Seth Goldenberg, Ph.D., Vice President, MedTech, Veeva Systems06.02.21
While COVID-19 brought uncertainty and disruption, it also accelerated innovation in medtech. Organizations and health authorities worked together to develop diagnostic tests and devices faster than ever before due to new, digital ways of working across product development.
However, more work lies ahead as companies prepare for higher market demand of medtech products1 and changes in regulations like EU MDR (Medical Device Regulation) and its accompanying IVDR. Organizations will continue to embrace digital solutions to transform how they work and speed the total product lifecycle. Following are four ways digital will drive positive change in medtech.
1. Increasing Evidence Requirements Will Force Clinical Data Management Modernization
Medtech studies have grown increasingly complex, requiring data collection and analysis on a scale much larger than ever before. Companies have to deal with growing volumes of information and new requirements from the EU MDR that place greater scrutiny on data management throughout the total product lifecycle.
To keep up with evolving regulations and the growing complexity of studies, we expect an industry shift toward more connected, digital, and transparent ways of managing clinical data. Modern systems will be crucial for tracking, analyzing, and sharing more extensive and diverse data sets both pre- and post-market. They'll also allow companies to better integrate real-world data from mobile devices and wearables with the information they're collecting in controlled settings.
Manual processes and legacy systems are no longer sufficient in this new age when accurate and meticulous data collection is of utmost importance. The companies that invest in digital cloud systems will speed clinical development and gain the agility they need to adapt for the future.
2. Growing Inspections and Audits Will Drive Large-Scale Quality Transformation
In 2019, the FDA issued 49 Class I recalls—the most the industry has witnessed in the last four years.2 Meanwhile, non-routine external quality events—such as FDA 483s, warning letters, and consent decrees—have cost the industry an average of $7.5 billion to $9.5 billion per year.3
Realizing the need to improve quality processes while innovating, many companies seek more advanced quality management systems (QMS) that will enable greater collaboration between internal teams, external partners, and regulators. Once the challenges stemming from the pandemic start to fade, medtech organizations will notice an increase in health authority inspections, making it an especially critical time to drive large-scale quality transformation.
With companies now required to demonstrate product quality using real-time data collected during post-market surveillance, fully automated electronic health authority submissions and non-electronic submission outputs will help ensure timely adverse event reporting and more proactive complaints handling. We can also expect improved applicability of advanced technology such as artificial intelligence (AI), which has been emerging within quality management, to help organizations maximize predictability.
A continued focus on remote inspections and audits as well as post-market surveillance will fuel transformation in lateral areas such as recall management and device tracking. These efforts will ultimately help companies comply with evolving regulations and drive industry-wide improvement across product quality and patient safety.
3. The Shift to Remote Auditing Will Digitize Quality and Improve Supply Chain Continuity
When COVID-19 hit, the Medical Device Coordination Group (MDCG) approved the use of remote auditing in specific cases to help ensure the continued supply of medical devices. While these changes were initially made out of necessity, auditing groups and medtech companies increasingly find remote audits to be a vastly efficient alternative to the traditional, in-person way of working.
As a result, remote auditing will become a permanent component of the quality workflow, even once travel and onsite restrictions are lifted. Not only will auditors be able to access required files more quickly, collaboration across regulatory, quality, and clinical teams will improve. Longer-term, the shift to remote auditing will drive companies to digitize quality processes and improve supply chain continuity.
The companies that invest in modern digital quality systems will be better positioned to reap the benefits of remote auditing. With content and data stored and accessed in one central application, they won't have to worry about updating multiple files in different systems, making information sharing much speedier and simpler. As teams get used to new ways of working, we'll experience less reliance on paper, fewer onsite audits, and a much more sustainable model for the future.
4. Claims Management Will Become More Important as Commercial Models Evolve
COVID-19 has decreased the number of face-to-face interactions between HCPs and sales, so many companies have invested heavily in broad-reach marketing methods—for example, television advertising—to get in front of customers. But this greater push toward direct-to-consumer marketing intensified the need for solid claims management and coordination between regulatory and commercial teams.
Reacting to this, companies will make a concerted effort to better manage creation and usage of marketing and product claims across the organization. With more connected systems and processes, marketing teams will have the necessary clarity concerning permitted claims or usage limitations. The legal and regulatory teams will gain visibility into how claims are being used at the local level.
Modernization efforts will ensure regulatory compliance, reduced risk, and help companies gain greater insight into their claims' effectiveness concerning marketing campaign performance. Moving forward, integrated claims management will create compelling upstream and downstream effects that can accelerate time-to-market and strengthen brand perception.
Digital Drives Improvements Across Product Development
COVID-19 accelerated the shift to more modern, digital ways of working out of necessity. But the question remains: Will medtech product development return to its former state post-pandemic? Based on the advancements we've seen, medtech is entering a period of continuous innovation that will drive the industry forward.
Companies will modernize data management to meet new and evolving regulatory requirements. Quality transformations will continue to meet growing audit and inspection requests. Claims management will improve as medtech enables seamless collaboration across teams or locations. As we look ahead, there is a significant opportunity to leverage digital solutions for long-term improvements across product development that can speed the total product lifecycle.
References
Seth J. Goldenberg, Ph.D., is responsible for Veeva MedTech global strategy, including customer engagement, market adoption, and product development. Goldenberg has nearly 20 years of experience supporting medtech companies as they navigate complex regulations and improve market access. Before joining Veeva, Goldenberg was director of product development strategy at North American Science Associates (NAMSA), where he supported medical device companies from inception through commercialization and post-market activities. Outside of Veeva, Goldenberg is an active member of the Regulatory Affairs Professionals Society (RAPS) and is the "entrepreneur in residence" at the Pennsylvania Pediatric Device Consortium. He holds a doctorate in pharmacology from the University of Washington and a master's degree from the school of biomedical engineering at Drexel University. He can be reached at seth.goldenberg@veeva.com.
However, more work lies ahead as companies prepare for higher market demand of medtech products1 and changes in regulations like EU MDR (Medical Device Regulation) and its accompanying IVDR. Organizations will continue to embrace digital solutions to transform how they work and speed the total product lifecycle. Following are four ways digital will drive positive change in medtech.
1. Increasing Evidence Requirements Will Force Clinical Data Management Modernization
Medtech studies have grown increasingly complex, requiring data collection and analysis on a scale much larger than ever before. Companies have to deal with growing volumes of information and new requirements from the EU MDR that place greater scrutiny on data management throughout the total product lifecycle.
To keep up with evolving regulations and the growing complexity of studies, we expect an industry shift toward more connected, digital, and transparent ways of managing clinical data. Modern systems will be crucial for tracking, analyzing, and sharing more extensive and diverse data sets both pre- and post-market. They'll also allow companies to better integrate real-world data from mobile devices and wearables with the information they're collecting in controlled settings.
Manual processes and legacy systems are no longer sufficient in this new age when accurate and meticulous data collection is of utmost importance. The companies that invest in digital cloud systems will speed clinical development and gain the agility they need to adapt for the future.
2. Growing Inspections and Audits Will Drive Large-Scale Quality Transformation
In 2019, the FDA issued 49 Class I recalls—the most the industry has witnessed in the last four years.2 Meanwhile, non-routine external quality events—such as FDA 483s, warning letters, and consent decrees—have cost the industry an average of $7.5 billion to $9.5 billion per year.3
Realizing the need to improve quality processes while innovating, many companies seek more advanced quality management systems (QMS) that will enable greater collaboration between internal teams, external partners, and regulators. Once the challenges stemming from the pandemic start to fade, medtech organizations will notice an increase in health authority inspections, making it an especially critical time to drive large-scale quality transformation.
With companies now required to demonstrate product quality using real-time data collected during post-market surveillance, fully automated electronic health authority submissions and non-electronic submission outputs will help ensure timely adverse event reporting and more proactive complaints handling. We can also expect improved applicability of advanced technology such as artificial intelligence (AI), which has been emerging within quality management, to help organizations maximize predictability.
A continued focus on remote inspections and audits as well as post-market surveillance will fuel transformation in lateral areas such as recall management and device tracking. These efforts will ultimately help companies comply with evolving regulations and drive industry-wide improvement across product quality and patient safety.
3. The Shift to Remote Auditing Will Digitize Quality and Improve Supply Chain Continuity
When COVID-19 hit, the Medical Device Coordination Group (MDCG) approved the use of remote auditing in specific cases to help ensure the continued supply of medical devices. While these changes were initially made out of necessity, auditing groups and medtech companies increasingly find remote audits to be a vastly efficient alternative to the traditional, in-person way of working.
As a result, remote auditing will become a permanent component of the quality workflow, even once travel and onsite restrictions are lifted. Not only will auditors be able to access required files more quickly, collaboration across regulatory, quality, and clinical teams will improve. Longer-term, the shift to remote auditing will drive companies to digitize quality processes and improve supply chain continuity.
The companies that invest in modern digital quality systems will be better positioned to reap the benefits of remote auditing. With content and data stored and accessed in one central application, they won't have to worry about updating multiple files in different systems, making information sharing much speedier and simpler. As teams get used to new ways of working, we'll experience less reliance on paper, fewer onsite audits, and a much more sustainable model for the future.
4. Claims Management Will Become More Important as Commercial Models Evolve
COVID-19 has decreased the number of face-to-face interactions between HCPs and sales, so many companies have invested heavily in broad-reach marketing methods—for example, television advertising—to get in front of customers. But this greater push toward direct-to-consumer marketing intensified the need for solid claims management and coordination between regulatory and commercial teams.
Reacting to this, companies will make a concerted effort to better manage creation and usage of marketing and product claims across the organization. With more connected systems and processes, marketing teams will have the necessary clarity concerning permitted claims or usage limitations. The legal and regulatory teams will gain visibility into how claims are being used at the local level.
Modernization efforts will ensure regulatory compliance, reduced risk, and help companies gain greater insight into their claims' effectiveness concerning marketing campaign performance. Moving forward, integrated claims management will create compelling upstream and downstream effects that can accelerate time-to-market and strengthen brand perception.
Digital Drives Improvements Across Product Development
COVID-19 accelerated the shift to more modern, digital ways of working out of necessity. But the question remains: Will medtech product development return to its former state post-pandemic? Based on the advancements we've seen, medtech is entering a period of continuous innovation that will drive the industry forward.
Companies will modernize data management to meet new and evolving regulatory requirements. Quality transformations will continue to meet growing audit and inspection requests. Claims management will improve as medtech enables seamless collaboration across teams or locations. As we look ahead, there is a significant opportunity to leverage digital solutions for long-term improvements across product development that can speed the total product lifecycle.
References
- McKinsey, Medtech's call to action: Meeting the demand surge caused by COVID-19, 2020
- FDA, U.S. FDA Medical Device Recalls Database, 2020
- McKinsey & Co, Capturing the value of good quality in medical devices, 2017
Seth J. Goldenberg, Ph.D., is responsible for Veeva MedTech global strategy, including customer engagement, market adoption, and product development. Goldenberg has nearly 20 years of experience supporting medtech companies as they navigate complex regulations and improve market access. Before joining Veeva, Goldenberg was director of product development strategy at North American Science Associates (NAMSA), where he supported medical device companies from inception through commercialization and post-market activities. Outside of Veeva, Goldenberg is an active member of the Regulatory Affairs Professionals Society (RAPS) and is the "entrepreneur in residence" at the Pennsylvania Pediatric Device Consortium. He holds a doctorate in pharmacology from the University of Washington and a master's degree from the school of biomedical engineering at Drexel University. He can be reached at seth.goldenberg@veeva.com.
