Global Medical Device Podcast Powered By Greenlight.guru

What makes Greenlight Guru unique and sets it apart from other medical device solutions? It’s 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 Maryann Mitchell, a Medical Device Guru and Solutions Engineer who has recently joined the Greenlight Guru team.Listen as Maryann shares fascinating details about her day-to-day working with device companies who are evaluating the Greenlight Guru Medical Device Success Platform (MDSP) to better understand their product and business needs and how Greenlight Guru's MDSP solution can help them achieve ultimate success.Some of the highlights of this episode include:Maryann’s background is in quality systems initiatives, and she has extensive experience with ISO 13485. She loves being a part of audits and truly enjoys defending quality systems.While Maryann has been through numerous ISO 13485 audits, she has experienced only a few FDA inspections. She explains that the

Medical device companies need to tell slightly different versions of their stories depending on the intended audience—investors, suppliers, regulators, clinicians, and patients—and each version must be strategically crafted and told in order to convey the right message.In this episode of the Global Medical Device Podcast Jon Speer talks to Brad Perriello, who previously cofounded MassDevice and now current founder and principal at Circle Hill Life Science Communications, about his unique line of work helping medical device companies learn how to effectively tell their story.Listen to this episode now to learn what your company can and can't say to different target audiences and how to effectively communicate your company’s core message and story so it positively resonates with the listener.Some of the highlights of this episode include:Brad Perriello, alongside fellow journalist Brian Johnson, founded the online medical device business journal MassDevice based on his belief that small businesses and startups

Is your body becoming more frail? Are you worried about fractures? Do you want to improve your bone health? Osteopenia and osteoporosis are very common problems that don’t have completely effective solutions, yet.In this episode of the Global Medical Device Podcast, Jon Speer talks to Laura Yecies, CEO of Bone Health Technologies, about the product journey of OsteoBoost, a vibration belt that aims to prevent osteopenia and osteoporosis that has recently received the FDA’s Breakthrough Device Designation (BDD). Learn what the BDD experience was like and how their team is currently navigating the FDA regulatory process and collecting the necessary clinical data with the hopes of soon placing OsteoBoost on the US market.Some of the highlights of this episode include:More than 50 million Americans are suffering from osteopenia and low bone density. Half of all women will have a fracture from osteopenia and osteoporosis - that’s more than heart attack, stroke, and breast cancer combined.As people get older, especi

FDA published a final rule, which goes into effect the first of September, to amend its “intended use” regulations.In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the implications of FDA’s final rule on intended use, manufacturer’s objective intent, and the role that it has with labeling.Some of the highlights of this episode include:When Mike and Jon refer to labeling, they are talking about the content of the label - the words used and claims made.High-level labeling describes intended use, indications for use, and label claims. Low-level labeling includes directions for use and package inserts. A claim is a claim whether put in high- or low-level labeling.High- and low-level labeling can be leveraged as a strategic, competitive advantage to minimize or streamline regulatory burden, which means how much effort and evidence is needed to go through the FDA and put on the market.Intended use focuses on a device (what it does, how it works, and wh

Have you ever thought about the versatility of an eQMS? As it turns out, the use of one medical device eQMS solution in particular is extending across multiple sectors.In this episode of the Global Medical Device Podcast, Jon Speer talks to Renee Rogge and Devin Hubbard, two academic professors/faculty members of biomedical engineering programs which are involved with the Greenlight Guru Academic Partner Program. Jon, Renee, and Devin discuss their work together in the program and Renee and Devin share their experiences using the eQMS from Greenlight Guru in the classroom and how it's helping students engage and better understand medical device risk and quality management concepts and practices.Some of the highlights of this episode include:Introducing Greenlight Guru to students has helped them to understand eQMS and how they can take the things they learn in theory and apply them in practice.Biomedical engineers need to be taught design principles, technical writing, and how to conduct tests and case studie

How efficient are your management reviews? Could improvements be made? It might be time to reevaluate and reconfigure your system processes to eliminate burdens and extract utmost value from these critical checkpoints while still satisfying compliance needs.In this episode of the Global Medical Device Podcast, Jon Speer talks to Taylor Brown, senior medical device guru at Greenlight Guru. Together, Taylor and Jon discuss the nuances of management reviews to help medical device managers and executives make better decisions for teams to achieve greater outcomes.Some of the highlights of this episode include:Learn the must-haves of management reviews, such as inputs, feedback, complaints, reporting, and audits during planned intervals, by following ISO 13485 and FDA 21 CFR Part 820 - Quality System Regulation.How often should management reviews be performed? The industry standard is once a year, but a lot could happen in 12 months. Greenlight Guru recommends management reviews twice a year, especially in the ear

Guru Edge. It's what makes Greenlight Guru so unique and particularly valuable to medical device companies. These Gurus form an elite team of medical device experts who serve Greenlight Guru customers in a variety of ways to ensure success throughout their product journey.In this episode of the Global Medical Device Podcast, Jon Speer talks to Ryan Behringer, a Training and Onboarding Medical Device Guru at Greenlight Guru.Listen to this episode to learn about Ryan's professional journey which brought him to Greenlight Guru and how he's helping companies with design of experiments, design controls, contextual inquiry, FDA QSR and ISO 13485 compliance, protocol/report writing, protocol execution, and quality system implementation and maintenance.Some of the highlights of this episode include:Ryan studied biomedical engineering and eventually zoned and honed in on medical device entrepreneurship.After graduating from college, Ryan worked for a startup in Omaha that was a Greenlight Guru customer. Ryan was able

Cybersecurity continues to be a crucial concern for medical device safety and effectiveness in the US, for manufacturers and regulators alike.In this episode of the Global Medical Device Podcast Jon Speer talks to Mike Drues from Vascular Sciences about the opportunities and challenges associated with medical device cybersecurity. Listen as Mike and Jon share their thoughts on the potential ways to eliminate or reduce cyber threats and encourage better cybersecurity practices for medical devices.Some highlights of this episode include:Cybersecurity is an important topic, but why is the FDA concerned about it? It’s important not to over-generalize.For example, identity theft may involve a physical medical device or Software as a Medical Device (SaMD). With that, a person’s personal information such as their credit card number could be stolen. Should not be the FDA’s concern.What about patient privacy? Personal health information or confidential electronic health records are a HIPAA matter - not the FDA’s conce

Many medical device companies experience challenges with managing clinical trials even in the most ideal settings, so what happens when big changes occur, like COVID-19 and new regulations, that compound those challenges? If only there was a solution...In this episode of the Global Medical Device Podcast, Jon Speer talks to Pall Johannesson, CEO and co-founder of Smart-Trial – a digital platform that helps medical device companies manage many, if not all, clinical data activities.Listen to Pall’s story about his solution for managing clinical trials, which has many similarities to that of Greenlight Guru, as he discusses his vision and the problem they're attempting to solve to help manufacturers, as well as patients, save time and money with clinical trial management.Some highlights of this episode include:Pall started Smart-Trial as a solution to solve the problem of the medical device industry being underserved. The technology being used to generate clinical evidence and collecting clinical data in clinica

What is the role of the importer, according to EU MDR? The requirements for this role have changed since the new regulation went into effect in May 2021 and it's important to understand the extent and impact of these changes.In this episode of the Global Medical Device Podcast, Jon Speer talks to René Van De Zande with MedEnvoy Global, a specialty solution for European regulatory compliance that offers importer representation services. In addition, René founded EMERGO in 1997, later becoming what's known today as EMERGO by UL.Listen to this episode as Jon and René discuss expectations, criteria, and obligations for importers under EU MDR and how this role should be managed for post-market surveillance, tracking, labeling, translations, and complaints.Some highlights of this episode include:Only two economic operators can be held responsible for placing a device on the market - a legal manufacturer that resides in the European Union or an importer.EU MDR does not clearly define who is who in the supply chain w

A Pre-submission can add tremendous value with the feedback given by FDA, which manufacturers can use to guide product development and marketing submission planning. There is an art to preparing a Pre-submission, though, so it's important to include the necessary contents (and avoid common pitfalls) that will yield the best possible results.In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about Pre-submissions. Listen as the two share recommendations about what content to include in a Pre-sub request to FDA as well as costly pitfalls to avoid with this particular Q-submission type.Some highlights of this episode include:A Pre-submission meeting is an opportunity to communicate with FDA prior to a marketing submission.About 3,306 medical device-related Pre-submission requests were made to FDA in 2020. In 2021, more than 1,500 Pre-submission requests have been made so far.Not all Pre-submission requests are made for meetings with FDA. About two-thirds of

What can you still do to help in response to the COVID-19 pandemic? The National Institute of Biomedical Imaging and Bioengineering (NIBIB) announced that its Point-of-Care Technology Research Network (POCTRN) is soliciting proposals to further advance SARS-CoV-2 testing technologies to fill specific unmet national needs through RADx Tech II, a fast-track program that leverages POCTRN.In this episode of the Global Medical Device Podcast Jon Speer talks to Mark Marino, Vice President of Growth and Strategy Development at VentureWell. VentureWell has been involved with the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) Program. Listen to this episode to learn more about the RADx Tech II program to fast-track eligible technologies to market in 2021.Some highlights of this episode include:Under this RADx Tech II solicitation, NIBIB is seeking proposals to accelerate validation, manufacturing scale up, and commercialization of innovative COVID-19 testing capabilities.Capabilities incl

Hungry for medical device industry knowledge? Greenlight Guru has you covered — now, medical device professionals can enjoy additional, sought-after training courses in the already popular educational platform, Greenlight Guru Academy, through a new partnership with Medical Device HQ.In this episode of the Global Medical Device Podcast, Jon Speer talks to Peter Sebelius, the founder and CEO of Medical Device HQ.Together, Peter and Jon discuss the importance of online learning and providing access to relevant, role-based training for medical device professionals. Listen now to understand the true value-add of this partnership and the further learning opportunities it brings the medical device industry.Some highlights of this episode include:Peter finds the process of developing or creating something new is almost as exciting as doing the actual technical work.Also, Peter believes that blended courses are helpful because people get to learn at their own pace and validate their understanding of the content throu

What did FDA report as the most-cited issues during medical device inspections for the fiscal year of 2020? Understanding the data can help you prepare against making these common, avoidable mistakes during your next quality system inspection.In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues with Vascular Sciences. Together, Mike and Jon discuss the FDA FY2020 data for medical device quality system inspections and evaluate the top three most cited QSR clauses that resulted in 483 observations.Some highlights of this episode include:The volume of inspections and number of findings, such as 483 observations and warning letters, were down - partially due to the COVID pandemic.Other reasons may include whether remote inspections are effective or even allowed. However, the number of 483s issued against medical device quality systems decreased by 50% in 2020.Top 3 Cited Claims: CAPAs, complaints, and design controls made up about 35% of all 483 observations issued by the FDA in 202

Close your eyes, take a deep breath in, and imagine your team operating at peak performance, exceeding goals and each member feeling and working at their best. Now, breathe out, letting out a sigh of relief knowing that's fully within the realm of possibility — through mindset training.In this episode of the Global Medical Device Podcast, Jon Speer talks to Kevin Bailey, mindset coach and founder of Dreamfuel, a mindset coaching solution for high growth companies.Kevin is the mindset coach for Greenlight Guru and has worked with Jon and Greenlight Guru employees over the years by providing mindfulness tools and techniques that teams can use to improve overall mindset. Listen to what Jon has learned from this mindset training and how the medical device community, too, can benefit from engaging in mindset practices at work.Some highlights of this episode include:Being the CEO of a high-growth startup proved to take a whole other level of work that required mental strength and resilience. Kevin used mental model

What are the pros, cons, and ramifications of the U.S. Department of Health and Human Services’ (HHS) proposal that impacts the medical device industry?In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the HHS proposal, which focuses on down-classifying and exempting more than 80 types of devices such as exam gloves, thermometers, imaging systems, infusion pumps, and ventilators.Some highlights of this episode include:In January 2021, HHS declassified a number of medical devices without first consulting or notifying FDA. As a result, the reclassification initiative is on hold pending a review due to regulatory freeze.The HHS proposal affects seven (7) Class I devices (all gloves) and eighty-three (83) Class II devices, such personal protective equipment (PPE) and thermometers.It’s ironic that regulatory quality requirements apply to products but don’t seem to apply to processes that regulate those products. It’s another example of not practicing w

If you love learning and want to level up your medical device industry knowledge on topics such as audits, document management, design controls, risk management, and more, Greenlight Guru Academy is your education destination.In this episode of the Global Medical Device Podcast, Jon Speer invites colleagues Aaron Lucas, Training and Education Manager, and Jesseca Lyons, Operations and Enablement Guru, to join the show and explain to listeners what Greenlight Guru Academy is and how the eLearning platform is helping users around the world advance their medical device careers.Some highlights of this episode include:Greenlight Guru Academy is a learning management system (LMS) path that allows medical device gurus, customers, and others to share knowledge and educational content and courses to encourage retention and effectiveness.About six years ago, whenever a new customer would come on board with Greenlight Guru, it was a manual process. Fast forward to a few years later, Greenlight Guru Academy has made that

Have you ever had to “sell” your brand to someone? To do this effectively, you must master the art of networking and selling whatever it is that you bring to the table.In this episode of the Global Medical Device Podcast, Jon Speer talks to Chip Helm, a Dental School dropout turned National Sales Manager of a multi-billion-dollar medical device company. Also, Chip is a guest lecturer and bestselling author who is creating a sales revolution.Together, Chip and Jon chat about the importance of a person's brand, which consist of three main types, and how medical device professionals can create new opportunities for growth with intentional self awareness tactics.Some highlights of this episode include:Chip’s Books: It doesn’t matter what career you take and where you go, his books teach basic principles of business and lessons that fit into anybody’s career, any company.Importance of Branding: Whether it’s your personal or professional brand, you have got to have self awareness to build, develop, and write your p

Have you ever wondered, what does a medical device guru actually do? What role do they play within Greenlight Guru and what value do they bring medical device companies in the context of the QMS software?In this episode of the Global Medical Device Podcast, Jon Speer talks to Tom Rish, a senior medical device guru and manager of the guru team at Greenlight Guru.Tom shares his unique insights into the life of a medical device guru at Greenlight Guru, how the guru team engages with customers beyond the software itself, and how the "Guru Edge" has come to be one of Greenlight Guru's most valuable offerings to medical device companies around the world.Some highlights of this episode include:Role of the Medical Device Guru: Collect as much feedback as possible from customers throughout the sales process to determine why they select Greenlight Guru’s QMS over other quality management systems.Medical Device Guru Team Philosophy: Give peace of mind to customers and help them meet their goals, whether it’s to launch a

The Guru edge: it's what makes Greenlight Guru so unique and valuable to the medical device companies it serves. The Guru team is comprised of industry experts with a knack for helping companies succeed; each of whom have a specific skillset and knowledge base that companies can tap into and leverage throughout their medical device journey.In this episode of the Global Medical Device Podcast, Jon Speer talks to Etienne Nichols, a Medical Device Guru at Greenlight Guru, to learn more about his expansive industry knowledge, experience, and passion, of which he uses in his approach to help customers work through the design and development process to bring safe, high quality products to market.