Digital healthcare was a rapidly evolving space even before the pandemic, while the latter further accelerated its growth. Even though societies are in the process of returning to the pre-pandemic situation, or at least in a “new normal”, digitally-enabled healthcare solutions seem to be here to stay.
3 top obstacles to launching a new digital health solution successfully.
The number of digital health solutions available in the past few years indicates the space’s demand and potential.
However, the proportion of the solutions that eventually become successful in the market is relatively low as new products have to overcome specific hurdles.
Such hurdles include, but are not limited to, regulatory approval, payor reimbursement, and low user adoption.
- Regulatory approval: The golden standard for proving a digital solution effective is the FDA (or EMA or other regulatory body) approval, which means we need data showing that a product benefits its users. Funding clinical trials is a major obstacle in this direction. Even though neither the FDA nor the EMA have issued specific guidelines for Digital health / Tx, the former has published several guidance documents, while in Europe the new German Digital Healthcare Act regulates specific requirements for the use of DTx with France also being on the pathway of implementing a similar approach.
- Reimbursement: This is a challenge startups usually face, as payors are less likely to consider products that do not have a proven return of investment.
- Low adoption: We attribute low adoption to the immaturity of the market and the lack of developers’ experience in promoting their products or even developing products that resonate with the users (essentially creating enough product-led adoption)
Strategies to overcome regulatory, reimbursement, and adoption hurdles when launching a digital solution.
An effective GTM (go-to-market) model is key to the overall success of a digital solution. Below we discuss potential strategies to overcome regulatory, reimbursement, and adoption hurdles, with a focus on the US market.
- Integrating with FDA-approved devices.
Exploring the option to integrate the offering (software, platform, etc.) into already FDA-approved devices is a strategy to obtain approval. Omada Health implemented this strategy and ensured success for its software offer.
- Focusing on healthcare insurers / providers and carriers who offer reimbursement and tieing pricing to the value created for your customers.
To overcome reimbursement hurdles, we recommend focusing on programs/plans willing to invest in innovative products and motivated to provide a holistic approach when considering patients’ benefits. Medicare and Medicaid are currently offering reimbursement for remote patient monitoring.
Also, carefully done pricing should consider both the clinical / QoL value (improvement in clinical disease endpoints and also QoL-related ones vs. the SoC or other available treatments) and the financial benefit for the provider (revenue generation, reduced costs) that the product offers.
- Reaching the right audience on the right channel with the right message.
The first step is to identify key stakeholders, segment them (e.g., based on their familiarity with digital tools) and adjust the approach depending on their preferences.
The second step is to use the proper channels to promote relevant messaging around the product; an omnichannel approach ensures effective message communication.
The third step is content optimization according to receivers’ needs and preferences (time availability, the preferred method of communication, etc.). Sharing only relevant information increases message deliverability.
Investing in an appropriately trained team that can deeply understand the clinical and financial aspects of the total offering is critical to successfully implementing all the above.
GTM strategy is the only way for a successful digital health product launch.
Although the plethora of available digital tools in healthcare indicates the high demand for effective solutions, only a few of them make it to the market.
A thoroughly designed and carefully implemented GTM strategy will result in solutions that add value to patient’s lives and healthcare systems.
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Sources:
https://blumbergcapital.com/digital-health-go-to-market-strategies/
https://www.pwc.ch/en/insights/health-industries/setting-commercial-teams-up-for-success.html
https://a16z.com/2021/10/19/the-new-go-to-market-playbooks-for-digital-health-startups/
https://edps.europa.eu/press-publications/publications/techsonar/digital-therapeutics-dtx_en