Dawn A. Lissy, President & Founder, Empirical11.26.18
It started with a wintry dusting of snow and ended in a blaze of autumnal glory. On top of a mini tour of Colorado’s best seasons, the two-day MPO Summit in Broomfield on Oct. 11-12 offered forecasts and insights into what it takes to weather changes in the medical device industry and how we can better serve our clients.
The point of the conference was to compare best practices among medical device outsourcing professionals to support a healthy client base. It featured a multi-session spotlight on innovations, challenges, trends, concerns, and education for those of us in this segment of the industry.
I was pleased to hear that rather than previous messages of “cut costs for clients at all costs,” the focus was on how to provide top-notch service through critical and value-added strategic partnerships between clients and vendors. I’ve never aspired to be the cheapest source of mechanical testing, regulatory consulting, or small-batch manufacturing. For 20 years, I’ve worked to develop a family of companies that may not be the lowest cost but are the highest value, so I eagerly embraced this change of focus from bottom line savings to top-level service.
I’m partial to this conference not just because the wonderful team at MPO gives me a byline, but also because this conference’s discussions don’t shy away from uncomfortable topics. The “elephant in the room” is always at the top of the agenda, and attendees respectfully tackle issues that are more often relegated to barstools than panel discussions.
But this was the conference for “real talk.” Previous years have included gloves-off discussions about the medical device tax, what to do about a dwindling labor pool of skilled workers who can manufacture devices, and some brutal truths about being a woman in a predominantly male industry.
I appreciate that respectful and open approach to topics that cause too many professionals to cringe. This year was no exception. From the regulatory implications of the EU Medical Device Regulation (MDR) compliance and how Brexit will impact operations to project breaking points, sessions focused on the often ugly truths behind successes and failures.
This has been a year full of mergers and acquisitions, which can be unsettling. As companies buy, reposition, and rebrand, there are layoffs, project delays, leadership changes, and other shifts that cause uncertainty. My experience both as an employee at an acquired company and as an observer from the small business space is that 1+1 does not equal 2 in these transactions. Unless an in-process project is critical, most forward movement pauses while the new owner decides the priority order of integration of systems.
As an outside service provider, my standing with the new entity is in question in the wake of a deal. This is not a comfortable spot. As new leadership evaluates contracts, projects can be cancelled without any notice and business relationships that spanned decades can disappear overnight. On the upside, these M&A activities also breed innovation—our industry has seen more leaps in technology advancements from new stakeholders pushing companies out of previously established comfort zones.
There was also a sobering update on the international regulatory climate and how that affects device development in the United States. It’s been common practice for device developers of new technologies (Class III devices) to first seek regulatory clearance abroad and work their way back to the U.S. Food and Drug Administration (FDA). Because FDA is generally considered the strictest, most demanding regulatory body in the world, device developers often pursue approvals in the European Union before the United States. But the pool of regulatory agencies abroad has shrunk from more than 90 to fewer than 70. Add to that a rush to meet the May 2020 MDR deadline, and we now have an audit queue that’s backed up past the 2020 implementation date. So new devices that could be improving patient outcomes are standing in line rather than making their way to the marketplace.
On a more positive note, more companies are taking advantage of the relatively new, under-used programs such as First in Human and early feasibility options for Class III devices. That’s paving the way for a faster pipeline through FDA for regulatory approval in the United States.
Professionals also shared war stories. I appreciated the candor and openness of Natasha Bond of Sana Health, Ben Walker of Innosphere, and Craig Weinberg of BDC Laboratories. I moderated their panel discussion, which laid out how to recognize when your brilliant plans aren’t working and how to course-correct.
My favorite quotes from participants in this session:
“The only thing more dangerous than an engineer who has never spoken to a customer is a marketer who has only spoken to one,” said Dave Nevrla, a cardiovascular medical device innovator and product marketing consultant who attended the summit.
“Knowledge comes from books, but wisdom comes from doing things wrong,” said Craig Weinberg, speaking from his experience as CEO of BDC Laboratories.
And words we should all live by from John McCloy, an engineer and entrepreneur: “If it’s not written down, it didn’t happen.”
The panel I moderated and every other session came back to the same question in some way: How do we develop connections that strengthen the industry?
The short answer: Check your ego at the door.
The longer answer: Develop deeper, more productive partnerships with clients through frequent, honest communication that leads to a team approach for problem-solving and innovative solutions. This requires a shared corporate culture that doesn’t shy away from difficult questions, owning up to mistakes, and forward focus. It’s about open dialogue that examines vulnerabilities, fears, and challenges. It’s developing trust, setting realistic expectations, and staying on the same page as you work toward mutual success.
Dawn Lissy is a biomedical engineer, entrepreneur, and innovator. Since 1998, the Empirical family of companies (Empirical Testing Corp., Empirical Consulting, LLC, and Empirical Machine, LLC) has operated under Lissy’s direction. Empirical offers the full range of regulatory and quality systems consulting, testing, small batch and prototype manufacturing, and validations services to bring a medical device to market. Empirical is very active within standards development organization ASTM International and has one of the widest scopes of test methods of any accredited independent lab in the United States. Because Lissy was a member of the U.S. Food and Drug Administration’s Entrepreneur-in-Residence program, she has first-hand, in-depth knowledge of the regulatory landscape. Lissy holds an inventor patent for the Stackable Cage System for corpectomy and vertebrectomy. Her M.S. in biomedical engineering is from The University of Akron, Ohio.
The point of the conference was to compare best practices among medical device outsourcing professionals to support a healthy client base. It featured a multi-session spotlight on innovations, challenges, trends, concerns, and education for those of us in this segment of the industry.
I was pleased to hear that rather than previous messages of “cut costs for clients at all costs,” the focus was on how to provide top-notch service through critical and value-added strategic partnerships between clients and vendors. I’ve never aspired to be the cheapest source of mechanical testing, regulatory consulting, or small-batch manufacturing. For 20 years, I’ve worked to develop a family of companies that may not be the lowest cost but are the highest value, so I eagerly embraced this change of focus from bottom line savings to top-level service.
I’m partial to this conference not just because the wonderful team at MPO gives me a byline, but also because this conference’s discussions don’t shy away from uncomfortable topics. The “elephant in the room” is always at the top of the agenda, and attendees respectfully tackle issues that are more often relegated to barstools than panel discussions.
But this was the conference for “real talk.” Previous years have included gloves-off discussions about the medical device tax, what to do about a dwindling labor pool of skilled workers who can manufacture devices, and some brutal truths about being a woman in a predominantly male industry.
I appreciate that respectful and open approach to topics that cause too many professionals to cringe. This year was no exception. From the regulatory implications of the EU Medical Device Regulation (MDR) compliance and how Brexit will impact operations to project breaking points, sessions focused on the often ugly truths behind successes and failures.
This has been a year full of mergers and acquisitions, which can be unsettling. As companies buy, reposition, and rebrand, there are layoffs, project delays, leadership changes, and other shifts that cause uncertainty. My experience both as an employee at an acquired company and as an observer from the small business space is that 1+1 does not equal 2 in these transactions. Unless an in-process project is critical, most forward movement pauses while the new owner decides the priority order of integration of systems.
As an outside service provider, my standing with the new entity is in question in the wake of a deal. This is not a comfortable spot. As new leadership evaluates contracts, projects can be cancelled without any notice and business relationships that spanned decades can disappear overnight. On the upside, these M&A activities also breed innovation—our industry has seen more leaps in technology advancements from new stakeholders pushing companies out of previously established comfort zones.
There was also a sobering update on the international regulatory climate and how that affects device development in the United States. It’s been common practice for device developers of new technologies (Class III devices) to first seek regulatory clearance abroad and work their way back to the U.S. Food and Drug Administration (FDA). Because FDA is generally considered the strictest, most demanding regulatory body in the world, device developers often pursue approvals in the European Union before the United States. But the pool of regulatory agencies abroad has shrunk from more than 90 to fewer than 70. Add to that a rush to meet the May 2020 MDR deadline, and we now have an audit queue that’s backed up past the 2020 implementation date. So new devices that could be improving patient outcomes are standing in line rather than making their way to the marketplace.
On a more positive note, more companies are taking advantage of the relatively new, under-used programs such as First in Human and early feasibility options for Class III devices. That’s paving the way for a faster pipeline through FDA for regulatory approval in the United States.
Professionals also shared war stories. I appreciated the candor and openness of Natasha Bond of Sana Health, Ben Walker of Innosphere, and Craig Weinberg of BDC Laboratories. I moderated their panel discussion, which laid out how to recognize when your brilliant plans aren’t working and how to course-correct.
My favorite quotes from participants in this session:
“The only thing more dangerous than an engineer who has never spoken to a customer is a marketer who has only spoken to one,” said Dave Nevrla, a cardiovascular medical device innovator and product marketing consultant who attended the summit.
“Knowledge comes from books, but wisdom comes from doing things wrong,” said Craig Weinberg, speaking from his experience as CEO of BDC Laboratories.
And words we should all live by from John McCloy, an engineer and entrepreneur: “If it’s not written down, it didn’t happen.”
The panel I moderated and every other session came back to the same question in some way: How do we develop connections that strengthen the industry?
The short answer: Check your ego at the door.
The longer answer: Develop deeper, more productive partnerships with clients through frequent, honest communication that leads to a team approach for problem-solving and innovative solutions. This requires a shared corporate culture that doesn’t shy away from difficult questions, owning up to mistakes, and forward focus. It’s about open dialogue that examines vulnerabilities, fears, and challenges. It’s developing trust, setting realistic expectations, and staying on the same page as you work toward mutual success.
Dawn Lissy is a biomedical engineer, entrepreneur, and innovator. Since 1998, the Empirical family of companies (Empirical Testing Corp., Empirical Consulting, LLC, and Empirical Machine, LLC) has operated under Lissy’s direction. Empirical offers the full range of regulatory and quality systems consulting, testing, small batch and prototype manufacturing, and validations services to bring a medical device to market. Empirical is very active within standards development organization ASTM International and has one of the widest scopes of test methods of any accredited independent lab in the United States. Because Lissy was a member of the U.S. Food and Drug Administration’s Entrepreneur-in-Residence program, she has first-hand, in-depth knowledge of the regulatory landscape. Lissy holds an inventor patent for the Stackable Cage System for corpectomy and vertebrectomy. Her M.S. in biomedical engineering is from The University of Akron, Ohio.
