When it comes to devising a digital health strategy for your business, there are two key decisions to make that will have a huge impact on the success of both the strategy and the eventual solution.
The first is whether to build the solution in-house, partner with a company with the necessary skills, experience, and people needed to build the solution, or buy an existing out-of-the-box solution. The second question concerns the approach to take when implementing the solution, and whether a project-based model or product-based model is the way to go.
Parts of this article are excerpts from our recent whitepaper Regulated Digital Health: Pharma’s Next Success Story. For more in-depth analysis, including commentary from experts from Pfizer, Takeda, Novartis and S3 Connected Health, download our free whitepaper now.
Build, Partner, or Buy?
When a pharma company decides to develop a digital health solution, several factors should be taken into consideration when it comes to how it will do this. These include the organization's internal level of resources, expertise, and skills in building digital health solutions, the long-term plans for scaling the solution, and the desired patient outcomes.
While a handful of the biggest organizations are building extensive in-house capabilities to develop, test, certify, and commercialize digital health solutions themselves, this approach is neither necessary nor feasible for many companies. Digital health platforms are emerging as a viable model for pharma to build solutions. There are two main types: core platforms created and used internally by pharma companies to create multiple products, and platforms developed by digital health specialists that have a core technology innovation, on top of which they can build custom digital health solutions.
Do The In-House Capabilities Exist to Build?
Creating a solution internally requires a pharma company to have a quality management system with an ISO 13485 certification with specific internal expertise. Specialist internal departments will be required as well, to work with patients and healthcare providers to prove the product’s worth in principal; develop the software and hardware that deliver the therapeutic benefit; test and validate it; work directly with regulators; launch, manage and monitor the solution in the market; and take on the various responsibilities that come with developing and maintaining software as a medical device.
Is Partnering Up The Right Approach?
Another option open to pharma companies is to partner with a specialist firm that can complete part, or all, of the process; perhaps via a managed service contract. This is an attractive option for pharma companies that can augment their existing capabilities and reduce burdens on internal teams.
Specialist firms offer a range of services including early product development, product testing, working with regulators, handling the day-to-day data operations, and handling much of the legal and regulatory responsibilities. The partner might also take on the responsibility of being the legal manufacturer.
In some cases, partnering with firms that has developed an underlying core platform for digital health (perhaps covering related disease areas that share an underlying evidence base) can speed the creation of a desired solution. The commercial model here could include revenue or profit share.
Can Third Party Specialists Deliver the Solution Required?
Pharma companies can contract specialist firms as needed, on a solution-by-solution basis, or foster longer-term relationships, with partner firms operating seamlessly with internal teams. Alternatively, they may sponsor a third party to develop a certain digital health solution; usually non-exclusively.
Strategic intent informs the development path, including this decision, which depends on a number of factors, including financial concerns, whether there’s a desire to ‘own’ the solution, and whether partnering is a fit for the business.
In addition to the technology and timeline issues that are considerations at this stage, planning for early and frequent engagement with all stakeholders must be assessed for suitability. It can be too easy to get lost in the technology aspects of the solution, but, like the development of all good digital products, it’s vital to prepare to interact with end-users throughout development for regular feedback.
During prolonged development paths, the budget is a constant concern, with reductions being sought at every corner. One area that must not be considered though, is around de-risking strategies. Built into this area is early and regular feedback throughout development, enabling ongoing iteration and improvement throughout development. While this might at the time seem like a way to save on time and costs, it only risks more significant strain on both when substantial feedback is received for the first time at launch.
Product-Based or Project-Based?
The second key decision to make is around adopting the product-based or the project-based model to develop the digital health solution.
Project-Based Model
In a project-based model, teams form to complete specific tasks, focused on one element of a project. These models usually require individuals to be pulled into a project from various teams at various stages and can lead to singular efforts, competing priorities, and a lack of data-sharing and interoperability. While it can work well for temporary goals, it may not fully solve problems for end-users and create differences of opinion and priorities within the organization
A shift has emerged in recent years, with companies foregoing that model, to operate in a product-based model instead, working from start to finish on the whole product, rather than centered on a specific area.
Product-Based Model
A product-based model is a business strategy that focuses on creating and delivering products that meet the needs of customers. It is centered around empowering product teams to deliver value for customers.
Working in an empowered product team, managers assess if a digital health solution is viable financially, technically feasible, and compliant with legal and regulatory requirements. A design lead ensures that the solution is desirable by providing a compelling user experience to each end-user while addressing key patient behavior challenges.
A product-centric approach also makes it easier to rapidly innovate and iterate because it focuses on customer experience, evolving requirements, and the strategic differentiation of a product or service.
Once all the above questions have been answered, your digital health strategy can move on to the next stage of development. We address the next stage of development in the whitepaper below.
For more in-depth analysis, including commentary from experts from Pfizer, Takeda, Novartis and S3 Connected Health, download our free whitepaper now.
