Dawn A. Lissy, President, Empirical09.12.23
I slipped the twist of metal on my finger and waited. A few seconds later, the ring had transmitted information about my heart rate, activity, calories burned, respiration rate, temperature, and still more detailed measurements about my personal health.
It’s so much more than a fashion statement. It’s a stylish snapshot of how far medical devices have come and what direction we’re headed in the future.
We’re in a growth phase similar to the 1980s, a period when medical devices started shifting from only stainless steel to other materials in search of better patient outcomes. In some ways, we’re still trying to catch up with the volume and type of changes stemming from that last major industry revolution.
My ring is a profound symbol for all this. As slick as it is, mine isn’t as fancy as the Evie, a new smart ring specifically designed for women. Movano Health, the company behind the ring, is seeking U.S. Food and Drug Administration (FDA) clearance for it as the first consumer wearable that is also a medical device.
A combo device such as wearable medtech presents a range of challenges for developers, manufacturers, and regulatory agencies, as well as all the stakeholders in the supply chain. Currently, if a developer has a device that can be regulated by more than one division within the FDA—such as a ring that collects data and runs on software—you must submit to the FDA to find out which of its regulatory departments is the primary for review. Then the developer has to figure out how to meet all the requirements of different agencies and find testing that covers both the physical and digital failures of the device. It’s a whole other level of testing that at this point, and it isn’t found under a single roof.
For all the information my pretty ring delivers, it and the Evie also raise questions not just about this specific type of device, but also the state of our industry. This tiny piece of technology requires a whole new supply chain, data sharing, regulatory approval processes, and oversight, including cybersecurity—specifically for patient information and protection. It’s one of many new advances that is forcing questions about how the medical device industry and regulatory agencies are going to pivot to keep up with the rapid pace of progress as our world becomes increasingly digital and connected through instant data.
Given the proliferation and rapid advancement of smart devices directly available to the consumer, that consumer is going to expect more and more of their life to be regulated and managed by the Internet of Things (IoT). That’s going to require intense data sharing—something we’re still trying to implement after decades of searching for common ground on this between healthcare providers, innovators, and regulatory agencies.
Data pooling is a prime example of this. For decades, regulatory agencies have been encouraging healthcare professionals to share information about what works and what doesn’t for a wide range of devices and procedures. In the first orthopedics town hall on that subject at AAOS, medical professionals continued to express concerns about proprietary information and questions about how that data would be mined and managed. Even if surgeons and other caregivers all suddenly agreed to enter years of data, we don’t yet have a cohesive net to gather that information. We don’t know who would maintain it or who would pay for such a system.
That data is crucial not just for better medical practices, but for emerging artificial intelligence, machine learning, and nanotechnology. There are astounding advances on those fronts from a technological standpoint; we now basically have microscopic robots that can hunt down cancer cells and assess or prevent bone fusion. Artificial intelligence (AI) can significantly speed up clinical trials, diagnostic procedures, automate hospital workflows, and enhance the Internet of Medical Things with wearable devices like my smart ring.
All this data requires intense cybersecurity, yet another pain and growth point for our industry. Entire hospital systems have been crippled by cyberattacks, and safeguarding patient information is a legal as well as ethical obligation. It’s a concern not just for devices and data pooling, but also to the COVID-19-induced surge in telehealth. It’s another facet of technology that introduces additional layers and potential complications of how medical professionals and the systems and devices they use safeguard the information that’s the foundation of accurate diagnoses, treatment, and basically any and all healthcare industry advancement. And, how do we test for the level of cybersecurity necessary to declare a device safe and effective?
As a professional with more than 30 years in the medical device industry, I feel like worlds are colliding in a way I’ve never seen before. I used to understand all of the different and separate elements of what it requires to get a medical device to market. But now, given the crossover between mechanical, electrical, software, patient data, cybersecurity, and other combo devices—including pharmacological applications—I struggle to keep it all straight.
I know I’m not the only one. This period of explosive growth is challenging us all to find new ways to adapt, embrace, and pivot to keep the pipeline of new solutions open and flowing to the patient who expects and deserves state-of-the-art care for the best possible health outcomes.
Dawn Lissy is a biomedical engineer, entrepreneur, and innovator. Since 1998, Empirical Technologies Corp. 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.
It’s so much more than a fashion statement. It’s a stylish snapshot of how far medical devices have come and what direction we’re headed in the future.
We’re in a growth phase similar to the 1980s, a period when medical devices started shifting from only stainless steel to other materials in search of better patient outcomes. In some ways, we’re still trying to catch up with the volume and type of changes stemming from that last major industry revolution.
My ring is a profound symbol for all this. As slick as it is, mine isn’t as fancy as the Evie, a new smart ring specifically designed for women. Movano Health, the company behind the ring, is seeking U.S. Food and Drug Administration (FDA) clearance for it as the first consumer wearable that is also a medical device.
A combo device such as wearable medtech presents a range of challenges for developers, manufacturers, and regulatory agencies, as well as all the stakeholders in the supply chain. Currently, if a developer has a device that can be regulated by more than one division within the FDA—such as a ring that collects data and runs on software—you must submit to the FDA to find out which of its regulatory departments is the primary for review. Then the developer has to figure out how to meet all the requirements of different agencies and find testing that covers both the physical and digital failures of the device. It’s a whole other level of testing that at this point, and it isn’t found under a single roof.
For all the information my pretty ring delivers, it and the Evie also raise questions not just about this specific type of device, but also the state of our industry. This tiny piece of technology requires a whole new supply chain, data sharing, regulatory approval processes, and oversight, including cybersecurity—specifically for patient information and protection. It’s one of many new advances that is forcing questions about how the medical device industry and regulatory agencies are going to pivot to keep up with the rapid pace of progress as our world becomes increasingly digital and connected through instant data.
Given the proliferation and rapid advancement of smart devices directly available to the consumer, that consumer is going to expect more and more of their life to be regulated and managed by the Internet of Things (IoT). That’s going to require intense data sharing—something we’re still trying to implement after decades of searching for common ground on this between healthcare providers, innovators, and regulatory agencies.
Data pooling is a prime example of this. For decades, regulatory agencies have been encouraging healthcare professionals to share information about what works and what doesn’t for a wide range of devices and procedures. In the first orthopedics town hall on that subject at AAOS, medical professionals continued to express concerns about proprietary information and questions about how that data would be mined and managed. Even if surgeons and other caregivers all suddenly agreed to enter years of data, we don’t yet have a cohesive net to gather that information. We don’t know who would maintain it or who would pay for such a system.
That data is crucial not just for better medical practices, but for emerging artificial intelligence, machine learning, and nanotechnology. There are astounding advances on those fronts from a technological standpoint; we now basically have microscopic robots that can hunt down cancer cells and assess or prevent bone fusion. Artificial intelligence (AI) can significantly speed up clinical trials, diagnostic procedures, automate hospital workflows, and enhance the Internet of Medical Things with wearable devices like my smart ring.
All this data requires intense cybersecurity, yet another pain and growth point for our industry. Entire hospital systems have been crippled by cyberattacks, and safeguarding patient information is a legal as well as ethical obligation. It’s a concern not just for devices and data pooling, but also to the COVID-19-induced surge in telehealth. It’s another facet of technology that introduces additional layers and potential complications of how medical professionals and the systems and devices they use safeguard the information that’s the foundation of accurate diagnoses, treatment, and basically any and all healthcare industry advancement. And, how do we test for the level of cybersecurity necessary to declare a device safe and effective?
As a professional with more than 30 years in the medical device industry, I feel like worlds are colliding in a way I’ve never seen before. I used to understand all of the different and separate elements of what it requires to get a medical device to market. But now, given the crossover between mechanical, electrical, software, patient data, cybersecurity, and other combo devices—including pharmacological applications—I struggle to keep it all straight.
I know I’m not the only one. This period of explosive growth is challenging us all to find new ways to adapt, embrace, and pivot to keep the pipeline of new solutions open and flowing to the patient who expects and deserves state-of-the-art care for the best possible health outcomes.
Dawn Lissy is a biomedical engineer, entrepreneur, and innovator. Since 1998, Empirical Technologies Corp. 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.
