Sean Fenske, Editor06.20.17
Late in April, UL, a global company that helps customers navigate market complexity, made the announcement that it was moving to acquire Emergo, a medical device consulting firm that helps customers access the largest and fastest growing markets worldwide. Given the state of the industry and the number of mergers that are occurring among both medical device OEMs and within the supporting supply chain, the move wasn’t a huge surprise. However, Emergo did make for an interesting target for UL. With this in mind, MPO reached out to both firms to get insight into the acquisition as well as how the combined entity could provide greater services to the medtech industry. And while we had their attention, we asked about their view of the rapidly changing regulatory landscape in the global marketplace as well as what they foresaw on the horizon. Taking the time to speak with MPO was Anil Patel, PE – director of strategy at UL, and Chris Schorre, Emergo’s vice president of global marketing.
Sean Fenske: What made Emergo an attractive acquisition for UL?
Anil Patel & Chris Schorre: UL’s mission is to help make safe living and working environments for people. Emergo helps clients get compliant products to the global marketplace. Emergo has a very broad understanding of regulations and standards from many different countries. UL’s medical business was focused in the U.S. and EU, and now through Emergo, has the ability take safe products to many parts of the world.
Fenske: How much overlap is there between the services offered by the two firms?
Patel & Schorre: Minimal. UL has been helping manufacturers with the U.S. market for a century and now Emergo can help manufacturers with many more countries and their unique patient needs. Both organizations will leverage their core competence to serve our customers, while maintaining an appropriate separation between UL Notified Body and Emergo services.
Fenske: How does the acquisition impact existing customers?
Patel & Schorre: The acquisition of Emergo by UL will have a very positive impact for the vast majority of Emergo's 2,800 clients. Traditionally, Emergo has had a strong foothold serving small- and medium-sized clients. Emergo clients will get easier access to UL's expertise in areas including non-clinical safety testing and human factors engineering. Likewise, many of UL's testing clients will get access to Emergo's deep pool of regulatory expertise and access to regulatory markets around the world. Of course, Emergo cannot provide advisory services to any of UL's Notified Body customers and that's a separation we take very seriously. UL is currently reviewing shared customers to ensure that Notified Body independence and impartiality is maintained.
Fenske: Had the firms had a history of collaborating together in the past?
Patel & Schorre: We’ve always maintained a very professional relationship, without a formal agreement in place. This now enables clients to go to one place to learn about medical device standards, testing, and regulations.
Fenske: How will the new combined entity address the regulatory changes that are happening in the world?
Patel & Schorre: Ask any QA/RA professional and they will tell you that regulations are becoming more complex. That’s a global trend, not just in the U.S. The recent introduction of the new Medical Device Regulations in Europe will put further strain on companies looking to maintain or gain certification in Europe. Companies really need to take a holistic view of the regulatory environment however. Europe cannot be treated as an isolated compliance effort; having an integrated approach to compliance in the U.S., Europe, Japan, and other major markets is an absolute necessity. Emergo and UL have a broader service offering that allows us to take a wider view of companies’ regulatory compliance efforts. For instance, many companies seeking 510(k) clearance in the U.S. need to get some sort of testing done on their products. These test reports are an important part of the submission process to the U.S. FDA, yet many companies don't have a good grip on exactly what test reports are required when beginning their 510(k). Working with a team that fully understands the testing requirements for a specific product is critical because it can shorten the total amount of time a company spends on gaining approval to sell in the market. Getting approval faster means the product is generating revenue sooner. UL is now better positioned to look at various different requirements in the form of standards and regulations to provide clients a focused route to regulatory support where they can have technical experts that understand the standards and regulation of multiple countries. UL will continue to provide Notified Body services but will be unable to provide services to Emergo clients.
Fenske: What is your opinion of the changes and improvements at the FDA. Do you agree they are improvements? Where are improvements still needed?
Patel & Schorre: We are actively working alongside stakeholders in regulatory forums to learn and distribute the most accurate information on relevant standards and regulations. Manufactures are best positioned to determine whether FDA reform efforts will result in more efficient reviews and increased speed to market. However, we are encouraged by FDA’s interest and efforts to better leverage third-party testing laboratories to speed premarket reviews.
Fenske: What’s coming with regard to regulatory issues that the industry can look forward to?
Patel & Schorre: Clearly manufacturers will need to stay on top of the current regulations and standards. The introduction of Unique Device Identification (UDI) will have a profound positive impact on the medical device industry. The UDI system, once fully implemented, has the potential to greatly improve product traceability and safety all the way through the supply chain.
Also, the opening of the EUDAMED database in Europe, expected to coincide with enforcement of the new MDR regulation in 2020, will give regulators, notified bodies, distributors, manufacturers, patients, and users alike further insight into the products that are on the market, the clinical studies they may be involved in, ongoing recalls, etc. Since there is currently no publicly accessible database of medical devices that have CE marking in Europe, this expansion of transparency is welcomed by many economic operators in Europe.
In addition, we are seeing large markets such as India establishing regulatory systems, helping to advance healthcare safety in some regions that really need it.
Fenske: What changes do you expect in the coming years? What’s ahead five/ten years from now?
Patel & Schorre: Over the next several years, hopefully regulators will continue to work together to further harmonize the gathering and sharing of information. The largest markets have joined efforts in the International Medical Device Regulators Forum (IMDRF), currently resulting in several interesting global initiatives including the Medical Device Single Audit Program (MDSAP). MDSAP is a positive step in this direction and we hope this program will continue to be expanded. For example, a manufacturer selling products in the United States, Europe, and Brazil would likely need to have their quality system separately inspected by the U.S. FDA, a European Notified Body, and ANVISA—the medical device regulator in Brazil. Essentially all of these entities are inspecting the same thing.
In the near-term, global regulatory compliance will continue to become more complex as some regulators shift to requiring technical documentation to be more of a living document, driven by new experiences gained during the lifetime of the device. This will drive the development of online regulatory compliance solutions that make it easier for manufacturers—large and small—to track existing and new approvals and applicable standards spanning numerous markets worldwide.
Apart from the regulatory developments, we also see new technological developments. Products are now being developed for which the legislation still must be written. Given the innovations in new materials and transmission of data, we think that there will be newer risks associated with the use of materials that come in contact with patients. In the area of data management, we see more new technologies that will help patients with newer, less invasive procedures; however, it will also mean that cybersecurity will be top of mind for patient data and product performance.
Fenske: Any other comments or thoughts you’d like to share?
Patel & Schorre: The UL family of companies is well placed to support customers during this time of great change in the regulatory environment. With appropriate separation, we can provide a broad spectrum of services, whether this is through Emergo’s thorough understanding of regulations or UL’s world-class testing services, UL is looking forward to supporting our customers.
Sean Fenske: What made Emergo an attractive acquisition for UL?
Anil Patel & Chris Schorre: UL’s mission is to help make safe living and working environments for people. Emergo helps clients get compliant products to the global marketplace. Emergo has a very broad understanding of regulations and standards from many different countries. UL’s medical business was focused in the U.S. and EU, and now through Emergo, has the ability take safe products to many parts of the world.
Fenske: How much overlap is there between the services offered by the two firms?
Patel & Schorre: Minimal. UL has been helping manufacturers with the U.S. market for a century and now Emergo can help manufacturers with many more countries and their unique patient needs. Both organizations will leverage their core competence to serve our customers, while maintaining an appropriate separation between UL Notified Body and Emergo services.
Fenske: How does the acquisition impact existing customers?
Patel & Schorre: The acquisition of Emergo by UL will have a very positive impact for the vast majority of Emergo's 2,800 clients. Traditionally, Emergo has had a strong foothold serving small- and medium-sized clients. Emergo clients will get easier access to UL's expertise in areas including non-clinical safety testing and human factors engineering. Likewise, many of UL's testing clients will get access to Emergo's deep pool of regulatory expertise and access to regulatory markets around the world. Of course, Emergo cannot provide advisory services to any of UL's Notified Body customers and that's a separation we take very seriously. UL is currently reviewing shared customers to ensure that Notified Body independence and impartiality is maintained.
Fenske: Had the firms had a history of collaborating together in the past?
Patel & Schorre: We’ve always maintained a very professional relationship, without a formal agreement in place. This now enables clients to go to one place to learn about medical device standards, testing, and regulations.
Fenske: How will the new combined entity address the regulatory changes that are happening in the world?
Patel & Schorre: Ask any QA/RA professional and they will tell you that regulations are becoming more complex. That’s a global trend, not just in the U.S. The recent introduction of the new Medical Device Regulations in Europe will put further strain on companies looking to maintain or gain certification in Europe. Companies really need to take a holistic view of the regulatory environment however. Europe cannot be treated as an isolated compliance effort; having an integrated approach to compliance in the U.S., Europe, Japan, and other major markets is an absolute necessity. Emergo and UL have a broader service offering that allows us to take a wider view of companies’ regulatory compliance efforts. For instance, many companies seeking 510(k) clearance in the U.S. need to get some sort of testing done on their products. These test reports are an important part of the submission process to the U.S. FDA, yet many companies don't have a good grip on exactly what test reports are required when beginning their 510(k). Working with a team that fully understands the testing requirements for a specific product is critical because it can shorten the total amount of time a company spends on gaining approval to sell in the market. Getting approval faster means the product is generating revenue sooner. UL is now better positioned to look at various different requirements in the form of standards and regulations to provide clients a focused route to regulatory support where they can have technical experts that understand the standards and regulation of multiple countries. UL will continue to provide Notified Body services but will be unable to provide services to Emergo clients.
Fenske: What is your opinion of the changes and improvements at the FDA. Do you agree they are improvements? Where are improvements still needed?
Patel & Schorre: We are actively working alongside stakeholders in regulatory forums to learn and distribute the most accurate information on relevant standards and regulations. Manufactures are best positioned to determine whether FDA reform efforts will result in more efficient reviews and increased speed to market. However, we are encouraged by FDA’s interest and efforts to better leverage third-party testing laboratories to speed premarket reviews.
Fenske: What’s coming with regard to regulatory issues that the industry can look forward to?
Patel & Schorre: Clearly manufacturers will need to stay on top of the current regulations and standards. The introduction of Unique Device Identification (UDI) will have a profound positive impact on the medical device industry. The UDI system, once fully implemented, has the potential to greatly improve product traceability and safety all the way through the supply chain.
Also, the opening of the EUDAMED database in Europe, expected to coincide with enforcement of the new MDR regulation in 2020, will give regulators, notified bodies, distributors, manufacturers, patients, and users alike further insight into the products that are on the market, the clinical studies they may be involved in, ongoing recalls, etc. Since there is currently no publicly accessible database of medical devices that have CE marking in Europe, this expansion of transparency is welcomed by many economic operators in Europe.
In addition, we are seeing large markets such as India establishing regulatory systems, helping to advance healthcare safety in some regions that really need it.
Fenske: What changes do you expect in the coming years? What’s ahead five/ten years from now?
Patel & Schorre: Over the next several years, hopefully regulators will continue to work together to further harmonize the gathering and sharing of information. The largest markets have joined efforts in the International Medical Device Regulators Forum (IMDRF), currently resulting in several interesting global initiatives including the Medical Device Single Audit Program (MDSAP). MDSAP is a positive step in this direction and we hope this program will continue to be expanded. For example, a manufacturer selling products in the United States, Europe, and Brazil would likely need to have their quality system separately inspected by the U.S. FDA, a European Notified Body, and ANVISA—the medical device regulator in Brazil. Essentially all of these entities are inspecting the same thing.
In the near-term, global regulatory compliance will continue to become more complex as some regulators shift to requiring technical documentation to be more of a living document, driven by new experiences gained during the lifetime of the device. This will drive the development of online regulatory compliance solutions that make it easier for manufacturers—large and small—to track existing and new approvals and applicable standards spanning numerous markets worldwide.
Apart from the regulatory developments, we also see new technological developments. Products are now being developed for which the legislation still must be written. Given the innovations in new materials and transmission of data, we think that there will be newer risks associated with the use of materials that come in contact with patients. In the area of data management, we see more new technologies that will help patients with newer, less invasive procedures; however, it will also mean that cybersecurity will be top of mind for patient data and product performance.
Fenske: Any other comments or thoughts you’d like to share?
Patel & Schorre: The UL family of companies is well placed to support customers during this time of great change in the regulatory environment. With appropriate separation, we can provide a broad spectrum of services, whether this is through Emergo’s thorough understanding of regulations or UL’s world-class testing services, UL is looking forward to supporting our customers.