Global Medical Device Podcast powered by Greenlight Guru

What makes Greenlight Guru unique? It’s Guru edge, composed of a team of medical device experts with over seventy years of combined industry experience. In this episode of the Global Medical Device Podcast, Jon Speer talks to Jesseca Lyons, a senior medical device guru at Greenlight Guru, a self-proclaimed design control junkie with a mechanical engineer background. Listen as Jesseca shares her insights on the importance of design controls and how a deep understanding of the different pieces and parts can lead to improved outcomes for both the device and patients who use it. Some highlights of this episode include: • Customer Success Team: Jesseca is passionate about the medical device industry and connecting with customers to make a difference in their lives. • Jesseca’s favorite aspect of being a guru is the opportunity to work on different types of devices and ideas from beginning to end of the development process. • Customer Success Stories: Audits can be intimidating, but terrified customers are put at ease due to Jesseca’s extensive preparation tips and best practices. • Opportunities to help medical device companies worldwide improve quality of life is a rewarding experience for patients, providers, engineers, and everyone else. • The Greenlight Guru True Quality Virtual Summit and other content/conferences are opportunities to share knowledge and experience that makes an impact. • Jesseca is a Type A personality that enjoys being in control and telling people what to do based on the best options available and to get things done. • Design controls are necessary, exist, and may change. Most people either like or dislike design controls, but they have a much greater impact than realized. • Probable or Improbable? Jesseca once hated risk management until figuring out that nobody wants to cause harm. Now, risk management is important and fun.

Where do you begin when building a quality management system (QMS) for a medical device? It’s a task that is often delayed until later stages of development. Don’t wait to implement a QMS; the consequences of waiting too long can lead to irreparable damage to your processes and, in some cases, product failures. In this episode of the Global Medical Device Podcast, Jon Speer talks to quality and regulatory expert Mike Drues, president of Vascular Sciences. Together they discuss why a QMS is so important to a company as it sets up its business and processes. Laying a proper foundation for a QMS to operate at its full capacity is just as critical, which involves a shared mindset and philosophy across the organization that reinforces a culture of True Quality. Some highlights of this episode include: • A QMS is not a system of compliance. It should describe how business is conducted through policies, procedures, processes, and philosophies. • If a QMS consists of devices not manufactured by the company, it’s an example of the copy-and-past approach to be compliant, but not customized. • A QMS is important to describe, document, and demonstrate roles, responsibilities, and rules to make decisions about products for patients. • A QMS focuses on four key areas: Accountability, traceability, consistency, and continuity. • Preamble/Introduction: One company’s QMS should not be a carbon copy of another company’s QMS. It should focus on its own mindset and philosophy. • Every QMS should include complaints, change management, and customer feedback to trigger notifications that affect safety, efficacy, and performance. • Product Lifecycle: During research and development, conduct post-market surveillance, beta test change management, and review risk management plan. • Document Management Control: All complaints and conflicts are not created equal. Get it right to make sure it’s effective and efficient.

What makes Greenlight Guru unique? The Guru Edge⁠—a team of medical device professionals with over eight decades of combined industry experience. Greenlight Guru’s mission is to improve quality of life, and those of customers, through True Quality products managed through its medical device quality management system (MDQMS) software. In this episode of the Global Medical Device Podcast, Jon Speer talks to Taylor Brown, a medical device guru for Greenlight Guru’s Customer Success team with 7+ years of industry experience. Taylor shares her valuable insights and learnings from auditing quality management systems as a certified Lead Auditor for ISO 13485. Some highlights of this episode include: • Taylor equates auditing to what needs to be done, just follow the rules, perform everything correctly, and understand how processes/people meet regulations. • Ins and Outs of ISO 13485: Understand the importance of following rules and regulations to be in compliance and not dread an audit. • Greenlight Guru: Taylor lives for meaningful lightbulb moments, such as when procedures, training, and guidelines make sense to bring devices to market. • Equalizer Experience: There’s no delay or stalker culture at Greenlight Guru to be efficient and get what you need completed. • Love/Hate Relationship: Audits with customers that implement Greenlight leads to losing fewer documents, a smoother process, and getting done sooner. • Celebrate successful customer stories, such as collaboration, continuous growth, and improvement. You don’t need to accomplish/implement everything on Day 1. • Every good idea starts with a plan. A phased approach sets clear expectations. If you don’t document something, you didn’t do it, according to the FDA. • Sometimes, it’s just not that deep. Due to the nature of the industry and pressure to comply quickly, people tend to over-complicate things and strive for perfection.

What is regulatory due diligence? Why does it matter, and how does it differ from other regulatory strategies and pathways? In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues of Vascular Sciences about the importance of and reasons for regulatory due diligence that all medical device professionals should understand. Some of the highlights of the show include: • Regulatory due diligence involves looking at what’s been done so far when a company is developing a medical device similar to one on the market already. • Due diligence is important for business, regulatory, and engineering/product development perspectives to know before investing time, effort, and resources. • Differences and Similarities: Regulatory due diligence, regulatory strategy, and regulatory pathway to market are not synonymous and may depend on another. • Regulatory due diligence can be applicable to new or existing medical devices. Due diligence from an existing device provides essential background information. • Reminders/Requirements: Update regulatory due diligence in quality management system (QMS) and risk management plan through product lifecycle. • Past, Present, Future Challenges: Evolve and emphasize changes/corrections for prevention, design, risk, manufacturing, and regulatory perspectives. • Decouple and Rebuild: FDA is inherently concerned about entirely new and/or novel medical devices and technologies. • Take a cross-functional team approach to understand different perspectives, roles, and tasks to produce improved quality and regulatory due diligence.

Are you discouraged by all of the negative news and sad stories about COVID-19? Let's shift the focus to a story centered on positivity and innovation that will reignite hope for a better, safer road ahead. In this episode of the Global Medical Device Podcast, Jon Speer talks to Dan Purvis, CEO and co-founder of Velentium. Dan shares some much needed positivity through the uplifting stories and experiences of Project V, a collaborative venture backed by Velentium, Ventec Life Systems, and General Motors (GM). Project V is making a lasting difference by mass producing ventilators comprised of five separate devices to save lives and meet worldwide demand in response to COVID-19. Some of the highlights of the show include: • One-Stop Shop: Velentium is an end-to-end design, development, and manufacturing firm that transforms intellectual property into fully submitted and approved commercial medical devices. • The nine key areas of a medical device are human factors, cyber security, test systems, electrical, firmware, mobile, Cloud, mechanical, systems engineering. • Ask ‘why’ before ‘what’ when it comes to Velentium. Cash is necessary in a business, but it’s not the reason ‘why,’ which is to change lives for a better world. • Project V: Ventec could build more ventilators, if more resources and help were available. Velentium and GM answered the call for action. Right thing to do! • Pieces, Parts, and Production: Ventec’s 5-in-1 ventilator, oxygen concentrator, cough assist, suction, and nebulizer (VOCSN) device was scaled to a simple ventilator line called, V+Pro. • Politics, Businesses, and Pace: What’s more important and necessary? Dan describes obstacles and how Project V device developers overcame them. From a quality perspective, ventilators must help, not hurt people. • Human Moments: Ask for help and take business, physical, interpersonal, and emotional risks by reaching out during isolation. You won’t regret it.

There is a spectrum of feelings someone may experience in the midst of a career transition. For some, however, being laid off can turn out to be one of the best things to ever happen to them. In this episode of the Global Medical Device Podcast, Jon Speer talks to Aaron Moncur, owner of Pipeline Design & Engineering and host of the Being an Engineer podcast, as they both reflect on the twists and turns of their professional journeys to help others realize their full potential and seize new career opportunities. Some of the highlights of the show include: • Falling out of love with your role or no longer working in a previously held role? Do things differently and focus on ownership of the entire process, not just pieces. • Situational or necessity? Aaron’s sense of entrepreneurship and making his own money has existed since childhood. Being laid off pushed him into taking action. • Losing your job or starting a business: which is more terrifying? Being laid off made Aaron feel physically ill, compared to the thrill of being a freelancer. • Owners and employees have different perspectives and motivation regarding everyday work. The demand is for people who do specific work or do it all. • How well does your measurement system work? If measurement systems analysis (MSA) creates inconsistent data, it leads to less confidence in products. • Entrepreneurs’ Organization (EO) offers guidance on how to build a business, seek clarity, obtain feedback, find mentors/coaches, and narrow your niche. • Culture of Closing and Collaboration: Medical device industry is schedule driven and technically challenged to deliver on time to solve a problem.

Most of us have read about, observed, participated in, and spoke with healthcare providers and medical device professionals collaborating during the COVID-19 crisis.  Creativity within reason can be an opportunity. Like many things in life, it’s not what happens to us that counts, it’s how we choose to respond. COVID-19 is not an excuse to cut corners. In this episode of the Global Medical Device Podcast Jon Speer invites guest Mike Drues of Vascular Sciences to join the show. Together, they share their own COVID-19 observations and insights into what has gone right and wrong, so far, for the medical device industry. Some of the highlights of the show include: • COVID-19’s unintended consequences on the medical device industry include new and agile product development, but funding challenges for some startups. • Emergency Use Authorization (EUA) is temporary, until the Secretary of Health and Human Services declares that the period of emergency is over. • Why is funding and regulatory pathways easier for COVID-19 medical devices? Devices already on the market can be modified or changed for a COVID indication. However, the ability to manage investors’ expectations is important. • Quick turnaround or years to go till getting back to business as usual? There’s always a need for short- and long-term opportunities to market medical devices. • Clinical Trials and Investigations: Healthcare providers and hospitals are shifting and reallocating resources to address perceived demand related to COVID crisis. • EUA equates to 510(k) due to underlying assumption of safety and efficacy, but EUA is not substantially equivalent to De Novo or PMA. • Altruistic vs. Opportunistic Attitudes: Filter motives, products, and people to accomplish post-market surveillance obligations, especially for COVID devices. • Lessons Learned: React accordingly, be proactive, address patient needs safely and effectively, and solicit feedback to improve quality of life.

What is a regulatory strategy? What are the components involved? In this episode of the Global Medical Device Podcast Jon Speer talks to Mike Drues of Vascular Sciences to provide listeners with practical and pragmatic tips on how to construct a meaningful, not misunderstood, misapplied, and misused regulatory strategy. Some of the highlights of the show include: • Pro Tip: Regulatory strategy is not synonymous with Pathway to Market (element), or 510(k) and De Novo (tactics). • Regulatory Strategy Executive Summary: Living artifact that serves as a communication tool to articulate pros, cons, benefits, risks, and options. • Executive Summary components may include device description, labeling matrix, classification and risk, and potential pathways to market. • Investor Pitch Deck: Demonstrate medical device idea by knowing all options, and possessing knowledge and experience of fluid and dynamic environment. • Conventional Wisdom: Easiest, fastest, cheapest path to market to get through regulatory challenges doesn’t always make sense for products and technology. • Future Features List: What do you want added to a medical device in the future? Start with the ultimate end in mind and work backwards to build strategy and plan. • Product Development Process: Bring in regulatory sooner than later, earlier the better. Changes after a design freeze are difficult, time consuming, and costly. • Summary, Recommendations, and Takeaways: Who is your audience? Will they understand the purpose? Offer proof.

Does your software as a medical device (SaMD) function properly? Does it meet the needs of the end user? What are the expectations for post-market clinical surveillance and real world evidence for SaMD products in particular? In this episode of the Global Medical Device Podcast Jon Speer talks to Kevin Coker, co-founder and CEO of Proxima Clinical Research. Kevin shares tips and advice on what companies need to know about clinical evaluation and validation for their Software as a Medical Device (SaMD). Some of the highlights of the show include: - What IS SaMD? Software intended to be used for a medical purpose without being a part of the hardware of the medical device. - What ISN'T SaMD? Hardware that doesn’t need to be updated to function, such as a pacemaker or other embedded medical devices. - IMDRF documents capture, evaluate, and monitor SaMD categories of classification for critical or non-critical functions. - EU MDR delay means big changes to classification rules for categories, specifically SaMD status and amount of evidence that needs to be collected. - Three Key Components of Clinical Evaluation: - Scientific Validity: Does software have a valid clinical association between software and targeted clinical condition? - Analytical Validation: Does software correctly process data the same way, every time? - Clinical Validation: Does software accurately and reliably achieve the intended purpose for the target population? - Clinical Evaluation vs. Clinical Trial: Gather existing data for the same or similar intended use. A clinical trial is not always necessary to generate and justify evidence. - Importance of Independent Review(er): Objective outside party analyzes SaMD to make sure it’s safe and effective to use for critical decisions. - Real World Evidence: Collect a broad dataset to better understand adverse events, conditions, and comorbidities that impact a medical device on society.

What is artificial intelligence (AI) and machine learning (ML) and how do the two differ in the medical device industry? How can companies leverage AI and ML in their medical devices to improve the quality of life? In this episode of the Global Medical Device Podcast Jon Speer talks to Devon Campbell, founder of Prodct LLC, and Anthony Habayeb, co-founder and CEO of Monitaur.ai about how AI and ML can be utilized to produce better, safer, smarter, and faster medical devices. Some of the highlights of the show include: • What is AI? John McCarthy, Father of AI, defined it as: “The science and engineering of making intelligent machines.” Basically, it’s Independent robots thinking and acting like humans, completely autonomously. • ML is a technique within AI that focuses on algorithms and models in software to reach real-time conclusions and decisions based on a foundation of learning, training, and rules. • What’s the reality of AI adoption in major industries? It’s challenging to get large, regulated, medical device companies to implement ML due to safety risks. Yet, it can be transformational. • Machine Learning Assurance: Guidance on how to perform audits of ML models to create assurances that build trust and confidence in a quality management system (QMS) and development process. • Culture of Quality Control: Mistakes can and will be made. Is AI and ML behaving within certain bounds and rendering good results in the medical device industry? • FDA encourages collaboration for companies to demonstrate ML assurance, mitigate risks, prove quality control mindset, understand Algorithmic Change Protocol (ACT), and provide post-market surveillance. • Lean in and Lead: Focus on safety and effectiveness to meet the needs of patients and caregivers by using AI in some way with medical devices.