4 Ways a Digital Shift Helps Adapt to Evolving Industry Requirements

Last year delivered mixed results for the medtech industry. With slower mergers and acquisitions¹ and stock performance lagging, leading medtech companies experienced a more significant drop than the S&P 500. But medtech companies also achieved an impressive 1,800 FDA approvals² or clearances in the first six months of 2022, and revenue growth remained a bright spot.

Looking ahead, the industry is already seeing a rebound in M&A activity that will likely continue, along with related divestitures, as medtech companies change their focus. Navigating a turbulent market, how can organizations keep up while remaining compliant? Here are the four areas where technology can help medtech companies adapt to evolving industry requirements.

1. Enabling Digital Trials
The pandemic drove new demand for technology in many industries, particularly in clinical trials. Lockdowns led the industry to conduct trial activities digitally and decentralized, such as enrollment, follow-up visits, and monitoring. However, the adoption of fully decentralized trials in medtech has been slow, as adding more applications has created challenges with accessing and sharing study data across applications.  

To support the shift toward patient-centric digital trials, it’s essential to bring together the clinical trials ecosystem on one unified platform. This means information can be shared easily while supporting the varying needs of sponsors, contract research organizations (CROs), research sites, and patients. The first step to get there is securing buy-in from all stakeholders involved on the tools and procedures needed. Taking a more collaborative approach can help streamline processes for research sites. 

Medtech companies considering digital trials should begin with a comprehensive vision for studies. Rather than taking temporary cost-cutting measures, adopting a digital trials strategy can deliver long-term improvements and faster, more cost-effective trials.

2. Preparing for New Regulations
The fundamental challenge for regulatory affairs is to get products cleared and approved globally, but it can be overwhelming for regulatory professionals to sift through countless updates. And the stakes couldn’t be higher: medtech companies found to be non-compliant risk raising patient safety concerns that can have products pulled from the market.

Many companies compensate by adding the headcount to work with existing databases of regulatory information. There are opportunities for medtech companies to consider more efficient approaches, especially since only 14% collect global registration data in a single system.³ Organizations adopting one centralized regulatory information management (RIM) system will ensure all stakeholders can access, analyze, and share regulatory content and data. This system would also allow companies to track whether a new regulation is applicable, note their justification, and provide regulators evidence of the company’s steps to remain compliant.

A RIM solution can transform new regulatory information into a meaningful format while connecting it to relevant product information. With an automated, digital RIM system, companies can feed regulatory information into the earliest stages of the product design lifecycle to guide product development and approval. 

3. Streamlining Supplier Quality Management
Medtech organizations navigated various issues during the pandemic, including finding additional suppliers to meet shortages. Companies are now expanding the number of partners and suppliers they work with, increasing compliance risks. With regulations continuously evolving, scrutinizing a supplier’s suppliers is necessary to identify potential problems well in advance.

The largest risks for medtech organizations include delays for parts that take longer to make and deliver. Time spent chasing down parts is time that can’t go toward ensuring quality across products.

Using an advanced quality management system (QMS) provides the analytics to evaluate potential risks in the supply chain and makes it easy to launch proactive strategies to address them. If suppliers also run processes digitally in one common QMS, they can update documentation and share it with regulatory teams in seconds. When marketing or promotional materials must change because of a new supplier relationship, teams can collaborate in one place to ensure the work gets done faster.

4. Improving Engagement with Key Opinion Leaders
Medtech companies hoping to break in with key opinion leaders (KOLs) should invest the time and resources needed to drive KOL engagement. Without having current or comprehensive data on market influencers, companies can risk uncoordinated or low-impact efforts that lead to delayed product adoption and loss of market share to competitors.

Most medtech companies lack a single source of all KOL activity and focus on maximizing individual engagement opportunities. Significant time and resources are spent planning these single engagement events (like conferences) instead of optimizing long-term relationships with the most impactful KOLs.

Identifying and prioritizing KOLs to drive ongoing engagement is the goal of every medtech firm. This can significantly impact the bottom line if they can do it with consistency and visibility across stakeholders.

Preparing for Success

Market dynamics and evolving regulations like EU MDR continue to keep medtech executives on their toes. Companies can ensure efficiency and compliance even during uncertain times by establishing a foundation for seamless data and document management. To drive business decisions and faster return on investment (ROI), companies must first address these ongoing challenges:

• Addressing silos. Many medtech firms operate by country or region, leading to disconnected data, processes, and systems. This makes it difficult to address changes or inconsistencies quickly. A siloed ecosystem also adds complexity during M&A deals, making it harder to harmonize across the organization.
• Accounting for additional data and post-market surveillance. Besides existing data and reporting requirements from the Medical Device Directive (MDD), new reports are required under these new regulations. This change could lead to more than 800 submissions and reports per year for larger companies.
• Maintaining MDR after the Date of Application (DoA). Companies should consider establishing sustainable MDR continuation to ensure long-term business continuity and compliance.
• Deciding who will manage ongoing MDR requirements—and putting the right tools and technology in place to support these team members—will be a critical next step. MDR goes well beyond regulatory affairs alone, and efficiently bringing together key information across regulatory, quality, clinical, and marketing claims can provide a competitive advantage. 

Medtech leaders prioritizing these key areas will position themselves to take advantage of technology and advance their processes for a more compliant and streamlined product development lifecycle. From clinical trials to the manufacturing supply chain, a shift toward digital, centralized systems will grant all stakeholders greater visibility and easier collaboration. Ultimately, these improvements can help ensure EU MDR and IVDR compliance, bolster patient safety, and get products to those needing them faster.  

References

1. bit.ly/mpo06231
2. go.ey.com/3pRT5P7
3. bit.ly/mpo06232

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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 medical technology companies as they navigate complex regulations and improve market access. He earned 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].