Global Medical Device Podcast powered by Greenlight Guru

What makes Greenlight Guru unique? It’s Guru edge⁠—a team of medical device professionals with decades of industry experience whose primary role within the company is to enable customer success. In this episode of the Global Medical Device Podcast, Jon Speer talks to Erica Loring, a medical device guru at Greenlight Guru. Erica shares her unique career journey working in the healthcare sector, which ultimately led her to enter the medical device and in-vitro diagnostic device space where she now provides world-class quality and regulatory support to device companies. Prior to joining Greenlight Guru, Erica worked in both the pharmaceutical and the biotech industry, serving as senior manager of quality and regulatory where she was responsible for implementing eQMS platforms for global enterprise companies. Some highlights of this episode include: As a medical device guru, Erica enjoys working with a wide range of companies, learns about various products, and helps those companies reach their goals by using a robust QMS. Erica’s superpowers, specialities, and strengths as a medical device guru revolve around all things regulatory and quality management to help companies function better and offer a sense of security. Conventional Wisdom: Are regulatory affairs and quality assurance the same or two different disciplines? Know it all and provide cross-functionality from product development to regulatory where quality doesn’t get in the way of productivity. Thought Process: Manufacturers, engineers, and others don’t have the mindset or systemic way to document inputs, outputs, and design development activities. Gentle hand or strict hindrance? Quality can enable or be an obstacle, but it’s the right thing to do. Check documentation, make changes, and meet demand. DiSC: If you have a hard time staying still, breathe and meditate for business development and personal growth. Strut industry knowledge to help companies. How can medical device companies be successful in today’s market? Time: Don’t rush or overlook anything. Plan for extra time and failures. People: Invest in the right and enough people, equipment, and space. Quality: Research and investigate suppliers. Make sure to have backups.

What is a multiple function device? From a high level, it’s a product with at least one portion that meets FDA’s Code of Regulations’ (CFR) definition of a medical device and at least one other portion that does not. In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about multiple function devices to help listeners gain a clear understanding of this increasingly popular device type.

What could go wrong as more medical device products are used at home and in similar non-traditional environments outside of hospitals and healthcare facilities by non-medical professionals? In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences. Jon and Mike discuss challenges related to safety, risk, and usability when medical devices intended for "at home" environments interface with untrained end-users.

What is FDA’s Safety and Performance Based Pathway and how does it relate to the Traditional, Special, and Abbreviated Premarket Notification 510(k) programs? In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the Safety and Performance Based Pathway that's designated for certain types of medical devices only and what eligible companies should consider when using this pathway for submitting a 510(k) to receive FDA clearance.

Reminiscing about past and present lessons learned from listening to conversations with this show’s most frequent guest, one important principle emerged: Teach others how to think, not what to think. In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues, president of the medical device consultancy firm, Vascular Sciences. Anyone who’s listened to the show knows that Jon and Mike are passionate about the world of medical devices, particularly design controls, regulatory affairs, and prudent engineering practices. Listen to this episode where they revisit how they met in December 2014 and what they have shared and learned through the years.

What sets Greenlight Guru apart from other quality management solutions? It’s Guru edge⁠—a team of medical device professionals with more than seventy years of combined industry experience. In this episode of the Global Medical Device Podcast, Jon Speer talks to Wade Schroeder, a medical device Guru at Greenlight Guru. As an electrical engineer and risk management enthusiast, Wade shares his unique approach to medical device product development and complying with regulations. He also shares a few of his favorite customer stories and offers his key recommendations to listeners on how to find success in the medical device industry.

Who looks forward to audits? Not most people except for maybe the actual auditor. Hold yourself accountable and stay audit-ready, so you can remove any pre existing concerns from the equation altogether. In this episode of the Global Medical Device Podcast, Jon Speer talks to Taylor Brown, a medical device guru at Greenlight Guru and certified Lead Auditor for ISO 13485. Taylor offers valuable tips on one of her favorite topics—audit etiquette. She explains her beliefs around how practicing a high level of conduct during audits alongside a right-sized quality system results in True Quality medical devices with high marks from your auditor.

What makes Greenlight Guru so unique, beyond its medical device QMS (MDQMS) software? Its Guru edge. In this episode of the Global Medical Device Podcast, Jon Speer talks to Tom Rish, a senior medical device Guru at Greenlight Guru. Tom brings a breadth of knowledge to the Guru team with a biomedical engineering background and experience developing implant and instrument systems for one of the world’s leading orthopedic companies. Tom expresses his unbridled commitment to helping medical device companies, for customers by leveraging our MDQMS software to bring safe, true quality products to market faster, and for listeners by offering practical advice on industry regulations, standards, and frameworks. Some of the highlights of the show include: Tom’s favorite aspect of being a Guru is trying new medical devices in the tech industry and learning the business side of sales, clients, and personalities. Tom shares his beliefs on the best way to approach regulations, standards, and frameworks by taking a step back and looking at the big picture — they’re not overly complicated, but fairly simple efficiencies. One-man Teams: Tom admires surgeons, sales reps, and others that strike out on their own to start something important to them. They knew what it took to commercialize a product, but not enough about medical device regulations. Right-size your QMS: Look at the regulations. Focus on areas important to you. What makes sense now and worry about operations and other quality items later. Procedure Overload: People like to define the most efficient way to get things done. Write and test procedures while doing them. Keys to Customer Success: Keep it simple, focus on what you need to now, and stick to your business plan. Non-stop Paperwork: You need documentation for your submission, audit, design controls, and risk matrix. Don’t wait, do it as you go through the process to add value and communicate with others.

The current COVID-19 pandemic and its impact on clinical trials has created a sense of chaos amongst medical device companies worldwide. Are there creative ways to stay on track while ensuring the safety of those involved? In this episode of the Global Medical Device Podcast, Jon Speer talks to Isabella Schmitt, Regulatory Affairs Consultant, and Stephanie Mull, Director of Clinical Project Management, from Proxima Clinical Research (CRO). Together, they discuss the challenges and concerns for medical device companies conducting clinical trials during the COVID-19 pandemic and offers new perspectives for listeners to consider in terms of potential efficiencies and cost savings to gain. Some of the highlights of the show include: - Challenges related to COVID-19 include sites suspending operations of clinical trials, and restricting CROs and subjects from traveling or coming to sites. - Some medical device spaces, products, and technologies have been impacted more than others. It’s more difficult than normal, but not impossible, to perform elective procedures, especially in hospitals. - Widespread, Worldwide: Clinical trials continue to be conducted in the United States, but in a different atmosphere with changes compared to other areas that have completely suspended trials temporarily, such as Europe and China. - Subject safety is the primary issue to be considered and evaluated related to risks, reasons, and causes to suspend clinical trials. - Staff Availability: Sites must have adequate and properly qualified and trained staff to conduct and provide oversight to continue clinical trials safely. - Electronic data capture (EDC) versus paper management of sites and studies for clinical trials is a more controllable way to document and collect data from patient monitoring and different types of visits. - Protocol deviations and amendments should be approved by the FDA before proceeding with a clinical trial. Subject safety, again, is always the first priority. - Human Factors: Changes should make medical device and clinical trial design more usable, such as patient monitoring from a safe distance due to COVID-19.

Are you considering patent protection for your software as a medical device? Should you keep your secret sauce via the trade secret route? Perform due diligence to stay ahead of the competition. In this episode of the Global Medical Device Podcast, Jon Speer talks to Kevin Buckley and Neil Thompson from Torrey Pines Law Group. Their biotech-focused legal firm specializes in artificial intelligence (AI) applied to medical devices. Together, they discuss intellectual property (IP) with software as a medical device (SaMD) and AI and machine learning (ML) powered technologies. Some highlights of this episode include: • Patent or not? From a patent perspective, it’s easier to understand protecting software from an IP perspective by considering the problem to be solved. • Perform a patent search using third-party vendors to determine if competitors have claimed inventions and infringement information. • Due diligence of competitive intelligence should address licensing, acquisition, investments, and freedom to operate that enhances research and development. • Interest in adapting AI, machine learning (ML), and SaMD is increasing as clients develop technologies from scratch (De Novo) for better ways to help people. • When deciding whether to seek patent protection on technology, consider international patent laws and follow the Alice: Two-step Rule for patent eligibility. • The pros and cons of choosing the patent protection over trade secret route include whether clients need limited or unlimited duration to enforce patent rights. • AI-enabled inventions, such as X-ray imaging, is software that utilizes and combines new/existing devices as systems using ML, algorithms, and datasets. • Regulatory pathways for medical devices include 510(k) and De Novo. Predicate devices may be required and potential improvements may be patentable.