Dawn A. Lissy, President & Founder, Empirical04.03.17
It was a lot to take in running on about five hours of sleep following an international flight complete with a lost luggage cliché. Representatives from multiple agencies—governmental, regulatory, medical device companies, hospital purchasers, materials experts, testing laboratories, and more—were coming together in Lima, Peru, for a workshop on medical device regulation and standards.
The goal: to learn more about developing infrastructure, processes, and systems to support a successful medical device industry in Peru—an emerging third-world country where roughly half the economy is related to precious metals and ores.
Further, it was all in Spanish, a language in which I can find a bathroom if I gesture wildly enough and—perhaps more importantly—order a Pisco sour (on a good day).
This was an exciting day despite lost luggage and lack of sleep; I was there on behalf of the U.S. Food and Drug Administration (FDA) to explain ASTM material test methods of orthopedic devices. I donned my translation headset and did my best to follow the conversation.
As I worked to reconcile the moving lips of the speaker on stage with the accented chatter in my ear, I realized it was an apt metaphor for Peru’s efforts to develop a domestic medical device industry. Similar to the conference, there appear to be multiple, simultaneous conversations about the same topics with the same goal. However, pieces are getting lost in the cross-talk.
To explain, I was part of a panel of industry experts invited to the Peruvian capital to share knowledge on a range of topics geared toward bolstering the emerging medical device industry in Latin America’s seventh largest economy.
This is new territory for Peru. Since the Spanish conquest, gold and silver have been defining forces in Peruvian culture and history. Thanks in part to the country’s democratic stabilization this century and strong prices for those precious metals in recent years, a country that has traditionally imported medical devices is working to build a domestic industry to support medical device development.
To do that, Peruvian officials are turning to agencies from countries (like the United States) with gold-standard, well-established markets for guidance. For this conference, I was joined by colleagues Terry Woods, solid mechanics laboratory leader with FDA; Spiro J. Megremis, director of the Research and Laboratories Science Institute, American Dental Association; Brian Berg, senior research fellow, Boston Scientific Corp; Stephen Spiegelberg, president, Cambridge Polymer Group; and Jessica Roop, international policy manager, American National Standards Institute (ANSI).
Roop told me this particular workshop is part of ongoing support from ANSI through the Standards Alliance, a public-private partnership between ANSI and USAID initiated in 2003. Trade between the two countries increased from $9 billion in 2009 to $14 billion in 2015. The medical device industry is just one sector showing significant growth under what Roop described as “an important bilateral relationship.”
“Standards Alliance activities since the beginning of the project have led to major progress in standards capacity for the Peruvian national standards body, Instituto Nacional de Calidad (INACAL),” she said. “Not only does Peru’s progress reveal an increased technical expertise in standards-related issues, technical trainings in sectors like medical devices present a promising shift toward higher-value products.”
Rocío Barrera Santos of Peru’s Ministry of Foreign Trade and Tourism, explained the efforts to establish a national quality system and standards to lay a foundation for an industry that could be competitive and protect consumer health. The ministry is one of at least five governmental agencies working to establish systems and standards.
Because this is an emerging industry for the country, a dearth of experts in Peru is affecting how quickly these standards are coming together, Barrera explained. A lack of a quality systems culture in Peru means there’s no current infrastructure to roll out processes for certifications, standards, and other layers of oversight and guidance the country requires to support a successful industry.
“It can be a challenge to bring these groups all to the table, and to reach the appropriate audience in a country like Peru,” Roop said. “ANSI relies on our strong network of members in the U.S. to help guide our outreach strategy and our strong partnership with INACAL in Peru.”
Barrera described the challenges as links in a chain they’re working to forge to bring medical device development to Peru. Because the regulations and processes are still being developed, manufacturing, research, and development have yet to gain much traction. They have few home-grown experts to aid the laborious process of developing systems to launch an effective, safe industry that can compete in a global economy.
As part of the ongoing effort to improve that technical expertise, this particular workshop offered perspectives from both the public and private sectors. Attendees learned how the FDA is structured (specifically, the premarket process), how an ASTM standard is created and implemented, and the importance of standardized processes and testing, especially from a manufacturing perspective. More technical and granular talks included details on dental implants, cardiovascular devices, and material test methods for orthopedic applications. The over-arching theme: the importance of standardization, quality processes and controls, public safety, and integration of public and private sector activities.
As the Peruvian market continues to develop, U.S.-based and international companies will have opportunities to support its growth. I truly believe we’re all in this industry not just to make a profit, but to improve patient care and outcomes. I’m proud to be part of a professional community supporting that on a global level. And as the president of an international regulatory consulting company, I see many more Pisco sours in my future. (Trust me, they’re worth the lost luggage.)
At this point, we’re all a little lost in translation, but saying the same thing. In supporting the growth of Peru’s industry, we’re broadening our own and creating new opportunities for all of us.
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 goal: to learn more about developing infrastructure, processes, and systems to support a successful medical device industry in Peru—an emerging third-world country where roughly half the economy is related to precious metals and ores.
Further, it was all in Spanish, a language in which I can find a bathroom if I gesture wildly enough and—perhaps more importantly—order a Pisco sour (on a good day).
This was an exciting day despite lost luggage and lack of sleep; I was there on behalf of the U.S. Food and Drug Administration (FDA) to explain ASTM material test methods of orthopedic devices. I donned my translation headset and did my best to follow the conversation.
As I worked to reconcile the moving lips of the speaker on stage with the accented chatter in my ear, I realized it was an apt metaphor for Peru’s efforts to develop a domestic medical device industry. Similar to the conference, there appear to be multiple, simultaneous conversations about the same topics with the same goal. However, pieces are getting lost in the cross-talk.
To explain, I was part of a panel of industry experts invited to the Peruvian capital to share knowledge on a range of topics geared toward bolstering the emerging medical device industry in Latin America’s seventh largest economy.
This is new territory for Peru. Since the Spanish conquest, gold and silver have been defining forces in Peruvian culture and history. Thanks in part to the country’s democratic stabilization this century and strong prices for those precious metals in recent years, a country that has traditionally imported medical devices is working to build a domestic industry to support medical device development.
To do that, Peruvian officials are turning to agencies from countries (like the United States) with gold-standard, well-established markets for guidance. For this conference, I was joined by colleagues Terry Woods, solid mechanics laboratory leader with FDA; Spiro J. Megremis, director of the Research and Laboratories Science Institute, American Dental Association; Brian Berg, senior research fellow, Boston Scientific Corp; Stephen Spiegelberg, president, Cambridge Polymer Group; and Jessica Roop, international policy manager, American National Standards Institute (ANSI).
Roop told me this particular workshop is part of ongoing support from ANSI through the Standards Alliance, a public-private partnership between ANSI and USAID initiated in 2003. Trade between the two countries increased from $9 billion in 2009 to $14 billion in 2015. The medical device industry is just one sector showing significant growth under what Roop described as “an important bilateral relationship.”
“Standards Alliance activities since the beginning of the project have led to major progress in standards capacity for the Peruvian national standards body, Instituto Nacional de Calidad (INACAL),” she said. “Not only does Peru’s progress reveal an increased technical expertise in standards-related issues, technical trainings in sectors like medical devices present a promising shift toward higher-value products.”
Rocío Barrera Santos of Peru’s Ministry of Foreign Trade and Tourism, explained the efforts to establish a national quality system and standards to lay a foundation for an industry that could be competitive and protect consumer health. The ministry is one of at least five governmental agencies working to establish systems and standards.
Because this is an emerging industry for the country, a dearth of experts in Peru is affecting how quickly these standards are coming together, Barrera explained. A lack of a quality systems culture in Peru means there’s no current infrastructure to roll out processes for certifications, standards, and other layers of oversight and guidance the country requires to support a successful industry.
“It can be a challenge to bring these groups all to the table, and to reach the appropriate audience in a country like Peru,” Roop said. “ANSI relies on our strong network of members in the U.S. to help guide our outreach strategy and our strong partnership with INACAL in Peru.”
Barrera described the challenges as links in a chain they’re working to forge to bring medical device development to Peru. Because the regulations and processes are still being developed, manufacturing, research, and development have yet to gain much traction. They have few home-grown experts to aid the laborious process of developing systems to launch an effective, safe industry that can compete in a global economy.
As part of the ongoing effort to improve that technical expertise, this particular workshop offered perspectives from both the public and private sectors. Attendees learned how the FDA is structured (specifically, the premarket process), how an ASTM standard is created and implemented, and the importance of standardized processes and testing, especially from a manufacturing perspective. More technical and granular talks included details on dental implants, cardiovascular devices, and material test methods for orthopedic applications. The over-arching theme: the importance of standardization, quality processes and controls, public safety, and integration of public and private sector activities.
As the Peruvian market continues to develop, U.S.-based and international companies will have opportunities to support its growth. I truly believe we’re all in this industry not just to make a profit, but to improve patient care and outcomes. I’m proud to be part of a professional community supporting that on a global level. And as the president of an international regulatory consulting company, I see many more Pisco sours in my future. (Trust me, they’re worth the lost luggage.)
At this point, we’re all a little lost in translation, but saying the same thing. In supporting the growth of Peru’s industry, we’re broadening our own and creating new opportunities for all of us.
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.
