Seth Goldenberg, Ph.D., Vice President, MedTech, Veeva Systems03.04.21
Medtech organizations have accelerated efforts to improve collaboration and efficiency across product development to address COVID-19 disruptions, changing regulations such as IVDR and EU MDR, and growing data scrutiny. Leading companies are adopting digital ways of working to ensure compliance, audit readiness, and speed. Here are three ways leaders including Alcon, Baxter Healthcare, Boston Scientific, Epredia, and Illumina are driving innovation in medtech.1
1. Connect Processes to Increase Efficiency
Changes to regulations now require companies to know every detail about a product at all times. These new evidence requirements are making it even more difficult to manage the product lifecycle with siloed systems. Organizations like Epredia are digitizing processes and connecting systems across functions to drive greater efficiency and visibility throughout the total product lifecycle.
“We wanted to have a single system with one harmonized process,” said Mark Ramser, senior director of global quality at Epredia. “We’re connecting quality and regulatory so updates in our QMS can automatically trigger activities in regulatory, simplifying change control.”
Medtech companies typically manage product development processes manually and across multiple disconnected systems, making it difficult to access information and slowing down execution. Modern cloud applications streamline these processes and unify development areas so teams have visibility across data and operations, speeding how products are brought to market.
2. Adopt Digital Solutions to Enable Virtual Healthcare
The industry has adopted new methods to engage with physicians and patients because of COVID-19 delays in healthcare and elective surgeries. Patients and doctors are embracing digital solutions that enable telehealth to ensure continuity of care. Organizations and doctors similarly are using digital tools to engage and train physicians virtually.
Boston Scientific, for example, is leveraging digital solutions to provide training and support to doctors. “We’ve seen an acceleration in telehealth, telementoring, teleproctoring, and direct case support,” said Dr. Ian T. Meredith, global CMO and executive vice president at Boston Scientific. “We used technologies for in lab or in surgery direct communication, bringing an expert proctor or assistant alongside the physician team.”
COVID-19 has changed how patients receive care and more organizations like Illumina are advancing to meet new patient requirements and expectations. “The industry is shifting care out of the clinics and into the home,” said Dr. Phil Febbo, senior vice president and chief medical officer at Illumina. “The pandemic supercharged that effort with increased adoption of virtual visits. Looking forward, finding the right combination of virtual and in-person care will be key.”
Digital solutions simplify doctor interactions and healthcare delivery, and reduce the patient burdens of time and travel. The companies that adopt these new ways of engaging doctors and treating patients will have a competitive advantage as healthcare transitions from the hospital to the clinic—and from the clinic to the home.
3. Modernize Regulatory Systems to Keep Pace with Dynamic Regulations
Regulatory requirements for medtech products are getting more complex, leading to data collection and analysis on a much larger scale. Organizations are managing growing volumes of data and new requirements that place greater scrutiny on data management throughout the total product lifecycle. Relying on paper-based and siloed systems and processes is no longer an option and the industry is rapidly modernizing regulatory operations to keep up.
One company leading the way in streamlining regulatory operations to address EU MDR is Alcon. “To meet changing regulations, no part of operations could be sacred,” said Lori Holder, senior director of global regulatory operations at Alcon. “You have to look at all parts of the organization across processes, documentation, and systems to ensure compliance readiness.”
EU MDR requires a broader scope of devices to undergo documentation review before going to market. Products that previously didn’t require notified body review (except during regular audits) now have to be pre-approved. Increased requirements for pre-market clinical evidence, labeling, post-market data, and publicly available product information are making it challenging for the industry to ensure compliance.
By digitizing and unifying its regulatory data and documents onto a single platform, Baxter Healthcare made it easier to manage change. “We saw value in bringing together all global regulatory information into one system,” said Larry Litle, senior director of global strategy and delivery at Baxter Healthcare. “Now we have information at our fingertips with connections to other systems, increasing efficiency in new product introduction and lifecycle management.”
Leading medtech companies are moving toward cloud regulatory applications that can share information with other systems, bringing together cross-functional teams for a holistic view across the total product lifecycle. For example, paper and email approvals can now be streamlined via a workflow and include a digital record and timestamp of each person who reviewed and approved documents, a stark contrast to providing wet signatures, hard copies, faxes, and hand deliveries.
Challenge the Medtech Status Quo to Speed Total Product Lifecycle
If 2020 taught us anything, it was that asking “what if” and answering “we can” has provided an unprecedented opportunity. We witnessed a strong, resilient industry capable of innovating during a pandemic. Medtech companies are changing how they work with digital and accelerating efforts to speed the delivery of medical devices and diagnostics.
Enabling better ways of working across the total product lifecycle will provide increased visibility and compliance. Digital solutions are helping the industry adapt to multiple changes in healthcare. Evolving regulatory requirements are leading companies to swap manual paper-based processes for modern cloud systems.
As the medtech industry continues to modernize, successful companies will keep innovating and advancing. They will meet rigorous requirements with new, digital ways of managing the total product lifecycle and help shape the future of healthcare.
Reference
Seth J. Goldenberg, Ph.D., is responsible for Veeva’s global strategy in the medtech industry, including customer engagement, market adoption, and product development. Goldenberg has nearly 20 years of experience supporting medtech companies to 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.
1. Connect Processes to Increase Efficiency
Changes to regulations now require companies to know every detail about a product at all times. These new evidence requirements are making it even more difficult to manage the product lifecycle with siloed systems. Organizations like Epredia are digitizing processes and connecting systems across functions to drive greater efficiency and visibility throughout the total product lifecycle.
“We wanted to have a single system with one harmonized process,” said Mark Ramser, senior director of global quality at Epredia. “We’re connecting quality and regulatory so updates in our QMS can automatically trigger activities in regulatory, simplifying change control.”
Medtech companies typically manage product development processes manually and across multiple disconnected systems, making it difficult to access information and slowing down execution. Modern cloud applications streamline these processes and unify development areas so teams have visibility across data and operations, speeding how products are brought to market.
2. Adopt Digital Solutions to Enable Virtual Healthcare
The industry has adopted new methods to engage with physicians and patients because of COVID-19 delays in healthcare and elective surgeries. Patients and doctors are embracing digital solutions that enable telehealth to ensure continuity of care. Organizations and doctors similarly are using digital tools to engage and train physicians virtually.
Boston Scientific, for example, is leveraging digital solutions to provide training and support to doctors. “We’ve seen an acceleration in telehealth, telementoring, teleproctoring, and direct case support,” said Dr. Ian T. Meredith, global CMO and executive vice president at Boston Scientific. “We used technologies for in lab or in surgery direct communication, bringing an expert proctor or assistant alongside the physician team.”
COVID-19 has changed how patients receive care and more organizations like Illumina are advancing to meet new patient requirements and expectations. “The industry is shifting care out of the clinics and into the home,” said Dr. Phil Febbo, senior vice president and chief medical officer at Illumina. “The pandemic supercharged that effort with increased adoption of virtual visits. Looking forward, finding the right combination of virtual and in-person care will be key.”
Digital solutions simplify doctor interactions and healthcare delivery, and reduce the patient burdens of time and travel. The companies that adopt these new ways of engaging doctors and treating patients will have a competitive advantage as healthcare transitions from the hospital to the clinic—and from the clinic to the home.
3. Modernize Regulatory Systems to Keep Pace with Dynamic Regulations
Regulatory requirements for medtech products are getting more complex, leading to data collection and analysis on a much larger scale. Organizations are managing growing volumes of data and new requirements that place greater scrutiny on data management throughout the total product lifecycle. Relying on paper-based and siloed systems and processes is no longer an option and the industry is rapidly modernizing regulatory operations to keep up.
One company leading the way in streamlining regulatory operations to address EU MDR is Alcon. “To meet changing regulations, no part of operations could be sacred,” said Lori Holder, senior director of global regulatory operations at Alcon. “You have to look at all parts of the organization across processes, documentation, and systems to ensure compliance readiness.”
EU MDR requires a broader scope of devices to undergo documentation review before going to market. Products that previously didn’t require notified body review (except during regular audits) now have to be pre-approved. Increased requirements for pre-market clinical evidence, labeling, post-market data, and publicly available product information are making it challenging for the industry to ensure compliance.
By digitizing and unifying its regulatory data and documents onto a single platform, Baxter Healthcare made it easier to manage change. “We saw value in bringing together all global regulatory information into one system,” said Larry Litle, senior director of global strategy and delivery at Baxter Healthcare. “Now we have information at our fingertips with connections to other systems, increasing efficiency in new product introduction and lifecycle management.”
Leading medtech companies are moving toward cloud regulatory applications that can share information with other systems, bringing together cross-functional teams for a holistic view across the total product lifecycle. For example, paper and email approvals can now be streamlined via a workflow and include a digital record and timestamp of each person who reviewed and approved documents, a stark contrast to providing wet signatures, hard copies, faxes, and hand deliveries.
Challenge the Medtech Status Quo to Speed Total Product Lifecycle
If 2020 taught us anything, it was that asking “what if” and answering “we can” has provided an unprecedented opportunity. We witnessed a strong, resilient industry capable of innovating during a pandemic. Medtech companies are changing how they work with digital and accelerating efforts to speed the delivery of medical devices and diagnostics.
Enabling better ways of working across the total product lifecycle will provide increased visibility and compliance. Digital solutions are helping the industry adapt to multiple changes in healthcare. Evolving regulatory requirements are leading companies to swap manual paper-based processes for modern cloud systems.
As the medtech industry continues to modernize, successful companies will keep innovating and advancing. They will meet rigorous requirements with new, digital ways of managing the total product lifecycle and help shape the future of healthcare.
Reference
- Veeva Systems, MedTech Summit Online, 2020.
Seth J. Goldenberg, Ph.D., is responsible for Veeva’s global strategy in the medtech industry, including customer engagement, market adoption, and product development. Goldenberg has nearly 20 years of experience supporting medtech companies to 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.
