In the realm of large MedTech companies, a robust Regulatory Advertising and Promotion (Ad Promo) / MLR program is crucial for the successful marketing of medical devices. Here's what such a program should encompass:
1. Optimized Ad Promo Procedure
A clear, efficient procedure for advertising and promotional materials is essential. This involves streamlined workflows that ensure compliance with regulatory requirements while facilitating rapid turnaround of marketing materials.
The process should be well-documented and followed meticulously. Every step from content creation to final approval must be transparent and traceable, reducing errors and speeding up the approval cycle.
3. Ad Promo System
Utilizing systems like Veeva Vault Promomats can significantly enhance the management of promotional materials. These platforms offer secure storage, version control, and an audit trail, which are vital for regulatory compliance.
4. MLR Review Team
A competent review team is the backbone of any Ad Promo program. This team should include members from regulatory affairs, legal, medical, and marketing, each bringing their expertise to ensure materials are compliant, accurate, and effective.
Perhaps the most critical element is defining clear roles and responsibilities. A matrixed approach where responsibility is too broadly shared often leads to inefficiencies. Instead, specific accountability should be assigned to minimize confusion and ensure action.
The Pitfalls of Shared Accountability
In many organizations, the failure of Ad Promo programs can be traced back to a lack of clear accountability. When everyone is responsible, in practice, no one is. This often leaves the marketing department bearing the brunt of inefficiencies, directly impacting their ability to equip sales teams with timely materials, which in turn leads to lost revenue.
Real-World Impact
In a transformation project I spearheaded, we tackled these issues head-on. By setting clear goals and metrics tied directly to financial outcomes, we achieved a savings of $2.2 million, equivalent to the cost of about 10 full-time employees. This success was not just about financial savings but also about streamlining operations across departments to support a sustainable future.
Ask any marketer in the MedTech industry, and they'll tell you that the Ad Promo process is often one of their least favorite aspects of the job. The root causes are multifaceted but include:
Inefficiencies and Delays: Often due to a lack of understanding or ownership of the process.
Misplaced Ownership: When the process management falls to a department unfamiliar with marketing needs, inefficiencies compound.
Solutions Through Training and Ownership
Training across all involved teams can significantly improve the process. However, the real shift comes from placing the ownership of the Ad Promo process with those who understand its impact on marketing objectives. Departments should:
Understand the Process: Every team involved should be trained on the regulatory implications of marketing materials.
Appreciate the Impact: Marketing should lead with support from regulatory and legal to ensure that the process supports business goals rather than merely compliance.
Conclusion
For MedTech companies, optimizing the Advertising and Promotion program isn't just about compliance; it's about enabling marketing to drive sales effectively. By focusing on clear procedures, technology, team expertise, and especially, responsibility, companies can transform one of the most challenging aspects of marketing into one of its most potent tools. Follow me as I will continue to share more specific details on how a robust and sustainable MLR program can be built with a laser focused approach.

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