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The importance of cervical cancer screening in the U.S.Why is cervical screening so important in the U.S. and globally? And how has the pandemic affected that screening? Today’s episode features Chris Beddard, VP of US Marketing at BD. She joins the podcast today to discuss a product she and her team have been working on to improve the lives of women. Chris is passionate about bringing awareness about health options to women around the world. Listen to the episode to hear what Chris has to say about why the test she’s been working on is special, what kinds of challenges a team faces when developing these tests, and why cervical cancer screening is so important. Some of the highlights of today’s episode include:What BD is doing and how Chris is working with itHow to go about choosing specific treatments to targetWhat makes the current test specialCervical screening focus on women in AfricaChallenges in developing testsWhy cervical cancer screening matters so muchThe ongoing impact of the pandemi

What is the customer’s ecosystem, and why do you need to know about it? In today’s episode, we spoke with Kari Haab about Customer Discovery for Medical Device companies.Kari Haab has been working in the medical device world for over 10 years. She’s a part-time mentor in residence at Western Michigan University and a Partner with Cantilever Business Partners, and an independent consultant for start-up organizations. Prior to this role, she was Vice President of Product Strategy, at Aquaro Histology. Kari has implemented quality management systems and led the launch of products through development, clinical trials, FDA and CFDA approval, and marketing campaigns during her years in the field. Listen to the episode to hear what Kari has to say about discovering the market fit for a device, overcoming the “bias of technology,” learning how to apply critical feedback to improve your product, and filling out the customer ecosystem.Some of the highlights of today’s show include:The process for customer discover

There’s a transition underway for devices that are currently under an EUA. People may not realize it, but this EUA, which was put into place under COVID, covers more than just COVID-related devices; many products are affected. Kyle Rose joins the podcast today to talk more about it. Kyle is the President of RookQS and works as a contract Quality Manager for multiple medical device companies, overseeing overall quality strategy and ensuring compliance through documentation and auditing services. Listen to the episode to hear what Kyle has to say about the EUA transition deadline, the potential uses for the EUA going forward, and what companies should focus on if they only started selling medical devices during the EUA.Some of the highlights of today’s show include:Whether there’s an EUA transition deadline yetWhat EUA companies need to be doing right now on the quality side of thingsWhat the EUA transition will look likeHow adverse events need to be documentedThe potential for the EUA as the norm in certain si

What pitfalls do SaMD companies run into when they set up their QMS? How can your company avoid making these QMS mistakes? Today’s guest, Karandeep Singh Badwal, is a Regulatory Affairs Quality Consultant who is well-versed in EU MDR, and regularly works with medical companies producing Class I, II, and III medical devices.Listen as we talk about what a quality management system is and what the goal of a QMS is, the importance of validating software, and the differences between AI and machine learning, among other things. Some of the highlights of this episode include:A quality management system is a structured system of procedures and processes covering all aspects of design, manufacturing, supply, risk management, management responsibilities, customer-related processes, corrective actions, and preventative actions.Quality management systems come in several forms.There are differences for QMSs at SaMD companiesValidating software means making sure it can do what needs to be done and produces consis

What is design assurance, and what function does it serve in the overall product design process? It’s not a role that gets a lot of upfront credit or name recognition, but it’s an important part of the process and impacts product development more than you may think at first.Orla Connaughton joins the podcast today to discuss design assurance with Etienne Nichols. Orla began as a mechanical engineer and has a Master’s degree in Project Management. She has 18 years of experience, mostly working in the medical device sector, and has worked at a Senior Management level for both multi-national and start-up organizations. She’s been running her own company, Aztek Medical, for over 8 years. And she has a lot to say about design assurance.Listen to the episode to hear the conversation as they discuss what’s involved in design assurance and why it’s so important. Orla shares how her thoughts on the scope of the design assurance process are related to The Lion King and how design assurance “packs the parachute” for the

What does it mean to let your values and principles guide you through the challenging times, including the black swan events? Just what is a black swan event anyway? Will you know what it is if you encounter it? In today’s episode of the Global Medical Device Podcast, we have a wide-ranging conversation with Mike Baca about the lessons we can learn from him as an industry leader and about the long game involved in a MedTech career. Mike is currently the president of White Rook Consulting, and he has more than 38 years of experience as a quality professional working with medical devices, including classes I, II, and III. He worked in a variety of quality roles for Johnson & Johnson, Medtronic, and Stryker before starting his own independent consulting firm. Today’s conversation covers a lot of ground, including the three phases of Mike’s career, how understanding VULCA can help you handle a black swan event, and how adopting a set of principles and values will guide you through challenging times.

The 510(k) is the workhorse of regulatory submissions to the FDA from the medical device industry in the United States. However, 510(k)s continue to be the source of problems, delays, and rejections. It only takes common sense and simple solutions to overcome these issues.In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues of Vascular Sciences about common 510(k) mistakes and how to avoid them. They also cover what has changed (if anything) in the past five years since Jon wrote the article, 7 Common Mistakes That Sink FDA 510(k) Clearance.Some of the highlights of this episode include:Mistake #1 - Inconsistency with Documentation: The intended use statement often is inconsistently put into other sections of the 510(k). It’s important to understand the difference between indications for and intended use.Mistake #2 - Not Using Checklist: The FDA’s 510(k) submission guidance provides a Refuse to Accept (RTA) checklist. Help yourself and reviewers out. The FDA states what it is go

How do you bring a medical device through the development process? What are issues that development engineers face during the different phases of the design controls process, especially when researching clinical evidence? In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Keith and Kevin Kallmes of Nested Knowledge. Following in the footsteps of their father who was a medical device inventor, the two brothers designed and developed a balloon catheter that was acquired by a major strategic. Some of the highlights of this episode include:Keith and Kevin focus on clinical, regulatory, and publication consulting in the data management/data analysis services industry.Like other entrepreneurs, Keith and Kevin understand the importance of central clinical outcomes data in every stage of the medical device development process for a product rooted in an unmet clinical need.Engineers tend to focus on the immediate task at hand. Entrepreneurs have to consider why startups succeed or

What should early-stage entrepreneurs and medtech companies consider with commercialization in relation to how regulatory strategy affects business roadmap, pitfalls companies fall into, and fundraising efforts? In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Duane Mancini, CEO and Managing Partner at Project Medtech. Duane has experience in go-to-market strategy, including regulatory and reimbursement, biocompatibility, pre-clinical efficacy testing, and clinical trial design and execution. He has developed a comprehensive understanding of what early-stage startups need to do to be successful.With all of the complexities of running a medtech company and taking a product to the market, Duane has seen a huge variation in how startups develop strategies and milestones. In this episode, we discuss how early decisions impact other aspects in the future and how companies can create a blueprint to build and grow long-term.Some of the highlights of this episode include:Fundraising

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 packagi

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 device

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 managemen

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 c

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 matter

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 physic

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 s

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 inte

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 o

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

Do your field teams still rely on map, spreadsheet, and note apps? How medical device companies have historically generated sales is no longer adequate for selling medical devices in today's market...and there's a new revenue intelligence tool to help you bridge the gap.In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Skylar Talley and Mark Mescher from MedScout, a territory prioritization and sales enablement platform.Skylar and Mark discuss early stage territory planning to get more medical device sales, different aspects of go-to-market strategies, and building and demonstrating meaningful value by understanding pain points. Some of the highlights of this episode include:Tools have evolved and MedScout’s platform is a huge step forward. Basically, it brings an Excel spreadsheet to life, maximizes territory data, and is very intuitive and useful for sales reps to understand.Skylar has observed an evolution from frameworks/methodologies on the market based on geographic cov