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.

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Identifying the Positive and Negative Effects of COVID-19 on the Medical Device Industry

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.

How Being Strategic During A Career Transition Can Yield The Best Opportunities

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.

Mass-Manufacturing a 5-in-1 Ventilator System for COVID-19 Relief

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.

What is Regulatory Due Diligence for Medical Devices?

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