The packaging of medical devices, especially sterilized products, is often overlooked and does not make news headlines until it’s done wrong. How can packaging and labeling prevent 510(k) delays? In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Jeff Barrett, CEO of J-Pac Medical, about packaging validation best practices.Jeff has 25 years of experience in the medical device industry, specializes in getting new devices to market, and scaling your commercialization. He has extensive knowledge and understanding of ISO 11607-1 & -2, Packaging for Terminally Sterilized Medical Devices.Some of the highlights of this episode include:Sterilization validations/revalidations take a lot of money ($40,000-80,000) and a long time (16-20 weeks) to complete.Don’t underestimate labeling - 40% of FDA recalls are due to labeling. Make sure your CM has good labeling controls.Over a third of all package validations fail the lab test for transit. The biggest reason why companies fail packaging validation is not understanding the various shipping modes and their related testing.ISO’s 11607 standard has two parts: Part 1 is about designing the package; Part 2 is validating the package. Also, there is a guidance document due to the complexity of the packaging process.The criteria for filing a 510(k) and steps related to packaging include validating that the seals are good from a sterile barrier standpoint and the product is good and has not changed over time because of transit testing or aging.From a design standpoint, document how the package has been designed and meets customers’ needs. Recently, the FDA added user testing to the standard for sterile transfer.Feasibility testing of prototypes and samples of vibration, drops, and humidity should be conducted to prevent potential problems. Ask engineers about product changes and the risks for redesign of packaging to know if the package will fail or pass.Memorable quotes from Jeff Barrett:“The FDA looks at a standard called ISO 11607. That is the Bible for medical device packaging validation. There’s two parts to it, Part 1 and Part 2. Part 1 is all about designing the package and Part 2 is about validating the package.” “Over a third of all package validations failed at the lab for transit. It’s staggering.” “Less so do we see damage to the product itself. So, I’d say, 8 out of 10 times on these failures, it’s the product and the seal failing, not the product breaking.” “One of the biggest problems we see is, (the FDA) they don’t do any validation. They say, ‘We’re going to do it later.’ That’s obviously a problem. You can’t market the product if the package hasn’t been validated. That’s why the FDA gives you a break on that.”“The bottom line is you’re trying to maintain the product without getting damaged and without the sterile barriers getting damaged. That is the end goal.”Links:Jeff Barrett on LinkedInJ-Pac MedicalEtienne Nichols on LinkedInISO 11607-1ISO 11607-2ISO 13485ASTM InternationalFDA - 510(k) ClearancesGG AcademyMedTech NationGreenlight Guru

What are submission deficiencies due to biocompatibility and how do medical device companies overcome them in trials, studies, and regulatory post-market surveillance?In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Chris Parker, Associate Department Head of In-Vivo Biocompatibility at Toxikon Corporation on how to overcome and prevent those submission deficiencies.Some of the highlights of this episode include:When a manufacturer puts their package together for a submission to the FDA, if it is not approved, then the FDA issues a deficiency or request for additional information due to a question or issue with some part of the submission.If a deficiency is issued, the FDA allows the manufacturer to handle it in one of two ways—either correct it through a memo/risk assessment or retest.It is better to be proactive rather than reactive when addressing a deficiency. A little bit of time upfront with the FDA will save a lot of time on the backend.Competition: When most medical devices are being developed, there is intent. Either it’s a completely new idea or existing product that another manufacturer offers that you want to build or improve upon.Prop 65 and new European regulations strive to keep out carcinogens, mutagens, reproductive toxins, and other compounds that at certain thresholds may be of concern and should not be included in devices or labeling is required.When it comes to quality, ISO standards and FDA regulations are in the best interest of the patient but may be a costly burden for the manufacturers. It takes units of a medical device to complete evaluations for biocompatibility testing.It takes days, months, or requires extensions for some companies to do remedial work and meet expectations when responding to a deficiency.Implement quality from the beginning with a quality management system (QMS) to understand expectations of standards, practices, and regulations. Memorable quotes from Chris Parker:“In a fair number of instances, there are cases where the FDA issues what we call a deficiency. It’s otherwise known as a request for additional information. But generally, what it is, is they have a question or an issue with some part of the submission.”“Be proactive, not reactive because then a little bit of time upfront will save you a lot of time on the backend.”“A lot of devices, when they are being developed, you’re doing it with intent in mind. Either it’s a completely novel, new idea or you saw a product and you said there’s a greater market than a particular other manufacturer offers, we want to jump into it or we want to improve it.”“Let’s try to keep out anything of potential concern that we can at any concentration.”Links:Chris Parker on LinkedInLabcorpEtienne Nichols on LinkedInFDA - Overview of Device RegulationFDA - Select Updates for Biocompatibility of Certain Devices in Contact with Intact SkinISO 10993-1:2018 - Biological evaluation of medical devicesProposition 65European Union Medical Device Regulation (EU MDR)Medical Design and Manufacturing Event (MD&M West)GG AcademyMedTech NationGreenlight Guru

Have you done Corrective and Preventive Actions (CAPA) on your CAPA process? If not, you need to seriously consider doing so because CAPA is the #1 reason why companies get 483 observations year after year.In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues of Vascular Sciences about whether your medical device company’s CAPA process needs a CAPA. Why are medical devices companies continuing to struggle with CAPAs?Some of the highlights of this episode include:Only 3-5% of adverse events of medical devices are actually reported to the manufacturer or FDA. People tend to report every little event as a CAPA or report nothing at all. The five most common reasons why the FDA issued 483 observations and warning letters over the last 5 years were CAPAs, customer complaints, purchasing controls, medical device reporting, and process validation.If CAPA is the #1 reason why companies are getting 483 observations and warning letters, it may be due to an ineffective quality management system (QMS).Things happen every day during the course of running a business. Processes and routines may not go routinely. When something happens unexpectedly, will it happen again? What are you changing to ensure it does not happen again?CAPAs continue be the #1 reason because people do not have a common sense understanding of the quality system regulation. They focus on the words, but do not try to understand the meaning.CAPAs often generate negative connotations—the process requires extra work and more resources, not in the budget, and time pressure. However, people should view CAPA’s as an opportunity to improve a product and prevent problems in the future. People do not follow procedures because sometimes they don’t even know that procedures exist, or those procedures are not updated/revised after events.Memorable quotes from this episode:“A CAPA is an opportunity to really do a deep dive investigation to determine, is there a systemic issue that is influencing that process that you are following?” Jon Speer “People don’t focus on the common sensical understanding.” Mike Drues “Unless regulation makes sense, I don’t care what the regulation is, unless it makes sense, it is not good regulation.” Mike Drues “Part of going through the CAPA procedure is to identify the root cause of the problem.” Mike Drues “Only 3-5% of adverse events of medical devices are actually reported to the manufacturer or to the FDA.” Mike DruesLinks:FDA - Corrective and Preventive Actions (CAPA)FDA - Form 483 Observations and Warning LettersFDA - Medical Device OverviewInternational Medical Device Regulators Forum (IMDRF)ISO 13485 CAPA21 CFR Part 820Mike Drues on LinkedInGreenlight Guru AcademyGreenlight Guru CommunityMedTech NationGreenlight Guru MedTech Lifecycle Excellence

What is the current state of unique device identification (UDI) in the United States versus the European Union (EU)? What are the current deadlines, complexities, and differences, as well as the four quadrants of UDI that companies need to be aware of? Don’t underestimate your time to comply because it always takes longer than expected.In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Gary Saner, Senior Manager of Information Solutions for Life Sciences at Reed Tech, about UDI and the current state of global implementation.Gary has been helping companies achieve UDI compliance on a global scale for years.  He is considered to be a thought leader and recognized authority on medical device UDI compliance.Some of the highlights of this episode include:As the U.S. FDA Class I UDI deadline approaches, companies should refer to the FDA’s final guidance, which describes the compliance policy regarding Global Unique Device Identification Database (GUDID) submission requirements for certain Class I devices considered consumer health products.Delays seem to be a part of the history of UDI. Manufacturers face challenges and pitfalls from UDI being rolled out easily. There are a number of issues with the brand new requirement in the United States.The four quadrants of UDI are identifying a product, reprocessed/reused products, reporting attributes, and documenting standard operating procedures (SOPs) in a quality management system (QMS).The EU has a complicated UDI implementation schedule, as well. Delays have been announced, but the impact was due to the European Commission completely revamping the regulatory platform. In Europe, UDI becomes one of the many things that a manufacturer has to learn, be educated on, and respond to. There’s no grandfathering of products, notified bodies, and patients. Portfolios are re-evaluated to meet new regulations.With the FDA and EU in place, the regulatory landscape typically uses one or the other as a precedent. Some health authorities around the world base their policies on one or the other. However, good global harmonization is not in place.Memorable quotes from Gary Saner:“This is a challenge in that this particular dataset has never really been assembled before. So, there’s no precedent for this.”“The other issue is sometimes you find the data and it’s not accurate or it hasn’t been touched for a while. It’s not current. It’s obsolete. There’s issues with formatting. Sometimes, the formatting of that data that’s held for internal processes is not the format that actually gets submitted to the FDA.”“There’s a little bit of a nuance about making sure the acknowledgements that come back from CDRH, there’s three acknowledgements, and making sure that they’re all complete for every single record.”“UDI becomes one of the many things that a manufacturer has to learn and be educated on and then respond to and there was no grandfathering of products.”“With the FDA and EU in place, the regulatory landscape typically uses one or the other as a precedent. Some of the other health authorities around the world will kind of base their policies on one or the other - US or EU.” Links:Information Solutions - Life Sciences at Reed TechGary Saner on LinkedInThe Ultimate Guide to UDIFDA - Unique Device Identification (UDI) SystemFDA - Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain DevicesCenter for Devices and Radiological Health (CDRH)European Union Medical Device Regulation (EU MDR)EU In Vitro Diagnostics Regulation (IVDR)EUDAMEDGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru MedTech Lifecycle ExcellenceGreenlight Guru YouTube ChannelEtienne Nichols on LinkedIn

How is the changing job market affecting careers for professionals in MedTech? How can video storytelling strategies and techniques impact talent access?   In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Joe Mullings, chairman and CEO of the Mullings Group companies, about finding true quality talent and celebrating excellence and hyper-competency to make lives better. Joe’s search firm is responsible for more than 8,000 successful searches in the medtech/healthtech/life sciences industry. DragonFly Stories produces attention and awareness campaigns for companies globally through TrueFuture. TMG360 Media utilizes the power of media and outreach in medtech/healthtech to move businesses and health forward.Some of the highlights of this episode include:Quality of Outcome vs. Opportunity: Organizations are realizing that it’s much more expensive to lose and replace a good player rather than retain a good player. The quality and output of an employee’s work matters.Networking should occur when you don’t need it. Be clever, bring value, give and not take, and create a brand around yourself.The workforce and global economy has changed because of the worldwide pandemic. Things are starting to settle down, and it’s time to reset, re-define, and re-evaluate employees’ responses to work and fulfillment.WFX: Where are employees willing and wanting to work—from home, anywhere, or in the office—and how does that affect organizations’ willingness when it comes to compensation, flexibility, and the networking process to retain talent?Two-way communication between workers and employers needs to be created to find balance and reduce friction for healthy relationships. The catalyst for people switching or leaving their jobs is to make more money. However, top performers want to move forward in their career from their own developmental perspective and grow their skills.The non-negotiables of working in the office or not depends on your degree and years of experience. If you’re new, it’s best to work in the office to learn and mimic others. Then, it depends on your job function.The best way to represent yourself in the marketplace is based on your behaviors and how you package yourself when appearing in front of others.Memorable quotes from Joe Mullings:“We are the #1 search firm in the world, first of all, in the medical device/healthtech industry with more than 8,000 successful placements over three decades.”“Compensation, right now, is also being driven by supply and demand.”“You’ve got better career choices now, and you’ve also got the ability to live, potentially, a better life.”“Let’s keep a better balance of power in the workforce instead of it being futile in nature where the companies call all the shots.”“The digital scales your idiocy as well as your competency equally.”Links:Joe Mullings on LinkedInThe Mullings Group - TMG SearchTMG360 MediaDragonFly StoriesTrueFutureOut of the CrisisEtienne Nichols on LinkedInGreenlight Guru AcademyGreenlight Guru CommunityMedTech NationGreenlight Guru

What is software as a medical device (SaMD)? How does one test SaMD? What testing is required? What are the risks related to your SaMD and its testing?  In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Rahul Kallampunathil, Vice President of Arbour Group’s Digital Compliance practice, about digitizing your SaMD testing.Rahul builds teams that help companies proactively manage compliance risks toward a true digital enterprise. He is an innovative thinker with more than 18 years of experience in risk management, compliance, and internal controls focused on information technology and data. Some of the highlights of this episode include:Rahul defines SaMD as software used to perform a medical purpose without being part of a hardware medical device. SaMD is capable of running on any general purpose platform, such as your Android or iOS mobile phone.SaMD is different from software in a medical device (SiMD). SaMD is independent from hardware; SiMD is embedded in a physical medical device.Also, there’s differences between SaMD and medical device data systems (MDDS). MDDS only transfers, stores, or displays medical device data, but it does not have an algorithm or business rule to help make medical decisions.IEC 62304 impacts SaMD organizations and how they approach the risk of their solution. All SaMDs are not equal, and it’s important to understand the level of risk in every SaMD.Companies should prepare for SaMD testing with a clinical evaluation to demonstrate a valid clinical association between SaMD’s output and targeted clinical condition.Before thinking about designing and developing a product, a quality management system (QMS) should be established. Software companies need to adopt and modify their QMS to serve their product and its users, while fulfilling FDA requirements.Rahul discusses the pros and cons of manual versus automated/electronic  documentation and testing, including risk management for patient safety.Best practices for SaMD testing are using agile and devops methodologies. Potential pitfalls are not testing continuously, even after the product is on the market. Memorable quotes from Rahul Kallampunathil:“Software as a medical device - it is software that is intended to be used for a medical purpose, and it performs that purpose without being part of a hardware medical device.”“There is no physical device, in this case, that you can touch and feel. It’s purely software.”“The nature of software - it’s something that you cannot touch or see. It’s all code. From a testing perspective, especially, there’s a lot of things that you need to pay attention to.” “The quality management system or quality management process, that has to be established even before you think about the product, even before you design the product.”Links:Rahul Kallampunathil on LinkedInEtienne Nichols on LinkedInArbour Group LLCFDA - SaMDFDA - Medical Device Data Systems (MDDS)FDA - CybersecurityIEC 62304International Medical Device Regulators Forum (IMDRF)Greenlight Guru YouTube ChannelGreenlight Guru CommunityGreenlight Guru AcademyMedTech NationGreenlight Guru

After three “Refusals To Accept” Guidance Documents from the FDA, why are there still so many submission issues? Who’s to blame? Learn from other people’s mistakes.  In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Mike Drues of Vascular Sciences about the FDA’s Refusal to Accept (RTA) policy and guidance. Some of the highlights of this episode include:After the FDA receives a 510(k), De Novo, Pre-Market Approval (PMA), or any other submission, the 2-step process is to conduct an administrative and then a substantive/scientific review.If a submission is rejected on the administrative review, it is completely the company’s fault, not the FDA’s. If the substantive review is rejected, however, there’s room for negotiation with the FDA.Most of the FDA’s acceptance checklists have been available for more than a decade, but companies submissions are still commonly rejected on administrative review.Electronic tools and software platforms, such as eSTAR, are supposed to help and facilitate the preparation process of submissions. The problem is, this is contingent on what information is entered.Potential hangups for companies using tools like eSTAR for the submission process are that they do not evaluate the quality of the content entered. That said, they do require a Table of Contents and the use of most current forms.Never leave any sections of your submission blank. At the very least, enter Not Applicable (N/A) and explain why - or risk the FDA rejecting the submission. It’s a company’s responsibility to make sure the FDA understands their device.The draft guidance documents have been published for a reason - don’t ignore them and risk a rejection for what could easily have been avoided. Memorable quotes from this episode:“If a submission gets rejected on an administrative review, that is 100% the company’s fault, it is not FDA’s fault.” Mike Drues“Approximately 60% of 510(k)s are rejected on RTA part of the administrative review.” Mike Drues“An eTool should help facilitate the process. However, caveat—it still is contingent on humans entering information.” Jon Speer“I would like the FDA to be just as careful with the claims that they put on their own website as they are when they are evaluating claims on a device coming in for a submission.” Mike Drues“One of the most common reasons why submissions are rejected is because a particular section is left out. Put yourself in the shoes of the reviewer. They have no idea why you are leaving out that section.” Mike DruesLinks:How To Avoid Having Your FDA Submission Rejected (And What To Do If It Is)Guidance: Refuse to Accept (RTA) Policy for 510(k)sGuidance: Acceptance Review for De Novo Classification RequestsGuidance: Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)Acceptance Checklists for 510(k)sMedical Device User Fee Amendments (MDUFA)FDA - Voluntary eSTAR ProgramWhat is the eSTAR Pilot Program and How Will it Improve FDA's 510(k) Review Process?Mike Drues on LinkedInGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight Guru CommunityGreenlight Guru

What are guerilla tactics for quality leadership? How do you implement a lean quality management system (QMS) and put requirements in place that are truly required - especially when there is the potential for personnel to resist change? In this episode of the Global Medical Device Podcast, Etienne Nichols discusses lean QMS implementation with Steve Gompertz, a leader in quality systems management with more than 30 years of experience in the medical device/technology industry. Some of the highlights of this episode include:Guerilla tactics for quality leadership that involve thinking outside of the box and trying to get things done without asking for permission from authorities. Sometimes the FDA unintentionally creates fear and creates imaginary boundaries in people’s minds that stifle their creativity.People will struggle and become frustrated when working with a burdened QMS and restrictive standard operating procedures (SOPs).The regulations and standards are intentionally vague and open to interpretation because it’s not possible to have a one-size-fits-all. Meet the intent of the requirements and be ready to defend them.Lean documentation is the best approach. Weed out the things you don’t need. In a regulated or unregulated space, it’s better to have clear, precise, and intentional documentation rather than a pile of papers.Sometimes regulations and standards create negative opinions because it’s human nature to not want to be told what to do. However, what is their purpose? To produce safe and effective medical devices while also turning a profit.Approaches to implementing guerilla tactics include burying or sneaking something in without calling it what it is and getting people to do the right thing without them always knowing they are doing it.Make sure your metrics don’t incentivize the wrong thing. Some companies measure document control in QMS based on time—how fast it takes to make changes? But does that actually make the process more effective and cost less? More likely, it incentivizes cutting corners.Steve recommends shifting your mindset about document control or value-added changes by first defining the problem correctly. Don’t make assumptions.Memorable quotes from Steve Gompertz:“The regs and the standards aren’t actually that specific too often. They are intentionally vague. Sometimes, that is a point of frustration with people. But when you think about it, they have to be.”“Step back, stop just reading what the words say, and start thinking about why are they there?”“When you create a quality system, you have to think about the architecture.”“If it isn’t documented, right, it didn’t happen. If it’s not documented right, things are going to go bad.”Links:Quality & Regulatory Consulting - QRx PartnersAsk Me Anything Session with Steve GompertzISO 13485FDA - Guidance Documents (Medical Devices)21 CFR Part 820 - Quality System RegulationThe 7 Habits of Highly Effective People by Stephen R. CoveyGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight Guru CommunityGreenlight Guru

The medical device sales industry is slow to change. It’s behind on how hospitals and physicians adopt and adapt to buying, sales strategies are out of date, and increased costs are leading to diminished returns. What are specific tactics that MedTech companies can take to develop their sales process?In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Omar Khateeb about preventing the death of medical sales with new data that shows where you can find prospective buyers for your medical device products.Omar is the founder of Khateeb and Co., which helps MedTech companies grow sales and drive product adoption through social media and content.Some of the highlights of this episode include:Omar describes the death of medical sales as the death of an old way. The world has changed and buyers in every industry have become more sophisticated. Social media content now influences buying decisions.Rather than unscheduled clinic and hospital visits with physicians, Omar describes the new way of medical sales as liking, commenting, and resharing their content.LinkedIn and other social media channels are powerful for communication and influence. The real value is building thought leadership and creating attention-getting content to persuade someone to meet with salespeople.Companies need new categories or different ways of doing something. A marketing campaign should include: What problem do you solve? Who do you solve that for? How are you solving it in a unique way?Be as specific as possible because your message needs to resonate with specific people. If you can’t satisfy one specific person, how can you satisfy an entire market? The riches are in the niches.There are pitfalls that some people and companies get into when utilizing a social media approach on their own. Spend more money to buy time. You can always make your money back, but you cannot get your time back. Memorable quotes from Omar Khateeb:“How the buyer’s journey for everybody, not just doctors, has become more sophisticated.”“We should be selling and marketing to physicians and hospitals using social media.”“You shouldn’t be posting stuff about your product as a salesperson.”“The riches are in the niches.”“I help medtech startups drive technology adoption and gross sales using social media.”Links:Omar Khateeb on LinkedInThe Death of Medical Sales: Igniting a New FutureUpending the Medtech Sales ModelAlex Hormozi on LinkedInGeoffrey MooreGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight Guru CommunityGreenlight Guru

FDA has issued new draft guidance on cybersecurity for software as a medical device (SaMD). If the FDA releases that draft guidance ‘as is,’ it will massively and negatively impact the SaMD industry and it’s imperative that manufacturers understand how to prepare. In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Chris Gates, director of product security at Velentium, about the shifting sands of medical device cybersecurity regulations for SaMD. Some of the highlights of this episode include:Chris views the FDA’s recent activity around cybersecurity requirements, regulations, and laws for SaMD as a necessity because manufacturers cannot seem to self-regulate. The Protecting and Transforming Cyber Health Care Act (PATCH) will give the FDA a direct mandate to manage the cybersecurity of medical devices.However, a clause in the PATCH Act allows for cybersecurity to extend to all existing legacy medical devices—not just new devices entering the market.As medical device manufacturers (MDMs) become aware of the clause, it’ll have a huge impact. MDMs will likely end support for device lines due to high costs. The biggest issue with the new guidance consensus vs. regulatory standards is alignment with software bill of materials (SBOM) tools.The most effort-intensive part of the new draft guidance is ongoing testing of anomalies to determine if they can be turned into vulnerabilities. The industry will be unable to keep up with additional testing because of resources and demand.All this added burden will be placed on MDMs at the cost of marginal improvements in cybersecurity. So, there’s no real benefit to the manufacturer.Structure a standard by not creating something brand new that is ill/undefined but align best practices to create secure medical devices.Memorable quotes from Chris Gates:“Legally-backed cybersecurity requirements by a regulatory agency are necessary to ensure secure devices are entering the marketplace and hopefully replacing the insecure legacy devices.”“This clause is going to have a huge impact on medical device manufacturers (MDMs) and I find it amazing how many MDMs are completely unaware of this.”“An SBOM is a software bill of materials. It’s an ingredients list for your application.”“This isn’t just one-and-done testing in your life cycle.”“You’re going to have a lot of extra work coming your way.”Links:Medical Device Cybersecurity for Engineers and ManufacturersRegulations (Submit comments to the FDA)Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket SubmissionsPATCH ActInternational Electrotechnical Commission (IEC)ISO (International Organization for Standardization)International Medical Device Regulators Forum (IMDRF)Chris Gates on LinkedInChris Gates EmailGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight Guru CommunityGreenlight Guru