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Global Medical Device Podcast powered by Greenlight Guru

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

Read more

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.

iTunes Ratings

33 Ratings
Average Ratings
26
6
1
0
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A must listen for medical device professional!

By MacJ2300 - Sep 09 2015
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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.

Med Device Experts

By Gertwerks - Sep 08 2015
Read more
If you are in the med device industry you NEED to listen to this great information

iTunes Ratings

33 Ratings
Average Ratings
26
6
1
0
0

A must listen for medical device professional!

By MacJ2300 - Sep 09 2015
Read more
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.

Med Device Experts

By Gertwerks - Sep 08 2015
Read more
If you are in the med device industry you NEED to listen to this great information

Listen to:

Cover image of Global Medical Device Podcast powered by Greenlight Guru

Global Medical Device Podcast powered by Greenlight Guru

Updated 3 days ago

Read more

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.

7 Habits of Highly Effective True Quality Medical Device Professionals

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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 professionals.

True quality does not simply refer to being compliant with regulations - but going above and beyond. It’s your responsibility to improve the quality of life.

Some of the highlights of the show include:

● Habit 1: Quality management system (QMS) should be simple and right sized; customize it to describe your business’ processes.
● Habit 2: Move away from paper-based approaches - may make your QMS fragile and not scale; digitize documentation with a purpose-based solution.
● Habit 3: Always be audit ready; if the FDA is coming, you shouldn’t behave differently or hide something. Be transparent, and let FDA show up anytime.
● Habit 4: Implement risk-based approaches and decision making; understand the scope, magnitude, and potential impact of issues and complaints.
● Habit 5: Be proactive rather than reactive to events; don’t wait for something to happen to do something about it. Monitor, evaluate, track, trend, and take action.
● Habit 6: Break down silos/barriers by understanding the purpose and benefits of regulations and regulatory agencies.
● Habit 7: Shift from compliance-minded to true quality focus; you develop, design, and test a product to make sure it’s safe and effective, but the ultimate power is knowing that it’s for real physicians and patients.

Links:

Mike Drues
Greenlight Guru
510(k)
The 7 Habits of Highly Effective People by Stephen Covey

Quotes:

“We’re all in this to improve the quality of life. We all have a quality role that we play into this process.” - Jon Speer

“Sometimes, convincing companies to go above and beyond is what is required. It’s not always an easy thing to do.” - Mike Drues

“Sometimes, people look at a quality system as a burden. I want you to look at it as something you get to do that describes your business’ processes.” - Jon Speer

“If you’re doing all the things that you should be doing anyway, then you have absolutely nothing to worry about.” - Mike Drues

Oct 17 2018

43mins

Play

Medical Device Industry Predictions for 2019

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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 Prediction #1: It’s going to be harder for medical devices to get to market and stay in the market in EU. Still confusing; clarity to come in 2019?
● 2018 Prediction #2: Mad dash to update ISO 13485 certification before deadline. Resources were constrained, some came late to the party, progress was made.
● 2018 Prediction #3: ISO 14971 will be revised for industry comment. Draft was released in September/October to receive comments. Be on the lookout for a revision around mid-year.
● 2018 Prediction #4: Health Canada will back off on MDSAP deadline. Would have provided constraints for many companies, but Canada didn’t back down.
● 2018 Prediction #5: Medical device companies shift from compliance-focused to quality-focused. FDA’s been proactive, some movement, but a long way to go.
● 2019 Prediction #6: Wearable medical devices will become more common. A trend with more consumer good companies entering medical device market.
● 2019 Prediction #7: EU MDR challenges. Will still be more difficult and unclear on how to get products to market.
● 2019 Prediction #8: FDA QSR harmonizing with ISO 13485:2016. FDA is interested in moving away from 21 CFR Part 820 for ISO 13485. Prepare for it!
● 2019 Prediction #9: The FDA’s Case for Quality. It’ll continue and gain momentum. Initiatives include Medical Device Discovery Appraisal Program.
● 2019 Prediction #10: Expect FDA to continue to shake up regulatory submission processes. Modernizing 510(k) process into Safety and Performance-based Pathway.

Dec 19 2018

15mins

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4 Facts That May Surprise You About FDA

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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 Regulatory Strategies is a former FDA reviewer and she shares with listeners some fun facts about the FDA and what we don’t see behind closed doors.

Some of the highlights of the show include:

● Fun Fact #1: FDA employees are not all about rules and red tape. They’re passionate about public health and do things creatively that benefit patients.
● Fun Fact #2: FDA is holder and keeper of Code of Federal Regulations (CFR) product codes. FDA has the ability to add or remove product codes.
● Fun Fact #3: Breakthrough Devices designation protects and promotes public health via access to timely development, assessment, and review of devices.
● Fun Fact #4: Opioid epidemic and pediatric care are two categories generating the most interest and activity regarding need for/availability of medical devices.

Jul 10 2019

29mins

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Why Design Verification Matters in Medical Device Design and Development

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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 during the research and development (R&D) process.

In this episode, Mike Drues of Vascular Sciences joins me to discuss the nuances of design verification, as it relates to quality and design controls.

Some of the highlights of the show include:
● The difference between design verification and design validation is whether you designed the product correctly vs. you designed the correct product.
● Conduct research prior to design verification to determine which questions to ask and tests to perform to solve the right problems.
● Trust but Verify: Never assume that users know what they really need. They may think they know the best solution, but that’s not always true.
● No-thought fallback position is testing according to standards or guidance documents as a design verification strategy.
● Present testing matrix as part of FDA pre-submission process. Avoid making design verification an afterthought.
● Plan, be proactive, and collaborate with regulatory bodies to prevent delayed product launches and loss of revenue.
● Quality engineers in R&D need to participate, prototype, iterate, and demonstrate/prove concepts before design verification to discover bad decisions.

Sep 11 2019

40mins

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The Bleeding Edge: Lessons Learned for the Medical Device Industry

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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, but it seemed liked the whole story was not being told. On today’s episode, Mike Drues, president of Vascular Sciences, joins Jon to explore different perspectives to give you a clear and complete picture of the industry.

The documentary focused on a few medical devices that caused harm to people, but neglected to say anything about medical devices that help people every day.

However, it elevated types of topics that start conversations and is a step to identifying opportunities for improvement. The solution is more communication, not less.

SOME OF THE HIGHLIGHTS OF THE SHOW INCLUDE:
-Those with products in the documentary declined to comment. Medical device professionals should be obligated to tell their side of the story.
-The documentary put a clinical face on the problem; not talking just about engineering, regulations, and biology - but about people’s lives.
-510(k) vs. Premarket Approval (PMA): Documentary described getting medical devices to market may be too easy and should require more clinical data.
-Whether following a 510(k) or PMA path, it does not mean that a medical device is safer than the other. FDA’s system is not perfect; bar needs to be set higher.
-Some permanent implant devices in the documentary were cleared by 510(k). Is that sufficient? May depend on a case by case basis of regulation vs. innovation.
-A medical device can get to market without having clinical data. So, clinical data may not be necessary or more is being expected pre- or post-market.
-Systemic breakdowns of quality management software (QMS) and numerous adverse events may require thorough processes, investigation, and reporting.
-FDA doesn’t have jurisdiction over practice of medicine and physicians, but over devices used by them. Do we need regulations to make devices safer?

Aug 17 2018

45mins

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When Should You Start a QMS?

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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, which helps establish and implement holistic, efficient, and practical product development and manufacturing strategies. Devon and Jon Speer discuss the importance of timing when starting a QMS for medical device companies to ensure future product success..

Some of the highlights of the show include:
● Emerging Trend: Almost all of Devon’s clients have no QMS, or have what they consider a QMS, but isn’t in reality.
● Mentor for MassChallenge: The global, zero-equity startup accelerator has helped more than 1,900 startups and raise more than $4.3 billion in funding.
● Hungry for Knowledge: What’s your core technology? Commercialization strategy? Development strategy? What do you need to do to take it to market?
● Lack of Appreciation: Startups should think through QMS and design control opportunities, strategies, and implementation sooner than later.
● Start Early with End in Mind: Make it easy to pivot later. If you don’t go through the effort that it takes, it’s difficult to backtrack.
● Best Practices: Look far forward and obtain external help and guidance from quality experts.
● Bigger Picture: Work with everyone involved to better understand challenges and changes with a company’s QMS, as it evolves and matures in real time.
● Patients who depend on your medical technology will appreciate your focus on true quality.

Aug 07 2019

30mins

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2016 Medical Device Regulatory Trends Year in Review

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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 the past year. Mike is a frequent guest on our show, and today we will be talking about the year in review.

Some of the topics you’ll hear discussed include:

- Some of the significant guidance documents that were new in 2016, including one on medical device reporting for manufacturers.
- Two guidances on when to submit a 510K and why these in particular are important.
- General wellness devices: What they are and what makes them different from regulated devices.
- Thoughts on the Use of Real-World Evidence guidance document.
- Why the guidance on 3D printing is so impactful.
- What might happen from a regulatory perspective in 2017, including more specific guidances and focusing on usability.
- Thoughts on whether the FDA should be in the business of putting out guidance documents.

Dec 29 2016

34mins

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Design Validation vs. Human Factors Validation

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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 factors at HS Design and AAMI Human Engineering Committee co-chair. She describes the similarities and differences between human factors vs. design validation.

Some of the highlights of the show include:

● What constitutes human factors validation? It involves an international standard and FDA guidance on rules that medical device professionals need to follow.
● Design validation focuses more on what’s expected during the audit of a human factors file, if you have a product that is a high risk for harm or injury.
● Most companies don’t know how to intertwine human factors within design and development practices. Use common sense to make a good product design.
● FDA helps developers understand what they need to do and document early on during the design process to avoid validation issues with a product later on.
● Past sales criteria is a major difference between design and human factors validation because it’s difficult to define and measure ease of use.
● Understand all elements that could impact a product’s design. Study your users and use environment before identifying and fixing design issues.
● A task analysis identifies each step users need to take and serves as evidence that you considered their needs and made necessary compromises.
● Mary Beth busts myths related to human factors and design validation, such as needing three people to evaluate and provide feedback on your product’s design.

Feb 13 2019

34mins

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Risk Management from a Regulatory & Product Development Point of View

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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 relates to on-label vs off-label use (Some really interesting points on this topic).

We suggest following the ISO 14971 standard which provides manufacturers with a framework to manage the risks associated with the use of medical devices.

Another helpful guidance document is TR 24971 (Yea it’s not free, but probably worth the couple hundred dollar investments). If your product will be released in Europe, then it’s good to know the European version as well.

FMEA is another popular risk management project tool and there are others available.

We then discuss the on-label use versus the off-label use of a product, and admittedly the whole thing is a dilemma.

From a product liability perspective, if legal counsel can show a manufacturer knew a risk associated with a product that they did not mitigate, then the manufacturer can be held to a higher level of liability.

We dive deeper into the topic as we discuss:

Setting a strategy regarding limiting discussion on use
The difference between intentional and unintentional off-label use
The meaning of unintentional misuse
Staying focused on the intended use of the product
When to push back with regulators

Risk management can be overwhelming if you let it. Approach it from a process point of view and understand the documentation suggested.

greenlight.guru is about to make following risk management so much easier, featuring a module that allows you to conduct risk management activities and integrate with design control activities all in one, cloud-based solution.

Your hosts today for the Global Medical Device Podcast, Jon Speer and Michael Drues Ph.D thank you for listening as they continue to share how you can implement their proven strategies at your organization.

Sep 02 2015

22mins

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Is FDA's New 'Safer Technologies Program' Applicable To Your Medical Device?

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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).

Requirements for eligible devices include those that significantly improve the safety of currently available treatments or diagnostics for underlying diseases or conditions associated with less serious morbidities and mortalities.

Today’s guest is Mike Drues of Vascular Sciences, who joins Jon Speer to discuss how this new program may be applicable to your medical device and design efforts.

Some of the highlights of the show include:
● The main difference is that STeP’s focus is on improving safety; BDP’s emphasis is on efficacy side of devices for more serious diseases, injuries, or conditions.
● BDP vs. STeP: Which is a better option, and why? Programs should have been combined because there’s a need to offer incentives for safety and effectiveness.
● STeP Eligibility Criteria:
○ If device obtains BDP designation, it’s not STeP eligible, and vice versa.
○ If device isn’t eligible for BDP, but offers significant advantage to treat and diagnose less serious diseases/conditions that meet benefit-risk profile.
● STeP mechanics eerily similar to BDP process:
○ Prepare pre-submission to address requirements and include abbreviated device description, data plan for clinical data, and tests to be performed.
○ Request pre-submission meeting with FDA, which intends to make a determination within 60 days.
● Order of Operation: Start STeP pre-submission now or later, and then follow up with traditional submission, even if FDA doesn’t approve pre-submission.

Oct 16 2019

33mins

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Modernizing 510(k) Program through new FDA Safety and Performance Based Pathway

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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 Sciences and in this episode, Jon Speer and Mike discuss the meaning and purpose behind this new guidance. The draft version of the guidance was Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria.

Some of the highlights of the show include:

● The guidance is part of FDA’s series of transformative steps to modernize the 510(k) program and advance the review of safe and effective medical devices.
● Is it possible to have a newer, more advanced technology that’s safer and more effective, but also substantially equivalent?
● What’s special about the new version of the guidance? All 510(k) submissions should be safety and performance based.
● FDA’s new version of the guidance spins it as a sub-type of the existing Abbreviated 510(k), but limited to well-understood/established technologies.
● Gold standard for showing substantial equivalence is to test your device against a predicate device and compare results.
● The indication for use is important to define what is or is not a similar technology or product family.
● Use new 510(k) safety and performance guidance when predicate is impractical or impossible to get. Totality of evidence is used to show substantial equivalence.
● FDA tends to push 510(k) path due to familiarity over its De Novo Program that most don’t understand. Instead, a catch-up version of 510(k) should be created.

Mar 27 2019

38mins

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Debunking Premarket Approval (PMA) Myths (And Why the PMA Path May Not Be as Scary as You Think)

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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 afraid that may kill your idea?

Mike Drues, president of Vascular Sciences, is with us today to do some premarket approval (PMA) myth busting and describes why a PMA path may not be as scary as you think.

Some of the highlights of the show include:

● PMAs are reserved for the highest risk devices (Class III and life-supporting).
● Utilize the patient-centered approach because assumptions are often made about risks and invasive vs. non-invasive devices.
● Can you use a predicate to show substantial equivalence for a PMA device? From a regulatory perspective, there is no concept of substantial equivalence.
● Use the MAUDE database and identify any precedence that has been set to gather knowledge about devices you are developing.
● You have a story to tell. Be able to explain your product, position, and why your product is good for the patient.
● All PMAs require clinical data. False! The vast majority of PMAs do require clinical data, but some PMAs do not require such data.
● What are the pros and cons of a PMA vs. a 510(k)? Most opt for a 510(k).
● Class III devices can do a PMA, or other options, including the Humanitarian Device Exemption (HDE) and Product Development Protocol (PDP).

May 15 2018

40mins

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An Overview of What Medical Device Developers Need to Know About Human Factors

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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 Bryant Foster, the Vice President of Research & Design at Research Collective. Bryant applies the principles of cognitive psychology to the design of new technologies and is a great resource on the topic.

Some of the highlights of the show include:

● What Bryant does as the VP of Research & Design at Research Collective and what his main focus is.
● The differences, overlaps, and intersections between human factors, design controls, project development, and research and development as these processes fit into the medical device industry.
● How companies should address the human factors standpoint.
● Common mistakes to avoid when considering the human factors.
● Human factors in usability and ergonomics as well as the difference between formative studies and validation.
● What a task analysis is and how that relates to the overall risk assessment.
● The importance of considering the various users of the product or device.
● What human factors has to do with post-market usability.

Dec 20 2017

35mins

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What Device Makers Need to Know About Design Verification and Validation with Mike Drues

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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 episode of the Global Medical Device podcast, we are delving into everything related to design verification and validation, which is often called the V&V.

We discuss why V&V is so important, the major differences between verification and validation, how they fit into your approval process and more.

Today we’re talking to a familiar guest and medical device expert Mike Drues, president of Vascular Sciences.

“We need to focus on asking the right questions. V&V is all about demonstrating what’s safe and effective.” – Mike Drues

Mike works for and consults with medical device companies located all over the world. He also works with the US FDA, Canada Health, and other regulatory and government agencies in the US, Canada, Europe and elsewhere in the world.

“When working with the FDA, tell, don’t ask. Lead, don’t follow.” – Mike Drues

In our discussion about V&V, some of the points you’ll hear about include:

- Validation and verification: What do these two words mean, what are the major differences between the two, and how do they both fit into your approval processes?

- How to know when you need to go to the FDA with a 510k form and when you can simply use a letter-to-file.

- The importance of knowing why you’re running the V&V tests to begin with.

- How you can use the Five Whys tool in your V&V process.

- Why it might not make sense to go through the V&V process, and how to approach the FDA to come up with a different procedure to satisfy the regulatory requirements.

- Advice on which questions to ask the FDA during the pre-submission process with the FDA.

May 10 2016

31mins

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Integrating Human Factors into Design Controls to Improve Patient Outcomes

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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 human factors and user experience consultancy. In this episode we discuss how to integrate human factors into design controls to reduce risk and improve patient outcomes.

Some of the highlights of the show include:

● Research Collective helps design medical devices that are easy to learn and efficient to use to reduce risk and improve patient outcomes.
● Product development involves experts and scientific knowledge about how people work, make decisions, and learn to reduce risk.
● Human factors is defined as area that applies all human sciences to design of products and processes.
● Usability consists of four components: Easy to learn, efficient to use, memorability, and subjective satisfaction.
● Human factors (above the neck) and ergonomics (below the neck) are one and the same, but have slightly different connotations.
● Best practices for human factors include understanding, testing, and evaluating user needs, capabilities, and limitations.
● Class II and III (some Class I) products require usability testing that includes observation. Design input should be objective and measurable.
● Victory Lap: Validation usability study should represent culmination of work completed to make sure people can use the product.

Jun 05 2019

41mins

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Medical Device Product Development Project Management Best Practices with Peter Sebelius

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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 management.

Peter is a certified PM and has vast experience in the industry and extensive knowledge of medical device standards. He is also a member of the joint working groups on ISO 13485 and Iso 14971.

Today we’ll talk about lean management and agile as it applies to the development of medical devices. Can you be lean and compliant at the same time?

“Medical device product development is far from a straight line.” - Jon Speer

Knowing when to turn on the design controls is a delicate balance. Design controls should be a framework - they don’t necessarily need to stifle the creative process. It doesn’t have to be restrictive.

“It was never intended in product management or design control to be changing technical solutions fundamentally while you’re in that process.” - Peter Sebelius

Today we’ll talk about:

- Can you be lean?
- Finding the right balance with design controls
- Using “TBDs”
- Project Management and Design Controls as ‘best practices’
- “Guide for the Project Management Body of Knowledge”
- “Shared responsibility is no responsibility”

“You can’t write something down that you haven’t thought through well.” - Peter Sebelius

Peter suggests that project managers should learn more about qualitative management and regulatory affairs. Make sure you know what’s good enough.

Peter provides online training on risk management, project management and design control. You can find him and learn more at gantus.com.

Feb 23 2016

23mins

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Grasping the Impact of Artificial Intelligence and Machine Learning on Medical Devices

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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 AI and ML is even finding its way into medical devices. Recently, the FDA issued a press release about the potential of AI and ML to fundamentally transform the delivery of health care.

This episode’s guest is Mike Drues of Vascular Sciences, who joins Jon Speer to discuss nuances, regulations, and implications to know when incorporating AI and/or ML into medical devices and software.

Some of the highlights of the show include:

● Is FDA’s statement about AI and ML simply marketing hype? Other medical devices have the same opportunity, even if AI and ML are not used.
● Most medical devices are 510(k)s and may already have such potential, if substantially equivalent to a device that currently exists.
● The FDA is basically proposing the use of AI and ML to make companies be more proactive with product improvements that help patients.
● The difference between AI, ML, and other technologies is that AI and ML have ability to learn, adapt, and evolve; but may create quality and regulatory issues.
● The regulatory logic of AI is nothing new or different, but it hasn’t caught up. How to do change management to learn and adapt needs to be offered
● AI software should give manufacturers recommended changes, how they should be handled, and when to identify change creep.
● Digital Health Software Pre-cert Program: Focuses on team, not device. Does this mean the FDA is moving away from 21 CFR Part 820 in favor of ISO 13485?
● Software as a medical device (SaMD) companies considering AI and ML should follow FDA’s proposed regulatory framework for AI- and ML-driven software.

Apr 11 2019

38mins

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Addressing Top Questions of QA/RA Candidates on Salary, Skill Sets and Job Satisfaction

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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 guest is Mitch Robbins is the founder and managing director of The Anthony Michael Group. As a recruiter, Mitch talks to QA/RA candidates every day and shares their most commonly asked questions.

Some of the highlights of the show include:

- Top QA/RA candidate questions relate to salary, skill sets, and job satisfaction.
- How does QA/RA professional’s salary compare to other medical device professionals? Salary depends on demographics, profession, and other metrics.
- Fundamental Factors: Location, scope of responsibility, co-workers, company culture, and type of technology are considered when making a career change.
- Don’t focus on money, job satisfaction is much more important than your salary.
- Research Determines Risk: Is company’s financial situation stable? What stage? Regulatory standpoint? Risk tolerance? Share rewards? Equity stake?
- How can QA/RA professionals improve their visibility within an organization to achieve promotion or career move: Take risks, volunteer for projects, and overcome transition challenges.
- Resources and Toolkits: Treat coworkers to coffee or lunch to discuss and shadow their quality and regulatory roles and responsibilities.
- If you’re happy, would you at least want to know about possible enhancements? When/if opportunity strikes, what would the next step in your career look like?

Nov 06 2019

35mins

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Why Medical Device Startups Need to Implement a ‘Right-Sized’ QMS with David Amor

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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 needs to be right-sized, and meeting all of the regulations can be one of the hardest hurdles to cross in this business.

Our guest today is here to talk about how you can surpass these hurdles, and David’s insight and resources will help you manage your quality system in the best way possible.

David Amor is a medtech consultant who’s behind the genius consultation firm at www.medgineering.com. And today he’s talking about exactly that: consultation for your quality management systems.

Managing the quality of your products is something that needs to be taken care of when you’re starting your business.

“The bigger your company gets, the more scrutiny you’re going to get from the FDA and the higher the expectation is from the FDA.” – David Amor

That’s why finding the right-size system for you right now is extremely important. Tune in now to find out how you can build your business and your management systems at the same time.

Today’s topics discussed:

- What startups should do to succeed in the medical device realm

- Understanding where your business fits within the field and the FDA’s regulations

- Practical implementation of quality systems and its regulations

- Finding the right size for your quality management system

- How to manage your quality systems while still focusing on the development of your medical devices

Resources mentioned:

David built his consultation website – www.myquickconsult.com – exclusively for startups, giving you access to Med Tech execs who can answer your questions and give you reviews on your quality systems. Email David at david@medgineering.com for a discount.

And don’t forget to visit greenlight.guru for your quality management system needs.

Dec 15 2015

26mins

Play

EU MDR: Not All Doom and Gloom

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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 and its In Vitro Diagnostic Regulation (IVDR). Rebecca is a former regulator herself, and now serves as Senior Director for Quality Assurance, Regulatory Affairs, and Clinical Affairs for the Advanced Wound Franchise of ConvaTec Limited.

Some of the highlights of the show include:

● EU MDR transition timeframe is very optimistic due to the complexity of today’s medical devices.
● The infrastructure needed to navigate through the regulations is still in progress. So, minimal guidance is a major challenge for the medical device industry.
● The medical device industry is at a crisis point where collaboration must occur to be able to support patients, public health, and healthcare institutions.
● An extension would pose additional challenges. The legal process takes time, decreases available resources, and delays implementation of changes.
● The capacity of notified bodies is expected to increase by the end of this year. Many devices need to go through process that were previously unregulated.
● Don’t panic, stay calm. Engage early on with notified body and provide technical documentation and clinical data regarding design controls.
● During the post-market phase, EU MDR/IVDR will impact companies’ quality management system (QMS) and infrastructure due to required reporting.

Download our free EU MDR gap analysis tool here → https://www.greenlight.guru/mdr-gap-analysis-tool

May 22 2019

32mins

Play

5 Myths about QA/RA Recruiting in the Medical Device Industry

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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 director of The Anthony Michael Group. As a recruiter, Mitch joins Jon Speer on the show to break down five myths about QA/RA recruiting and discuss the dos and don’ts medical device companies should consider when hiring these professionals.

Some of the highlights of the show include:
- Myth #1: Recruiting isn’t necessarily the hiring manager’s responsibility, but also involves Human Resources (HR) or Talent Acquisition to own hiring decisions.
- Myth #2: No time to invest in recruitment process to hire elite talent because so much time is spent micromanaging average performers.
- Myth #3: Trust your gut feeling. It’s never wrong. You know an elite person when you see them.
- Myth #4: Elite talent/top performers can’t be hired because our business can’t compete with perks and benefits offered by billion-dollar companies.
- Myth #5: Elite talent is expensive. We can’t afford to hire them because money is their top consideration. The best of the best won’t work for peanuts.
- Job Posts: Only 32% of people in the employment market are actively looking for a job, but up to 80% are open to opportunities.
- Resumes should summarize role and outcomes delivered. Update regularly to create document that conveys a compelling and relevant story of contributions.
- All Talk or True Talent: Conduct a test drive scenario to demonstrate and validate candidate’s actual skills. The cost of a mis-hire is 13 times the leader’s salary.

Dec 11 2019

43mins

Play

How to Solve the Medtech Value Equation with Quality Data

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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 to experience? How will you overcome those?

Today’s guest is Devon Campbell, founder of Prodct, LLC, who joins Jon Speer to discuss the value equation for MedTech companies to elevate and escalate quality and improve value.

Some of the highlights of the show include:
- Data Process: Sooner than later, think through the deployment and infrastructure for a company’s quality management system (QMS) to generate quality data.
- Quality Strategy Mindset: Learn to appreciate, understand, and demonstrate the value and purpose of quality data.
- Due Diligence: Multiple reasons exist for MedTech companies getting their product or process into the hands of users sooner and serve as revenue source.
- Deliver not just data, but extensive confidence in that data and in a way that end users and stakeholders value and trust, as well as reduce risk.
- Quality data is not a one-time occurance. Reproduce and repeat data consistently for process validation and scalability.
- How does QMS strategy inform and offer value? Provides ability to articulate and appreciate quality by knowing where you are and want to be with your company.
- Elements to consider for a value equation include technology, quality infrastructure, go-to-market regulatory strategies, and data integrity.

Dec 04 2019

32mins

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Why Supplier Quality Management Is So Important For Medical Device Companies

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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 relationships between those in the company and those outside of the company?

Today’s guest is Mike Drues of Vascular Sciences, who joins Jon Speer to review and discuss the details of supplier quality management.

Some of the highlights of the show include:
- What is supplier quality management? Anybody outside the main company that provides products/services that directly/indirectly go into medical devices.
- Why supplier quality management is important? Manufacturers must use good judgement when establishing and meeting quality system (QS) requirements.
- Necessary evil or supplier quality management failure? Used for years, Ethylene Oxide (EtO) sterilization for medical devices is now a public health emergency.
- EtO is flammable, carcinogenic, and key ingredient in thermobaric weapons. Companies should identify and consider other options for valid sterilization.
- Defining critical vs. non-critical is not enough. Use risk-based approach when assessing criticality levels of suppliers for your products and processes.

Nov 27 2019

39mins

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FDA is Expanding its Case for Quality Program... Should Your Company Participate?

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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 for its Case for Quality Initiative.

Today’s guest is Mike Drues of Vascular Sciences. We discuss the benefits and incentives for compliant and noncompliant companies to participate in the Case for Quality program. Compliance doesn’t necessarily ensure quality.

Some of the highlights of the show include:

● Pilot Program Premise: Partnership between FDA, MDIC, and CMMI Institute to promote compliance and focus on true quality products and processes.
● Case for Quality is newer program with somewhat skewed participation from larger companies due to incentives favoring PMA Class III products.
● Case for Quality: Advantages for participating include being excused from routine FDA inspections when state of compliance was demonstrated previously.
● Making changes to positively impact PMA products involves challenging process to submit a supplement. Are regulatory requirements for changes necessary?
● Micromanage Case for Quality: Root cause for such regulations is to prevent shortcuts and oversee those that don’t know what or how to be in compliance.
● Why are some companies not in compliance? They should participate in the Case for Quality Initiative to learn what they need to do.

Nov 20 2019

36mins

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Preparing for EU MDR

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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 medical device companies will be transitioning to the new European regulation.

Today’s guest is Isabella Schmitt, regulatory affairs consultant with Proxima Clinical Research. Isabella joins Jon Speer in this episode to share what listeners need to do to prepare for EU MDR, despite the recently announced two-year delay of EUDAMED.

Some of the highlights of the show include:
- Why EU MDR? Effort to address uproar over ruptured implant devices with unknown materials that made some patients sick.
- What is EU MDR? The purpose is increased focus on safety and the entire lifecycle approach, not only pre-market approval (PMA).
- Compliant Equivalency: Isabella describes biological and technological factors, as well as data and test requirements for clinical use and support.
- Preparation - First Step: Assess general safety and performance requirements (GSPRs) via gap analysis of existing, needed, and publicly available data.
- Startup vs. Established Products/Companies: Understand compliance of GSPRs, intended use, description of device, standard of care, and alternative options.
- EUDAMED: Medical database with access to and reporting of clinical investigation information, post-market surveillance, universal device identifiers (UDIs).

Nov 13 2019

30mins

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Addressing Top Questions of QA/RA Candidates on Salary, Skill Sets and Job Satisfaction

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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 guest is Mitch Robbins is the founder and managing director of The Anthony Michael Group. As a recruiter, Mitch talks to QA/RA candidates every day and shares their most commonly asked questions.

Some of the highlights of the show include:

- Top QA/RA candidate questions relate to salary, skill sets, and job satisfaction.
- How does QA/RA professional’s salary compare to other medical device professionals? Salary depends on demographics, profession, and other metrics.
- Fundamental Factors: Location, scope of responsibility, co-workers, company culture, and type of technology are considered when making a career change.
- Don’t focus on money, job satisfaction is much more important than your salary.
- Research Determines Risk: Is company’s financial situation stable? What stage? Regulatory standpoint? Risk tolerance? Share rewards? Equity stake?
- How can QA/RA professionals improve their visibility within an organization to achieve promotion or career move: Take risks, volunteer for projects, and overcome transition challenges.
- Resources and Toolkits: Treat coworkers to coffee or lunch to discuss and shadow their quality and regulatory roles and responsibilities.
- If you’re happy, would you at least want to know about possible enhancements? When/if opportunity strikes, what would the next step in your career look like?

Nov 06 2019

35mins

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Is FDA's New 'Safer Technologies Program' Applicable To Your Medical Device?

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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).

Requirements for eligible devices include those that significantly improve the safety of currently available treatments or diagnostics for underlying diseases or conditions associated with less serious morbidities and mortalities.

Today’s guest is Mike Drues of Vascular Sciences, who joins Jon Speer to discuss how this new program may be applicable to your medical device and design efforts.

Some of the highlights of the show include:
● The main difference is that STeP’s focus is on improving safety; BDP’s emphasis is on efficacy side of devices for more serious diseases, injuries, or conditions.
● BDP vs. STeP: Which is a better option, and why? Programs should have been combined because there’s a need to offer incentives for safety and effectiveness.
● STeP Eligibility Criteria:
○ If device obtains BDP designation, it’s not STeP eligible, and vice versa.
○ If device isn’t eligible for BDP, but offers significant advantage to treat and diagnose less serious diseases/conditions that meet benefit-risk profile.
● STeP mechanics eerily similar to BDP process:
○ Prepare pre-submission to address requirements and include abbreviated device description, data plan for clinical data, and tests to be performed.
○ Request pre-submission meeting with FDA, which intends to make a determination within 60 days.
● Order of Operation: Start STeP pre-submission now or later, and then follow up with traditional submission, even if FDA doesn’t approve pre-submission.

Oct 16 2019

33mins

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Understanding the Benefit-Risk Determinations of FDA's Latest Guidance Documents

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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 guest Mike Drues of Vascular Sciences to join the show as the two discuss FDA’s two, new guidance documents that provide additional transparency, consistency, and objectivity regarding benefit-risk determinations.

Some of the highlights of the show include:

● Differences between Documents: Under what circumstances that pose a greater risk are acceptable for product submissions vs. appendices related to ISO 14971.
● New nine-page benefit-risk assessment worksheet is oversimplified and presents a non-traditional instead of analytical approach to determining benefit-risk.
● New guidance documents don’t mention 510(k) device, but why? People should already know about uncertainty and risk of 510(k) medical devices via predicates.
● Higher risk is acceptable in various classifications of medical devices, including PMAs and BDPs, and when dealing with small populations.
● Adding to the complexity of medical devices, the guidance documents now include low-, medium-, and high-risk categories and criteria of uncertainty.
● Pay attention to patient’s perspective of uncertainty when available. Are patients willing to truly accept risks and uncertainty to achieve unmet clinical need?
● Mitigate uncertainty in other ways, such as through labeling, degree of need, and clinical evidence/market data of product.
● Probable Benefit of HDE: Efficacy at a lower statistical power may diminish uncertainty due to giving patients early access to a medical device.

Oct 02 2019

36mins

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Leveraging Technology and Rapid Prototyping Methodologies during Product Development

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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 Engineering at Xometry, describes nuances to consider and how to leverage technology and rapid prototyping methodologies. Specifically, Greg shares Xometry’s different procurement and fulfilment strategies and options that help simplify and speed up the medical device process.

Some of the highlights of the show include:

● Procurement Problems: Xometry makes and fulfills on-demand custom manufactured parts for medical devices.
● Prototyping: When to start? What types to create? What are verification and validation requirements? Why consider past, present, and future iterations?
● Today’s Trends: Greg describes the evolution of materials, functions, and technologies (i.e., 3D printing, injection molding, and urethane casting).
● What problem will the medical device solve? Prototyping helps identify and define user needs, materials, form-fit-function requirements, and human factors.
● Agile/Iterative Product Development: Start early to make modifications and iterations to be flexible and leverage prototype for verification and validation.
● Material Selection: Prototyping identifies advantages and disadvantages of trying different materials to determine which to use for medical devices.
● A rapid prototype can be used for verification, if a rapid type of material can function and perform during testing and performance.
● Rapid prototyping can be used for first-run production, depending on market size. Consider low-volume vs. mass production tool due to cost and possible changes.

Sep 25 2019

39mins

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Why Design Verification Matters in Medical Device Design and Development

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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 during the research and development (R&D) process.

In this episode, Mike Drues of Vascular Sciences joins me to discuss the nuances of design verification, as it relates to quality and design controls.

Some of the highlights of the show include:
● The difference between design verification and design validation is whether you designed the product correctly vs. you designed the correct product.
● Conduct research prior to design verification to determine which questions to ask and tests to perform to solve the right problems.
● Trust but Verify: Never assume that users know what they really need. They may think they know the best solution, but that’s not always true.
● No-thought fallback position is testing according to standards or guidance documents as a design verification strategy.
● Present testing matrix as part of FDA pre-submission process. Avoid making design verification an afterthought.
● Plan, be proactive, and collaborate with regulatory bodies to prevent delayed product launches and loss of revenue.
● Quality engineers in R&D need to participate, prototype, iterate, and demonstrate/prove concepts before design verification to discover bad decisions.

Sep 11 2019

40mins

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Implementing Changes to SaMD under New EU MDR

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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 episode, Andrew Wu and I discuss the ramifications of these changes. Andrew is a software consultant with Rook Quality Systems and software as a medical device (SaMD) expert.

Some of the highlights of the show include:

● Most noticeable change is a broader definition of what qualifies as a medical device to include prediction and prognosis of diseased state.
● SaMD classification changes are drastic but vague following MDR implementation.
● Gap analysis should be performed to identify changes that companies need to make to conform with changes.
● Groups that will most likely experience the greatest impact due to classification and qualification changes:
○ Products on market in EU as Class I software will be uplisted as Class IIa.
○ Products that provide clinical information for informed clinical decisions.
● Timeline and Some Next Steps: Demonstrate conformance, update quality management system (QMS), notify regulatory body to MDR by May 25, 2020.
● Plan, prioritize, and understand your regulatory conformance strategy going forward.
● Compare and Contrast EU MDR and US FDA: Developing regulatory framework in different directions, but share consensus on sensitive nature and usage.

Sep 04 2019

37mins

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Career Tips for QA/RA Professionals in the Medical Device Industry

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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, founder and managing director of The Anthony Michael Group, offers tips for Quality Assurance and Regulatory Affairs (QA/RA) professionals on how to prepare for such a career.

Some of the highlights of the show include:
● The Anthony Michael Group is executive search firm that focuses on the medical device industry and places regulatory and quality leadership talent.
● Common quality and regulatory themes impacting the medical device industry include expediting time to market and keeping up with post-market changes.
● Regulatory and quality professionals help companies overcome obstacles to get things done and accomplish product development goals.
● Mindsets and Skill Sets: Differentiate low and high performers by understanding how their function and responsibilities fit with other pieces of the business.
● Market changes and expectations have evolved from must-have to integrated and cross-functional approach with increased respect.
● In the future, Mitch expects the “gig” economy to continue to grow with a contingent and consultant workforce.
● Build employee value proposition (EVP), candidate value proposition (CDP), and your brand and portfolio of expertise, recognition, and outcomes.
● Network, get certified, be resourceful, and add value by taking risks, volunteering for projects, and putting yourself in uncomfortable situations.

Aug 28 2019

30mins

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Right-sizing your QMS

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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 you do to correct it?

Today’s guest, Mike Drues of Vascular Sciences, and I discuss this topic through the lenses of regulatory and quality factors to share with listeners the best ways to approach and succeed in right-sizing your QMS.

Some of the highlights of the show include:

● QMS: Policies and procedures in place to meet regulatory requirements and define design, development, manufacturing, and servicing of medical devices.
● Two Extremes: Company’s QMS is too light because of vague and ambiguous verbiage, or too weighted with burdensome specifics; neither of which is a right-sized QMS.
● Company Pulse: To effectively right-size your QMS, you must understand who your company is, where you are, what stage you’re at in the process, and who’s involved.
● Perform a gap analysis, on-site visit, and internal audit to evaluate existing procedures and adjust as necessary.
● Companies that don’t follow their own procedures create regulatory, quality, and product liability problems.
● If you can’t measure it, you can’t improve it: Achieve consistent, repeatable, and reproducible outcomes.
● The difference between compliance and true quality, and why it’s important: Improve quality of life and provide the best possible outcome for patients.
● Are rules meant to be broken? Don’t follow rules blindly, especially if they don’t make sense. Be practical and pragmatic.

Aug 21 2019

38mins

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Challenges with Pediatric Medical Devices

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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 prescription drugs, specifically with children in mind.

Some of the highlights of the show include:
● Smaller versions of adult medical devices and drugs for pediatric population may not be the best solution or solve the problem.
● Lack of availability is due to lack of market. Drugs approved by the FDA for adults are relabeled for kids.
● Two-thirds of all drugs prescribed to children have not been studied or labeled specifically for them, and 90% of the drugs given to newborns are off-label.
● Physicians modify and improvise: Technical challenges include designing and developing pediatric-specific products that change and grow as the child does.
● How can industry get companies to focus on life-sustaining/life-saving devices and drugs for pediatric market? Clinical trials, informed consent, and 3D printing.
● Most medical products are required to show safety and efficacy; HDE only requires probable benefit.
● Real world evidence needed to support pediatric medical device submissions.
● Necessity is the Mother of Invention: Doctors retrofitted breathing tube for Saybie, a micro preemie the size of an apple.

Aug 14 2019

31mins

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When Should You Start a QMS?

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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, which helps establish and implement holistic, efficient, and practical product development and manufacturing strategies. Devon and Jon Speer discuss the importance of timing when starting a QMS for medical device companies to ensure future product success..

Some of the highlights of the show include:
● Emerging Trend: Almost all of Devon’s clients have no QMS, or have what they consider a QMS, but isn’t in reality.
● Mentor for MassChallenge: The global, zero-equity startup accelerator has helped more than 1,900 startups and raise more than $4.3 billion in funding.
● Hungry for Knowledge: What’s your core technology? Commercialization strategy? Development strategy? What do you need to do to take it to market?
● Lack of Appreciation: Startups should think through QMS and design control opportunities, strategies, and implementation sooner than later.
● Start Early with End in Mind: Make it easy to pivot later. If you don’t go through the effort that it takes, it’s difficult to backtrack.
● Best Practices: Look far forward and obtain external help and guidance from quality experts.
● Bigger Picture: Work with everyone involved to better understand challenges and changes with a company’s QMS, as it evolves and matures in real time.
● Patients who depend on your medical technology will appreciate your focus on true quality.

Aug 07 2019

30mins

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How General Wellness Devices Have Opened a Pandora's Box of Confusion

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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 devices, general wellness devices, or both?

In this episode, Jon Speer invites guest Mike Drues of Vascular Sciences to join the show as the two discuss the pros and cons, go-to-market pathways, and other considerations for general wellness products.

Some of the highlights of the show include:
● FDA does not regulate or classify general wellness devices that don’t diagnose, treat, or prevent a disease, injury, or condition.
● General wellness devices are required to do what they claim to do through prudent engineering.
● A general wellness device can still be considered a medical device, which creates confusion and false claims.
● Should manufacturers take the wellness or regulated route? Try both by putting versions of the same device on the market at the same time.
● Dumbed-down vs. stronger labeling: If the technology and risk are the same, how can FDA treat the same device differently?
● A wellness device exemption justification describes the device to explain how it meets labeling, technology, and risk requirements.
● FDA does not have a wellness device database to address problems by requiring pre-submissions, registrations, notifications, or other options.
● If Mike is “too busy” to help, that’s his code for, “You’re not doing what you should be doing.”

Jul 31 2019

34mins

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Regulating Artificial Intelligence and Machine Learning-based Software as a Medical Device

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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 possible with such technology and innovation.

In this episode, Allison Komiyama and Michelle Rubin-Onur of Acknowledge Regulatory Strategies discuss regulatory guidance documents related to SaMD created by the International Medical Device Regulators Forum (IMDRF) and U.S. Food and Drug Administration (FDA).

Some of the highlights of the show include:

● IMDRF’s definition of SaMD is software intended to be used or performed for at least one medical purpose without being part of a hardware medical device.
● SaMD field follows four guidance documents that provide key definitions, risk categorization, quality management systems (QMS), and clinical evaluation.
● Manufacturers are encouraged to provide feedback regarding performance, input, and intended use changes and submissions via FDA’s discussion paper.
● When categorizing SaMD, consider the significance of information provided and state of healthcare situation or condition.
● SaMD must undergo a three-step process: Valid clinical association, analytical validation, and clinical evaluation.
● The benefit of using a QMS to understand and mitigate risks helps FDA understand SaMD.
● To Do List: Complete FDA’s call to action; attend Reg AF Conference; and go to Greenlight Guru’s True Quality Roadshow.

Jul 24 2019

41mins

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Importance of Software Requirements in Product Development

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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 listeners to consider with their medical device product development efforts.

Some of the highlights of the show include:
- The medical device industry is about 5-10 years behind the times with adopting state-of-the-art technology.
- A successful medical device depends on accommodating requirements and stakeholders; requirements change through communication and collaboration.
- Be vague and add details about concept, features, and customer use as you go through product design and development.
- Design controls avoid the all-too-common practice of identifying requirements afterwards.
- Any type of software development methodology/process can be used for a medical device, including waterfall (iterative), agile, scrum, or sprints.
- At Galen Data, Chris uses the iterative method to define requirements, build prototypes, and get design into the hands of users.
- Requirements, development, validation, and human factors are interconnected and related when designing a medical device.
- Concerns regarding connectivity and cybersecurity are valid; there’s risk in transmitting medical data, but even greater risk when not doing so.

Jul 17 2019

32mins

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4 Facts That May Surprise You About FDA

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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 Regulatory Strategies is a former FDA reviewer and she shares with listeners some fun facts about the FDA and what we don’t see behind closed doors.

Some of the highlights of the show include:

● Fun Fact #1: FDA employees are not all about rules and red tape. They’re passionate about public health and do things creatively that benefit patients.
● Fun Fact #2: FDA is holder and keeper of Code of Federal Regulations (CFR) product codes. FDA has the ability to add or remove product codes.
● Fun Fact #3: Breakthrough Devices designation protects and promotes public health via access to timely development, assessment, and review of devices.
● Fun Fact #4: Opioid epidemic and pediatric care are two categories generating the most interest and activity regarding need for/availability of medical devices.

Jul 10 2019

29mins

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Design History File Ready Ideation: An Innovative Approach to Product Development

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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, Innovation and Design Coach at Trig, joins the show to discuss the reasons why he created DHFRI and its benefits.

Some of the highlights of the show include:

● Andrew’s definition of DHFRI is holistic view of medical device development through collaboration across multiple functions.
● DHFRI uses four Canvas tools to gather and brainstorm ideas:
○ Diligence Dashboard: Business risks of medical device development.
○ Waterfall Method: Supports iteration over time for product development.
○ Human Factors Engineering/Prototyping: Encourages formative work that needs to be done to reduce risk within product being built.
○ Risks and Hazards: Identifying and listing potential problems.
● Creativity and regulations can coexist; startups and established companies should immediately implement design controls.
● Design for Commercialization: Andrew’s industrial designer skillset and mindset produces understanding of manufacturing to meet clinical needs.
● FDA’s openness has increased regarding creative regulatory, not constraints related to medical device classifications and pathways.

Jul 03 2019

37mins

Play