Four Ways the Shift to Digital Will Accelerate Medtech Innovation

The medtech industry is in a time of unprecedented change to address challenges that impact the entire product development lifecycle. New regulatory requirements (EU MDR and IVDR), pricing pressures, and the need to support new clinical trial models are adding complexity to medtech. Companies are undergoing operational transformation to streamline systems and processes, as well as accelerate innovation.

In looking ahead, key developments in precision medicine, digital therapeutics, medical affairs, and EU regulations will shape the industry. Below are four top trends that will push medtech forward.

1. Diagnostics and Pharma Forge a Better Path for Personalized Treatment
The genomics revolution is accelerating as costs drop and disease states expand, driving increased collaboration between genomics organizations and pharmaceutical companies. With no signs of slowing, these partnerships will redefine precision medicine with new companion products (CDx) personalized for the patient, as well as therapeutic drugs. As a result, companies will be able to better identify the risk of adverse events or opportunities to adjust treatments for higher efficacy.

With a collaborative, patient-centric approach, the collection and sharing of outcomes will be critical for future advancements. This will lead to a shift toward more connected, digital landscapes that enable seamless and automated data exchange across stakeholders.

2. Digital Therapeutics Will Go Mainstream as Payers Increase Reimbursement
When Pear Therapeutics secured reimbursement for rSET1—a prescription digital application used to treat substance use disorder—from Massachusetts’ Medicaid program this year, it set a significant milestone for the industry, becoming the first company to receive payer funding for a digital therapeutic. Now, with the pathway toward reimbursement open, expect to see digital therapeutics enter a new phase of growth in 2022.

For a market with a projected global value of $56 billion by 2025,2 this presents a massive opportunity for medtech and pharma companies to broaden their portfolios. As more companies run digital therapeutics trials to gather clinical evidence for reimbursement, larger and more diverse data sets will need to be tracked and analyzed. After the products are prescribed, real-world evidence will also need to be collected and reviewed equally as efficiently.

All this data will ultimately provide more insight into patient behavior but it will also create more complexity. Modern approaches to data management will be critical to the commercialization and regulatory compliance of these products.

3. Direct-to-Consumer Will Make Medical Affairs a Medtech Priority
With the rise of at-home tests and diagnostics, patients are more educated and informed about medical procedures and devices. Meanwhile, an evolving reimbursement landscape and changing regulations emphasize direct-to-consumer outreach, keeping patients out of hospitals and in the home.

These changes will drive more medtech companies to establish robust medical affairs operations. This is a positive development for the industry because educating patients with timely information has proven to improve adherence, satisfaction, and clinical outcomes.³

The shift to patient-focused education requires delivering information at the right time through the right channel. Companies that invest in end-to-end medical content management will be better positioned to respond to patient inquiries quickly. Long-term, medical affairs will help medtech companies ensure the safe and appropriate use of products at home or a doctor’s office—a significant win for the industry. Organizations that can scale this important function will have a clear competitive advantage through improved patient engagement, adoption, and outcomes.

4. European Regulatory Requirements Get Real, Driving Massive Operational Changes
The industry has been preparing for EU MDR and IVDR for nearly five years, yet more critical work remains to ensure compliance. This is especially important as medtech adapts to changing market conditions and growing global demand.

An area in need of transformation, for example, is claims management. Claims are continuing to get narrower and more defined. To adequately manage claims under regulatory changes, companies need to connect regulatory and marketing content operations processes. Regulatory teams leveraging end-to-end claims management processes can drive faster reviews and approvals, improve compliance, and gain insights into actionable data like claim usage and campaign performance.

As the clock ticks toward the full implementation of EU MDR and IVDR, the industry will continue to modernize operations to establish a stronger data foundation, improve connections across cross-functional teams, and drive real-time visibility into data and content. If companies can do this, they will be much better prepared for implementations.

Medtech Embraces Digital to Speed Innovation
With budding industry changes and direct-to-consumer skyrocketing, more medtech companies are reimagining their operations. There’s been an acceleration to digital and connected systems that can drive speed and agility across the product lifecycle. Positive change is happening, supported by modern technologies. This shift will allow medtech firms to keep pace with market dynamics—from patient demands and expectations to growing regulatory requirements—and speed the delivery of life-changing devices and diagnostics to patients. 

References

1. MobiHealthNews, MassHealth to Cover Pear Therapeutics’ reset and reset-O, 2021
2. Insider Intelligence, Digital Therapeutics: DTx Market Trends and Companies in the Growing Digital Health Industry, 2021
3. Journal of Medical Internet Research, Educating Patients by Providing Timely Information Using Smartphone and Tablet Apps: Systemic Review, 2020

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Seth J. Goldenberg, Ph.D., is responsible for Veeva MedTech’s 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 [email protected].