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Why Biocompatibility Should be Addressed by Every Medical Device Company
Global Medical Device Podcast powered by Greenlight Guru
11/04/20 • 48 min
11/04/20 • 48 min
Meet a Guru: Erica Loring
Global Medical Device Podcast powered by Greenlight Guru
10/27/20 • 38 min
10/27/20 • 38 min
Measuring the Impact of AI/ML Technologies on the Current Medical Device Landscape
Global Medical Device Podcast powered by Greenlight Guru
01/06/21 • 44 min
01/06/21 • 44 min
Understanding FDA's New Intended Use Rule and its Implications
Global Medical Device Podcast powered by Greenlight Guru
08/11/21 • 35 min
FDA published a final rule, which goes into effect the first of September, to amend its “intended use” regulations.
In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the implications of FDA’s final rule on intended use, manufacturer’s objective intent, and the role that it has with labeling.
Some of the highlights of this episode include:
- When Mike and Jon refer to labeling, they are talking about the content of the label - the words used and claims made.
- High-level labeling describes intended use, indications for use, and label claims. Low-level labeling includes directions for use and package inserts. A claim is a claim whether put in high- or low-level labeling.
- High- and low-level labeling can be leveraged as a strategic, competitive advantage to minimize or streamline regulatory burden, which means how much effort and evidence is needed to go through the FDA and put on the market.
- Intended use focuses on a device (what it does, how it works, and what is its mechanism of action). Indications for use focuses on the patient (what illness, injury, disease, or condition is the device intended to prevent, diagnose, or treat).
- Why do we need a new rule about intended use? The intended use rule is important for medical device manufacturers because labeling is not limited to what they say or print.
- The root cause for the rule relates to manufacturers’ saying or claiming one thing, but inferring and implying another thing. FDA does not regulate, at least not yet, the names of medical devices.
- Manufacturer's Objective Intent: If manufacturer knows or has knowledge of facts that product, device, or drug would be used for conditions or purposes other than what is advertised/claimed, manufacturer may need to provide adequate labeling.
- Manufacturers also need to consider product liability and reimbursement implications of a device being used for purposes other than what’s on the label.
Memorable quotes from this episode:
“When we refer to labeling, at least when I refer to it, I’m not talking about the sticky piece of paper that we stick on a package or in a box that a medical device comes in, nor am I talking about the graphics that go onto that label.” Mike Drues
“There have been numerous and continues to be numerous warning letters, recalls, etc, etc, etc, that are strictly related to content or lack thereof or misinformation that’s on labeling.” Jon Speer
“FDA does not regulate, at least not yet, the names of medical devices. So, you can embed a claim in the name of your device without it being subject, at least directly, to FDA regulation.” Mike Drues
“Don’t just focus on what you say in your labeling, also consider what you don’t say and how you don’t say it.” Mike Drues
Links:
FDA finalizes long-awaited intended use rule
FDA Delays Implementing Parts of 'Intended Use' Rule
Federal Register’s Regulations Regarding “Intended Uses”
FDA - Center for Devices and Radiological Health (CDRH)
The Greenlight Guru True Quality Virtual Summit
MedTech True Quality Stories Podcast
08/11/21 • 35 min
A Breakthrough Device that Aims to Prevent Osteoporosis
Global Medical Device Podcast powered by Greenlight Guru
08/19/21 • 24 min
Is your body becoming more frail? Are you worried about fractures? Do you want to improve your bone health? Osteopenia and osteoporosis are very common problems that don’t have completely effective solutions, yet.
In this episode of the Global Medical Device Podcast, Jon Speer talks to Laura Yecies, CEO of Bone Health Technologies, about the product journey of OsteoBoost, a vibration belt that aims to prevent osteopenia and osteoporosis that has recently received the FDA’s Breakthrough Device Designation (BDD).
Learn what the BDD experience was like and how their team is currently navigating the FDA regulatory process and collecting the necessary clinical data with the hopes of soon placing OsteoBoost on the US market.
Some of the highlights of this episode include:
- More than 50 million Americans are suffering from osteopenia and low bone density. Half of all women will have a fracture from osteopenia and osteoporosis - that’s more than heart attack, stroke, and breast cancer combined.
- As people get older, especially women, shrinking is a real issue that is usually due to a fracture that causes pain as well as breathing and digestive problems.
- People with hip fractures have a 20-plus percent mortality rate. Hip fractures are difficult to recover from and a high percentage of people lose their independence.
- Currently, there are no approved treatments for osteopenia. Basically, your only options are to get enough Calcium and Vitamin D and do high-impact exercise. Give your bones enough stimulation to lessen the decline.
- There are medications for osteoporosis. However, the side effects, the way they work, and indications for use are for people with osteoporosis.
- When vs. If: Most people will eventually get osteopenia. Heredity is a factor that influences less dense and smaller bones. Lifestyle matters, such as excessive drinking and smoking or steroid use can have an impact on bone density.
- Also, if you are an astronaut or go into space, bone loss is accelerated. Evidence from NASA shows that using whole body vibration improves bone density.
- People must use such a device regularly, it is expensive, and it requires doing nothing for a period of time. Bone Health Technologies is developing OsteoBoost, a more practical and easy-to-use product that leverages whole body vibration.
Memorable quotes from Laura Yecies:
“Osteopenia is an incredibly common problem, and we have over 50 million Americans suffering from low bone density.”
“If you walk around a nursing home, people are there typically for one of two reasons - they have Alzheimer’s or they have a hip fracture.”
“Most people will eventually get it.”
“There’s a body of evidence from NASA about using whole body vibration essentially to improve bone density. Astronauts lose a lot of bone when they are in space. Their bone loss is accelerated.”
Links:
U.S. Food and Drug Administration (FDA)
FDA: Breakthrough Devices Program
The Greenlight Guru True Quality Virtual Summit
MedTech True Quality Stories Podcast
08/19/21 • 24 min
Why Storytelling Matters for Medical Device Companies
Global Medical Device Podcast powered by Greenlight Guru
08/26/21 • 26 min
Medical device companies need to tell slightly different versions of their stories depending on the intended audience—investors, suppliers, regulators, clinicians, and patients—and each version must be strategically crafted and told in order to convey the right message.
In this episode of the Global Medical Device Podcast Jon Speer talks to Brad Perriello, who previously cofounded MassDevice and now current founder and principal at Circle Hill Life Science Communications, about his unique line of work helping medical device companies learn how to effectively tell their story.
Listen to this episode now to learn what your company can and can't say to different target audiences and how to effectively communicate your company’s core message and story so it positively resonates with the listener.
Some of the highlights of this episode include:
- Brad Perriello, alongside fellow journalist Brian Johnson, founded the online medical device business journal MassDevice based on his belief that small businesses and startups drive everything that lead to the biggest outcomes.
- Although medical device companies know their story best, they do not always effectively tell people their story, what they do, and why they do what they do.
- Startups telling their story is applicable and important to raise funds, but engineers are not strong narrative writers or speakers. They tend to focus too much on details, which can derail the intended message.
- A medical device company’s core message and story is the same, but is communicated differently. For instance, investors want to know the ROI, patients want to know if it’s safe and effective, physicians want to know about safety, efficacy, and cost.
- When hiring outside help with communications, they should be familiar with the medical device industry because the regulatory environment is strictly unique.
- Be aware of quality systems, design controls, and reimbursement issues.
- Some things change over time, and some things never change. Find an unmet need and help patients and others by figuring out what they need to hear. Be able to effectively communicate with all audiences.
- Social media evolves quickly and provides powerful communications tools with massive reach. Companies succeed by having a dedicated team member who knows how to leverage each platform based on the audience.
Memorable quotes from Brad Perriello:
“These folks know their stories really, really well...but they don’t know how to tell them all the time.”
“Through no fault of their own, they’re not really effectively telling people, this is our story, this is what we’re about, and this is why.”
“The old adage is that engineers can’t write.”
Links:
Brian Johnson of MassMEDIC on LinkedIn
FDA - 510(k) Premarket Notification
The Greenlight Guru True Quality Virtual Summit
MedTech True Quality Stories Podcast
08/26/21 • 26 min
Addressing the 'Who, What, When' of Quality in the Medical Device Industry
Global Medical Device Podcast powered by Greenlight Guru
09/09/21 • 28 min
There are many schools of thought when it comes to the 'who, what, and when' of quality management for medical devices.
In this episode of the Global Medical Device Podcast Jon Speer talks to Christie Johnson with Kasota Engineering, a consulting firm focused on quality in the medical device industry.
Listen to this episode as Jon and Christie offer their insights and guidance on medical device quality management best practices.
Some of the highlights of this episode include:
- Who manages quality? Most startups first hire someone with years of experience, but Christie encourages early firms to embrace the teach mentality. Christie enjoys training teams to build an understanding of quality from scratch.
- What is quality? Those with a willingness and capability to learn can be coached to know what a quality management system is and needs to include initially.
- Two Schools of Thought: Companies either view quality as, do it later when the time is right or that’s not my job. Quality is a way for companies to ensure safety and efficacy. Put your products and services at the center of your universe.
- Christie’s philosophy is to never do what traditional consultants in the industry do. She never just shows up, throws some documents down, and walks away.
- Which QMS to implement? The system that you should implement is the one that your team will use. Make it simple and fast. If your team cannot understand and readily use the tool, they’re not going to do it or follow the procedure/process.
- Delivering a QMS without providing step-by-step training can lose functionality. Start with baby steps into processes, especially for those without experience.
- What to include? You don’t need to comply with regulations right away. Put things in place - early data, suppliers - document/record what you’re doing during the research and discovery phase. Tell your story and take credit for your hard work.
- Why are you struggling? The reality is it takes longer than six months to one year to get your idea or product on the market. Trial knowledge can reduce risk.
Memorable quotes from Christie Johnson:
“If you can read and understand the regulation and if you can sit and work with me and help me understand your background and I can coach you, we can start putting in place your early quality system.”
“Our philosophy is very much to never do what traditional consultants in the industry do, which is show up, throw some documents down, and walk away.”
“The system that you should implement is the one that your team will use and make it easy.”
“It’s really easy to get lost or just ignore the quality system that’s in place, especially if you come into an organization that already has way more than they need.”
Links:
National Institutes of Health (NIH) - Rapid Acceleration of Diagnostics (RADx)
The Greenlight Guru True Quality Virtual Summit
MedTech True Quality Stories Podcast
09/09/21 • 28 min
Focusing on the Intent of the UDI Requirements from FDA's Final Guidance Doc
Global Medical Device Podcast powered by Greenlight Guru
09/16/21 • 38 min
When the Unique Device Identification (UDI) system was first announced by FDA several years ago, the accompanying draft guidance left much ambiguity and confusion among manufacturers who struggled to understand what it was, why it mattered, and what to even do with it.
In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the recently published final guidance document on the UDI system from FDA.
Listen as Jon and Mike provide clarity for manufacturers regarding the true intent of FDA's final guidance on the UDI system, explaining the nuances, benefits, and potential impact of UDI for medical devices and technologies in the US.
Some of the highlights of this episode include:
- What is a UDI? Companies have different formats, technologies, or options available, such as an automatic identification and data capture system, to add barcodes, quick response codes, or RFID chips to devices and other products.
- Many companies are getting in trouble with the FDA because of some aspect of UDIs - whether it’s rejected regulatory submissions or manufacturing inspections generating 483 observations.
- Mike believes the reason why is because many people are focusing on following the UDI regulation (and guidance) without understanding its intent.
- Fundamental problems that companies are experiencing are not due to the details of UDI implementation, but not knowing or understanding the need to add UDIs to medical devices.
- UDI identifies the specific product, manufacturer, and batch, lot, or serial number. UDI is for traceability in case there is a problem, complaint, or recall.
- Challenges of implementing UDIs on labels include if the device is too small, software doesn’t include packaging, and patient compliance.
- Unique vs. Universal: Does ‘unique’ as defined in UDI by the FDA universally match the European Union and other regulatory bodies? It’s unlikely that a global or universal device identifier will be standardized.
Memorable quotes from this episode:
“It’s amazing to me how many companies, including some of my customers, are getting in trouble with FDA - whether it comes to regulatory submissions that are being rejected or manufacturing inspections that they’re getting 483 observations on because of some aspect of UDIs.” Mike Drues
“It’s taking us, quite frankly, a heck of a long time to do something that Walmart was doing more than 20 years ago. Why the heck is it taking us so long?” Mike Drues
“The gist of a UDI is to identify the specific product and manufacturer and potentially even the batch or lot or serial number of that product.” Jon Speer
“This should not be a foreign concept to anybody. This is a concept of traceability - that’s all a UDI is - traceability.” Mike Drues
Links:
FDA UDI Homepage: Unique Device Identification System
FDA finalizes long-awaited UDI guidance (RAPS, July, 2021)
Brazil’s new UDI requirements for medical devices: Compliance implications for manufacturers
Code of Federal Regulations (CFR)
FDA - 510(k) Submission Process
FDA - Software as a Medical Device (SaMD)
FDA - Premarket Approval (PMA)
...
09/16/21 • 38 min
When to Throw the Least Burdensome Flag on FDA
Global Medical Device Podcast powered by Greenlight Guru
10/06/21 • 34 min
What if you submit your 510(k), IDE, or other submission type to FDA only to get an additional information request (AI request)? What do you do for requests that seem overly burdensome? Thanks to a new FDA pilot program known as the Least Burdensome Flag, manufacturers now have a process and methodology they can deploy if and when this scenario arises.
In this episode of the Global Medical Device Podcast host Jon Speer talks to guest Mike Drues, President of Vascular Sciences, about the ways in which manufacturers should approach responding to AI requests via the Least Burdensome Flag program from FDA CDRH.
Some of the highlights of this episode include:
- You do have options to push back if you think the FDA’s response or request for more information, data, or testing is overly burdensome or unnecessary.
- Understand why the FDA is asking you for additional testing or to collect additional data. The FDA should be able to give you a legitimate reason.
- Despite some trite responses, FDA cannot ask you to do whatever it wants. The FDA must give a specific reason, and then you decide whether to accept or fight against it and wave the least burdensome flag.
- Informal and formal options include understanding concerns of the agencies and working with review team to come up with a compromise or amicable solution.
- Escalating the issue is another option with an email or phone call to move things along and voice your concerns. If a compromise cannot be made, document the final product.
- The goal of the Least Burdensome Flag is to quickly address the FDA’s requests that submitters do not believe are least burdensome or held to a different standard than the legally marketed predicate device.
- Before throwing the Least Burdensome Flag, you need to meet specific criteria: Try to address concerns with the lead reviewer, limit it to two topic areas, and submit it within 60 calendar days of FDA issuing the request or deficiency letter.
- The last resort option is taking the issue to court. Tread cautiously because you can win the battle, but lose the war.
Memorable quotes from Mike Drues:
“Why is FDA asking us to do this additional testing, collect this additional data, whatever? FDA should be able to give you a legitimate reason as to why they’re looking for this information.”
“We should respect the FDA, but at the same time, they should respect us.”
“The goal of the Least Burdensome Flag is to quickly address FDA requests.” “Whatever we do, that needs to be justified. There needs to be a reason for doing it...needs to be justified based on the biology and engineering.”
Links:
Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions
FDA/CDRH Webinar - The Least Burdensome Provisions: Concept and Principles
Investigational Device Exemption (IDE)
ISO 10993 - Biological Evaluation of Medical Devices
Code of Federal Regulations (CFR)
Medical Device User Fee Amendments (MDUFA)
The Greenlight Guru True Quality Virtual Summit
MedTech True Quality Stories Podcast
10/06/21 • 34 min
How to Efficiently Raise Funds for Your Medical Device Company
Global Medical Device Podcast powered by Greenlight Guru
10/24/18 • 34 min
10/24/18 • 34 min
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FAQ
How many episodes does Global Medical Device Podcast powered by Greenlight Guru have?
Global Medical Device Podcast powered by Greenlight Guru currently has 352 episodes available.
What topics does Global Medical Device Podcast powered by Greenlight Guru cover?
The podcast is about Health & Fitness, Medicine, Podcasts and Business.
What is the most popular episode on Global Medical Device Podcast powered by Greenlight Guru?
The episode title 'Why Biocompatibility Should be Addressed by Every Medical Device Company' is the most popular.
What is the average episode length on Global Medical Device Podcast powered by Greenlight Guru?
The average episode length on Global Medical Device Podcast powered by Greenlight Guru is 37 minutes.
How often are episodes of Global Medical Device Podcast powered by Greenlight Guru released?
Episodes of Global Medical Device Podcast powered by Greenlight Guru are typically released every 4 days, 23 hours.
When was the first episode of Global Medical Device Podcast powered by Greenlight Guru?
The first episode of Global Medical Device Podcast powered by Greenlight Guru was released on Oct 24, 2018.
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