How MHA helped a medical diagnostics company strengthen its medical affairs function through a governance assessment

Introduction

Founded more than 50 years ago, our client is a multinational diagnostics company, currently serving patients in more than 150 countries. The company is headquartered in the European Union with a large U.S. presence, including multiple U.S. subsidiaries. Their clients range from hospital laboratories to pharmaceutical manufacturer quality teams and commercial food safety teams.

What was the challenge?

The company’s U.S. medical affairs function had been developing, and it had to deal with an aggressively focused commercial organization while integrating a new U.S. based team and working alongside an established global medical affairs function. As a result, key functions within U.S. medical affairs were not yet formalized and important governance documentation was either insufficient or missing entirely. This led to unclear roles and responsibilities, ineffective internal processes, and increased risk overall. In addition, the situation created the potential for valuable scientific and medical insights to go unseen or not be fully utilised.

What was our approach and solution?

We were asked to conduct a governance assessment of the medical affairs function, followed by supplementary implementation work for necessary governance documentation that was to be identified during the assessment.

The governance assessment was conducted through a documentation review as well as stakeholder interviews with the leadership team of the Medical Affairs team to understand the current state and future direction of the team.

Our formal report identified several issues including:

1. Strategic gaps and weaknesses in current medical affairs activities and processes
2. One-off activities with high medical, scientific and/or compliance risk
3. Key medical affairs activities with a complete lack of governance documentation
4. Current governance documentation with a lack of clear, defined roles and responsibilities
5. Key medical affairs activity with inadequate resources to support implementation efforts

The report included findings detailing the gaps identified and an implementation roadmap with prioritization and proposed timing of each recommended action.

Following the presentation of the report, we supported the implementation roadmap, serving as trusted advisors in discussions with other functions and navigating roadblocks or reprioritizations as they occurred.

We have continued to collaborate with the company’s medical affairs function by providing training to the larger U.S. medical affairs team, including topics such as advisory boards and FDA label interpretation as well as supporting evidence generation strategies with the global medical affairs team.

What did we achieve?

By identifying key gaps in the U.S. medical affairs function, we were able to provide the team with practical policies, processes, and other governance documents to formalize key processes and establish mature medical functions. This, in turn, allowed the medical affairs professionals to focus their expertise, furthering the medical and scientific objectives of the organisation.