149 episodi

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

    • Economia
    • 4.0, 1 valutazione

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.

    How to Construct an Effective Regulatory Strategy

    How to Construct an Effective Regulatory Strategy

    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 practical and pragmatic tips on how to construct a meaningful, not misunderstood, misapplied, and misused regulatory strategy.

    Some of the highlights of the show include:

    • Pro Tip: Regulatory strategy is not synonymous with Pathway to Market (element), or 510(k) and De Novo (tactics).
    • Regulatory Strategy Executive Summary: Living artifact that serves as a communication tool to articulate pros, cons, benefits, risks, and options.
    • Executive Summary components may include device description, labeling matrix, classification and risk, and potential pathways to market.
    • Investor Pitch Deck: Demonstrate medical device idea by knowing all options, and possessing knowledge and experience of fluid and dynamic environment.
    • Conventional Wisdom: Easiest, fastest, cheapest path to market to get through regulatory challenges doesn’t always make sense for products and technology.
    • Future Features List: What do you want added to a medical device in the future? Start with the ultimate end in mind and work backwards to build strategy and plan.
    • Product Development Process: Bring in regulatory sooner than later, earlier the better. Changes after a design freeze are difficult, time consuming, and costly.
    • Summary, Recommendations, and Takeaways: Who is your audience? Will they understand the purpose? Offer proof.

    • 41 min
    What you Need to Know about Clinical Evaluation & Validation for Software as a Medical Device (SaMD)

    What you Need to Know about Clinical Evaluation & Validation for Software as a Medical Device (SaMD)

    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 SaMD products in particular?

    In this episode of the Global Medical Device Podcast Jon Speer talks to Kevin Coker, co-founder and CEO of Proxima Clinical Research. Kevin shares tips and advice on what companies need to know about clinical evaluation and validation for their Software as a Medical Device (SaMD).

    Some of the highlights of the show include:

    - What IS SaMD? Software intended to be used for a medical purpose without being a part of the hardware of the medical device.
    - What ISN'T SaMD? Hardware that doesn’t need to be updated to function, such as a pacemaker or other embedded medical devices.
    - IMDRF documents capture, evaluate, and monitor SaMD categories of classification for critical or non-critical functions.
    - EU MDR delay means big changes to classification rules for categories, specifically SaMD status and amount of evidence that needs to be collected.
    - Three Key Components of Clinical Evaluation:
    - Scientific Validity: Does software have a valid clinical association between software and targeted clinical condition?
    - Analytical Validation: Does software correctly process data the same way, every time?
    - Clinical Validation: Does software accurately and reliably achieve the intended purpose for the target population?
    - Clinical Evaluation vs. Clinical Trial: Gather existing data for the same or similar intended use. A clinical trial is not always necessary to generate and justify evidence.
    - Importance of Independent Review(er): Objective outside party analyzes SaMD to make sure it’s safe and effective to use for critical decisions.
    - Real World Evidence: Collect a broad dataset to better understand adverse events, conditions, and comorbidities that impact a medical device on society.

    • 36 min
    How to Use Artificial Intelligence & Machine Learning to Produce Better, Smarter, Safer Devices

    How to Use Artificial Intelligence & Machine Learning to Produce Better, Smarter, Safer Devices

    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 quality of life?

    In this episode of the Global Medical Device Podcast Jon Speer talks to Devon Campbell, founder of Prodct LLC, and Anthony Habayeb, co-founder and CEO of Monitaur.ai about how AI and ML can be utilized to produce better, safer, smarter, and faster medical devices.

    Some of the highlights of the show include:
    • What is AI? John McCarthy, Father of AI, defined it as: “The science and engineering of making intelligent machines.” Basically, it’s Independent robots thinking and acting like humans, completely autonomously.
    • ML is a technique within AI that focuses on algorithms and models in software to reach real-time conclusions and decisions based on a foundation of learning, training, and rules.
    • What’s the reality of AI adoption in major industries? It’s challenging to get large, regulated, medical device companies to implement ML due to safety risks. Yet, it can be transformational.
    • Machine Learning Assurance: Guidance on how to perform audits of ML models to create assurances that build trust and confidence in a quality management system (QMS) and development process.
    • Culture of Quality Control: Mistakes can and will be made. Is AI and ML behaving within certain bounds and rendering good results in the medical device industry?
    • FDA encourages collaboration for companies to demonstrate ML assurance, mitigate risks, prove quality control mindset, understand Algorithmic Change Protocol (ACT), and provide post-market surveillance.
    • Lean in and Lead: Focus on safety and effectiveness to meet the needs of patients and caregivers by using AI in some way with medical devices.

    • 45 min
    510(k) Tips and Answers to Frequently Asked Questions for Medical Device Companies

    510(k) Tips and Answers to Frequently Asked Questions for Medical Device Companies

    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 should it be prepared? What’s the Refuse To Accept (RTA) checklist?

    In this episode of the Global Medical Device Podcast, Mike Drues of Vascular Sciences joins host Jon Speer to tackle these and other common questions, and offer tips on the Premarket Notification 510(k) process to help companies achieve FDA clearance to sell their medical device in the United States marketplace.

    Some of the highlights of the show include:
    • What is a Premarket Notification 510(k)? Regulatory pathway to bring Class II medical devices (or Class I) using substantially equivalent predicate devices to market in the United States.
    • Different regulatory pathway options include:
    • 510(k) types: Traditional, Special, and Abbreviated/Performance
    • De Novo
    • Premarket Approval (PMA)
    • When to submit 510(k)? When development, design freeze, verification/validation testing, and documentation are done. FDA may accept promissory notes.
    • When to prepare and compile 510(k)? Requirements and other prudent engineering for safety and efficacy are met, such as clinical evidence and data.
    • RTA Checklists for 510(k)s: Process involves administrative and scientific/substantive reviews.

    • 43 min
    Addressing the PPE Shortage with a No Cost Solution for Healthcare Providers

    Addressing the PPE Shortage with a No Cost Solution for Healthcare Providers

    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 Devon Campbell from MasksOn.org to discuss the impactful efforts being made through the MasksOn initiative that’s providing personal protective equipment and relief at no cost during the coronavirus pandemic.

    MasksOn.org is a non-profit effort to mass-produce reusable, sanitizable emergency masks and distribute it to those clinicians who do not have access to FDA-approved equipment. Listen now to learn more about the project and how you can get involved to help protect clinicians and save countless lives.

    Some of the highlights of the show include:

    • Medical Device Product Development: Devon and Sanjay share lessons learned about moving quickly or spending too much time on regulatory details.
    • User-forward Process: Put physicians and users first and foremost throughout design and development to create a solution that solves a problem.
    • MasksOn’s level of investment included multiple design iterations, beta testing, tight timeline, user feedback, and quickly getting product developed and shipped.
    • If most masks make you feel claustrophobic, MasksOn’s retrofitted scuba masks and valve mechanisms are simple, safe, and comfortable.
    • Regulatory Challenges: FDA’s PPE guidance clearly describes labeling and emergency use authorization (EUA), such as for medical provider masks.
    • MasksOn’s Distribution Strategy: Word of mouth went viral as a side effect to COVID hotspot map. Lots of little things make a big difference in people’s lives.
    • Non-Profit Purpose: Raise in-kind and direct donations to keep clinicians safer. MasksOn is almost halfway there with about $2 million of its $5 million goal.
    • Lack of Ego Environment: Nothing gets in the way of progress because MasksOn is a non-profit organization, led by physicians, and run by volunteers.

    • 32 min
    [LIVE] How EU MDR Changes are Impacting the Medical Device Ecosystem

    [LIVE] How EU MDR Changes are Impacting the Medical Device Ecosystem

    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 the official postponement of EU MDR. Once official, the DoA would be amended by one year, so when referring to the DoA as 26 May 2020 this would now be 26 May 2021.

    This live episode of the Global Medical Device Podcast was recorded at the Greenlight Guru True Quality Roadshow in Houston, with host Jon Speer his special guest Evangeline Loh, vice president of regulatory affairs at Emergo Group. Together they discuss key challenges medical device professionals are facing with EU MDR, how to best manage those challenges, and its impact on the medical device ecosystem.

    Some of the highlights of the show include:

    - EU MDR: The medical device regulation was scheduled to start on May 26, 2020, but will likely be postponed due to disruptions caused by the COVID-19 pandemic.
    - Second Corrigendum: Self-certified Class I medical devices under the current MDD 93/42/EEC will be up-classified under MDR and will not need to be certified to the new regulation until May 25, 2024.
    - Ecosystem Challenge: Delays have the medical device enterprise scrambling to find systems to register and market their medical devices to be compliant.
    - Number of Notified Bodies: MDR has 11 designated notified bodies, which is a significant increase. EU Commission plans to designate several more soon.
    - Beat the Clock: The advantage to receiving MDR certification before May 2024 by engaging a notified body to review/issue it is to become a legacy device.
    - Brexit (UK withdraws from EU): How will it impact and be impacted by EU MDR? From a regulatory regime perspective, it represents more work and duplication.
    - Despite delays, deadlines are approaching and will impact everyone. It’s important to monitor and understand what’s happening around the world.

    • 30 min

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