Today due to regulatory restrictions Medical Affairs teams take more responsibility with less resources. Medical Advisors have to coordinate and integrate different medical data and types of knowledge and achieve external recognition for providing credible and unbiased medical information. Development and leadership of the Medical Strategy for each product, including collaboration with Business and R&D and others will ensure the product’s cross-functional life-cycle strategy and planning. In some cases when Medical Affairs still position itself as reactive scientific support function for Commercial, there may be lack need in strategic plannig, value definition and impact measurement. Though the spreading changes in regulatory environment will make Medical Affairs build new capabilities and become equal to R&D and Business. Having cross-functionally aligned Medical Affairs Brand Strategies will ensure deeper engagement with medical stakeholders, creation of new evidence data and its dissemination.
1. Make sure you understand why you need a Medical Affairs strategy for your brand.
Strategy is a dynamic process of defining your direction and making decisions on allocation resources to implement the plans. In case your organization has separate budgeting from Commercial, you obviously need to justify the your costs and demonstrate the results. Strategic planning is a tool of cost and other resource allocation that you need to have to reach your goals. Even if your budget belongs to Commercial you still need to continuously review Medical activities costs, follow up with Marketing on how your strategy is being implemented, and perform a cross-functional annual strategic review to ensue a clear and valuable Medical contribution.
2. Understand the current situation.
In order to determine the Medical Strategy of the brand, it is necessary to understand the current position and the possible directions through which you can pursue a specific course of action. You have to challenge the status quo through addressing good open questions to internal and external stakeholders. Make sure you have clear answers on 3 key questions – What do you do? (what is your current tactics?) – For who do you do that? (what is the customer?) – How do you do that? (which steps you undertake).
3. Prioritize perceived unmet medical and clinical needs.
Unmet medical needs are identified based on the situational analysis that includes medical SWOT analysis of the competitor brand customer perception. The main goal of a SWOT analysis is to understand the environment. Each analysis should conclude in a number of medical and clinical unmet needs. The next step will be to prioritize them as high, medium and low priority.
4. Build up your Strategic Medical Imperatives.
Propose clear and short strategic actions addressing high priority needs. Each unmet need should be addressed with 1-2 corresponding actions (strategic imperatives).
5. Translate each Strategic Medical Imperative into specific, meaningful tactics.
Tactics should describe what must be achieved. Using the conventional and innovative tools as CME, Advisory Boards, Medical Publication, remote MSL visits, etc, prepare a specific activity plan linked with the Commercial plan and calculate the costs. Your plan should contain resources, responsible and time-lines.
6. Elaborate clear metrics for your activities.
You will need this not only to measure your progress, but also to demonstrate your impact value to the stakeholders. Lots of ideas for metrics seem good until you try to use them. One test of the quality of a metric is whether or not you can actually measure how you approach your goal. In addition, it’s important that all relevant parties agree that the metrics appropriately measure what they are intended to measure, so Commerial colleagues to certain extent may be involved into KPI elaboration process.
7. Make sure that your Medical Strategy is aligned with Commercial strategy, but is not promotional.
Medical Strategy has to be based on fulfilling medical gaps or needs revealed in the Business strategy. Tight collaboration and deep understanding of Marketing role will ensure best integration of Medical strategy with Marketing activities. Tactically best sequence of aligned Strategy elaboration is when Marketing first prepares their strategy keeping in mind that Medical strategy will follow and both have to be synergistically linked. In case Medical Affairs is a separate non-promotional department, make sure that your plan doesn’t contain promotional claims or statements that could potentially be misinterpreted as such.
8. Learn from execution and review the strategy regularly.
Strategy is a dynamic process of responding to environment changes and real life evidence. Your KPI dashboard may serve as a tool for internal and external strategy alignment.
by Dr. Alexander Tolmachev