This is a guest post by Matthew Thompson, Professor UW Department of Family Medicine and Director UW Primary Care Innovation Lab, our partner in our inaugural TRAILS Competition. Learn more about the TRAILS competition here.
Most technologies used in health care settings don’t make it to market without evidence supporting them. Even so, developing an evidence pathway—a plan for what evidence is needed at each stage of product development to allow it to progress along to implementation and market—is often overlooked.
So, why is evidence needed? For pharmaceuticals, the evidence pathway is highly structured. New drugs move from early-phase drug trials, to later phases of clinical trials, leading to regulatory approval and marketing. However, for most other health care technologies such as diagnostic tests, non-invasive devices and health apps, the evidence needed from invention to implementation is far less clear.
Focusing solely on FDA approval as the gateway to widespread sales and adoption is not likely to lead to success. I am often struck by a mismatch in resources between building a proof of concept and gathering evidence. Wider types of evidence will be demanded (by payers, for example) when taking a new health care technology to market, but often most efforts are dedicated to the proof of concept.
Unlike new drugs, many health technology innovations are created based on individual experiences and anecdotal evidence. Evidence-based innovation is the purposeful application of rigorously collected and analyzed data from multiple sources to inform the design and application of an innovation at all stages of development. The basic idea of evidence-based health innovation is that good-quality innovation should be based on a combination of critical thinking, creativity, and the best available evidence.
Evidence can come from many sources including talking with potential customers, observing users, reading the published literature, conducting a survey, utilizing existing records, and various other types of data collection. At the sixth annual digital health summit, over 100 digital health CEOs talked about ditching pilot studies in favor of a longer roadmap. We call this roadmap the evidence pathway.
But, the evidence needed at each stage of the product life cycle can be a potential minefield, particularly for small, new health care startups. Even large, well-established technology companies struggle with this. One way of thinking about this evidence pathway is to think about generating the right evidence, using the right methods, at the right time.
At PCI-Lab, we help companies generate evidence at every stage. For early startups, we can help identify the market opportunity and define the needs. For later-stage companies, we can help refine the product through feedback from patients and primary care physicians.
As part of this blog series for Cambia Grove’s TRAILS Competition, my PCI Lab colleagues will talk in more detail about what we mean by the right evidence (what data is needed?), the right methods (how is quality, rigorous evidence generated?), at the right time (how do you create a pipeline for data collection?). More to come!