Global Medical Device Podcast Powered By Greenlight.guru

What makes Greenlight Guru unique? It’s the Guru edge⁠—a team of medical device professionals with a ton of industry experience.In this episode of the Global Medical Device Podcast, Jon Speer talks to Laura Court, a medical device Guru at Greenlight Guru, about her journey in the medical device industry, which ultimately brought her to Greenlight Guru, and Laura shares tips for success she's learned along the way.Some of the highlights of this episode include:Laura gained hands-on manufacturing experience because she believes medical device professionals can’t design a product well if they don’t know how it’s made or what is gone through to get a product made and put on the market.What made Laura move towards Greenlight? Ultimately, it was her love of helping people and getting out on the floor to help people who make products.Laura sought advice and looked to manufacturers for knowledge to validate products because they knew the systems and processes better than anyone and she wanted to help fix problems.Als

As some veteran FDA reviewers leave and new ones are hired, knowledge is not always passed on seamlessly... To that end, regulatory professionals are often left to their own devices to find the guidance, support, and resources they need to fulfill their important roles in the medical device industry.In this episode of the Global Medical Device Podcast, Jon Speer talks to Allison Komiyama, a former FDA reviewer who is an expert in regulatory submissions, quality systems, and biocompatibility evaluation. Listen to Allison share her thoughts on what she wishes she had known as an FDA reviewer, providing valuable insights for regulatory professionals in the medical device industry.Some highlights of this episode include:New FDA reviewers are trying to navigate what’s important by asking questions because they have been working from home, never been onsite, and haven’t met their manager or other team members.FDA managers are trying to make sure that their teams get the training and mentorship that they need, but i

Great uncertainty brings great opportunities for growth...career growth. Currently, regulatory roles are one of the highest in demand in the medical device industry. In this episode of the Global Medical Device Podcast, Jon Speer talks to Mitch Robbins, founder and managing director at The Anthony Michael Group. Listen as Mitch shares his unique insights and perspectives into why there's such a high demand right now for regulatory and quality roles and how you can find your next career opportunity with the help of a regulatory affairs recruitment solution for employers and candidates.Some highlights of this episode include:The COVID-19 pandemic affected everything, including hiring practices. Companies started to shut down progressively and put hiring people on hold. Since April-May 2020, Mitch’s firm has worked non-stop with organizations that need help placing regulatory and quality talent.COVID has caused leaders to look at things differently, if they want to continue their business. Some are unc

What are the differences, similarities, and potential benefits of FDA’s Breakthrough Devices Program (BDP) and Safer Technologies Program for Medical Devices (STeP)?In this episode of the Global Medical Device Podcast, Jon Speer talks to Isabella Schmitt, Director of Regulatory Affairs for Proxima Clinical Research (CRO).Together, Isabella and Jon discuss the FDA’s Breakthrough Devices Program and Safer Technologies Program and how manufacturers can determine if one or either is worth pursuing for their medical device. BDP is popular, STeP has the potential to be, but is not quite there yet given it’s a much newer program.Some highlights of this episode include:BDP designations are for medical devices that treat or diagnose life-threatening or irreversibly debilitating conditions. BDP designations have an improvement over the current standard of care, may be new technology, or modification of existing technology. BDP designations show or have the potential to show that they are more effective and safe.ST

Is the widespread panic over the EU In-vitro Diagnostics Regulation (IVDR) justified? For many device professionals, the one year countdown to the IVDR deadline in May 2022 is almost here, causing much anxiety about whether compliance is even possible.In this episode of the Global Medical Device Podcast, Jon Speer and his guest Joanne LeBrun, VP of Quality Systems at MDC Associates, shine light on EU IVDR transition concerns and the challenges the medical device industry faces, like the notified body shortage.Some highlights of this episode include:Why are some notified bodies not interested? There’s a ton of work, audits, and corrective actions. They don’t view it as necessary to move forward and pursue.First, notified bodies plan a wait-and-see approach to find out how the EU MDR goes on May 27. The notified bodies are overwhelmed and resources are limited.The EU MDR has more constituents involved and is a bit more straightforward to implement than the IVDR. The IVDR has less constituents but more things th

It's easy to get so wrapped up in the risk management of your medical device that you forget about managing your business risk with the same level of diligence and ongoing attention.In this episode of the Global Medical Device Podcast, Jon Speer talks to Michael Cremeans, Life Sciences Industry Practice Leader at Hylant. Together, Mike and Jon talk about how medical device companies should approach and manage business risk, which systems and tools can help, and advice on how to review contracts and terms and conditions.Some highlights of this episode include:Are you ready to grow your company? Is it the right time for a business owner to think about the business, liability, and intellectual property? Time to engage Mike.There are consequences to a company’s distribution model and selling strategy.  Each has a different set of contracts and risks that need to be assessed and receive recommendations.Insurance is there for when you need it, even if you don’t understand it. Contractual liability is usua

Are you 'Team Waterfall' or 'Team Agile' for your product development methodology of choice?The waterfall methodology used to be the industry norm for medical device product development until an alternative approach known as the agile methodology emerged, leading to competing opinions over which product development approach is best. In this special 200th episode of the Global Medical Device Podcast, host Jon Speer and his guest Devon Campbell, founder and CEO at Prodct, discuss the waterfall and agile methodologies for medical device product development, how they were first introduced and how they are interpreted and used today, while also dispelling common myths about the two approaches.Listen as the battle between the methodologies is finally laid to rest by Jon and Devon, with one key theme emerging: the name of your chosen methodology is not nearly as important as the defined processes you follow during product development and throughout the course of your medical device project.Some highlights

Who loves internal auditing? Probably 99.99 percent of medical device professionals answered “not me!” While it may not be everyone’s favorite pastime, internal audits are very important...especially if you have or want a true quality culture and mindset of continuous improvement.  In this episode of the Global Medical Device Podcast, Jon Speer talks to Sara Adams, a medical device guru at Greenlight Guru.Sara loves to talk about internal audits. She shares her valuable wisdom of internal audits as well as learnings from leading Corrective and Preventive Action (CAPA) investigations and implementations, process improvements, and supplier and regulatory audits throughout her career in the medical device industry.Some of the highlights of the show include:Internal audits shouldn’t be about checking a box. If you know about problems, fix them first. Internal auditing offers opportunities for improvement. From a risk perspective, where are the trends and weak areas? Find them before someone else do

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

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 antagon

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

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

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 rule

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 classi

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

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, id

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/s

What do manufacturers need to know about the Safer Technologies Program (STeP) for Medical Devices from FDA? How is STeP different from similar programs, like the Breakthrough Devices Program? Which devices are eligible?In this episode of the Global Medical Device Podcast, host Jon Speer and his guest Mike Drues from Vascular Sciences offer answers to these questions and educate listeners on this new, voluntary program, helping manufacturers with eligible devices leverage STeP for easier, faster entrance into the US marketplace.

One of the main differentiators that makes Greenlight Guru so unique is its Guru Edge. The medical device gurus ⁠are a team of medical device professionals with decades of combined industry experience and subject matter expertise.In this episode of the Global Medical Device Podcast, Jon Speer talks to Sara Adams, a medical device guru at Greenlight Guru. Sara shares how her professional journey began as a biomedical engineer in the post-manufacturing industry. Listen as Sara offers valuable advice to listeners about her work as a quality engineer leading Corrective and Preventive Action (CAPA) investigations and implementations, process improvements, and supplier and regulatory audits.