Michael Barbella, Managing Editor02.07.22
Lee knew something was wrong.
He was dizzy, nauseous, and feeling a bit...off. The vagueness of his symptoms immediately set Lee’s mind racing with unpleasant thoughts, thrusting him down the medical rabbit hole.
Then his heart began to race, beating so uncontrollably that Lee was convinced he was having a heart attack. Clinical tests ruled out a myocardial infarction but discovered the Chinese national suffered from atrial fibrillation (Afib)—an irregular, often very rapid heartbeat that can spawn blood clots in the heart and lead to both strokes and heart attacks.
Doctors traced Lee’s Afib to a heart valve malfunction and tried treating it—albeit unsuccessfully—with medication. Without drugs, Lee’s next best remedial option was pulmonary vein isolation cardiac ablation (PVI), an advanced nonsurgical treatment that neutralizes the abnormal electrical activity responsible for arrhythmias. PVI procedures are performed using a catheter, which burns or freezes small areas of the heart muscle; the resulting scar tissue prevents aberrant electrical signals from traveling through the pulmonary veins to the heart and triggering the arrhythmia. Conducted via radiofrequency or cry balloon, PVI procedures have yielded significant success rates, resolving the issue in 50 percent to 80 percent of Afib patients, depending on underlying factors such as prior heart disease.
While PVI has become a cornerstone of catheter-based Afib therapies over the last decade or so, the treatment is not widely available in China due to inadequate physician training. Nearly 10 million arrhythmia patients in the Middle Kingdom could potentially benefit from PVI, according to Johnson & Johnson, but only 900 doctors are currently trained and certified to perform the procedure (more than 11,000 patients per practitioner). The disparity essentially has hampered J&J’s efforts to boost the number of trained physicians.
That imbalance, however, could soon be allayed thanks to a resourceful solution from the Johnson & Johnson Medical Devices Procurement team. Armed with extensive research, the team asked 17 suppliers for ideas on quickly training Chinese doctors on Afib treatment techniques. Within six weeks, the team found its salvation in a solution that involved artificial intelligence and image recognition.
The winning idea uses video recordings as its basis (not unlike the existing system) but harvests the power of AI to accelerate the physician training cycle. Chinese doctors currently train on real or simulated PVI cases with a supervisor’s help—the physician’s actions are visually recorded and sent to an expert for evaluation and feedback, a process that typically takes a month or more due to the high volume of submissions and limited number of expert evaluators in the country. Doctors use the feedback to conduct another documented (presumably improved) procedure, and submit their recording for assessment. The process repeats until the physician is certified in PVI surgeries, which can take about 12-14 months.
The plan the Procurement team chose uses AI to compare a physician’s recording to thousands of recordings of successful PVI catheter ablations. Feedback is given within minutes, thus helping reduce certification time to an average of six months.
The new training procedure launched last fall and is expected to add 600 PVI-certified physicians to China’s workforce, enabling 120,000 additional life-saving procedures over the next three years, J&J claims.
J&J’s inventive solution to better physician training epitomizes the unconventional approach to research and development (R&D) many medtech manufacturers are pursuing in the wake of product pricing pressures, value-based care, and more recently, supply chain snafus triggered by a disruptive worldwide pandemic.
“When we complement internal efforts with [the] best external innovation, we achieve transformative solutions for our patients,” Ibraheem Badejo, senior R&D director for Ethicon External Front End Innovation at Johnson & Johnson Innovation, stated in a December 2021 MedTech Mini-Cast. “...innovation can come from anywhere.”
It certainly can. Since the turn of the millennium, innovation increasingly has come from government R&D initiatives, industry partnerships, and academic institutions. Singapore’s biomedical R&D center, for example, has produced both SARS and COVID-19 assays, H1N1 flu and dengue vaccines, and a cancer drug in the 18 years since its launch. The government-built center (Biopolis) also helped turn the sovereign city-state into a major Asia-Pacific research hub that has helped fuel Singapore’s $19.57 billion biomedical manufacturing industry. The sector expanded faster than Singapore’s overall manufacturing industry over the last two decades, posting a 9 percent CAGR and employing 24,384 workers, portioned 65-35 percent respectively between medical technology and pharmaceutical production, University of Cambridge data show.
“The design of Biopolis encourages sharing between business and research...” a February 2021 University report states. “The cluster does appear to foster this collaborative culture between researchers, businesses, and end-users, with a number of centres, memoranda, and consortia. For example, co-location of the Biopolis site with the National University of Singapore, the National University Hospital, the Lee Kong Chian School of Medicine, and the Duke-NUS Graduate Medical School offered close links to potential users of newly developed biomedical products and services.”
The same real estate tactic helped turn Galway, Ireland, into a global medtech mecca over the last 20 years. Home to world-renowned research academy NUI Galway, the city hosts more than a half-dozen top-ranked medical technology companies, including Alere, Beckman Coulter, Boston Scientific Corp., Medtronic plc, and Zimmer Biomet Holdings Inc. The 177-year-old university’s various research centers and initiatives are globally recognized as “go-to” hubs for medical device investigations and clinical trials.
The Lambe Institute for Translational Research is currently conducting more than 100 clinical trials on cancer, diabetes, and cardiovascular disease treatments, while the CORRIB Research Centre for Advanced Imaging is analyzing coronary artery bypass grafting based solely on non-invasive CT images of coronary arteries (FAST TRACK CABG study).
Meanwhile, CURAM - the Science Foundation Ireland Research Centre for Medical Devices is partnering with Boston University, Queens University Belfast, and the Georgia Institute of Technology to develop new cardiovascular disease treatments and large-scale transport mechanisms for high-quality therapeutic cells. CURAM and NUI Galway also leveraged their respective research prowess over the last two years to fight COVID-19, with the former devising a new cell therapy for severe SARS-CoV-2 patients, and the latter creating a handheld device for rapid testing.
“With the onset of COVID-19, innovations in diagnostics have taken center stage in the global healthcare market, including R&D,” noted Samir Parikh, global vice president of R&D and Clinical Affairs at Hologic. “The global pandemic created a challenging time for diagnostic R&D, but already fostered a lot of opportunities for innovation and unique collaborations to address the numerous diagnostic challenges we’re facing as a society today.”
Indeed, a spirit of partnership helped companies successfully conduct R&D during a pandemic. Medtech manufacturers, drug developers, biotech firms, academic institutions, public health establishments and non-healthcare businesses battled the virus through shared data, know-how and ideas.
University of Exeter spinout Attomarker, for instance, paired with Mantracourt Electronics to develop a COVID-19 triple antibody testing device that differentiates the source of antigens (vaccination or previous infection). Mantracourt designed the product’s power distribution module, USB components, and the USB hub, and replaced several cables. Overall, the microelectronic provider improved the kit while reducing costs by roughly 60 percent and reducing noise.
Similarly, privately held NanoDx Inc. teamed up with IBM Research and SkyWater to boost and expand precise, rapid testing for SARS-CoV-2 and several other conditions. NanoDx tapped IBM Research for its metal oxide semi-conductive compatible nanoscale sensors and SkyWater for help in scaling the product. NanoDx’s two-minute point-of-care COVID-19 test is designed to detect and quantify biomarkers (analytes) from a small fluid specimen.
“We’ve seen a heightened focus in the diagnostic market, particularly around PCR and rapid antigen tests to detect COVID-19. While the growth in this industry has been quite large, we think that the concept of testing, although not new, will remain for years to come,” explained Scott Payne, senior project engineer for TEAM Technologies, a Morristown, Tenn.-based “end-to-end” manufacturing solutions provider for medical device and dental products. “The level of technology in the [lateral flow assay] LFA/IVD sector has been propelled forward tremendously due to COVID testing creating the need for high volumes of test manufacturing, ease of testing requirements (self-test focus), and information-sharing (contact tracing, connectivity) integrated into the product.”
Remote Research
Driven by the need to understand and combat COVID-19, the global healthcare community mobilized and collaborated in unprecedented ways over the last two years. The pandemic blurred the lines between rival medtech and pharmaceutical firms, significantly accelerating both vaccine and therapeutic product development.
Medtronic dauntlessly broke down competitive barriers in March 2020 by publicly sharing design specifications for its portable Puritan Bennett 560 ventilator. The company posted schematics, product manuals, design files, and software code to its website to help address growing worldwide demand for the life-saving machines; within a week of the posting, more than 90,000 people had registered for the Puritan Bennett blueprint.
Open sourcing the ventilator plans was a bold move for Medtronic, considering the multinational has long been accustomed to protecting its IP. But it was a savvy deed too, as it catapulted the company to the forefront of a new approach to professional collaboration and medical R&D that could very well outlast the pandemic.
Besides spawning unconventional and oftentimes unique collaborations, SARS-CoV-2 forced the corporate world to adopt virtual (remote-operated) business models to ensure operational continuity. Digital interactions replaced in-person communication, prompting shifts in non-patient-facing activities, including quality, regulatory affairs, and R&D.
“The most significant change brought on by COVID-19 has been the introduction of remote R&D work,” Hologic’s Parikh said. “To ensure our employees’ safety during the onset of COVID-19, we transitioned to a remote work environment. As a company, we had minimal experience with facilitating remote R&D work, particularly for capital equipment. Our team dedicated a lot of energy to ensuring everybody felt comfortable working remotely, putting the proper technologies in place to ensure success, and doubling down on our communication pathways to help work continue. While our foundational approach to R&D has remained the same, remote work challenged us to collaborate and communicate in new ways to ensure ongoing innovation.”
And those new ways paid off: In fiscal 2020, Hologic developed and launched the Aptima SARS-CoV-2 assay, which runs on the Panther system, and the Panther Fusion SARS-CoV-2 real-time in-vitro diagnostic, which runs on the Panther Fusion system.
Boston Scientific Corp. maintained its R&D mojo as well in the pandemic’s early days: The medtech behemoth partnered with custom packaging provider Prent Thermoforming (a division of Prent Corporation) to manufacture face shields for front-line workers.
Boston Scientific, Hologic, and countless other medical device companies used the latest digital communication tools (Zoom, Slack, G Suite) to help employees stay connected and productive while the world shut down. These platforms have been particularly useful for medtech firms conducting clinical research, as they helped ensure the continuity of product trials amid lockdowns and intermittent coronavirus-mandated restrictions.
Trial continuity, however, is not the only benefit of virtual (decentralized) studies. Such an approach also can accelerate the pace of innovation, broaden a trial’s geographic coverage, and recruit lower-income and underrepresented populations that previously could not participate in clinical investigations. The latter two advantages can help improve trial participant diversity and scientific outcomes.
“The COVID-19 pandemic challenged the traditional approach to clinical trials, which required participants to travel to brick-and-morter study sites,” Reynold Panettieri Jr., vice chancellor for translational medicine and science, and director of the Rutgers University Institute for Translational Medicine, told Rutgers Today last fall. “A crisis requires a nimble approach. Virtual clinical trials...are fundamentally changing the way the industry conducts clinical trials.”
They’re changing clinical trial composition outside the industry, too. Rutgers has taken a decentralized approach to several studies, including a trial to better understand COVID-19 testing patterns among underserved and vulnerable populations, and an investigation into the efficacy of a probiotic-based immunity “booster” for unvaccinated people with prior SARS-CoV-2 infections.
Rutgers enlisted telehealth giant Vault Medical Services to oversee trial recruitment and diagnostics. Study subjects participate remotely through virtual data collection and telemedicine consultations, and evidence is collected through home computers, smartphones or devices, and clinician visits.
Though the studies are ongoing, the decentralized approach has already yielded positive results. Rutgers credits the virtual platform with reducing trial costs and recruitment time (the latter by 50 percent), and expanding both the geographic reach and diversity of participants.
“As our logistics went virtual, we took an Amazon-like approach to clinical trials, obtaining specimens through FedEx and collecting data from people without requiring them to leave their homes,” Panettieri said. “This at-home clinical trial format has broadened the population who can participate, such as lower-income and underrepresented participants, who were previously unable to engage in clinical trials due to work schedules or transportation access, and has allowed us to broaden the studies’ geographic coverage.”
Broaden it quite considerably, actually: Using Vault’s SARS-CoV-2 testing database and social media, the immunity booster study team recruited participants in five states spread over 1,500 miles (New York, New Jersey, Georgia, Minnesota, and Texas).
The coronavirus testing pattern cohort, on the other hand, used the virtual trial model to maximize engagement and participant diversification. The study (NJ HEROES) aimed to better understand COVID-19’s effects on Blacks and Latinos—two historically under-represented clinical trial populations—and increase testing among both minority groups. Vault provided remote testing kits for each of the study’s 1,963 participants in four New Jersey counties where Rutgers academic medical centers are located.
With improved patient engagement and diversity, and lower costs, decentralized clinical trials are bound to become more commonplace in the near term as telehealth and mobile technology make it increasingly easier and more convenient for people to participate in scientific research. But that ease and convenience comes at a price—namely, more responsibility for study subjects.
Since virtual trial participants are left mostly to their own devices (no pun intended) they end up shouldering more responsibility in study processes and outcomes. Without formal trial administrators, for example, patients are charged with receiving the investigational product, completing study assessments, recording data, and troubleshooting equipment or technical issues, the latter of which can be difficult for older populations and those who are not technologically savvy.
Additionally, patients in decentralized trials can easily skew results by mishandling products or lacking knowledge of the investigational device(s). Moreover, these products are tested in unsterile environments, which can cause data discrepancies or unforeseen (medical) complications.
Perhaps most importantly, though, virtual studies lack the physical contact some patients crave and many clinical investigations require (particularly for implantable devices like stents, catheters, or pacemakers).
“Virtual interaction has replaced in-person meetings during COVID-19 and it will continue,” stated Michael McShane, project engineer at Flambeau Inc., a thermoplastics manufacturer headquartered in Baraboo, Wis. “It has helped by providing an alternative to a phone call and provided an opportunity to collaborate while still isolating. However, it hurt camaraderie and collaboration, and the best ideas are not always shared virtually, due to an underlying skepticism of the technology.”
R&D Funding Outlets
Despite changes to the clinical research process, medtech product development still follows the same pathway, yielding either incremental improvements to existing solutions or truly transformational innovation.
For much of the last two decades, device manufacturers have funneled R&D dollars into incremental products. One of the best examples of this type of innovation is Medtronic’s MiniMed Insulin Pump portfolio: Each successive model offers new features and system upgrades. The 530G device automatically suspends insulin delivery when a patient’s blood sugar levels are dangerously low, while the waterproof 630G version features a color screen with auto brightness and airplane mode for travel. The 670G edition automatically adjusts insulin levels every five minutes, and the 770G variant connects via Bluetooth to smartphones.
“New features and benefits introduced in new products were not broadly transformative,” said Tom Zarella, marketing director for medical device design firm Concise Engineering Inc. of Clearwater, Fla. “This is true of most medical device products entering the market. Beyond R&D investment, transformative change in the medical device field takes time and money to permit the clinical adoption of the innovative technology and in some cases, wait for the newly trained healthcare workers to adopt innovative technology. This longer-term adoption trend is commonplace and requires endurance, persistence, and appropriate funding to finance the wait until the realization of the anticipated revenue.”
It also takes teamwork. Transformational innovation often isn’t possible without an able partner.
Case in point: J&J is collaborating with Microsoft to build a cloud-connected software platform for its digital surgery ecosystem. Using Microsoft’s Azure cloud, artificial intelligence, and machine learning, J&J is aiming to improve patient outcomes, increase device connectivity, and accelerate digital innovation and transformation in digital surgery.
“Companies appear to be allocating more R&D dollars to transformational innovation because as they grow and consolidate, they need blockbuster products to maintain their growth trajectory,” noted Michael Hoch, vice president of R&D at Plano, Texas-based Integer Holdings Corporation, a medical device outsource manufacturer serving the cardiac, neuromodulation, vascular, and portable medical markets. “They are also focused more on transformational innovation because most companies have a network of external development and manufacturing partners they can rely on for complex subassemblies and complementary products that are more incremental in nature.”
Innovation type, however, hasn’t been as important lately as product genre. Over the last 24 months, many medtech firms have shifted gears to focus their R&D efforts on COVID-19 -related diagnostic solutions.
Companies like Hologic, Roche Holding AG, Abbott, Quest Diagnostics, Becton Dickinson and Company, Thermo Fisher Scientific Inc., and numerous others quickly pivoted during the pandemic’s early days to devise tests to detect SARS-CoV-2 infections, while multinational drug developers (Pfizer, Moderna, J&J) poured billions of dollars and innumerable manhours into vaccine research.
“There has been a major outpouring of investment in 2021. This usually occurs for a number of reasons, but we have seen a huge interest in diagnostics due to the COVID-19 crisis,” stated Steve Maylish, chief commercial officer of Fusion Biotec, a product development firm headquartered in Orange, Calif. “Fusion has been asked to do transformational and incremental innovation. Much of it has centered around providing lab quality results in a point-of-care device. This can involve miniaturization, inventing a new way of applying an existing technology, or providing a new technical solution.”
Those technical solutions will likely require more technical tools, too. AI, machine learning, data analytics, device connectivity, and global partnerships will help fuel medtech R&D in the decades ahead, experts contend.
“The approach to R&D will remain constant in the foreseeable future, but the tools we use will become more sophisticated,” Payne said. “Whether it is software, artificial intelligence, global collaboration, blockchain technology, etc., these tools will enable research, design, and development of advanced processes and equipment used to power the science of R&D itself.”
Power on.
He was dizzy, nauseous, and feeling a bit...off. The vagueness of his symptoms immediately set Lee’s mind racing with unpleasant thoughts, thrusting him down the medical rabbit hole.
Then his heart began to race, beating so uncontrollably that Lee was convinced he was having a heart attack. Clinical tests ruled out a myocardial infarction but discovered the Chinese national suffered from atrial fibrillation (Afib)—an irregular, often very rapid heartbeat that can spawn blood clots in the heart and lead to both strokes and heart attacks.
Doctors traced Lee’s Afib to a heart valve malfunction and tried treating it—albeit unsuccessfully—with medication. Without drugs, Lee’s next best remedial option was pulmonary vein isolation cardiac ablation (PVI), an advanced nonsurgical treatment that neutralizes the abnormal electrical activity responsible for arrhythmias. PVI procedures are performed using a catheter, which burns or freezes small areas of the heart muscle; the resulting scar tissue prevents aberrant electrical signals from traveling through the pulmonary veins to the heart and triggering the arrhythmia. Conducted via radiofrequency or cry balloon, PVI procedures have yielded significant success rates, resolving the issue in 50 percent to 80 percent of Afib patients, depending on underlying factors such as prior heart disease.
While PVI has become a cornerstone of catheter-based Afib therapies over the last decade or so, the treatment is not widely available in China due to inadequate physician training. Nearly 10 million arrhythmia patients in the Middle Kingdom could potentially benefit from PVI, according to Johnson & Johnson, but only 900 doctors are currently trained and certified to perform the procedure (more than 11,000 patients per practitioner). The disparity essentially has hampered J&J’s efforts to boost the number of trained physicians.
That imbalance, however, could soon be allayed thanks to a resourceful solution from the Johnson & Johnson Medical Devices Procurement team. Armed with extensive research, the team asked 17 suppliers for ideas on quickly training Chinese doctors on Afib treatment techniques. Within six weeks, the team found its salvation in a solution that involved artificial intelligence and image recognition.
The winning idea uses video recordings as its basis (not unlike the existing system) but harvests the power of AI to accelerate the physician training cycle. Chinese doctors currently train on real or simulated PVI cases with a supervisor’s help—the physician’s actions are visually recorded and sent to an expert for evaluation and feedback, a process that typically takes a month or more due to the high volume of submissions and limited number of expert evaluators in the country. Doctors use the feedback to conduct another documented (presumably improved) procedure, and submit their recording for assessment. The process repeats until the physician is certified in PVI surgeries, which can take about 12-14 months.
The plan the Procurement team chose uses AI to compare a physician’s recording to thousands of recordings of successful PVI catheter ablations. Feedback is given within minutes, thus helping reduce certification time to an average of six months.
The new training procedure launched last fall and is expected to add 600 PVI-certified physicians to China’s workforce, enabling 120,000 additional life-saving procedures over the next three years, J&J claims.
J&J’s inventive solution to better physician training epitomizes the unconventional approach to research and development (R&D) many medtech manufacturers are pursuing in the wake of product pricing pressures, value-based care, and more recently, supply chain snafus triggered by a disruptive worldwide pandemic.
“When we complement internal efforts with [the] best external innovation, we achieve transformative solutions for our patients,” Ibraheem Badejo, senior R&D director for Ethicon External Front End Innovation at Johnson & Johnson Innovation, stated in a December 2021 MedTech Mini-Cast. “...innovation can come from anywhere.”
It certainly can. Since the turn of the millennium, innovation increasingly has come from government R&D initiatives, industry partnerships, and academic institutions. Singapore’s biomedical R&D center, for example, has produced both SARS and COVID-19 assays, H1N1 flu and dengue vaccines, and a cancer drug in the 18 years since its launch. The government-built center (Biopolis) also helped turn the sovereign city-state into a major Asia-Pacific research hub that has helped fuel Singapore’s $19.57 billion biomedical manufacturing industry. The sector expanded faster than Singapore’s overall manufacturing industry over the last two decades, posting a 9 percent CAGR and employing 24,384 workers, portioned 65-35 percent respectively between medical technology and pharmaceutical production, University of Cambridge data show.
“The design of Biopolis encourages sharing between business and research...” a February 2021 University report states. “The cluster does appear to foster this collaborative culture between researchers, businesses, and end-users, with a number of centres, memoranda, and consortia. For example, co-location of the Biopolis site with the National University of Singapore, the National University Hospital, the Lee Kong Chian School of Medicine, and the Duke-NUS Graduate Medical School offered close links to potential users of newly developed biomedical products and services.”
The same real estate tactic helped turn Galway, Ireland, into a global medtech mecca over the last 20 years. Home to world-renowned research academy NUI Galway, the city hosts more than a half-dozen top-ranked medical technology companies, including Alere, Beckman Coulter, Boston Scientific Corp., Medtronic plc, and Zimmer Biomet Holdings Inc. The 177-year-old university’s various research centers and initiatives are globally recognized as “go-to” hubs for medical device investigations and clinical trials.
The Lambe Institute for Translational Research is currently conducting more than 100 clinical trials on cancer, diabetes, and cardiovascular disease treatments, while the CORRIB Research Centre for Advanced Imaging is analyzing coronary artery bypass grafting based solely on non-invasive CT images of coronary arteries (FAST TRACK CABG study).
Meanwhile, CURAM - the Science Foundation Ireland Research Centre for Medical Devices is partnering with Boston University, Queens University Belfast, and the Georgia Institute of Technology to develop new cardiovascular disease treatments and large-scale transport mechanisms for high-quality therapeutic cells. CURAM and NUI Galway also leveraged their respective research prowess over the last two years to fight COVID-19, with the former devising a new cell therapy for severe SARS-CoV-2 patients, and the latter creating a handheld device for rapid testing.
“With the onset of COVID-19, innovations in diagnostics have taken center stage in the global healthcare market, including R&D,” noted Samir Parikh, global vice president of R&D and Clinical Affairs at Hologic. “The global pandemic created a challenging time for diagnostic R&D, but already fostered a lot of opportunities for innovation and unique collaborations to address the numerous diagnostic challenges we’re facing as a society today.”
Indeed, a spirit of partnership helped companies successfully conduct R&D during a pandemic. Medtech manufacturers, drug developers, biotech firms, academic institutions, public health establishments and non-healthcare businesses battled the virus through shared data, know-how and ideas.
University of Exeter spinout Attomarker, for instance, paired with Mantracourt Electronics to develop a COVID-19 triple antibody testing device that differentiates the source of antigens (vaccination or previous infection). Mantracourt designed the product’s power distribution module, USB components, and the USB hub, and replaced several cables. Overall, the microelectronic provider improved the kit while reducing costs by roughly 60 percent and reducing noise.
Similarly, privately held NanoDx Inc. teamed up with IBM Research and SkyWater to boost and expand precise, rapid testing for SARS-CoV-2 and several other conditions. NanoDx tapped IBM Research for its metal oxide semi-conductive compatible nanoscale sensors and SkyWater for help in scaling the product. NanoDx’s two-minute point-of-care COVID-19 test is designed to detect and quantify biomarkers (analytes) from a small fluid specimen.
“We’ve seen a heightened focus in the diagnostic market, particularly around PCR and rapid antigen tests to detect COVID-19. While the growth in this industry has been quite large, we think that the concept of testing, although not new, will remain for years to come,” explained Scott Payne, senior project engineer for TEAM Technologies, a Morristown, Tenn.-based “end-to-end” manufacturing solutions provider for medical device and dental products. “The level of technology in the [lateral flow assay] LFA/IVD sector has been propelled forward tremendously due to COVID testing creating the need for high volumes of test manufacturing, ease of testing requirements (self-test focus), and information-sharing (contact tracing, connectivity) integrated into the product.”
Remote Research
Driven by the need to understand and combat COVID-19, the global healthcare community mobilized and collaborated in unprecedented ways over the last two years. The pandemic blurred the lines between rival medtech and pharmaceutical firms, significantly accelerating both vaccine and therapeutic product development.
Medtronic dauntlessly broke down competitive barriers in March 2020 by publicly sharing design specifications for its portable Puritan Bennett 560 ventilator. The company posted schematics, product manuals, design files, and software code to its website to help address growing worldwide demand for the life-saving machines; within a week of the posting, more than 90,000 people had registered for the Puritan Bennett blueprint.
Open sourcing the ventilator plans was a bold move for Medtronic, considering the multinational has long been accustomed to protecting its IP. But it was a savvy deed too, as it catapulted the company to the forefront of a new approach to professional collaboration and medical R&D that could very well outlast the pandemic.
Besides spawning unconventional and oftentimes unique collaborations, SARS-CoV-2 forced the corporate world to adopt virtual (remote-operated) business models to ensure operational continuity. Digital interactions replaced in-person communication, prompting shifts in non-patient-facing activities, including quality, regulatory affairs, and R&D.
“The most significant change brought on by COVID-19 has been the introduction of remote R&D work,” Hologic’s Parikh said. “To ensure our employees’ safety during the onset of COVID-19, we transitioned to a remote work environment. As a company, we had minimal experience with facilitating remote R&D work, particularly for capital equipment. Our team dedicated a lot of energy to ensuring everybody felt comfortable working remotely, putting the proper technologies in place to ensure success, and doubling down on our communication pathways to help work continue. While our foundational approach to R&D has remained the same, remote work challenged us to collaborate and communicate in new ways to ensure ongoing innovation.”
And those new ways paid off: In fiscal 2020, Hologic developed and launched the Aptima SARS-CoV-2 assay, which runs on the Panther system, and the Panther Fusion SARS-CoV-2 real-time in-vitro diagnostic, which runs on the Panther Fusion system.
Boston Scientific Corp. maintained its R&D mojo as well in the pandemic’s early days: The medtech behemoth partnered with custom packaging provider Prent Thermoforming (a division of Prent Corporation) to manufacture face shields for front-line workers.
Boston Scientific, Hologic, and countless other medical device companies used the latest digital communication tools (Zoom, Slack, G Suite) to help employees stay connected and productive while the world shut down. These platforms have been particularly useful for medtech firms conducting clinical research, as they helped ensure the continuity of product trials amid lockdowns and intermittent coronavirus-mandated restrictions.
Trial continuity, however, is not the only benefit of virtual (decentralized) studies. Such an approach also can accelerate the pace of innovation, broaden a trial’s geographic coverage, and recruit lower-income and underrepresented populations that previously could not participate in clinical investigations. The latter two advantages can help improve trial participant diversity and scientific outcomes.
“The COVID-19 pandemic challenged the traditional approach to clinical trials, which required participants to travel to brick-and-morter study sites,” Reynold Panettieri Jr., vice chancellor for translational medicine and science, and director of the Rutgers University Institute for Translational Medicine, told Rutgers Today last fall. “A crisis requires a nimble approach. Virtual clinical trials...are fundamentally changing the way the industry conducts clinical trials.”
They’re changing clinical trial composition outside the industry, too. Rutgers has taken a decentralized approach to several studies, including a trial to better understand COVID-19 testing patterns among underserved and vulnerable populations, and an investigation into the efficacy of a probiotic-based immunity “booster” for unvaccinated people with prior SARS-CoV-2 infections.
Rutgers enlisted telehealth giant Vault Medical Services to oversee trial recruitment and diagnostics. Study subjects participate remotely through virtual data collection and telemedicine consultations, and evidence is collected through home computers, smartphones or devices, and clinician visits.
Though the studies are ongoing, the decentralized approach has already yielded positive results. Rutgers credits the virtual platform with reducing trial costs and recruitment time (the latter by 50 percent), and expanding both the geographic reach and diversity of participants.
“As our logistics went virtual, we took an Amazon-like approach to clinical trials, obtaining specimens through FedEx and collecting data from people without requiring them to leave their homes,” Panettieri said. “This at-home clinical trial format has broadened the population who can participate, such as lower-income and underrepresented participants, who were previously unable to engage in clinical trials due to work schedules or transportation access, and has allowed us to broaden the studies’ geographic coverage.”
Broaden it quite considerably, actually: Using Vault’s SARS-CoV-2 testing database and social media, the immunity booster study team recruited participants in five states spread over 1,500 miles (New York, New Jersey, Georgia, Minnesota, and Texas).
The coronavirus testing pattern cohort, on the other hand, used the virtual trial model to maximize engagement and participant diversification. The study (NJ HEROES) aimed to better understand COVID-19’s effects on Blacks and Latinos—two historically under-represented clinical trial populations—and increase testing among both minority groups. Vault provided remote testing kits for each of the study’s 1,963 participants in four New Jersey counties where Rutgers academic medical centers are located.
With improved patient engagement and diversity, and lower costs, decentralized clinical trials are bound to become more commonplace in the near term as telehealth and mobile technology make it increasingly easier and more convenient for people to participate in scientific research. But that ease and convenience comes at a price—namely, more responsibility for study subjects.
Since virtual trial participants are left mostly to their own devices (no pun intended) they end up shouldering more responsibility in study processes and outcomes. Without formal trial administrators, for example, patients are charged with receiving the investigational product, completing study assessments, recording data, and troubleshooting equipment or technical issues, the latter of which can be difficult for older populations and those who are not technologically savvy.
Additionally, patients in decentralized trials can easily skew results by mishandling products or lacking knowledge of the investigational device(s). Moreover, these products are tested in unsterile environments, which can cause data discrepancies or unforeseen (medical) complications.
Perhaps most importantly, though, virtual studies lack the physical contact some patients crave and many clinical investigations require (particularly for implantable devices like stents, catheters, or pacemakers).
“Virtual interaction has replaced in-person meetings during COVID-19 and it will continue,” stated Michael McShane, project engineer at Flambeau Inc., a thermoplastics manufacturer headquartered in Baraboo, Wis. “It has helped by providing an alternative to a phone call and provided an opportunity to collaborate while still isolating. However, it hurt camaraderie and collaboration, and the best ideas are not always shared virtually, due to an underlying skepticism of the technology.”
R&D Funding Outlets
Despite changes to the clinical research process, medtech product development still follows the same pathway, yielding either incremental improvements to existing solutions or truly transformational innovation.
For much of the last two decades, device manufacturers have funneled R&D dollars into incremental products. One of the best examples of this type of innovation is Medtronic’s MiniMed Insulin Pump portfolio: Each successive model offers new features and system upgrades. The 530G device automatically suspends insulin delivery when a patient’s blood sugar levels are dangerously low, while the waterproof 630G version features a color screen with auto brightness and airplane mode for travel. The 670G edition automatically adjusts insulin levels every five minutes, and the 770G variant connects via Bluetooth to smartphones.
“New features and benefits introduced in new products were not broadly transformative,” said Tom Zarella, marketing director for medical device design firm Concise Engineering Inc. of Clearwater, Fla. “This is true of most medical device products entering the market. Beyond R&D investment, transformative change in the medical device field takes time and money to permit the clinical adoption of the innovative technology and in some cases, wait for the newly trained healthcare workers to adopt innovative technology. This longer-term adoption trend is commonplace and requires endurance, persistence, and appropriate funding to finance the wait until the realization of the anticipated revenue.”
It also takes teamwork. Transformational innovation often isn’t possible without an able partner.
Case in point: J&J is collaborating with Microsoft to build a cloud-connected software platform for its digital surgery ecosystem. Using Microsoft’s Azure cloud, artificial intelligence, and machine learning, J&J is aiming to improve patient outcomes, increase device connectivity, and accelerate digital innovation and transformation in digital surgery.
“Companies appear to be allocating more R&D dollars to transformational innovation because as they grow and consolidate, they need blockbuster products to maintain their growth trajectory,” noted Michael Hoch, vice president of R&D at Plano, Texas-based Integer Holdings Corporation, a medical device outsource manufacturer serving the cardiac, neuromodulation, vascular, and portable medical markets. “They are also focused more on transformational innovation because most companies have a network of external development and manufacturing partners they can rely on for complex subassemblies and complementary products that are more incremental in nature.”
Innovation type, however, hasn’t been as important lately as product genre. Over the last 24 months, many medtech firms have shifted gears to focus their R&D efforts on COVID-19 -related diagnostic solutions.
Companies like Hologic, Roche Holding AG, Abbott, Quest Diagnostics, Becton Dickinson and Company, Thermo Fisher Scientific Inc., and numerous others quickly pivoted during the pandemic’s early days to devise tests to detect SARS-CoV-2 infections, while multinational drug developers (Pfizer, Moderna, J&J) poured billions of dollars and innumerable manhours into vaccine research.
“There has been a major outpouring of investment in 2021. This usually occurs for a number of reasons, but we have seen a huge interest in diagnostics due to the COVID-19 crisis,” stated Steve Maylish, chief commercial officer of Fusion Biotec, a product development firm headquartered in Orange, Calif. “Fusion has been asked to do transformational and incremental innovation. Much of it has centered around providing lab quality results in a point-of-care device. This can involve miniaturization, inventing a new way of applying an existing technology, or providing a new technical solution.”
Those technical solutions will likely require more technical tools, too. AI, machine learning, data analytics, device connectivity, and global partnerships will help fuel medtech R&D in the decades ahead, experts contend.
“The approach to R&D will remain constant in the foreseeable future, but the tools we use will become more sophisticated,” Payne said. “Whether it is software, artificial intelligence, global collaboration, blockchain technology, etc., these tools will enable research, design, and development of advanced processes and equipment used to power the science of R&D itself.”
Power on.
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Outsourcing provides numerous benefits to medical device manufacturers: flexibility, accelerated time to market, access to expertise, increased efficiency, variable capacity, and cost savings. But seeking outside assistance with research and development is not always an easy choice due to the risks associated with the practice. The decision to outsource ultimately depends on various factors, including company size, product in development, market forces, regulatory challenges, and funding. While there are no set rules for outsourcing R&D most medtech firms adhere to the following guidelines when considering their outsourcing options:
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