Jennie Lynch, Senior Market Advisor, Healthcare, Enterprise Ireland10.01.21
Throughout the past 18-(plus) months, healthcare providers and patients alike have grown more familiar with and confident in utilizing digital and remote healthcare solutions. With an increasing level of patients and providers turning to wearable devices, at-home lab tests, and telemedicine platforms, the digital route to patient engagement is quickly becoming mainstream.
The health and life science sectors have seen significant growth in remote diagnostic monitoring. This widespread use and acceptance is driving a very high level of new tech and product development. The combination of Ireland’s long history of supporting health technology upstarts, entrepreneurs, and established multinationals has positioned the country as a hotbed for development and innovation.
Enterprise Ireland, Ireland's trade and innovation agency that partners with Irish enterprises to help them grow, innovate, and win export sales in global markets, estimates there are roughly 180 domestic life sciences companies in Ireland employing more than 25,000 and generating annual sales of more than $6 billion. These indigenous life science companies include pharma, biotech, diagnostics, and therapeutics, but the lion's share is medical device businesses.
Telehealth and digital health innovations utilizing a sophisticated level of AI, data mining, cloud platform integrations, IoT devices, and patient self-help platforms are now firmly at the forefront of healthcare service development. We will see a high level of advancement specifically within homecare with deeper virtual interaction with healthcare professionals, including video-based virtual appointments. Brick and mortar hospitals and healthcare systems, emergency departments, and ICUs will also evolve to use data from these multiple collection points (live, real-time data as well as historical patient records) to provide improved, more responsive care and enhanced patient outcomes.
A Global Healthcare Disruption
In the U.S. in early 2020, digital telemedicine was utilized by roughly 11 percent of patients and clinicians. That percentage jumped substantially to 46 percent by the end of the year. From a digital technology perspective, over $3 billion of venture capital was invested into digital health within the last three quarters of 2020, illustrating an enormous pivot within V.C. investment and technology adoption.
While Europe and the U.S. operate on different playing fields, for the most part, the changes that we're seeing are being felt on both sides of the Atlantic. Regulation has been relaxed across the board from the FDA, as well as from a European Medical Agency perspective. In the U.S., we saw the Emergency Use Authorization (EUA) implementation for new technologies to combat COVID. In Europe, they postponed implementing the Medical Device Reporting regulation (21 CFR Part 803) that contains mandatory requirements for manufacturers, importers, and device-user facilities to report certain device-related adverse events and product problems to the FDA for at least another year.
What we see globally is regulations are becoming a little looser, which is fostering increasing levels of innovation. This reevaluation of regulations has undoubtedly helped get many new technologies implemented and adopted, and also created forward momentum for developing a new generation of medical devices and standard procedures. From a U.S. and European standpoint, there's strong alignment in this area. Just as the pandemic demanded collaboration among states within the U.S., it also encouraged the U.S. and European countries (including Ireland) to work more closely together. The experience has brought all agencies and industries to think in a much more synergistic manner, which has been a positive development.
Investing for Health
Enterprise Ireland partners with entrepreneurs, Irish businesses, and the research and investment communities to develop Ireland's international trade, innovation, leadership, and competitiveness. The organization represents over 4,500 client companies across a network of 40 overseas offices. Its client companies continue to prosper despite global challenges, with total export sales of 25.486 billion euros during 2020—an increase of 0.3 percent over 2019. North America represents 18 percent of Enterprise Ireland client company exports with 4.5 billion euros.
As of 2020, more than 900 Enterprise Ireland-supported companies were operating across the U.S., and over just the last two years, these companies established an additional 125 new presences. More than 110,000 people are now employed by Irish-owned companies in the United States, with Enterprise Ireland client companies directly employing more than 87,000 people.
Several Irish medtech companies have significant U.S. operations out of Boston, bringing excellent local employment, investments, and ideas to the city's already thriving tech ecosystem. Irish-based companies include NovaLeah, HealthBeacon, Applied Process, Nuritas, and SilverCloud Health. All of these Enterprise Ireland-supported companies continue to make a significant impact, adding jobs and providing innovative solutions and technologies in the Boston area.
Other examples of Irish companies excelling in the digital health space include Shimmer, a provider of wearable wireless sensor products and solutions; patientMpower, a digital healthcare company with solutions to ensure specialist healthcare teams can remotely monitor patients with respiratory conditions without the need for patients to attend the hospital; LetsGetChecked ships at-home health tests right to a patient’s front door; and the Salaso Health platform is a HIPAA-compliant and secure telemedicine service that allows healthcare providers to continue patient-centered care remotely.
Progressing Safely
As the demand for worn devices, remote patient monitoring, digital telemedicine, and other connected services continue to grow exponentially, not only are regulations and standards of care evolving rapidly, all these advances and disruptions will drive significant progress in cybersecurity and how patient data and privacy can be protected.
Cybersecurity within healthcare is becoming a big topic for public and private healthcare systems in the U.S., Europe, and globally. As organizations look to bring electronic patient records online and upload data to cloud-based systems so the information can be accessed by virtually any provider, anywhere, at any time, the data must be secure and protected.
This is a significant concern for the industry, and it's happening now. This is a fast-paced area of development that is still accelerating, with multiple players working to ensure the industry can stay on top of growing demands. Cybersecurity is a critical linchpin in the overall implementation of digital healthcare.
While the uptick in the use of telemedicine and devices last year was significant, it's only the beginning. There are still enormous gaps for digital health to fill, and device and service developments must go hand-in-hand with advancements in security. Just because we're changing the boundaries about how we engage with patients, that does not mean patient safety will be any less of a priority.
So far, from a cybersecurity and a digitization perspective, the FDA has been reliant on manufacturers to ensure their own devices, platforms, and software are secure. But as more and more adoption takes place, the FDA will need to come to the forefront and establish a consistent, unified approach for securing the entire healthcare, medtech, and medical device industries. Security and privacy regulations must be ironclad and apply to all technologies, no matter the sector or sub-sector.
As patients begin to control many aspects of their own healthcare, the privacy of an individual's data and information needs to be safeguarded. This is a big area where the FDA will be critical in ensuring that processes are in place to protect new types of data collection, sharing, and overall management.
Supply Chain Health
Another impact of the COVID experience has been its spotlight on the global supply chain within the healthcare industry. Supply chain health has always been an important issue in technology manufacturing. Its critical importance was exposed at the onset of the pandemic with the slowing of supply chains and finished goods from APAC and the resulting impact on many businesses in North America. A bad supply chain issue became a lot worse for many in the electronics industry last fall when a fire at Japanese chipmaker, AKM, resulted in significant component shortages.
Earlier this year, the importance of supply chain resilience was elevated by the White House as an issue of national security, and an executive order on resilient supply chains was issued. And when a strong gust of wind pushed the mega-sized container ship, Ever Given, off course in the Suez Canal in March, it blocked a critical East/West supply artery, causing billions of dollars in delays to the global economy. For these reasons, Enterprise Ireland works to maintain Ireland as a reliable and trusted partner from a supply chain perspective.
A change we're seeing now is companies are looking to move away from having a single, large supplier and instead, building relationships with multiple, smaller suppliers (often from different countries) they can pivot with in the event of a supply chain disruption. We are working closely alongside all of our client companies to ensure they have the latest, most accurate information with regard to the demands of the market, and the opportunities that exist for strategic supply chain relationships.
A needs-driven supply-chain strategy is something we have implemented within our life sciences team across all the different sub-sectors. The pandemic crystallized the value of a resilient supply chain strategy and forced companies to pivot into various sectors for innovative solutions.
A Dynamic Five-Year Outlook
Over the next five years, we're going to see not only all the changes we discussed in this article from a digitization perspective within all aspects of life sciences, but we're also going to see a high level of inflection points with healthcare and non-traditional industries.
For example, as medtech and healthcare become more digitized, there will be a greater reliance on communications technologies. We are engaging regularly with our colleagues and companies that focus on 5G and telecommunications technologies to help bring together ideas and potential partners to help move these integration rollouts forward efficiently and securely.
In addition to other industries in healthcare supporting roles, we will also see many traditional companies expand their roles, as well as non-traditional companies getting firmly into the healthcare space. We saw CVS, Walgreens, and Walmart step up with the vaccine rollout to help fill a healthcare void. JP Morgan just launched its own healthcare company. Google and Amazon have been very active within this space as well, and their global reach and command of cloud services will have a massive impact on the industry.
Irish companies have also shown their ability to pivot, and Enterprise Ireland recently helped facilitate an exciting partnership between small electric home and appliance icon Hamilton Beach and our client company HealthBeacon. HealthBeacon will provide a smart Injection Care Management System (ICMS) in the U.S. and Canada under the new brand name Hamilton Beach Health beginning in the fourth quarter of 2021.
The ICMS includes a new Smart Sharps Bin from Hamilton Beach Health, powered by HealthBeacon. Combined with its companion app, the system provides medication management reminders, tracks adherence, and provides for the safe and convenient disposal of used sharps through the U.S. Postal Service’s approved mail-back program.
HealthBeacon is the world's first and only FDA-cleared Smart Sharps Bin that intelligently helps patients on a broad range of chronic treatments for conditions such as diabetes, rheumatoid arthritis, multiple sclerosis, asthma, obesity, and migraines. Hamilton Beach Brands will be the exclusive marketer and distributor to the direct-to-consumer and retail channels in the U.S. and Canada. HealthBeacon will manufacture, activate the technology, manage data and security, and collect and replace the disposal bins. This is a unique, significant, trail-blazing go-to-market approach within the healthcare industry, but it's very much just the beginning.
With extensive expertise in medical technology and the pharma sector, Irish companies were able to pivot quickly when the pandemic hit. This resulted in Ireland being ranked fifth in the world for the export of COVID-19-related products and services and sixth in the global market of countries that responded best in terms of innovation to the pandemic.
Technology is enabling health organizations to become more efficient from a distance while at the same time, collecting more accurate, detailed, and pro-active information, ensuring new data platforms, devices, and approaches become critical in the healthcare industry.
Conclusion
The future of medtech is being developed now, and as we all move forward, Ireland is uniquely positioned with its thriving digital health sector to collaborate with global partners to achieve business goals and fast-track their roadmap to innovation.
Jennie Lynch is a senior market advisor and healthcare lead for Enterprise Ireland in the United States. She is based out of Enterprise Ireland’s Boston office, and manages a portfolio of more than 100 Irish life sciences companies with a focus on medtech, pharmaceuticals, and digital health sectors. Prior to joining Enterprise Ireland in 2018, Lynch was a senior client engagement manager for Lux Research in Boston.
The health and life science sectors have seen significant growth in remote diagnostic monitoring. This widespread use and acceptance is driving a very high level of new tech and product development. The combination of Ireland’s long history of supporting health technology upstarts, entrepreneurs, and established multinationals has positioned the country as a hotbed for development and innovation.
Enterprise Ireland, Ireland's trade and innovation agency that partners with Irish enterprises to help them grow, innovate, and win export sales in global markets, estimates there are roughly 180 domestic life sciences companies in Ireland employing more than 25,000 and generating annual sales of more than $6 billion. These indigenous life science companies include pharma, biotech, diagnostics, and therapeutics, but the lion's share is medical device businesses.
Telehealth and digital health innovations utilizing a sophisticated level of AI, data mining, cloud platform integrations, IoT devices, and patient self-help platforms are now firmly at the forefront of healthcare service development. We will see a high level of advancement specifically within homecare with deeper virtual interaction with healthcare professionals, including video-based virtual appointments. Brick and mortar hospitals and healthcare systems, emergency departments, and ICUs will also evolve to use data from these multiple collection points (live, real-time data as well as historical patient records) to provide improved, more responsive care and enhanced patient outcomes.
A Global Healthcare Disruption
In the U.S. in early 2020, digital telemedicine was utilized by roughly 11 percent of patients and clinicians. That percentage jumped substantially to 46 percent by the end of the year. From a digital technology perspective, over $3 billion of venture capital was invested into digital health within the last three quarters of 2020, illustrating an enormous pivot within V.C. investment and technology adoption.
While Europe and the U.S. operate on different playing fields, for the most part, the changes that we're seeing are being felt on both sides of the Atlantic. Regulation has been relaxed across the board from the FDA, as well as from a European Medical Agency perspective. In the U.S., we saw the Emergency Use Authorization (EUA) implementation for new technologies to combat COVID. In Europe, they postponed implementing the Medical Device Reporting regulation (21 CFR Part 803) that contains mandatory requirements for manufacturers, importers, and device-user facilities to report certain device-related adverse events and product problems to the FDA for at least another year.
What we see globally is regulations are becoming a little looser, which is fostering increasing levels of innovation. This reevaluation of regulations has undoubtedly helped get many new technologies implemented and adopted, and also created forward momentum for developing a new generation of medical devices and standard procedures. From a U.S. and European standpoint, there's strong alignment in this area. Just as the pandemic demanded collaboration among states within the U.S., it also encouraged the U.S. and European countries (including Ireland) to work more closely together. The experience has brought all agencies and industries to think in a much more synergistic manner, which has been a positive development.
Investing for Health
Enterprise Ireland partners with entrepreneurs, Irish businesses, and the research and investment communities to develop Ireland's international trade, innovation, leadership, and competitiveness. The organization represents over 4,500 client companies across a network of 40 overseas offices. Its client companies continue to prosper despite global challenges, with total export sales of 25.486 billion euros during 2020—an increase of 0.3 percent over 2019. North America represents 18 percent of Enterprise Ireland client company exports with 4.5 billion euros.
As of 2020, more than 900 Enterprise Ireland-supported companies were operating across the U.S., and over just the last two years, these companies established an additional 125 new presences. More than 110,000 people are now employed by Irish-owned companies in the United States, with Enterprise Ireland client companies directly employing more than 87,000 people.
Several Irish medtech companies have significant U.S. operations out of Boston, bringing excellent local employment, investments, and ideas to the city's already thriving tech ecosystem. Irish-based companies include NovaLeah, HealthBeacon, Applied Process, Nuritas, and SilverCloud Health. All of these Enterprise Ireland-supported companies continue to make a significant impact, adding jobs and providing innovative solutions and technologies in the Boston area.
Other examples of Irish companies excelling in the digital health space include Shimmer, a provider of wearable wireless sensor products and solutions; patientMpower, a digital healthcare company with solutions to ensure specialist healthcare teams can remotely monitor patients with respiratory conditions without the need for patients to attend the hospital; LetsGetChecked ships at-home health tests right to a patient’s front door; and the Salaso Health platform is a HIPAA-compliant and secure telemedicine service that allows healthcare providers to continue patient-centered care remotely.
Progressing Safely
As the demand for worn devices, remote patient monitoring, digital telemedicine, and other connected services continue to grow exponentially, not only are regulations and standards of care evolving rapidly, all these advances and disruptions will drive significant progress in cybersecurity and how patient data and privacy can be protected.
Cybersecurity within healthcare is becoming a big topic for public and private healthcare systems in the U.S., Europe, and globally. As organizations look to bring electronic patient records online and upload data to cloud-based systems so the information can be accessed by virtually any provider, anywhere, at any time, the data must be secure and protected.
This is a significant concern for the industry, and it's happening now. This is a fast-paced area of development that is still accelerating, with multiple players working to ensure the industry can stay on top of growing demands. Cybersecurity is a critical linchpin in the overall implementation of digital healthcare.
While the uptick in the use of telemedicine and devices last year was significant, it's only the beginning. There are still enormous gaps for digital health to fill, and device and service developments must go hand-in-hand with advancements in security. Just because we're changing the boundaries about how we engage with patients, that does not mean patient safety will be any less of a priority.
So far, from a cybersecurity and a digitization perspective, the FDA has been reliant on manufacturers to ensure their own devices, platforms, and software are secure. But as more and more adoption takes place, the FDA will need to come to the forefront and establish a consistent, unified approach for securing the entire healthcare, medtech, and medical device industries. Security and privacy regulations must be ironclad and apply to all technologies, no matter the sector or sub-sector.
As patients begin to control many aspects of their own healthcare, the privacy of an individual's data and information needs to be safeguarded. This is a big area where the FDA will be critical in ensuring that processes are in place to protect new types of data collection, sharing, and overall management.
Supply Chain Health
Another impact of the COVID experience has been its spotlight on the global supply chain within the healthcare industry. Supply chain health has always been an important issue in technology manufacturing. Its critical importance was exposed at the onset of the pandemic with the slowing of supply chains and finished goods from APAC and the resulting impact on many businesses in North America. A bad supply chain issue became a lot worse for many in the electronics industry last fall when a fire at Japanese chipmaker, AKM, resulted in significant component shortages.
Earlier this year, the importance of supply chain resilience was elevated by the White House as an issue of national security, and an executive order on resilient supply chains was issued. And when a strong gust of wind pushed the mega-sized container ship, Ever Given, off course in the Suez Canal in March, it blocked a critical East/West supply artery, causing billions of dollars in delays to the global economy. For these reasons, Enterprise Ireland works to maintain Ireland as a reliable and trusted partner from a supply chain perspective.
A change we're seeing now is companies are looking to move away from having a single, large supplier and instead, building relationships with multiple, smaller suppliers (often from different countries) they can pivot with in the event of a supply chain disruption. We are working closely alongside all of our client companies to ensure they have the latest, most accurate information with regard to the demands of the market, and the opportunities that exist for strategic supply chain relationships.
A needs-driven supply-chain strategy is something we have implemented within our life sciences team across all the different sub-sectors. The pandemic crystallized the value of a resilient supply chain strategy and forced companies to pivot into various sectors for innovative solutions.
A Dynamic Five-Year Outlook
Over the next five years, we're going to see not only all the changes we discussed in this article from a digitization perspective within all aspects of life sciences, but we're also going to see a high level of inflection points with healthcare and non-traditional industries.
For example, as medtech and healthcare become more digitized, there will be a greater reliance on communications technologies. We are engaging regularly with our colleagues and companies that focus on 5G and telecommunications technologies to help bring together ideas and potential partners to help move these integration rollouts forward efficiently and securely.
In addition to other industries in healthcare supporting roles, we will also see many traditional companies expand their roles, as well as non-traditional companies getting firmly into the healthcare space. We saw CVS, Walgreens, and Walmart step up with the vaccine rollout to help fill a healthcare void. JP Morgan just launched its own healthcare company. Google and Amazon have been very active within this space as well, and their global reach and command of cloud services will have a massive impact on the industry.
Irish companies have also shown their ability to pivot, and Enterprise Ireland recently helped facilitate an exciting partnership between small electric home and appliance icon Hamilton Beach and our client company HealthBeacon. HealthBeacon will provide a smart Injection Care Management System (ICMS) in the U.S. and Canada under the new brand name Hamilton Beach Health beginning in the fourth quarter of 2021.
The ICMS includes a new Smart Sharps Bin from Hamilton Beach Health, powered by HealthBeacon. Combined with its companion app, the system provides medication management reminders, tracks adherence, and provides for the safe and convenient disposal of used sharps through the U.S. Postal Service’s approved mail-back program.
HealthBeacon is the world's first and only FDA-cleared Smart Sharps Bin that intelligently helps patients on a broad range of chronic treatments for conditions such as diabetes, rheumatoid arthritis, multiple sclerosis, asthma, obesity, and migraines. Hamilton Beach Brands will be the exclusive marketer and distributor to the direct-to-consumer and retail channels in the U.S. and Canada. HealthBeacon will manufacture, activate the technology, manage data and security, and collect and replace the disposal bins. This is a unique, significant, trail-blazing go-to-market approach within the healthcare industry, but it's very much just the beginning.
With extensive expertise in medical technology and the pharma sector, Irish companies were able to pivot quickly when the pandemic hit. This resulted in Ireland being ranked fifth in the world for the export of COVID-19-related products and services and sixth in the global market of countries that responded best in terms of innovation to the pandemic.
Technology is enabling health organizations to become more efficient from a distance while at the same time, collecting more accurate, detailed, and pro-active information, ensuring new data platforms, devices, and approaches become critical in the healthcare industry.
Conclusion
The future of medtech is being developed now, and as we all move forward, Ireland is uniquely positioned with its thriving digital health sector to collaborate with global partners to achieve business goals and fast-track their roadmap to innovation.
Jennie Lynch is a senior market advisor and healthcare lead for Enterprise Ireland in the United States. She is based out of Enterprise Ireland’s Boston office, and manages a portfolio of more than 100 Irish life sciences companies with a focus on medtech, pharmaceuticals, and digital health sectors. Prior to joining Enterprise Ireland in 2018, Lynch was a senior client engagement manager for Lux Research in Boston.
