In the past, we made the assumption that as a small team, we need a laser focus to push forward. This has been ingrained in us from the teachings of a US infrastructure with a clear path to market. The steps may be bureaucratic and long, but they are also consistent, documented, and well understood. Input produces an output. But we don’t work in the US, we work in Africa with a fluid landscape where the incentives are different.
This requires a new multi-approach to kicking off our initial pilot study for Hemafuse. Originally, our laser focus approach involved coordinating with a single clinical site in Sub-Saharan Africa. The partnership seemed to have the capability/titles/clinical experience to get Hemafuse in the hands that want to use it. Finding the hands wasn’t difficult. The trick is also finding clinicians with the time and support to truly scrutinize a medical device’s first time in surgery.
Systematic, research-focused protocols (like it sounds) are a lot of work. Feel free to ask any specialist in academia; their jobs are not easy. And without major incentives for publication, often a tool for career advancement, the cost/benefit of doing a small pilot study is not always available to all of our African partners.
Lucky for us, not all. It was time to seek a second opinion. And we were overwhelmed with the response.
Through several of our Baltimore-based partners, the Gates Foundation network and some cold calls, we discovered that these doctors are calling to do the research. We just needed to present them with the option. The quantity and quality of the responses has been massive; and our confidence in coordinating this study abroad has been restored. And led to some significant realizations on our approach.
The research support and new leads generated by expanding our geographic scope for this initial pilot has not only enabled our clinical strategy, but begun to anecdotally increase demand. Unlike clinicians and researchers in other contexts, our current partners repeatedly ask questions on supply chain management and how they can build purchase capacity in their institution. Their intent is beyond the initial research study. They are excited by the possibility of such an innovation becoming a valuable tool in their practice, once it’s been proven.
Our original, narrow focus on a single country for smaller studies was a short-sighted assumption around speed through regulatory and first sales. By looking beyond that single variable, we’ve reminded ourselves that we are building a system and rediscovered our mission: incentivizing stakeholders along the entire value chain. This engagement continues to be scarce as evidenced by our clinician’s entrepreneurial and multi-lateral concerns. Their hospitals, and the distributors that supply them, will eventually be our customers. Their investments in the innovation of Hemafuse at this early stage will influence our B2B relationships well into the future.
Want to hear more about Sisu's mission? Come see CMO, Katie Kirsch, talk at Light City's Health Innovation Conference.