One of the single biggest causes of Medtech startup failure is young entrepreneurs going to mass marketing and sales prematurely – when neither the product nor the company are ready and mature enough to meet the expectations and needs of the clinical user community. Essentially, a false start.
Simply put: even though a product performed well on the bench, in pre-clinicals, or in early human feasibility studies, these efforts are not an accurate predictor of how the product will work in a more demanding and competitive commercial setting.
Allow me to suggest a more systematic and step-wise approach that will mitigate financial risks and optimize longer-term business results.
We’ll look at two initial steps here:
1 – Pay attention to clinical workflow
When a company completes the critical step from functioning prototype to an alpha first-stage human-use product designed and built under a properly-qualified QMS, it is strategically important to obtain user feedback on human factors (a scientific assessment that evaluates and understands human interactions in relation to other elements of a workplace system. It is the application of theory, principles, data and methods of design in order to optimize safety, human well-being and overall system performance) and the impact of the product on clinical workflow.
More often than not, the feedback coming from this tightly monitored user group loops back to certain design features that are critical to effective commercial utility and adoption. This phase, often described as a “controlled release” phase, is strategically important in an entrepreneur’s path to success.
2- Utilize Strategic Commercialization
The second design iteration (resulting from the user feedback from the alpha-controlled release phase), often described as the beta product, is the company’s better ticket towards commercialization. But hold on! Let’s ask the next important question: what is the best and most doable way of initial commercialization?
I describe it as “Strategic Commercialization”. Rather than a “spray & pray” or shotgun approach , a highly-targeted and strategically-driven sales approach will usually generate significantly better results with lower risks.
My next blog will describe this strategy and the underlying reasons why it makes good business sense.