Dawn A. Lissy, President & Founder, Empirical11.07.17
In a year of political and social discord, international conflict, and natural disasters, the big news in the medical device industry really didn’t make headlines—even within our sector. But as 2017 comes to a close, I consider fee hikes, biocompatibility, 3D printing, and the best news I’ve heard in decades to be the industry headlines for a turbulent 12 months.
You Want How Much for That?!
As the mainstream media covered the escalating war of words between President Trump and Kim Jong Un, the U.S. Food and Drug Administration (FDA) dropped a bomb at the end of FY17: an abnormally steep increase in registration fees for a standard 510(k) submission. The cost rose from $4,690 in September 2017 to $10,566 the following month. It’s a hike no one saw coming or has been able to explain.
At Empirical, it left us scrambling to push through as many submissions as possible before the rate more than doubled. We put in four submissions on the Friday before the fee structure officially changed. We can only assume many other businesses throughout the industry felt similar pressure to beat the clock and adjust budgets and time tables to manage the change.
We’re still trying to figure out how or why this happened. No word yet from official channels on the point of the price gouge, and we may very well see a significant slowdown of submissions in coming months as device developers from all industries work to adapt.
Biocompatibility Boondoggle
In yet another move that will tremendously impact timelines and budgets, FDA now requires a new level of biocompatibility testing—13 tests, to be exact. This actually went into effect mid-2016, but regulators didn’t begin enforcing it until late 2017.
So now in addition to decontamination, sterilization, and dry time validations, this range of biocompatibility tests adds yet another expense of time and money. Previously, reference articles could be cited to satisfy review requirements for a material that has been vetted and used for decades—titanium, for example. FDA now requires a full battery of tests proving the biocompatibility of the finished device, regardless of the base material used in manufacturing. The concern, likely valid, is elevated infection rates if the finished device has been exposed to manufacturing and/or handling materials or chemicals that could make the finished good “dirty.”
That being said, FDA will still listen to reason. We recently wrote a memo justifying that not all of the ISO 10993 tests are applicable or necessary if appropriate controls are in place, which FDA accepted. We take comfort in the fact that good science, understanding the concerns of a reviewer, and proving your case is still possible. Still, good process control is critical to providing consistently biocompatible finished goods.
Additive Manufacturing Hits and Misses
Last year, I touched on the benefits and drawbacks of additive manufacturing in our industry (See my column “3D Printing: Third Industrial Revolution or Productivity Stalemate?” in the October 2016 edition of MPO). The benefits of 3D printed medical devices with a custom fit—surgical instruments, dental applications, prosthetics, orthopedic and cranial implants, and more—are significant and exciting.
But I maintain we’re still not at the point where it’s always the best solution for small business owners and individual innovators. Medical device development isn’t just about the end-user. To get to the patient, we have to consider manufacturing methods, standards of care, time, costs, expectations, finishing processes, and regulatory concerns.
Traditional device manufacturers understand that process and have the resources and tools to bring a device to market. There are turnkey setups in place. Since additive manufacturing has yet to develop a sub-segment specific to medical devices, there’s a heavy outsourcing lift to meet regulatory requirements. A developer may end up with a beautiful patient-specific implant, but he or she will likely have to go to multiple vendors to ensure quality controls such as material conformance, certificates, and validated processes for consistency in output.
'Extra, Extra! Read All About It! FDA Publishes Mechanical Performance Data for Substantial Equivalence!'
This is hands-down my favorite headline. A 510(k) submission is about substantial equivalence. Predicate data proves to FDA that your device’s safety and efficacy has been established because it’s similar to an existing device on the market. But without predicate data, you have to come up with it. That means citing a published article or performing side-by-side testing.
However, if you cite articles, you never know if you’re using the same methodology. And if you test an existing device that requires a script to obtain, how do you legally procure that device?
It’s been the elephant in the room throughout my entire career. We don’t ask questions about where test parts come from. Neither does the FDA, which established its predicate guidelines in 1976. But requiring device developers to test existing devices has, over the course of 41 years, developed what is essentially a black market of predicates that sell for a premium. Then developers had to pay for those very expensive devices—which have already been fully tested and accepted—to be tested again.
This has been an ongoing conversation throughout the industry. I’m one of many who suggested to FDA there has to be a better way to collect and share predicate data. I consider that the single biggest obstacle in a 510(k) application.
This year, FDA hired a team of co-op students and interns to categorize the information in their internal database and publish blind information. At this point, the information is limited to cervical intervertebral body fusion devices. A lumbar version will follow. At Empirical, we’re currently heading the team writing ASTM guidance documents for pedicle screws to join in the effort of making that information accessible, affordable, and easy to legally obtain.
It’s not a quick project, but I’m very encouraged by the progress so far. And now FDA has the tools and the processes to make it happen on a much broader scale. Hopefully, what’s begun as a boon to spine will eventually encompass all of orthopedics.
To me, that’s the best news all year.
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.
You Want How Much for That?!
As the mainstream media covered the escalating war of words between President Trump and Kim Jong Un, the U.S. Food and Drug Administration (FDA) dropped a bomb at the end of FY17: an abnormally steep increase in registration fees for a standard 510(k) submission. The cost rose from $4,690 in September 2017 to $10,566 the following month. It’s a hike no one saw coming or has been able to explain.
At Empirical, it left us scrambling to push through as many submissions as possible before the rate more than doubled. We put in four submissions on the Friday before the fee structure officially changed. We can only assume many other businesses throughout the industry felt similar pressure to beat the clock and adjust budgets and time tables to manage the change.
We’re still trying to figure out how or why this happened. No word yet from official channels on the point of the price gouge, and we may very well see a significant slowdown of submissions in coming months as device developers from all industries work to adapt.
Biocompatibility Boondoggle
In yet another move that will tremendously impact timelines and budgets, FDA now requires a new level of biocompatibility testing—13 tests, to be exact. This actually went into effect mid-2016, but regulators didn’t begin enforcing it until late 2017.
So now in addition to decontamination, sterilization, and dry time validations, this range of biocompatibility tests adds yet another expense of time and money. Previously, reference articles could be cited to satisfy review requirements for a material that has been vetted and used for decades—titanium, for example. FDA now requires a full battery of tests proving the biocompatibility of the finished device, regardless of the base material used in manufacturing. The concern, likely valid, is elevated infection rates if the finished device has been exposed to manufacturing and/or handling materials or chemicals that could make the finished good “dirty.”
That being said, FDA will still listen to reason. We recently wrote a memo justifying that not all of the ISO 10993 tests are applicable or necessary if appropriate controls are in place, which FDA accepted. We take comfort in the fact that good science, understanding the concerns of a reviewer, and proving your case is still possible. Still, good process control is critical to providing consistently biocompatible finished goods.
Additive Manufacturing Hits and Misses
Last year, I touched on the benefits and drawbacks of additive manufacturing in our industry (See my column “3D Printing: Third Industrial Revolution or Productivity Stalemate?” in the October 2016 edition of MPO). The benefits of 3D printed medical devices with a custom fit—surgical instruments, dental applications, prosthetics, orthopedic and cranial implants, and more—are significant and exciting.
But I maintain we’re still not at the point where it’s always the best solution for small business owners and individual innovators. Medical device development isn’t just about the end-user. To get to the patient, we have to consider manufacturing methods, standards of care, time, costs, expectations, finishing processes, and regulatory concerns.
Traditional device manufacturers understand that process and have the resources and tools to bring a device to market. There are turnkey setups in place. Since additive manufacturing has yet to develop a sub-segment specific to medical devices, there’s a heavy outsourcing lift to meet regulatory requirements. A developer may end up with a beautiful patient-specific implant, but he or she will likely have to go to multiple vendors to ensure quality controls such as material conformance, certificates, and validated processes for consistency in output.
'Extra, Extra! Read All About It! FDA Publishes Mechanical Performance Data for Substantial Equivalence!'
This is hands-down my favorite headline. A 510(k) submission is about substantial equivalence. Predicate data proves to FDA that your device’s safety and efficacy has been established because it’s similar to an existing device on the market. But without predicate data, you have to come up with it. That means citing a published article or performing side-by-side testing.
However, if you cite articles, you never know if you’re using the same methodology. And if you test an existing device that requires a script to obtain, how do you legally procure that device?
It’s been the elephant in the room throughout my entire career. We don’t ask questions about where test parts come from. Neither does the FDA, which established its predicate guidelines in 1976. But requiring device developers to test existing devices has, over the course of 41 years, developed what is essentially a black market of predicates that sell for a premium. Then developers had to pay for those very expensive devices—which have already been fully tested and accepted—to be tested again.
This has been an ongoing conversation throughout the industry. I’m one of many who suggested to FDA there has to be a better way to collect and share predicate data. I consider that the single biggest obstacle in a 510(k) application.
This year, FDA hired a team of co-op students and interns to categorize the information in their internal database and publish blind information. At this point, the information is limited to cervical intervertebral body fusion devices. A lumbar version will follow. At Empirical, we’re currently heading the team writing ASTM guidance documents for pedicle screws to join in the effort of making that information accessible, affordable, and easy to legally obtain.
It’s not a quick project, but I’m very encouraged by the progress so far. And now FDA has the tools and the processes to make it happen on a much broader scale. Hopefully, what’s begun as a boon to spine will eventually encompass all of orthopedics.
To me, that’s the best news all year.
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.
