Global Medical Device Podcast powered by Greenlight Guru

What are the similarities and differences between an in vitro diagnostic (IVD) device machine and a medical device?  In this episode of the Global Medical Device Podcast, Jon Speer talks to Milton Yarberry, Director of Medical Programs at Integrated Computer Solutions (ICS).Jon and Milton discuss practical pointers for determining and describing the similarities and differences between the two types of devices. Milton also offers some helpful recommendations for IVD manufacturers to consider when it comes to regulatory compliance and their quality system.Some highlights of this episode include:An IVD consists of the agents, instruments, and systems used for the diagnosis of disease or other health conditions, such as HIV, hepatitis, diabetes, and flu.From a patient perspective, the IVD is not invasive. A sample of something, such as saliva, urine, or blood from the patient is taken. Then, the sample is prepared and put through an IVD for analysis to determine the results of a specific test. An IVD is the equipment that analyzes the patient’s sample, not the actual patient. The IVD focuses on the fidelity and accuracy of the tested sample. There’s risk for the patient. Who’s performing the test (lab or licensed clinician), what’s being tested for (non-life threatening disease or not), and if results are inaccurate.Information has to be crystal clear because the user population could be a child, elderly person, or otherwise who takes the wrong action or misinterprets actions that could lead to death. If you have been tested for the coronavirus (COVID), how was the sample collected? How long was the swab that went up your nose? How long was it in?An IVD is a medical device and is subject to the same pre- and post-market controls. It needs a quality system and similar risk-based classification.Treat people and their data in your clinical study well. A lab developed test (LDT) and investigative device should not be perceived as a regulatory path.Memorable quotes from this episode:“That’s the key difference. There’s no patient. There is a sample.” Milton Yarberry“It clearly gives you a target population, a way they’re going to use it, a way they can misinterpret it, and all of those should become mitigations in your design.” Milton Yarberry“You can tell if you hit the right spot if the person wants to punch you.” Milton Yarberry“It’s hard to translate some of that science, that research, that clinical, that laboratory side of things into something that’s commercialized and into something that’s regulated.” Jon Speer“It’s a mindset of the manufacturer that I think is the main difference.” Milton YarberryLinks:Integrated Computer Solutions (ICS)ICS & Greenlight Guru PartnershipCenters for Disease Control and Prevention (CDC) - Waived TestsClinical Laboratory Improvement Amendments (CLIA)FDA - CLIA Waiver by Application510(k) Premarket Notification IEC Standard 6236621 CFR Part 820ISO 13485Laboratory Developed Tests (LDT)EU MDR and IVDREmergency Use Authorization (EUA)Greenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

For medical device professionals, there are the “knowers” and the “doers.” One group is knowledgeable about quality best practices and product realization needs, but may not know how, or have the desire, to act upon it. The other group puts that knowledge into action by doing the best practices that are needed to realize the product needs and [seize all] opportunities.In this episode of the Global Medical Device Podcast, Jon Speer talks to John Kapitan, CEO at Kapstone Medical, about the difference between knowing and doing as medical device professionals and how to do what’s right for the success of your medical device.Some highlights of this episode include:People view quality differently and need to overcome pessimistic and negative perceptions. Quality is a mindset and helps companies solve business problems.Quality is knowing the right thing to do versus doing it. Some people are ignorant because quality is not their role and do not necessarily know best practices. Other people are outwardly antagonistic who know the right thing to do, but choose not to do it for a variety of reasons.  Apathetic people have an idea of what to do or have been told what to do and want to do the right thing by the patients, regulatory bodies, and investors. Quality is common sense that focuses on best practices, documentation, and performance. Rather than caring about traditional technical quality related areas, a quality system is one of the last things some companies/investors consider.Pre-revenue and pre-commercialization companies don’t need to build a quality system that has all the bells and whistles. Start with the core and add-on as needs arise.There is a right and wrong way to implement quality in any organization. Take an efficient, effective, and pragmatic approach to understand compliance and the must-haves, not the nice-to-haves. Make sure to have someone on your team to discuss and champion quality, and implement a quality system that runs the company, not the company running it. Memorable quotes from John Kapitan:“I want to do the right thing. I know I can learn because I don’t know everything and there’s probably better ways to do this. More efficient ways, more effective ways to do this.”“If quality is not your role, you’re not necessarily going to be on top of what good practice is, what best practice is for quality, and what quality requirements are from FDA or overseas. You may be ignorant of just what to do and how to do it. ”“Quality is common sense. It’s not procedures, it’s common sense. It’s how would you do this if you were going to have this device put in your own body or your family members?”“There is a right way and a wrong way to implement quality in any organization.”“It’s always about prioritizing what we spend time thinking about, what we talk about, and what we invest in.”Links:John Kapitan on LinkedInKapstone MedicalFDA - Design ControlsISO 13485 - Medical Devices Premarket Notification 510(k)Premarket Approval (PMA)Investigational Device Exemption (IDE)Greenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Are you on the frontlines of developing new medical devices and technologies during COVID-19? Or, are you a customer who has benefited from using them?    In this episode of the Global Medical Device Podcast, Jon Speer talks to Alison Lee about her PPE startup Breathe99, which pivoted operations in developing its high-quality face mask product to meet respiratory needs and provide personal protection during the coronavirus pandemic.Some of highlights of this episode include:Breathe99’s mask filters 97 and 99 percent of airborne particles. It is not N95 certified, yet, but was designed based on those requirements.The prototype of the B1 mask offered protection with complete sealing around the mouth and nose, but allowed adequate breathing through a high-quality filter.The kickstarter for the B1 mask didn’t reach its goal, but then came an obviously serious and urgent need for high-quality respiratory protection. So, the kickstarter campaign for the B2 mask started. A total of more than $750,000 was raised.Positive Feedback—Doctors, teachers, volunteers, and other people feel safer wearing Breathe99’s B2 mask. It’s allowed them to continue doing their job.The FDA regulatory product approval process and NIOSH certification is not straightforward. Documenting users’ needs and testing requirements is a long-term path that requires proper and realistic planning.Alison discusses how Greenlight has been a resource for bringing the B2 mask to market. It offers peace of mind by going step by step at an appropriate pace to navigate the design and development process.The bureaucratic and complicated regulatory process takes much longer than expected. It presents common challenges, such as checks and balances of medical devices, change orders, and regulatory approval. Medical Device Journey: Learn while you’re learning it. Be deliberate and perform due diligence to be part of the solution. Understand your scope, users’ needs, and why it’s important to design appropriate, safe, and effective products. Memorable quotes from Alison Lee:“We’re a startup company based in Minneapolis that makes a high-quality face mask that filters 97 and 99 percent of airborne particles. Can’t say we’re N95-certified yet, but those are the requirements that we’ve designed our mask around.”“We love hearing about how people feel safer wearing our mask. It’s allowed them to continue doing their job.” “That stamp of approval from NIOSH and from the FDA is really, really important for people to trust our product.” “Be aware of your scope, and you can really only do that by talking to people as soon as possible before you, I guess, make an assumption. We definitely thought the regulatory process would be a lot faster.”

Do you fear needles and the associated pain? No one understands this fear more than physicians who see it firsthand with their patients day in and day out. And one physician in particular set out to do something about it.In this episode of the Global Medical Device Podcast, Jon Speer talks to Dr. Amy Baxter, CEO and founder at Pain Care Labs. Amy discusses the pros and cons of being a physician, entrepreneur, and inventor of reusable, physiologic medical products to eliminate unnecessary pain.Some highlights of this episode include:The medical world works on 2-D pharmaceutical schematics, but doctors’ minds work on three dimensions. Physician inventors see the whole body, person, and need to develop effective medical products.Physician inventors think they know everything, so it’s difficult for them to follow ISO 13485 and painstaking medical device development and not get frustrated. The time duration for Amy’s innovation and invention journey took years to get patents, meet regulatory requirements, and address the opioid crisis. Pain management is esoteric and subjective. Amy encourages physician inventors to fall in love with their problem, not their solution. Pain, chronic or not, is a real problem. Amy shares life lessons for physician colleagues with innovative ideas. Find a group like Greenlight Guru or GCMI to understand navigation early on. Branding matters, so choose wisely.Also, Amy advises physician investors to not get hung up on non-disclosure agreements (NDAs). Nobody steals an idea, they steal a medical product.Amy expects the future of pain management to include multiple specific energy devices in people’s medicine cabinets to use before and after surgery. Mechanical stimulation will be the primary one because it’s easy and safe to use.Buzzy® is a palm-sized device that combines cold and mechanical stimulation to block pain and improve muscle soreness, blood flow, and recovery. The VibraCool® Cryo-vibration product, VibraCool’s M-Stim, is 2-3.4 times superior to electrical stimulation (TENS) for physical therapy. It has demonstrated 35% fewer opioid tablets. Also, a lower back pain device is in clinical trials and expected to be released this year.Memorable quotes by Amy Baxter:“We see the whole body, we see the whole person, and we see the need.”“The downside of being a physician inventor is that we both feel like we know everything.” “Wanting to be able to do something is really the push that puts a lot of physicians into the entrepreneurial space.”“Fall in love with your problem, don’t fall in love with your solution.”“Try your idea out on someone who does not love you.”Links:Pain Care LabsISO 13485 - Medical DevicesISO 14971 - Application of Risk ManagementFDA - Part 11EU MDRNIH Small Business Innovation Research (SBIR))/Small Business Technology Transfer (STTR) Mayday FoundationGlobal Center for Medical Innovation (GCMI)Dr. Richard MelkerMedical Device Podcast, Ep 186: Building a Startup in the MedTech Industry Greenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Why does the FDA have three systems in place to address and handle risk related to medical devices? Each system serves a different purpose, but are all three actually necessary?In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about FDA’s three systems of risk for medical devices and the unique interdependencies and distinctions between them.Some highlights of this episode include:Three systems for medical device risk from FDA: product classification, significant vs. nonsignificant risk, software level of concern.The FDA’s classification system handles risk by classifying medical devices as Class I, II, or III. The higher the class, the higher the risk. The lower the class, the lower the risk. Yet, risk is a broad subject and there are a ton of exceptions.Also, classification numbers/levels used by the FDA in the United States do not translate in a linear way to those in the European Union (EU) and elsewhere. There are similar systems but different rules that are philosophically different. The significant vs. nonsignificant risk system focuses on clinical trials for medical devices. All clinical evaluations of investigational devices, unless exempt, must have an approved investigational device exemption (IDE).The software level of concern is important because it determines the level of documentation required for software development. The default classification for any new medical device is Class III. If it’s a new device, it’s not well-established and the benefits and risks are relatively unknown.When it comes to labeling, say anything as long as you can prove and support it. When technology stays the same but the labeling claim changes, risk changes.  The determination of significant or nonsignificant risk is not made by the FDA or Institutional Review Board (IRB), but the medical device company.The software level of concern consists of Class a, b, and c. Does the software have no possibility of causing injury or damage to health? Is non-serious injury possible? Or, is serious injury or death possible?Memorable quotes by Mike Drues:“Theoretically, the classification of your medical device depends on risk. In other words, the higher the class, the higher the risk. The lower the class, the lower the risk.”“The default classification for any new medical device is Class III, which basically means we set the bar at the highest possible level.”“Oftentimes in regulation, we do things not because they make sense, but because that’s the way we’ve done them in the past.”  “The determination of significant or nonsignificant risk is not up to the FDA. It’s not even up to your IRB, or Institutional Review Board, it’s up to the company.”Links:FDA - Classify Your Medical DeviceFDA - Significant Risk and Nonsignificant RiskFDA - Software Level of ConcernFDA - Product Code Classification DatabaseInvestigational Device Exemption (IDE)De Novo Classification ProcessCenter for Devices and Radiological Health (CDRH)Requests for Feedback and Meetings for Medical Device SubmissionsMike Drues on LinkedInGreenlight Guru Webinar - Advanced Strategies and Tactics for Using the De Novo PathwayGreenlight Guru Webinar - Understanding the Medical Device Classification SystemGreenlight Guru Podcast EP 37: Significant Risk vs. Nonsignificant Risk Devices - What's the Difference? Greenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

How are in vitro diagnostic (IVD) devices similar and different from medical devices? How should IVD manufacturers approach quality management and other key elements based on these similarities and differences?In this episode of the Global Medical Device Podcast, Jon Speer talks to Joanne LeBrun from MDC Associates, which offers quality systems consulting, regulatory consulting, and implementation training.Joanne offers valuable insights on the topic of managing quality for in vitro diagnostic devices and the unique relationship these devices have to medical devices in terms of industry best practices and tools that manufacturers can use to produce high quality devices that are safe and effective for end users.Some highlights of this episode include:IVDs are different from medical devices and therefore treated differently. The difference between IVDs and medical devices is the way performance is proven.Read the FDA and EU regulations for medical devices and IVDs because changes are immense for the classification of devices. The amount of growth for IVD startups is driven by the up cropping of contract manufacturers. There’s a lot more bringing it to market with less resources.The pandemic has been good for the medical device industry and for bringing products from concept to fruition and through regulatory approvals quickly.Don’t reinvent the wheel. Focus on your technology and seek advice from quality professionals to achieve efficiency and effectiveness.Or, make space for the FDA to move in for months for an inspection and audit. Do the right thing and know what the right thing is. Keep your audit manageable.Perform quarterly quality fire drills with a robust internal quality audit program to prepare ahead of time. Review inventory, complaints, deviations, and more to be current on compliance. Big Mistakes and Common Challenges: Starting design control and risk management too late. It doesn’t take that much effort to document work. Memorable quotes by Joanne LeBrun:“The difference between IVDs and medical devices is the way that you can prove performance.”“The quality systems are similar, but if you’re a medical device person and you’re headed into an IVD situation, do keep in mind that it is quite different and the rules for IVDs are just a little bit more forgiving than in a medical device arena.”“There’s a lot more bringing it to market with less resources to be able to use some of those contractors.”“The pandemic, while it’s been very hard on a lot of people and I don’t certainly belittle that, it has been very, very good for our industry and has been very good for bringing products from concept to fruition and through regulatory approvals so fast, maybe too fast.” Links:Joanne LeBrun on LinkedInMDC AssociatesFDA - Medical DevicesEuropean Union Medical Device Regulation (EU MDR)EU IVDRISO 13485 Quality Management for Medical DevicesAbbott LaboratoriesGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Does your medical device qualify for an investigational device exemption (IDE)? What does this process involve and what does FDA expect of these manufacturers? There is plenty to consider when it comes to the IDE timeline and process.In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill “Mr. Regulatory” who sheds valuable light on the topic of IDE, which allows an investigational device to be used in a clinical study to collect safety and effectiveness data, and how to navigate this process in an efficient and compliant manner.Some highlights of this episode include:FDA has a few programs to consider when it comes to safety and significant risk or not for products. High-risk devices could fall into a non-significant risk study.Exempt or not? Make sure to provide sufficient information to identify significant or not risks based on objective evidence. COVID-19 issues prompted FDA to post guidance on statistical considerations, confounding factors, and remote monitoring for IDE and clinical studies.When does FDA require an IDE? If it’s a new device category or significant departure from the existing technology, FDA will probably need clinical data.All PMA devices do not require an IDE. Also, a device that follows the 510(k) path does not require clinical data, but an IDE may be requested with a clinical study for marketing submissions and reimbursement. The contents of an IDE application must include 12 items, such as the name and address of the sponsor; a complete report of prior investigations of the device and an accurate summary of those sections of the investigational plan; and a description of the methods, facilities, and controls used for the manufacture, processing, packing, storage, and installation of the device.Within 30 days, the FDA is expected to give a decision on the submission. The study will be approved, approved with conditions, or disapproved.Memorable quotes by David Pudwill:“Everybody wants to be breakthrough, but not everybody is breakthrough.” “There are a lot of clinical studies that are just exempt from IDE regulations.”“Even high-risk devices could fall into a not significant risk kind of a study.”“There’s always a chance that the FDA is going to disagree with you, if you think it’s non-significant risk. FDA is going to lean, in general, towards a slightly more conservative judgement on gray area issues.” “Specifically, if it’s a new sort of category of device or a significant departure from the existing technology, you’re probably going to need clinical information.”Links:David Pudwill (Mr. Regulatory) on LinkedInMr. Regulatory WebsiteMr. Regulatory on YouTubeFDA - Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission ProgramInvestigational Device Exemption (IDE)FDA - IDE  BasicsPodcast - An Introduction to FDA’s Regulation of Medical DevicesPremarket Approval (PMA)Premarket Notification 510(k)De Novo ClassificationHumanitarian Device Exemption (HDE)Breakthrough Devices Program (BDP)Early Feasibility Studies (EFS) ProgramEFS Breakthrough Device Designation Safer Technologies Program (STeP)Center for Devices and Radiological Health (CDRH) LearnInstitutional Review Boards (IRB)Significant Risk vs. Non-Significant Risk for Medical Devices21 CFR Part 812Greenlight Guru AcademyGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Are you a medical device professional or company seeking suppliers? Or, are you a supplier yourself? There’s a supplier management solution that will make your job a whole lot easier.In this episode of the Global Medical Device Podcast, Jon Speer talks to Bassil Akra, CEO and Co-owner of ‎QUNIQUE, a quality and regulatory consultancy. Previously, Bassil worked with the notified body, TÜV SÜD.Bassil discusses QUNIQUE’s Quality Engine (QE) solution for supplier management, which helps manufacturers find compliant solutions to fulfill obligations and achieve continuity that puts medical devices on the market.Some highlights of this episode include:QE is a one-stop shop, like Amazon is for consumer products and Google is to ask questions about everything. However, QE specifically searches for healthcare, medical devices, pharma, and IVD products and service providers. QE is a platform invented but not influenced by QUINIQUE. Every notified body and registered consultants are listed. With QE, you can find, identify, select, and contact global suppliers.To join and register for QE, book a membership package, choose a service provider type, and search by selecting relevant criteria. QE includes testing labs, distributors, suppliers, and requests. Otherwise, if you’re searching for results, you have to connect with multiple places and people.Evaluating, monitoring, and selecting suppliers can be frustrating and time consuming. QE simplifies supplier management. Transparency is necessary to have fair competition and a clear supplier selection. Then, you no longer need to be dependent on a single supplier.Memorable quotes from Bassil Akra:“We are helping manufacturers and we are finding solutions toward getting them really compliant, but getting them also in a lean way fulfilling their obligation and being able to achieve the target of market continuity and getting their device on the market.” “Every one of us is nowadays struggling to find things.”“It is not the end list, this is the beginning. We’re going to extend this platform to get more transparency on the market.” “We have a large number of service providers who are unknown and they are available when we need them but we don’t know about them.” “Transparency is all what we need in life to have fair competition and a clear supplier selection.”Links:Watch this episode on YouTubeBassil Akra on LinkedIn‎Quality EngineQUNIQUE GroupEuropean CommissionEuropean Union Medical Device Regulation (EU MDR)European Union In-Vitro Diagnostics Regulation (EU IVDR) Notified BodiesTÜV SÜDMedTech EuropeAdvaMedGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Premarket Approval (PMA) is a FDA regulatory pathway designated for Class III medical devices that has historically been known to evoke a fearful, negative response by medical device professionals.In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill, known in the industry as Mr. Regulatory, about the reasons why the PMA process is so dreaded by manufacturers bringing a Class III medical device to market in the United States.

Why is design, manufacturing, quality, and culture so important in the medical device industry? These key elements must exist and function in synchrony so that a medical device can save and improve patient lives.In this episode of the Global Medical Device Podcast, Jon Speer talks to Dan Purvis, CEO at Velentium—a design, development, and manufacturing firm that takes medical devices through an entire lifecycle.Dan gives listeners an update on Project V, an initiative involving the mass production of ventilators comprising five separate devices aimed at saving lives and meeting worldwide demand in response to COVID-19.Some highlights of this episode include:Velentium partnered with Ventec Life Systems, General Motors (GM), and the U.S. Government to build 30,000 ventilators and 141 manufacturing test stands in a 6-8 week period for Project V.Managing Manufacturing: The challenge with COVID is that so much is unknown. CDC provides guidelines for who can/cannot be in your facility, but not for who should/should not be allowed in your facility.Humans are hurting because of COVID. The gain or loss of productivity focuses on these key areas: Messiness of COVID, quality manufacturing, and culture of safety. How can a company maintain a culture of empathy, and at the same time, get a job done to pay the bills?Top Tips and Best Practices: Data Repositories: Move, store, and transition source code files, data, and other information as soon as possible to the Cloud.Design and Development: Foster a culture of understanding, efficiency, and flexibility.Four Variants of Design:Design for Manufacturability: Device passes design controls and receives approval, but it is extremely expensive and/or impossible to make.Design for Test: Testing throughout as you go, including product characterization testing and design verification testing.Design for Longevity: Manufacturable but think about design materials around longevity-oriented parts.  Design for Quality: Analyze for number of times used, shelf-life, patient safety, and cybersecurity.Memorable quotes from Dan Purvis:“That project was extremely successful. Thirty-thousand ventilators were built in Kokomo, Indiana, in an automotive factory that had not ever built a ventilator before.” “When you send these devices out into the marketplace, one hospital at a time, you can be assured that they’re going to do good just like they were intended to.” “Remind people that this is the real deal. Most of us, if not all Americans at this point, know someone who has passed away. Or, they know someone who knows someone who has passed away.” “The science is clear that when we are masked up and distanced, we have a much better chance of not spreading the disease.”