Dawn A. Lissy, President & Founder, Empirical06.04.18
You don’t have to be a Greek philosopher to understand the only constant is change; we see it every day in our personal and professional lives. The medical device business is driven by disruptive change fueled by our commitment to continually do more for and better by our clients—the patients.
Here are my top five examples of how the past 15 years have pushed us past old limits with events, technologies, and policies that have shifted, shaped, and shaken our industry.
SHIFTED: FDA Wants to Hear from Us on How to Be Better
The U.S. Food and Drug Administration (FDA) launched its Entrepreneurs-in-Residence (EIR) program in 2012 to better engage industry experts and enhance its performance as a regulatory body. On its website, the agency asks for our help. “We don’t always have all the answers,” reads the first sentence of the EIR landing page. That’s why it calls for industry experts to join this sweeping effort to improve communication with and processes for the professionals who rely on FDA for approvals and feedback. I was one of the first experts tapped to participate. Our first task was creating a road map for all stakeholders to gain approval for a Class III device. Next, we looked at roadblocks to regulatory approval and how to navigate them. Everything we did came back to enhancing consistency and transparency. It was clear FDA wanted to make things easier for us while still maintaining rigorous standards to improve patient health, and I was grateful to be a part of it. I encourage any of my peers who are considering getting involved to share their talents.
SHIFTED: FDA Decides the Glass Is Half Full
Class III devices—generally new technologies that require the highest level of regulatory scrutiny—have been a hard sell for innovators partly because they’re a hard sell to investors. The level of testing, documentation, and research is daunting enough, but it was the make-or-break panel meeting that typically caused clients the most angst. To present and defend their idea to a group of experts empaneled to safeguard consumer safety with the power to kill a device multiple years and millions of dollars in the making is a daunting task. So when our client Cartiva received premarket approval in a record-breaking 71 days (average time span for Class III PMAs is 159 days), we were happily stunned. (Read more on how Cartiva prepped for that panel review in the May 2017 edition of MPO.) It signaled not just a breakthrough for our client, but for FDA as well. The agency has historically often been viewed as a hurdle for device developers to overcome. This quick approval signaled an important cultural shift: rather than working to prevent dangerous devices from entering the market, FDA is working to speed life-enhancing advancements to the consumer. It’s a significant organizational change that’s many years in the making.
SHAPED: Printing Implants and More
Additive manufacturing has morphed from the stuff of science-fiction plots to something you can add to your home crafting tool box via Amazon. When 3D printing first entered the market, it was hailed as the start of the third industrial revolution. Initially, it was expensive and limited to specific materials. But it’s now a common, affordable option for many medical device developers. It’s a means to create devices that are designed for the individual, which provides a whole new level of fit, complex geometries, and customization. But it’s not always the best option for manufacturing. There are still questions about whether the process can create inclusions that affect patient health, and there are currently no long-term studies of such devices because we’re still in the short term. But even over this short term, it’s had an indelible effect on our industry.
As a company, Empirical is on the lookout for how this technology will shape the regulatory space. FDA requirements for substantial equivalence involve similarity to other devices; the scrutiny is instead on manufacturing processes and repeatability. Validated processes for additive manufacturing suppliers is a critical consideration as you shop for vendors. In December 2017, FDA issued guidance documents specific for 3D-printed devices. We’re also planning to learn more at ASTM’s Symposium on Structural Integrity of Additive Manufactured Parts Nov. 7-8 in Washington, D.C.
SHOOK: The Law of Unintended Consequences—the Medical Device Tax
It was lost in the broader public debate over the benefits and pitfalls of the Affordable Care Act, but the medical device industry continues to suffer the negative effects of the 2013 medical device tax included in the historic legislation. That 2.3 percent excise tax on medical device supplies has been suspended for another two years, but we’re still feeling its negative effects. Despite the stay, damage was done. It has stifled research and development, diminished investments in startups, prompted major corporations to move overseas, and incited both job cuts and a dedicated effort to repeal by industry groups. According to the Advanced Medical Technology Association (which lobbies for the tax’s repeal), 71 percent of companies surveyed would reinstate previously foregone hiring and 85 percent would reinstate previously foregone R&D if the tax were repealed.
SHAPED: Paging Dr. Roboto to the OR
The very first use of robot-assisted surgery was in 1985, but it wasn’t until 2000 that the da Vinci Surgery System was approved by the FDA. Since then, robotic surgery has become increasingly popular. According to Reuters, robotics assisted surgery is expected to account for one in three surgeries by 2021. The University of Pennsylvania School of Medicine recently performed the world’s first robot-assisted spinal surgery. For the medical device industry, that means more and a wider variety of instruments and support structures to facilitate that growth. It also means more competition within the robotics subset of the market that’s expanding internationally as equipment costs come down. FierceBiotech reported Medtronic will soon launch its robotic surgery system and Johnson & Johnson plans to enter the arena as well. At Empirical, we’re seeing more requests for testing from small companies that are developing instrument sets and implant systems for use with Medtronic’s navigation system.
At Empirical, we’re looking forward to shifting, shaping, and shaking things up over the next 15 years and beyond. We’re proud to be part of an industry that works constantly to challenge ourselves, our assumptions, and perceived limits.
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.
Here are my top five examples of how the past 15 years have pushed us past old limits with events, technologies, and policies that have shifted, shaped, and shaken our industry.
SHIFTED: FDA Wants to Hear from Us on How to Be Better
The U.S. Food and Drug Administration (FDA) launched its Entrepreneurs-in-Residence (EIR) program in 2012 to better engage industry experts and enhance its performance as a regulatory body. On its website, the agency asks for our help. “We don’t always have all the answers,” reads the first sentence of the EIR landing page. That’s why it calls for industry experts to join this sweeping effort to improve communication with and processes for the professionals who rely on FDA for approvals and feedback. I was one of the first experts tapped to participate. Our first task was creating a road map for all stakeholders to gain approval for a Class III device. Next, we looked at roadblocks to regulatory approval and how to navigate them. Everything we did came back to enhancing consistency and transparency. It was clear FDA wanted to make things easier for us while still maintaining rigorous standards to improve patient health, and I was grateful to be a part of it. I encourage any of my peers who are considering getting involved to share their talents.
SHIFTED: FDA Decides the Glass Is Half Full
Class III devices—generally new technologies that require the highest level of regulatory scrutiny—have been a hard sell for innovators partly because they’re a hard sell to investors. The level of testing, documentation, and research is daunting enough, but it was the make-or-break panel meeting that typically caused clients the most angst. To present and defend their idea to a group of experts empaneled to safeguard consumer safety with the power to kill a device multiple years and millions of dollars in the making is a daunting task. So when our client Cartiva received premarket approval in a record-breaking 71 days (average time span for Class III PMAs is 159 days), we were happily stunned. (Read more on how Cartiva prepped for that panel review in the May 2017 edition of MPO.) It signaled not just a breakthrough for our client, but for FDA as well. The agency has historically often been viewed as a hurdle for device developers to overcome. This quick approval signaled an important cultural shift: rather than working to prevent dangerous devices from entering the market, FDA is working to speed life-enhancing advancements to the consumer. It’s a significant organizational change that’s many years in the making.
SHAPED: Printing Implants and More
Additive manufacturing has morphed from the stuff of science-fiction plots to something you can add to your home crafting tool box via Amazon. When 3D printing first entered the market, it was hailed as the start of the third industrial revolution. Initially, it was expensive and limited to specific materials. But it’s now a common, affordable option for many medical device developers. It’s a means to create devices that are designed for the individual, which provides a whole new level of fit, complex geometries, and customization. But it’s not always the best option for manufacturing. There are still questions about whether the process can create inclusions that affect patient health, and there are currently no long-term studies of such devices because we’re still in the short term. But even over this short term, it’s had an indelible effect on our industry.
As a company, Empirical is on the lookout for how this technology will shape the regulatory space. FDA requirements for substantial equivalence involve similarity to other devices; the scrutiny is instead on manufacturing processes and repeatability. Validated processes for additive manufacturing suppliers is a critical consideration as you shop for vendors. In December 2017, FDA issued guidance documents specific for 3D-printed devices. We’re also planning to learn more at ASTM’s Symposium on Structural Integrity of Additive Manufactured Parts Nov. 7-8 in Washington, D.C.
SHOOK: The Law of Unintended Consequences—the Medical Device Tax
It was lost in the broader public debate over the benefits and pitfalls of the Affordable Care Act, but the medical device industry continues to suffer the negative effects of the 2013 medical device tax included in the historic legislation. That 2.3 percent excise tax on medical device supplies has been suspended for another two years, but we’re still feeling its negative effects. Despite the stay, damage was done. It has stifled research and development, diminished investments in startups, prompted major corporations to move overseas, and incited both job cuts and a dedicated effort to repeal by industry groups. According to the Advanced Medical Technology Association (which lobbies for the tax’s repeal), 71 percent of companies surveyed would reinstate previously foregone hiring and 85 percent would reinstate previously foregone R&D if the tax were repealed.
SHAPED: Paging Dr. Roboto to the OR
The very first use of robot-assisted surgery was in 1985, but it wasn’t until 2000 that the da Vinci Surgery System was approved by the FDA. Since then, robotic surgery has become increasingly popular. According to Reuters, robotics assisted surgery is expected to account for one in three surgeries by 2021. The University of Pennsylvania School of Medicine recently performed the world’s first robot-assisted spinal surgery. For the medical device industry, that means more and a wider variety of instruments and support structures to facilitate that growth. It also means more competition within the robotics subset of the market that’s expanding internationally as equipment costs come down. FierceBiotech reported Medtronic will soon launch its robotic surgery system and Johnson & Johnson plans to enter the arena as well. At Empirical, we’re seeing more requests for testing from small companies that are developing instrument sets and implant systems for use with Medtronic’s navigation system.
At Empirical, we’re looking forward to shifting, shaping, and shaking things up over the next 15 years and beyond. We’re proud to be part of an industry that works constantly to challenge ourselves, our assumptions, and perceived limits.
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.
