Dawn A. Lissy, President & Founder, Empirical11.04.19
As much as I appreciate advantages of modern communication, I want to look someone in the eye for a difficult discussion. Email can’t properly convey emotion. Texts don’t always capture tone. Even FaceTime isn’t as effective as face-to-face when broaching sensitive topics.
When I was part of the U.S. Food and Drug Administration’s (FDA) Entrepreneurs-in-Residence program 2012-2013, I learned the cardiovascular industry hosted full-day town hall meetings where they invited all stakeholders in the industry (regulatory, scientists, surgeons, contract research organizations, insurance companies, service providers, and medical device manufacturers) to the table for frank discussions about the state of their industry. At the time I thought, “Why doesn’t orthopedics do that?”
Because I work primarily with small businesses—the Empirical family of companies provides mechanical testing and regulatory consulting—I’ve seen the knowledge gap first-hand. Larger companies actively engage with industry groups like Orthopedic Surgical Manufacturers Association and AdvaMed. But smaller companies or lone surgeons with great ideas and big dreams are often out of the loop. They can miss key changes, often don’t know about new guidance documents, or have a hard time navigating a regulatory path.
Fortunately, representatives from FDA, American Academy of Orthopedic Surgeons (AAOS), and industry organizations also recognized the need for direct discussion, and have been working to host such an event. The AAOS/FDA/Industry Townhall is taking place March 24, 2020, at the AAOS annual meeting in Orlando.
All the stakeholders will converge here to discuss what’s happened in the past year—research, breakthroughs, regulation, problems—and what’s new coming up the next year. This is a chance to gather as an industry for our shared goal—improved patient outcomes.
I strongly encourage my peers and colleagues to attend this meeting. The goal is to establish a forum for some deep, honest discussions, share important news, and foster productive relationships to move our industry forward. The agenda, exact time, and location have not yet been finalized. (Check the AAOS website closer to the conference date for details.)
Dr. Raymond Golish, chair of the AAOS Biomedical Engineering Committee, is moderating a panel of top industry leaders he said will be tackling topics that require open, frank discussion.
“The thesis of this town hall is that it’s a provocative, interactive forum to rethink how these…stakeholder groups work together to create innovation in the 21st century,” Golish said.
Given global, domestic, and industry-specific challenges, the future of orthopedics and patient health depends on open lines of direct, honest communication.
“The reason why we need to rethink this as opposed to business-as-usual is that currently innovation in orthopedic care faces stiff headwinds,” Golish said. “The headwinds are due to challenges in venture funding all the way through payor affairs.”
The regulatory community has played a huge part in moving this town hall forward. FDA was extremely receptive to bringing our community together for an open forum. For the past year, they’ve assigned a dedicated group to work with AAOS to launch this conversation to maintain momentum and advance the industry.
“Improved patient care is intimately connected to improved technology,” Golish said. “The extraordinary success of orthopedic surgery is supported by a lot of factors, but one is certainly technology. We have to work hard at fostering an ecosystem of innovation for this to continue.”
To support that ecosystem, we have to be discussing the best way to make that happen. The foundation of innovation is built on the free flow of ideas. This initial town hall’s goal is to convene people with questions and people with answers.
“It’s not a coincidence that the AAOS has reorganized its charges and strategic plan around quality and value,” Golish said. “Independently but simultaneously, the FDA has reorganized its strategic plan around quality and total product lifecycle. Industry is looking for new ways to use these paradigms to continue innovating.”
It’s a new approach to an old challenge: How do we work together to do better by our patients? I believe we start by congregating in the same room with open minds and an open mic. Golish agreed.
“I wouldn’t be enthusiastic about it if it were just another talking shop and business as usual,” Golish said. “This is really designed to take a fresh approach.”
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.
When I was part of the U.S. Food and Drug Administration’s (FDA) Entrepreneurs-in-Residence program 2012-2013, I learned the cardiovascular industry hosted full-day town hall meetings where they invited all stakeholders in the industry (regulatory, scientists, surgeons, contract research organizations, insurance companies, service providers, and medical device manufacturers) to the table for frank discussions about the state of their industry. At the time I thought, “Why doesn’t orthopedics do that?”
Because I work primarily with small businesses—the Empirical family of companies provides mechanical testing and regulatory consulting—I’ve seen the knowledge gap first-hand. Larger companies actively engage with industry groups like Orthopedic Surgical Manufacturers Association and AdvaMed. But smaller companies or lone surgeons with great ideas and big dreams are often out of the loop. They can miss key changes, often don’t know about new guidance documents, or have a hard time navigating a regulatory path.
Fortunately, representatives from FDA, American Academy of Orthopedic Surgeons (AAOS), and industry organizations also recognized the need for direct discussion, and have been working to host such an event. The AAOS/FDA/Industry Townhall is taking place March 24, 2020, at the AAOS annual meeting in Orlando.
All the stakeholders will converge here to discuss what’s happened in the past year—research, breakthroughs, regulation, problems—and what’s new coming up the next year. This is a chance to gather as an industry for our shared goal—improved patient outcomes.
I strongly encourage my peers and colleagues to attend this meeting. The goal is to establish a forum for some deep, honest discussions, share important news, and foster productive relationships to move our industry forward. The agenda, exact time, and location have not yet been finalized. (Check the AAOS website closer to the conference date for details.)
Dr. Raymond Golish, chair of the AAOS Biomedical Engineering Committee, is moderating a panel of top industry leaders he said will be tackling topics that require open, frank discussion.
“The thesis of this town hall is that it’s a provocative, interactive forum to rethink how these…stakeholder groups work together to create innovation in the 21st century,” Golish said.
Given global, domestic, and industry-specific challenges, the future of orthopedics and patient health depends on open lines of direct, honest communication.
“The reason why we need to rethink this as opposed to business-as-usual is that currently innovation in orthopedic care faces stiff headwinds,” Golish said. “The headwinds are due to challenges in venture funding all the way through payor affairs.”
The regulatory community has played a huge part in moving this town hall forward. FDA was extremely receptive to bringing our community together for an open forum. For the past year, they’ve assigned a dedicated group to work with AAOS to launch this conversation to maintain momentum and advance the industry.
“Improved patient care is intimately connected to improved technology,” Golish said. “The extraordinary success of orthopedic surgery is supported by a lot of factors, but one is certainly technology. We have to work hard at fostering an ecosystem of innovation for this to continue.”
To support that ecosystem, we have to be discussing the best way to make that happen. The foundation of innovation is built on the free flow of ideas. This initial town hall’s goal is to convene people with questions and people with answers.
“It’s not a coincidence that the AAOS has reorganized its charges and strategic plan around quality and value,” Golish said. “Independently but simultaneously, the FDA has reorganized its strategic plan around quality and total product lifecycle. Industry is looking for new ways to use these paradigms to continue innovating.”
It’s a new approach to an old challenge: How do we work together to do better by our patients? I believe we start by congregating in the same room with open minds and an open mic. Golish agreed.
“I wouldn’t be enthusiastic about it if it were just another talking shop and business as usual,” Golish said. “This is really designed to take a fresh approach.”
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.
