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Global Medical Device Podcast powered by Greenlight Guru

Updated 5 days ago

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

32 Ratings
Average Ratings
25
6
1
0
0

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

32 Ratings
Average Ratings
25
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
Cover image of Global Medical Device Podcast powered by Greenlight Guru

Global Medical Device Podcast powered by Greenlight Guru

Updated 5 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.

Rank #1: 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

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Rank #2: 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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Rank #3: Evaluating FDA’s “New” Proposed Fast-Track Alternative Approach to the 510(k) Pathway

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This past month, the FDA drafted a guidance on a quick path to approval as an alternative to the 510(k). The question is, is this really anything new? Today, we’ll be talking to Mike Drues, president of Vascular Sciences, and he’s going to help us all understand what’s different about this fast track and how it might benefit you.

Some of the highlights of the show include:

● What the new draft is about and how long this fast track has really been around.
● Some thoughts on the ramifications for the FDA and medical device companies since President Trump came into office.
● The FDA’s revised definition of “least burdensome.”
● Why, despite increased marketing and hype, the “new” path is not really new at all.
● What “abbreviated” means in this case and why it doesn’t necessarily mean faster or easier.
● Some questions to ask yourself if you want to know if you are working on something new or novel.

Jan 10 2018

29mins

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Rank #4: 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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Rank #5: 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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Rank #6: Medical Device Product Development Value Proposition

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

Today’s guest is Scott Phillips, CEO of StarFish Medical. He offers advice on how to approach value proposition depending on the stage of your business.

Some of the highlights of the show include:

● What does your company value? Point priorities in the right direction.
● Founders start a company because they want to make an impact, offer value, but own most of it.
● Equity Preservation for Startups: Avoid the trajectory of delusion after raising millions of dollars of capital.
○ Be skeptical of advice
○ Identify and address risks
○ Focus on what investors value
○ Understand value of minimum viable product (MVP)/lean startup concept
● StarFish uses a framework that addresses 12 functional areas to identify client’s target audience, IT environment, reimbursement strategy, and other factors.
● There’s plenty of horror stories about when things go bad. Also, it can be considered bad business when companies rush to get in human-type studies.
● Equity Preservation for Established Companies: Basically the same as startups, except the notion that future money is cheaper than current money doesn’t apply.
● Established companies tend to place more emphasis on regulatory processes, submissions, and clearances. StarFish helps startups fill gaps in such areas.
● Those in a product management role at a startup often have a tech background and don’t understand the role’s responsibilities.

Feb 06 2019

32mins

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Rank #7: 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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Rank #8: 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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Rank #9: 5 Most Common Problems With Your CAPA Process

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What are the most common problems with the CAPA process?

Today, frequent guest Mike Drues, president of Vascular Sciences and Jon are going to dive into that question and get you the answers you need and want.

SOME OF THE HIGHLIGHTS OF THE SHOW INCLUDE:
● Why the CAPA process is such a big issue within the industry and why Jon wrote a column on it.

● What businesses are doing instead of focusing on CAPA and why this is one of the major problems with the process, as well as why a cross-functional team is vital.

● How a management review board can help when it comes to regulations, as well as the fine line between micromanagement and giving a company too much latitude when it comes to meetings with the management review board.

● Being reactive vs. being proactive.

● Why it’s important to respect, but not fear, the FDA. Mike also talks about who you should fear when it comes to liability.

● Thoughts on whether the CAPA is used too frequently or not frequently enough.

● Thoughts on establishing criteria and giving companies the responsibility to establish that criteria themselves.

● The root cause of problems with the CAPA process and what companies can do about it.

Mar 21 2018

39mins

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Rank #10: What Devicemakers Need to Know about the FDA Pre-submission Process (Part Two)

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FDA Pre-submissions: They're a hot, timely topic.

We had a recent episode on the pre-submission process, but because there is so much to know, we decided to have our expert speaker, Mike Drues, back to make sure our listeners have the information necessary to properly deal with the FDA.

Regulatory non-compliance is one of the biggest risks that medical device companies face, and it’s so important to have a good rapport with the FDA and any other relevant regulatory agencies.

Mike Drues is the president of Vascular Sciences. He’s an expert on regulatory topics, as he works with all different types of medical device companies in addition to working with the FDA and other regulatory bodies.

Some of the topics that we discuss today include:
- Why the pre-submission process has become such a hot topic.
- The mechanics of the submission process.
- The content of the pre-submission meeting and what questions should be answered.
- Why you should not have expectations as to how long the process will take.
- How early in the pre-development process you should contact the FDA.
- Why the majority of submissions are rejected.
- How this process can help you get through changes made post-submission.

Oct 18 2016

33mins

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Rank #11: 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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Rank #12: The Intersection of Medical Device Usability and Risk Management

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Today we’re going to be talking to our good friend Mike Drues from Vascular Sciences about the intersection of usability and risk management. There are so many tips and great pointers that you will not want to miss this show. Have a pen and paper or your note-taking device available, because this episode is chock-full of information that you won’t want to forget.

Some of the highlights of the show include:

● What usability means and how it applies to the medical device production process.
● Where the FDA stands on the topic of usability and what types of guidance documents are available.
● How the topic is handled by international and world agencies in addition to the FDA, as well as how cultural differences can impact usability studies.
● The difference between a usability study and a clinical trial. A usability study is focused on the user and a clinical trial is focused on the patient, but today, the two are often one and the same.
● Why usability needs to be more “real-world.” Many times, what the engineer intends is not how the doctor or surgeon will actually use the device.
● The importance of instructions for use and labeling, and how that relates to risk management.
● The relationship between usability and product liability.

Apr 27 2017

31mins

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Rank #13: Helping Prepare Biomedical Engineers Entering the Workforce

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Students offer hope for our future. They will be developing products that can save our lives, or at least improve our quality of life. We need to give them as much guidance and advice as possible.

On today’s episode, we have Associate Professor Andrew DiMeo, who shares his mission and what he is trying to do with the biomedical program at the University of North Carolina and North Carolina State University.

Some of the highlights of the show include:

● Andrew’s biomedical product development course is based on quality and regulatory.
● It is possible to be creative and innovative in a restrictive regulated environment, like biomedical engineering.
● Some people believe regulations/controls and the status quo prevent them from getting things done.
● The reasons why controls and regulations are necessary.
● How to prepare biomedical engineers entering the workforce.
● Andrew teaches students by using a real-life medical system.
● Regulations should be kept simple to avoid being too restrictive.
● Andrew describes a siloed world where collaboration is key.

Apr 25 2018

33mins

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Rank #14: 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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Rank #15: 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

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Rank #16: How To Improve Your Medical Device Design Reviews

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

They peel back the lens on what has worked for them over the years and how you can implement their proven strategies at your organization.

Design Reviews are clearly a topic that this group has some strong, and at times, counter intuitive thoughts on.

In this 24 minutes episode, our experts really get down to sharing actionable tips and advice that your team can start using today to help improve your Design Reviews.

They reveal their candid opinions and advice on a range of Design Review related topics including:

• Why Design Reviews are important?
• How do Design Reviews fit within Design Controls?
• Explain the concept of an “independent reviewer” and why this is necessary?
• When should Design Reviews take place? And how often?
• What should not be included within a Design Review?
• How are Design Reviews the same (or different) from a Phase Review?
• What actionable tips & advice do you have to improve Design Reviews?

Jul 07 2015

24mins

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Rank #17: Comparing FDA Submission Types: 510(k) vs. De Novo vs. 513(g) vs. Pre-Submission

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It can be confusing to know which submission type is the correct one for your particular development situation. Today we’re going to talk to Mike Drues, president of Vascular Sciences and regulatory guru, about what to keep in mind as you decide whether to use the 510(k), De Novo, 513(g), or Pre-Sub process.

Some of the highlights of the show include:

● The difference between the 510(k) and the De Novo submissions and how to decide between them.
● An explanation of why the 510(k) submission process does not include proof of product safety or efficacy.
● Why the number of De Novo submissions is so small and what the process entails in terms of proving safety, as well as how it compares to the pre-market approval (PMA) process.
● How the relationship between a medical device company and the FDA resembles a poker game.
● Some statistics on the 510(k) and the PMA: How many are rejected the first time they’re submitted and why.
● When you should do a 513(g) vs. a pre-sub: how the two processes differ and when you should use each.

Aug 18 2017

32mins

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Rank #18: Why Design Inputs Are So Important to the Success or Failure of Your Project with Matt Romey

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In episode 10 of the Global Medical Device podcast we welcome Matt Romey from the Azzur Group. Matt is a project manager for the Azzur Group and has been involved with many medical device projects. He was a founding employee and executive team member at GluMetrics, a venture-backed startup that raised over $67M.

Matt has 20 years experience in the medical equipment design industry and has plenty of knowledge to share with new startups. During today’s conversation Matt and Jon will discuss the importance of Design Controls, which they both share a passion for.

"Design controls are yes, required by law, but they also represent good business practices." - Matt Romey

Matt believes so much in the importance of design controls that at one of his companies he had a line from the FDA Design Control guidance document taped to his wall that stated, “It is a well established fact that the cost to correct design errors are lower when errors are caught earlier in the design and development process.”

"The 1 - 10 -100 rule. That's where if you catch it early in the process it may cost you a dollar to fix, then a little bit later in the process it will be maybe 10 dollars. Once you get into production... 100 dollars." - Jon Speer

The most important thing to keep in mind while working on medical device design is user needs. These user needs will guide you to the right questions so that design inputs are effective and relevant.

Today’s highlights include:

● Matt explains how good quality design control is just part of good business practices.

● You will hear why the classic “waterfall diagram” may not be the best guideline for a project.

● Why when you find design inputs, they need to be testable.

"Design inputs should be a translation of your user needs to some sort engineering specification that can be measurable." - Matt Romey

Dec 09 2015

24mins

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Rank #19: Biocompatibility Nuances and its Impact on Medical Devices

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Biocompatibility can be challenging and frustrating when developing a medical device. Why do you have to spend time and money to do the same testing, if the materials used in your device have already been tested, approved, and put in medical devices on the market? Biocompatibility impacts the majority of medical devices.

Today’s guest is Josh Crist, a biocompatibility expert who used to work for the FDA and is now with Biologics Consulting and he and Jon discuss the nuances of biocompatibility.

Some of the highlights of the show include:

● Best practices for biocompatibility include using the ISO 10993 test matrix for evaluating tissue, duration, and other factors.
● A common misconception about the test matrix is how the FDA determines and considers cumulative contact.
● Are all tests absolutely necessary? Are there other ways to reduce testing requirements? Consider chemical characterization and risk assessments.
● Josh describes challenges he experienced as both a biocompatibility consultant and FDA reviewer.
● What the FDA expects with chemical characterization: Master file, testing on final finished device, and more.
● Start with FDA’s biocompatibility guidance documents, interact early on with FDA during pre-submission process, and conduct quantitative and qualitative tests.
● “I promise…” days are gone. Other options for 510(k) to avoid getting additional information (AI) letter or not substantially equivalent (NSE) decision.
● Most common mistake made by companies when it comes to biocompatibility is not testing.

May 15 2019

38mins

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Rank #20: Understanding the Connection Between Complaints, CAPAs, and MDRs

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Today we are going to talk about the connection between complaints, CAPAs, and MDRs. They are all interrelated and they have a big part of developing your company’s culture and affecting your risk management processes.

Mike Drues, president of Vascular Sciences and expert on all regulatory matters when it comes to medical device development and production, will be our guest today. Mike is a regular guest on the show, and our listeners know that he really knows his stuff. Be sure to take the time to listen to the show.

Some of the highlights of the show include:

- The connection between Medical Device Reports (MDRs) and complaints: Does one lead to the other? Sometimes it’s a two-way street.
- Whether the current criteria for necessitating a CAPA should be investigated and maybe changed.
- Why reframing the negative thought process behind getting a complaint into thinking about it as an opportunity can keep companies thriving and patients safer.
- The importance of having a criteria for when an MDR or complaint should give rise to a CAPA.
- How frequent reviews of a product line can help you track the root causes of various issues and see the forest through the trees.
- Thoughts on risk management and the importance of having a sound risk management process can mitigate, but not eliminate, risk.

May 24 2017

37mins

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