How to market diagnostic imaging software as a medical device (SaMD)

Challenge 

Our client, a leading pharmaceutical company, has developed an AI-ML-supported algorithm to support diagnostic imaging using its clinical trial data. This algorithm can assist physicians in making diagnosis and treatment decisions by providing them with automated visualisations and quantitative metrics. Although the prognostic value of these quantitative measures has been extensively discussed in literature, their use in clinical practice is limited due to the fact that it is time-consuming and the clinical meaningfulness has not yet been validated.

The new AI-supported imaging software represents a potential change in the standard of care. Developing the software required a deep understanding of the regulatory pathway, as few such applications have been successfully launched worldwide, and the client was entering unchartered territory. The competitive landscape, different deployment models, customer needs, and value drivers also had to be analysed and evaluated. In addition, our client needed to understand how to market the software to achieve broad market adoption and make it commercially viable in key markets such as the US and EU.

Together with the client, we had to answer the following questions:

• How should the regulatory pathway and submission package, including the intended use statement, be designed for this SaMD?

• What evidence is required to support the intended product profile scenarios and technical performance and to meet the needs of the different stakeholders (authorities, payers, healthcare providers, patients, etc.)?

• What are the opportunities and risks of this software from the perspective of potential customers?

• What deployment and associated business models would maximise the value of this software?

• What should the commercialization roadmap for bringing this software to market look like?

As the development team was breaking new ground for the client, it also required a convincing business case and good storytelling to gain the necessary support and traction within the company.

Solution 

To acquire the necessary knowledge and because of the large impact on the commercial potential of the software, we took a highly customer-centric approach. Our solution was a joint project with the client, where we brought in both an inside-out and an outside-in perspective. We conducted many interviews with different stakeholders to get a deep understanding of their requirements. Our agile approach allowed us to provide recommendations for the development of the software and adapt it to the needs of the customers. For example, we found that radiologists appreciate the fully automated imaging capabilities of the software, but also prefer to retain some degree of control over the outcomes and have the ability to modify them if necessary. The client is considering this recommendation and might include it in the future.

To assess the inside-out perspective, we first examined the approval strategy, as the requirements within the regulatory process for SaMD approval were not yet fully defined. We conducted an analogues assessment of more than ten types of approved SaMD in the field of diagnostic imaging to analyse the clinical and technical requirements for approval. Based on this assessment, we could advise the client on an optimal regulatory strategy to increase the likelihood of approval. In a next step, we developed target product profiles and commercial models for the SaMD. We used a value framework with the three dimensions of use case, value generation, and deployment model.

The potential business models were then further evaluated in the outside-in part of the analysis. We conducted an in-depth voice-of-the-customer analysis to obtain a multi-perspective view on the commercial potential of this SaMD. Interviews with more than 35 stakeholders in the US, Germany, France, UK, and Italy – including analysing and treating physicians, hospital procurers, and IT experts – enabled us to perform country-specific analyses. Stakeholder-specific questions covered all topics from the diagnostic imaging landscape to acceptable software pricing levels. These findings were summarised in a comprehensive report with clear recommendations for implementation.

Capturing the actual market needs allowed us to provide recommendations for a targeted and customer-centric product development.

Results

We provided the client with a roadmap to maximise the commercial potential of the developed AI-ML diagnostic imaging software. To make the commercial strategy tangible for implementation, the go-to-market roadmap also set out the next steps to be taken for the successful launch of this SaMD.

The inside-out and outside-in perspective enabled the client to gain the necessary strategic insights to align the product development to the customers’ needs. Furthermore, the customer insights played an essential part in the software’s implementation and integration strategy to achieve broad acceptance in medical centres.

Lastly, with the help of our assessment and compelling storytelling, the client's team was able to gain internal stakeholder buy-in for the project and justify the subsequent investment in product development.

At the heart of our global strategy, 'The New Equation', is our focus on putting the client at the centre and striving for sustainable outcomes rather than short-term goals. This project was no different. We brought together our team of unconventional problem solvers with different skillsets to achieve long-term results and ensure sustainable success of the client’s business.