Demand for immediate, relevant information is on the rise across medtech. Patients and physicians alike seek real-time, accurate content, challenging medical device and diagnostics companies to swiftly deliver reliable information. Concurrently, regulatory bodies are intensifying their scrutiny over claims and marketing materials. In response to these dual challenges, many medtech companies are embracing the concept of a centralized claims library to enhance efficiency, reduce risks, and elevate marketing strategies. And if you aren’t then you need to.
One leading medical device company realized a 90% reduction in review time (from 30 to 2 hours per content piece) and 80% reduction in approval time (from 120 to 24 days) after instituting a claims library with automated claims linking functionality.
Here are ten reasons you should implement a claims library.
1. Enhance Compliance and Risk Mitigation
Establish a single source of truth for marketing claims with clear substantiation, mitigating the risk of inconsistent or inaccurate messaging. This ensures regulatory compliance and helps prevent potential legal challenges.
2. Eliminate Repetitive Review
A formal claims library with substantiating evidence streamlines discussions and approval processes, reducing duplicate reviews of content which saves time, improves consistency, and expedites time-to-market for promotional materials.
“How many times have you agreed upon language and six months later you have someone change roles and you are having to reinvent the wheel on the exact same claim. That’s what the claims library does for us…it eliminates that repetitive conversation.” -Rosetta Mazzei, Promotional Advertising Committee Chair, CooperSurgical, Inc.
3. Simplify Document Preparation
A modern MLR (Medical, Legal, Regulatory) review tool with claims management capabilities offers auto-claims linking, which automatically finds and greenlights statements within materials against the claims library, including commonly used variations of each core claim. This expedites content creation and speed-to-market.
4. Improve Collaboration
Entire organization can access and understand approved claims fostering better communication across departments.
5. Ensure Messaging Consistency
Enforce standardized language ensuring all stakeholders adhere to a common message, which enhances brand alignment across platforms, from websites and social media to print materials and sales training content.
6. Reduce Reviewer Burden
Pre-validated claims in documents simplify the reviewer’s task, focusing their efforts on the overall context of the promotional piece rather than linguistic and factual checks. In a particularly complex piece this automation and reduced cognitive burden can also decrease risk of human error.
“It’s contentious because every claim comes back for review over and over and over and over…you forget what you said if you are reviewing hundreds of pieces a month” -Kate Nichol, VP of Clinical and Medical Affairs, LivaNova
7. Expedite Global-to-Local Process
As you expand globally, localization becomes crucial. A claims library facilitates the adaptation of claims for different regions while maintaining the core message, reducing translation efforts, and ensuring adherence to local regulations.
8. Actionable Traceability
With a properly linked library, if a claim needs to be retired, updated, or replaced for any reason the documents where the claim is used can be pulled quickly and easily. If integrated with the Digital Asset Management (DAM) system they can also be pulled from circulation quickly in an emergency.
“If you were to get an audit or a finding that something was problematic [with a claim], how do you find where those materials or those claims are being used? What materials are they in? How do we pull them back?” -Becki Brasher, Senior Regulatory Manager, Medtronic
9. Audit Readiness
Auditors no longer need to spend hours questioning multiple people to determine which part of a research study applies to a particular claim. Audit trails show the history of the workflow that produced the document to demonstrate that the process meets regulatory demands.
10. Set the Foundation for Omnichannel Capabilities
A true omnichannel content distribution facilitates the delivery of the right content through the right channel at the right time to your audience in an agile fashion, while maintaining compliance.
While a centralized repository of approved claims takes organizational effort to stand-up , it offers a host of benefits, encompassing regulatory compliance, speed to market, consistency, cost reduction, and enhanced collaboration. Under pressure for more content and increased regulatory scrutiny, it’s the right time for medtech companies to embrace reality and harness the power of a well-structured claims library.
John Lerch, Director, Commercial Strategy, Veeva MedTechTo learn more, please reach out to your Veeva Account Partner or visit veeva.com/medtech/promomats.