Better Claims Management Starts at the Source

EU MDR brought sweeping changes to the medtech industry. In fact, the cost of compliance is estimated at over $8 billion.¹ Add in the risks of fines and not obtaining regulatory approval like the CE mark, and the cost of non-compliance could be even more impactful to the bottom line. Now that EU MDR changes are here, new regulatory updates are coming. It is time for leaders to take action and enable more analysis of research and evidence to substantiate marketing claims.

Meeting these requirements is harder for marketing content teams that use lengthy, manual processes to gather and share information. These approaches are slower, create data and document silos, and don’t facilitate collaboration across teams.

There is, however, a better way to manage marketing and product claims across the organization. Embracing a more connected technology landscape allows for seamless information sharing across functions and faster workflows, which accelerates claims substantiation.

Getting Claims Right
Claims management is an essential part of commercializing a product and getting it to patients. But evolving commercial models bring a new “pull culture,” where patients proactively seek out information about medical devices and diagnostics. This translates to earlier and more thorough engagement, requiring faster content creation, review, and approval to meet patient expectations.

On average, it takes 21 days for content approval,² but with a comprehensive digital asset management (DAM) system that utilizes medical, legal, regulatory (MLR) review, content can move from the approval stage to patient consumption much faster. To accelerate the process, organizations can connect their DAM with regulatory information management (RIM) systems to ensure that all claims are easily substantiated using data from clinical trials.

A connected infrastructure across regulatory and marketing allows each area to work together for sustained compliance. As a result, marketing teams obtain the clarity they need around permitted claims or usage limitations, and legal, clinical, and regulatory teams gain local, national, and international claims visibility. Stakeholders involved in the product lifecycle can also review and approve claims, ensuring alignment. Bringing together commercial content with regulatory operations delivers one source for information that encompasses all claims-related content. This allows teams to access real-time information and support the increasing volumes of data needed to create compelling and compliant content.

The Benefits of a Connected Approach
Applying a connected approach to claims management can deliver immediate gains such as better collaboration and seamless information exchange. Long term, teams can expect to see the following benefits:

• Greater Speed. Seamless information sharing eliminates manual tasks such as data entry and onsite document searches. When cross-functional teams work better together, they can secure faster reviews and approvals.
• Improved Compliance. Automatic updates across systems ensure compliance with changes to country- or region-specific regulations. Incorporating new guidance or regulatory changes saves time and effort in preparation and maintains compliance.
• More Insights. Connecting systems enables easy sharing of reports, benchmarks, metrics, and communications. For example, teams have access to actionable data around claim usage and campaign performance.

Transforming Claims Management
Medtech leaders looking for a better way to manage claims can start by assembling a team of change agents. These key team members understand the challenges both regulatory and marketing teams face and can serve as liaisons with other departments and groups. 

Next, determine where duplicative processes and inefficiencies exist. This should include discussions with key stakeholders across various functional areas. Determine methods for content sharing and storage while considering each group’s unique needs and format preferences. 

Tap into the digital strategies and technologies that streamline claims and processes. For example, visual indicators of previously approved content and images can speed development and approval. It is essential to take a holistic view of the entire process, ensuring alignment between your teams, the technology, and external partners. Because of the medtech industry’s unique challenges, including partners will help figure out the optimal way to manage claims at your organization. Here is a simplified version of an ideal process:

• Map out what each team wants to say about a new product, its intended use case, and how it will be substantiated 
• Agree on where the single source for information will reside and who has accountability
• Share outcomes from the sessions with clinical teams
• Execute a targeted study
• Verify the data and prepare it for regulatory submission
• Confirm approval and share details with marketing to determine what can or cannot be used
• Develop campaign materials such as brochures and images, and submit them for approval
• Publish to governing organizations

This approach includes all relevant stakeholders and highlights cross-team collaboration. When supported with connected systems across regulatory and commercial teams, leadership can make more informed decisions throughout the process, accelerating the content lifecycle from creation to distribution.

As organizations begin to embark on the journey, claims management transformation could not be timelier. The quest for quality information by governing bodies and patients will continue to increase, and with it, the need for commercial and regulatory teams to work together using reliable data. Establishing a more connected way of working will significantly simplify claims management for the benefit of the industry and the patient. 

References

1. Medtech Dive, EU MDR Costing Smaller Medtechs 5% of Their Annual Sales: Survey, 2020
2. Veeva Systems, Emerging Trends in Global HCP Engagement, 2021

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Terri Howard has over 20 years of experience in life sciences, with the last decade focused on regulated content management technology for the medical device industry. She has worked with industry leadership teams to form and influence change in regulatory business practices. Howard joined Veeva Systems in 2015 as director of strategy to help medical device companies leverage cloud technology to bring products to market faster and more efficiently. She can be reached at [email protected].