233 episodes

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

Global Medical Device Podcast powered by Greenlight Guru Greenlight Guru's Jon Speer + Medical Device Entrepreneurs, Executives, Inventors & Consultants; R&D, Quality, Regulatory

    • Business
    • 4.7 • 43 Ratings

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

    Assessing the Global Regulatory Landscape

    Assessing the Global Regulatory Landscape

    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 understand how it impacts your business and product.
    In this episode of the Global Medical Device Podcast Jon Speer talks to Adnan Ashfaq, founder of Simplimedica, about the changing global regulatory landscape, offering many valuable nuggets of wisdom to help medical device professionals navigate those changes accordingly.
    Some of the highlights of this episode include:Adnan describes the transition to EU MDR as an interesting but rocky and rolling landscape. Some companies acted quickly, but others are still waiting to take action and are not convinced of things that they have to do.Pieces are still being put in place. Medical device and in vitro diagnostic regulations have their own massive challenges. Also, there’s challenges with EUDAMED, designated notified bodies, and SaMD.EU MDR was supposed to go into effect in May 2020, but due to COVID-19 and other reasons, it was pushed off for a year. Guidance drafts were available in 2014-2015, but only a few hundred companies have made that full transition.According to a survey conducted by RWS, 53% of organizations are impacted by both EU MDR and IVDR, yet only 4% of those organizations admit that the regulations are a top priority.Companies with a medical device should proceed to effectively implement EU MDR or it may cost them their business. Also, refer to the definition of medical device that includes monitoring, prediction, and prognosis.Adnan encourages companies to not underestimate the cost of quality and regulatory. Build it in and know your market. With labeling and packaging, don’t forget about Brexit and associated symbols/marks.Regulations happened to catch up with technological advancements and public safety to become more transparent because patients were traumatized or died due to failure of efficacy in medical devices not being tested appropriately.Memorable quotes from Adnan Ashfaq:“They’ve really had to rethink their entire commercial strategy - whether they want to keep their devices within the European market, whether it’s financially feasible for them to continue doing that, or whether they want to rethink their entire strategy and think globally where their best markets are.”
    “I think it really boils down to what is the priority, and a lot of businesses don’t actually realize to keep themselves in business that they need to see this as a high priority.”
    “Regulations are mandatory, they are not optional.”
    “Don’t underestimate the cost of quality and regulatory and very often, that is done. You have to build it in. You have to know your market.”
    Links:Adnan Ashfaq on LinkedIn
    Welcome to Simplimedica - Simplifying Device Regulation
    Guidance - MDCG endorsed documents and other guidance - Public Health - European Commission
    European Union Medical Device Regulation (EU MDR)
    European Union In Vitro Diagnostic Regulation (EU IVDR)
    RWS - Almost three-quarters of medical device companies ready to meet the European Union’s MDR and IVDR regulations
    EUDAMED
    FDA - Software as a Medical Device (SaMD)
    Brexit
    Greenlight Guru Academy
    The Greenlight Guru True Quality Virtual Summit
    MedTech True Quality Stories Podcast
    Greenlight Guru YouTube Channel
    Greenlight Guru

    • 24 min
    Quality Insights from a 40+ Year Veteran of the Medical Device Industry

    Quality Insights from a 40+ Year Veteran of the Medical Device Industry

    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 control of incontinence.
    Listen to Buzz share his valuable insights from spending four decades in the medical device industry, developing products that address and improve quality of life and truly make a difference in patient lives.
    Some of the highlights of this episode include:Guard Cash: It takes some medical device startups to raise additional rounds of funding and capital, but don’t give up or be ashamed to ask for advice about designing and developing devices to get them to market.Anytime you develop a medical device product, you must test, maybe redesign, connect with target customers, and overcome the FDA’s regulatory challenges.More than 60 million women experience female urinary incontinence and another 17 million deal with fecal incontinence. Yet, treatments such as medications and surgery aren't effective.The two types of female incontinence are stress urinary incontinence due to weak pelvic floor muscles caused by childbirth or high-impact exercise and urge incontinence caused by the overactive detrusor bladder muscle.Herschel decided to develop a device that treats both types of incontinence. Attain is a transvaginal device that delivers dual stimulation signals to all muscles involved in causing incontinence.No woman has ever died from urinary incontinence, but it dramatically changes their lifestyle. Attain allows women to get away from using pads and diapers to stay dry and avoid leakage.Memorable quotes from Herschel Peddicord:“Female urinary incontinence - it is an absolutely huge market. More than 60 million women deal with urinary incontinence and another 17 million deal with fecal incontinence.”
    “Incontinence in 90% of the cases is a muscle issue.”
    “We have about a 93% success rate at stopping urinary incontinence.”
    “As far as we know, no woman has ever died from urinary incontinence, but it dramatically changes their lifestyle.”
    Links:InControl Medical
    Keiretsu Capital, LLC
    FDA - 510(k) Clearances
    Affordable Care Act
    Greenlight Guru Academy
    The Greenlight Guru True Quality Virtual Summit
    MedTech True Quality Stories Podcast
    Greenlight Guru YouTube Channel
    Greenlight Guru

    • 25 min
    When to Throw the Least Burdensome Flag on FDA

    When to Throw the Least Burdensome Flag on FDA

    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 to a new FDA pilot program known as the Least Burdensome Flag, manufacturers now have a process and methodology they can deploy if and when this scenario arises.
    In this episode of the Global Medical Device Podcast host Jon Speer talks to guest Mike Drues, President of Vascular Sciences, about the ways in which manufacturers should approach responding to AI requests via the Least Burdensome Flag program from FDA CDRH.
    Some of the highlights of this episode include:You do have options to push back if you think the FDA’s response or request for more information, data, or testing is overly burdensome or unnecessary.Understand why the FDA is asking you for additional testing or to collect additional data. The FDA should be able to give you a legitimate reason.Despite some trite responses, FDA cannot ask you to do whatever it wants. The FDA must give a specific reason, and then you decide whether to accept or fight against it and wave the least burdensome flag.Informal and formal options include understanding concerns of the agencies and working with review team to come up with a compromise or amicable solution.Escalating the issue is another option with an email or phone call to move things along and voice your concerns. If a compromise cannot be made, document the final product.The goal of the Least Burdensome Flag is to quickly address the FDA’s requests that submitters do not believe are least burdensome or held to a different standard than the legally marketed predicate device.Before throwing the Least Burdensome Flag, you need to meet specific criteria: Try to address concerns with the lead reviewer, limit it to two topic areas, and submit it within 60 calendar days of FDA issuing the request or deficiency letter.The last resort option is taking the issue to court. Tread cautiously because you can win the battle, but lose the war.Memorable quotes from Mike Drues:“Why is FDA asking us to do this additional testing, collect this additional data, whatever? FDA should be able to give you a legitimate reason as to why they’re looking for this information.”
    “We should respect the FDA, but at the same time, they should respect us.”
    “The goal of the Least Burdensome Flag is to quickly address FDA requests.” “Whatever we do, that needs to be justified. There needs to be a reason for doing it...needs to be justified based on the biology and engineering.”
    Links:Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions
    FDA/CDRH Webinar - The Least Burdensome Provisions: Concept and Principles
    510(k) Submission Process
    Investigational Device Exemption (IDE)
    ISO 10993 - Biological Evaluation of Medical Devices
    Code of Federal Regulations (CFR)
    Medical Device User Fee Amendments (MDUFA)
    Mike Drues on LinkedIn
    Greenlight Guru Academy
    The Greenlight Guru True Quality Virtual Summit
    MedTech True Quality Stories Podcast
    Greenlight Guru YouTube Channel
    Greenlight Guru

    • 34 min
    Past, Present, Future State (and World) of Quality in the Medical Device Industry

    Past, Present, Future State (and World) of Quality in the Medical Device Industry

    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 episode of the Global Medical Device Podcast Jon Speer is joined by Mark Alpert, director of quality at Greenlight Guru with thirty years of industry experience in quality, about the past, present, and future global landscape of medical device quality.
    Some of the highlights of this episode include:Mark and Jon agree that the medical device industry is at a crossroads currently because Europe is a ‘hot mess’ when it comes to quality. Countries with different agendas and requirements led to inconsistencies and interpretations of laws.It takes time, often several years, for companies to transition to new or revised regulations and standards. Some companies are only beginning to implement, adopt, and change their processes in a way that they understand what risk-based approach means for their management systems.Some medical device companies have lost their way when it comes to quality, and many believe the quality profession is partly to blame for being driven by tools, not data.Mark describes a do versus don’t do mindset to bring creativity, objectivity, and ability to scale back into the procedure process, such as during audits.Do not seek or expect perfection. Do the best you can to move forward and know that there are opportunities for improvements. Demonstrate confidence, compliance, and processes in place that drive improvement.Memorable quotes from this episode:“I think today, we’re also at a very interesting crossroads when it comes to quality. There’s a number of different facets.” Jon Speer
    “It’s going to take years before companies can really adopt, implement, flow down, and make it inherent in how they do business every day.” Mark Alpert
    “Once complexity creeps into the system, you’re just about guaranteeing mistakes will be made that will result in some non-conformances.” Mark Alpert
    “A lot of companies, I think their quest is towards compliance.” Jon Speer
    Links:ISO 13485
    ISO 9001
    FDA - Medical Devices
    FDA - Quality System Regulation
    European Union Medical Device Regulation (EU MDR)
    European Union In Vitro Diagnostics Regulation (EU IVDR)
    Mark Alpert on LinkedIn
    The Global Medical Device Podcast: Quality - Who, What, When with Christie Johnson from Kasota Engineering
    Greenlight Guru Academy
    The Greenlight Guru True Quality Virtual Summit
    MedTech True Quality Stories Podcast
    Greenlight Guru YouTube Channel
    Greenlight Guru

    • 27 min
    Focusing on the Intent of the UDI Requirements from FDA's Final Guidance Doc

    Focusing on the Intent of the UDI Requirements from FDA's Final Guidance Doc

    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 struggled to understand what it was, why it mattered, and what to even do with it.
    In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the recently published final guidance document on the UDI system from FDA.
    Listen as Jon and Mike provide clarity for manufacturers regarding the true intent of FDA's final guidance on the UDI system, explaining the nuances, benefits, and potential impact of UDI for medical devices and technologies in the US.
    Some of the highlights of this episode include:What is a UDI? Companies have different formats, technologies, or options available, such as an automatic identification and data capture system, to add barcodes, quick response codes, or RFID chips to devices and other products.Many companies are getting in trouble with the FDA because of some aspect of UDIs - whether it’s rejected regulatory submissions or manufacturing inspections generating 483 observations.Mike believes the reason why is because many people are focusing on following the UDI regulation (and guidance) without understanding its intent.Fundamental problems that companies are experiencing are not due to the details of UDI implementation, but not knowing or understanding the need to add UDIs to medical devices.UDI identifies the specific product, manufacturer, and batch, lot, or serial number. UDI is for traceability in case there is a problem, complaint, or recall.Challenges of implementing UDIs on labels include if the device is too small, software doesn’t include packaging, and patient compliance.Unique vs. Universal: Does ‘unique’ as defined in UDI by the FDA universally match the European Union and other regulatory bodies? It’s unlikely that a global or universal device identifier will be standardized.Memorable quotes from this episode:“It’s amazing to me how many companies, including some of my customers, are getting in trouble with FDA - whether it comes to regulatory submissions that are being rejected or manufacturing inspections that they’re getting 483 observations on because of some aspect of UDIs.” Mike Drues
    “It’s taking us, quite frankly, a heck of a long time to do something that Walmart was doing more than 20 years ago. Why the heck is it taking us so long?” Mike Drues
    “The gist of a UDI is to identify the specific product and manufacturer and potentially even the batch or lot or serial number of that product.” Jon Speer
    “This should not be a foreign concept to anybody. This is a concept of traceability - that’s all a UDI is - traceability.” Mike Drues
    Links:FDA UDI Homepage: Unique Device Identification System
    CDRH Guidance: Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) (July, 2021)
    FDA finalizes long-awaited UDI guidance (RAPS, July, 2021)
    Brazil’s new UDI requirements for medical devices: Compliance implications for manufacturers
    Code of Federal Regulations (CFR)
    FDA - 510(k) Submission Process
    FDA - Software as a Medical Device (SaMD)
    FDA - Premarket Approval (PMA)
    ABILIFY
    Mike Drues on LinkedIn
    Greenlight Guru Academy
    The Greenlight Guru True Quality Virtual Summit
    MedTech True Quality Stories Podcast
    Greenlight Guru YouTube Channel
    Greenlight Guru

    • 38 min
    Addressing the 'Who, What, When' of Quality in the Medical Device Industry

    Addressing the 'Who, What, When' of Quality in the Medical Device Industry

    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 to Christie Johnson with Kasota Engineering, a consulting firm focused on quality in the medical device industry.
    Listen to this episode as Jon and Christie offer their insights and guidance on medical device quality management best practices.
    Some of the highlights of this episode include:Who manages quality? Most startups first hire someone with years of experience, but Christie encourages early firms to embrace the teach mentality. Christie enjoys training teams to build an understanding of quality from scratch.What is quality? Those with a willingness and capability to learn can be coached to know what a quality management system is and needs to include initially.Two Schools of Thought: Companies either view quality as, do it later when the time is right or that’s not my job. Quality is a way for companies to ensure safety and efficacy. Put your products and services at the center of your universe.Christie’s philosophy is to never do what traditional consultants in the industry do. She never just shows up, throws some documents down, and walks away.Which QMS to implement? The system that you should implement is the one that your team will use. Make it simple and fast. If your team cannot understand and readily use the tool, they’re not going to do it or follow the procedure/process.Delivering a QMS without providing step-by-step training can lose functionality. Start with baby steps into processes, especially for those without experience.What to include? You don’t need to comply with regulations right away. Put things in place - early data, suppliers - document/record what you’re doing during the research and discovery phase. Tell your story and take credit for your hard work.Why are you struggling? The reality is it takes longer than six months to one year to get your idea or product on the market. Trial knowledge can reduce risk.Memorable quotes from Christie Johnson:“If you can read and understand the regulation and if you can sit and work with me and help me understand your background and I can coach you, we can start putting in place your early quality system.”
    “Our philosophy is very much to never do what traditional consultants in the industry do, which is show up, throw some documents down, and walk away.”
    “The system that you should implement is the one that your team will use and make it easy.”
    “It’s really easy to get lost or just ignore the quality system that’s in place, especially if you come into an organization that already has way more than they need.”
    Links:Christie Johnson on LinkedIn
    Kasota Engineering
    National Institutes of Health (NIH) - Rapid Acceleration of Diagnostics (RADx)
    Devon Campbell with Prodct
    FDA - Medical Devices
    ISO 13485
    Meet a Guru - Taylor Brown
    Greenlight Guru Academy
    The Greenlight Guru True Quality Virtual Summit
    MedTech True Quality Stories Podcast
    Greenlight Guru YouTube Channel
    Greenlight Guru

    • 28 min

Customer Reviews

4.7 out of 5
43 Ratings

43 Ratings

MacJ2300 ,

A must listen for medical device professional!

If a medical device professional, there are a must. The pod casts appeal to everyone within your organization, from CEO to Engineer to Quality to Regulatory. Very informative.

Esmath ,

Effective Regulatory Strategy

I appreciate your comment on being hopeful when bringing in regulatory early and bringing regulatory late as if it were a dreaded requirement.

med device industry insights ,

tips and pointers

This podcast is geared towards medical device professionals and current hot topics in the industry. Plenty of tips and tidbits provided from industry veterans.

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