-submission Process (Part Two) from 2019-11-07T15:07:26

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, ba...

Using the Bucket Method for Medical Device Risk Management w/ Mike Drues from 2019-11-07T15:07:25

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 r...

Tips for Success When It Comes to IEC 60601 with Leo Eisner from 2019-11-07T15:07:25

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 w...

2016 Medical Device Regulatory Trends Year in Review from 2019-11-07T15:07:24

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 t...

An Overview of What Device Makers Need to Know About CAPA from 2019-11-07T15:07:23

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...

How Surgical Innovation Associates Found the Benefit of Quality Beyond Just Compliance from 2019-11-07T15:07:23

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 insigh...

Significant Risk vs. Nonsignificant Risk Devices - What's the Difference? from 2019-11-07T15:07:23

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, ...

What Devicemakers Need to Know About Medical Device Reporting (MDR) from 2019-11-07T15:07:23

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, presiden...

How Phagenesis Is Using Regulatory Affairs as They Develop a Treatment for Dysphagia from 2019-11-07T15:07:23

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 ...

How FDA Interacts with Medical Devices When They Are Imported into the US from 2019-11-07T15:07:22

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 import...

How SimplicityMD Is Leveraging Technology to Help Get Their Devices to Market Faster from 2019-11-07T15:07:22

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 foc...

Understanding the Connection Between Complaints, CAPAs, and MDRs from 2019-11-07T15:07:21

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 ...

When Design Inputs Go Wrong + Design Your Label Like You Design Your Device from 2019-11-07T15:07:21

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 fre...

The Intersection of Medical Device Usability and Risk Management from 2019-11-07T15:07:21

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...

Understanding FDA’s Proposed Conformity Assessment Pilot Program from 2019-11-07T15:07:20

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 regulato...

Understanding the Difference Between a General Wellness Device and a Regulated Medical Device from 2019-11-07T15:07:20

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...

Lessons to Be Learned From Recent FDA Inspections from 2019-11-07T15:07:19

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. Tod...

Why the 510(k) Process Is So Stressful & How You Can Help Streamline It from 2019-11-07T15:07:19

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, fr...

How Competitive Regulatory Strategy Differs from Regular Regulatory Strategy from 2019-11-07T15:07:19

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 regu...

Comparing FDA Submission Types: 510(k) vs. De Novo vs. 513(g) vs. Pre-Submission from 2019-11-07T15:07:19

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 regulator...

How Process Excellence Leads to Product Excellence from 2019-11-07T15:07:19

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 wo...

Common Mistakes That Can Tank Your FDA 510(k) Submission from 2019-11-07T15:07:18

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...

Understanding How to Use Real-World Evidence for Medical Device Regulatory Decisions from 2019-11-07T15:07:18

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-...

An Overview of What Medical Device Developers Need to Know About Human Factors from 2019-11-07T15:07:17

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 B...

Challenges with Applying Risk Management Throughout the Manufacturing Process from 2019-11-07T15:07:17

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 compa...

Evaluating FDA’s “New” Proposed Fast-Track Alternative Approach to the 510(k) Pathway from 2019-11-07T15:07:16

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, preside...

What Substantial Equivalence Means as It Applies to 510(k)'s & Why It's So Important from 2019-11-07T15:07:15

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 re...

5 Most Common Problems With Your CAPA Process from 2019-11-07T15:07:14

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 n...

How to Determine the Operational Quality of a Quality System Using a Performance Assessment from 2019-11-07T15:07:14

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 qualit...

Debunking Premarket Approval (PMA) Myths (And Why the PMA Path May Not Be as Scary as You Think) from 2019-11-07T15:07:13

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 af...

Tips, Tricks & Best Practices for Complying with ISO 13485:2016 from 2019-11-07T15:07:13

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. ...

Helping Prepare Biomedical Engineers Entering the Workforce from 2019-11-07T15:07:13

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. ...

How to Ensure Your Quality Management System is Effective and Benefits Patients from 2019-11-07T15:07:13

When it comes to quality management compliance, would you consider yourself a box checker or a true quality professional? On today’s episode, we talk with Mike Drues, president of Vascular Science...

How to Think About Quality and Regulatory as Your Company Scales from 2019-11-07T15:07:12

As companies transition from being a start-up or small company to a more established business and bring new medical devices to market, they tend to not put a lot of thought into their processes, sy...

How to Design for Compliance with IEC 60601 from 2019-11-07T15:07:12

Have you ever designed a medical device that has electrical components? Was it frustrating to go through the electrical safety testing - the IEC 60601 standards? Claus Roemer Andersen, a complianc...

FDA Proposes Allowing Medical Device Makers to Summarize Malfunctions: What does that Mean for You? from 2019-11-07T15:07:12

The FDA announced a new proposal regarding the bundling of device malfunctions when Medical Device Reporting (MDR). On today’s episode, we have Mike Drues, president of Vascular Sciences, to help ...

How to Use the Abbreviated FDA 510(k) Pathway to Your Advantage from 2019-11-07T15:07:12

Do you know how to use the FDA’s abbreviated 510(k)? Since only 2 percent of 510(k)s have gone the abbreviated path, it’s likely an accurate assumption that many don’t know how to use it. Today, ...

What you Need to Know about FDA's Progressive Programs from 2019-11-07T15:07:11

Are you familiar with FDA’s progressive programs for medical device companies? Do you know about Expanded Access, the Expedited Access Pathway (EAP) Program, or Breakthrough Devices Program (BDP)?...

What are the Regulatory Expectations for Software as a Medical Device (SaMD)? from 2019-11-07T15:07:11

These days, medical devices often include software or are standalone software. So, software as a medical device (SaMD) is a hot topic, and regulatory bodies have been updating regulations and laun...

The Bleeding Edge: Lessons Learned for the Medical Device Industry from 2019-11-07T15:07:11

Sometimes, do things make you go, “Hhhmmmm…” Jon Speer recently watched a documentary about the medical device industry that made him do just that. Much of the information presented was factual, b...

AI Explainability: What that Means and Why it Matters in the Medical Device Industry from 2019-11-07T15:07:11

What is AI explainability? Why does it matter in health care? On today’s episode, we have Marla Phillips, director of Xavier Health, who shares why AI will transform how the medical device industr...

How Human Factors Impact Your Medical Device from 2019-11-07T15:07:11

Human factors can be a tricky topic that creates confusion, especially when it comes to medical devices. On today’s episode, we have Mike Drues, president of Vascular Sciences, to help us dive deep...

Regulatory Tips & Observations from a Former FDA Reviewer from 2019-11-07T15:07:10

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 Strat...

Questions to Ask Before Hiring Your QA/RA Consultant from 2019-11-07T15:07:10

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...

What You Need to Know About The FDA CDRH Experiential Learning Program from 2019-11-07T15:07:10

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 di...

Latest Updates on CDRH Standards Program & IEC 60601 from 2019-11-07T15:07:10

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?...

15 Habits of Highly Effective Regulatory Professionals from 2019-11-07T15:07:10

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 h...

How to Embrace Risk for Safer Devices from 2019-11-07T15:07:10

No matter what you are working on, there are risks involved. Product development is complicated.So, learn to embrace risk, and use it to your benefit to make your product safer. Think of what you c...

Understanding The Differences Between Clearance vs Approval vs Granted from 2019-11-07T15:07:09

Are you confused by regulatory terminology? Clearance. Approval. Granted. Do these terms matter or make a difference when it comes to medical devices and working with the FDA? Yes, they do! Mik...

Streamlining The Device Marketing Authorization Process from 2019-11-07T15:07:09

There are a few additional steps to take when it comes to the Medical Device Single Audit Program (MDSAP) and ISO 13485-2016 regulatory process to get appropriate marketing clearances or approvals....

The New Special 510(k) from 2019-11-07T15:07:09

Have you heard the recent buzz about the FDA’s supposed new Special 510(k) Pilot Program? Is it really new? Or has its existing program just been repackaged? On today’s episode, I talk to Mike Dr...

What's New With PMAs from 2019-11-07T15:07:09

How do you feel about pre-market approval (PMA) for Class III medical devices? Most businesses are not excited about products that require a PMA. But don’t look at it as the Kiss of Death. Embrac...

How to Efficiently Raise Funds for Your Medical Device Company from 2019-11-07T15:07:09

Are you in the midst of raising funds for a device that you are trying to bring to market? It can be challenging, and even more so due to the regulatory impact. Jon ...

7 Habits of Highly Effective True Quality Medical Device Professionals from 2019-11-07T15:07:09

What is true quality? How do you achieve it? In this episode, Jon Speer of Greenlight Guru and Mike Drues of Vascular Sciences discuss habits of highly effective, true quality medical professiona...

Aligning True Quality and Compliance with MDDAP from 2019-11-07T15:07:08

What does true quality mean? How does it relate to compliance? Today’s guest on The Global Medical Device Podcast is George Zack of Two Harbors Consulting. George shares his thoughts on these t...

Explaining the Significance of Voluntary Consensus Standards from 2019-11-07T15:07:08

What are Voluntary Consensus Standards? Why should you care about them? What role do they play in your regulatory submission process? In this episode, Mike Drues of Vascular Sciences and I discus...

Medical Device Industry Predictions for 2019 from 2019-11-07T15:07:08

It’s time to recap what happened in the medical device industry this year and start to think about what’s expected to happen in 2019. Some of the highlights of the show include: ● 2018 Predictio...

FDA Plans to Modernize 510(k) - Is the Sky Falling? from 2019-11-07T15:07:08

Have you heard the news? FDA caused quite a stir when it recently announced transformative changes that will modernize its 510(k) program to improve the safety and effectiveness of medical devices....

Understanding the Blurred Lines Between Consumer Tech and MedTech from 2019-11-07T15:07:08

Did you know that the Apple Watch was recently granted de novo classification requests by the FDA? Pretty exciting news for the medical device industry, which is experiencing a crossover of traditi...

Medical Device Product Development Value Proposition from 2019-11-07T15:07:07

It doesn’t matter how long a company has been in business. Startups to established companies need to remain focused on the value proposition of its device product development efforts. Today’s gue...

Why You Should Fear Product Liability Attorneys More Than Regulatory Agencies from 2019-11-07T15:07:07

Regulatory compliance is critically important. However, some think product liability is just as important, if not more. Today’s guest is Mike Drues of Vascular Sciences and we discuss how compani...

Quality Systems Management (QSM) vs. Quality Management System (QMS) - What's The Difference? from 2019-11-07T15:07:07

Do you know the difference between quality management system (QMS) and quality systems management (QSM)? Today’s guest is Larry Mager of Mgmt-Ctrl. He describes the difference between QMS and QSM...

Who Should Own Your QMS? from 2019-11-07T15:07:06

Does your medical device company prefer to outsource the responsibility of its quality management system (QMS) to a third-party supplier? Companies need to understand the ramifications of not ownin...

Design Validation vs. Human Factors Validation from 2019-11-07T15:07:06

Human factors and risk create a lot of confusion in the medical device industry. What do you need to do from a design control perspective? Today’s guest is Mary Beth Privitera, principal - human ...

Modernizing 510(k) Program through new FDA Safety and Performance Based Pathway from 2019-11-07T15:07:05

FDA recently released a new guidance document titled, Safety and Performance Based Pathway, which pertains to its Premarket Notification 510(k) process. Today’s guest is Mike Drues of Vascular Sc...

Nonbinding Feedback is a New Guidance You Should Know About from 2019-11-07T15:07:05

FDA has been busy working on guidance documents, including Nonbinding Feedback After Certain FDA Inspections of Device Establishments. Mike Drues of Vascular Sciences joins Jon Speer on the Global...

How and When to Consider Human Factors from 2019-11-07T15:07:05

When should you begin to consider human factors with your medical device design and development efforts? There are some simple and straightforward actions to assess human factors needs sooner than ...

Grasping the Impact of Artificial Intelligence and Machine Learning on Medical Devices from 2019-11-07T15:07:04

It seems like every time you turn on the TV, there’s commercials, movies, and shows that highlight the use of artificial intelligence (AI) and/or machine learning (ML). The current trend of using A...

The 100th Episode: A Few of My Favorite Moments from 2019-11-07T15:07:03

Drumroll, please. It’s time to celebrate the 100th episode of the Global Medical Device Podcast! Jon Speer, 2-series podcast host, VP of QA/RA and founder of Greenlight Guru, reflects on some of ...

Live Atlanta True Quality Roadshow Panel: The Changing Quality & Regulatory Paradigm from 2019-11-07T15:07:03

Do you love quality and regulatory and keeping up with all things related to the medical device industry? There’s never a shortage of changes to learn about. Greenlight Guru is traveling around the...

Biocompatibility Nuances and its Impact on Medical Devices from 2019-11-07T15:07:02

Biocompatibility can be challenging and frustrating when developing a medical device. Why do you have to spend time and money to do the same testing, if the materials used in your device have alrea...

How to Make De Novo a Viable Option for your Medical Device from 2019-11-07T15:07:02

Is de novo a realistic regulatory pathway? Or, the “kiss of death” for your product? No, to de novo? Think again. Who cares about de novo? We do! Today’s guest is “Dr. De Novo “(a.k.a. Mike Drues o...

Greenlight Guru In the Classroom: A University's Real-world Approach from 2019-11-07T15:07:01

Greenlight Guru continues to bridge the gap in biomedical engineering education by helping students learn and understand the importance of quality systems, design controls, and risk management. B...

EU MDR: Not All Doom and Gloom from 2019-11-07T15:07:01

Feeling gloom, doom, concern, and fear about the new European Union Medical Device Regulation (EU MDR)? In this episode, Rebecca Sheridan shares some positive insights and updates regarding EU MDR...

Integrating Human Factors into Design Controls to Improve Patient Outcomes from 2019-11-07T15:06:58

The relationship between human factors and design controls often creates confusion in the medical device industry. Today’s guests are Russ Branaghan and Bryant Foster from Research Collective, a hu...

Is Your Medical Device Company CAPA Happy? from 2019-11-07T15:06:57

The medical device industry could be more proactive than reactive when managing systemic issues. We’re talking about the Corrective and Preventive Action (CAPA) process. In this episode, Jon Spee...

Looking at the Sunset of FDA's Alternative Summary Reporting Program from 2019-11-07T15:06:56

The FDA recently decided to discontinue its alternative summary reporting program due to the allegation that millions of medical device reports (MDRs) that included product-related malfunctions wer...

Challenges with MedTech Innovation from 2019-11-07T15:06:56

The medical device industry strives to develop high quality and innovative products that will contribute to the improvement of patients’ lives Today’s guest is Bruce Gingles, one of my first boss...

Importance of Software Requirements in Product Development from 2019-11-07T15:06:55

Software and other requirements are critically important to medical device product development. In this episode, Chris DuPont, co-founder and CEO of Galen Data, provides his best practices for li...

4 Facts That May Surprise You About FDA from 2019-11-07T15:06:55

From creating product codes to following regulations, do you ever wonder what goes on inside the U.S. Food and Drug Administration (FDA)? In this episode, Allison Komiyama of Acknowledge Regulato...

Design History File Ready Ideation: An Innovative Approach to Product Development from 2019-11-07T15:06:55

As a medical device professional, do you know about Design History File Ready Ideation (DHFRI)? It’s an innovative and creative approach to product development. In this episode, Andrew DiMeo, Inn...

How General Wellness Devices Have Opened a Pandora's Box of Confusion from 2019-11-07T15:06:54

Do you have a Fitbit, Apple Watch, or other general wellness device to track your activity, monitor your heart rate, lose weight, or count calories? Are these smart technologies considered medical ...

Regulating Artificial Intelligence and Machine Learning-based Software as a Medical Device from 2019-11-07T15:06:54

Artificial intelligence (AI) and machine learning (ML) seem to be involved in everything, including medical devices and software as a medical device (SaMD). So, regulatory ramifications are possibl...

Challenges with Pediatric Medical Devices from 2019-11-07T15:06:53

Challenges continue with the design and development of pediatric medical devices. In this episode, Mike Drues of Vascular Sciences, and I discuss the lack of availability for such devices and pre...

When Should You Start a QMS? from 2019-11-07T15:06:53

Early-stage startups often wonder when the right time is to consider a quality management system (QMS)? Is it ever too soon to start a QMS? Today’s guest is Devon Campbell, founder of Prodct LLC,...

Right-sizing your QMS from 2019-11-07T15:06:52

Is your quality management system (QMS) right-sized to fit with the people, processes and purpose of your medical device company? How do you know if it is or isn't? If it is wrong-sized, what can y...

Career Tips for QA/RA Professionals in the Medical Device Industry from 2019-11-07T15:06:51

Medical device quality and regulatory professionals face changes, challenges, requirements, standards, and so much more. It’s a challenge for them to keep up. In this episode, Mitch Robbins, foun...

Why Design Verification Matters in Medical Device Design and Development from 2019-11-07T15:06:50

Design verification can be a difficult stage for medical device companies to carry out effectively. This is especially true when quality engineers limit their testing activities to only take place ...

Implementing Changes to SaMD under New EU MDR from 2019-11-07T15:06:50

Classification, qualification, and other changes to Software as a Medical Device (SaMD) under the new European Medical Device Regulation (EU MDR) continue to create angst and uncertainty. In this ...

Is FDA's New 'Safer Technologies Program' Applicable To Your Medical Device? from 2019-11-07T15:06:49

FDA recently announced its new Safer Technologies Program (STeP), which intends to make medical devices and combination devices eligible through the Breakthrough Devices Program (BDP). Requiremen...

Understanding the Benefit-Risk Determinations of FDA's Latest Guidance Documents from 2019-11-07T15:06:49

If you haven’t realized it yet, risk management in the medical device industry isn’t going away. How do you navigate, capture, and document when and what to do? In this episode, Jon Speer invites...

Leveraging Technology and Rapid Prototyping Methodologies during Product Development from 2019-11-07T15:06:49

Do you know everything there is to know about prototyping, product iteration, and manufacturing to get your medical device to market? In this episode, Greg Paulsen, the Director of Application En...

Addressing Top Questions of QA/RA Candidates on Salary, Skill Sets and Job Satisfaction from 2019-11-07T15:06:48

Quality Assurance and Regulatory Affairs (QA/RA) professionals need to keep their finger on the pulse of what’s happening in the medical device industry to explore career opportunities. Today’s g...