The Debrief

Even though the DiGa framework has opened a new path for reimbursement, it is not enough; significant investments in marketing and sales are needed. After being listed, the big challenge is to educate and convince doctors. No one has found the silver bullet yet, but it seems like an approach that may work is a mix of the traditional detailed promotion and innovative promotion strategies. From a sales perspective, the consultant-like model is better than the salesperson model. 

During the pandemic, some SaMD products were marketed under the enforcement discretion; those that have not received approval using one of the regulatory pathways are at risk to be removed. These companies need to follow the FDA draft guidance for transitioning to stay on the market. 

The marriage of digital health and oncology is very new, with companies still figuring out the best approach. For entrepreneurs, it is important to have as many options as possible, so flexibility in approach is required. The ability to pivot between, or potentially combine, business and particularly reimbursement models is something that companies should consider. 

 

Dealing with employers requires a different approach than with life science or medical partners. While a strong evidence base is still vital, it will be examined differently. Some of the metrics required will be less about the healthcare outcome and more about productivity, and employee satisfaction. That said, clinical trials remain important ways to illustrate the efficacy of a solution. Credibility is important and clinical evidence is often a foot in the door, even if a partner does not have the expertise to dissect it in detail.