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Why the Endpoint is actually the Starting Point in Medtech

market driven innovation regulatory strategy Jan 19, 2022

When you are developing a new medical device, it is tempting to start by brainstorming, developing prototypes, and running demos for investors and others. But this approach will often lead you to a solution that doesn't meet the key considerations required for adoption.

Instead, you should start at the endpoint and work backwards.

Here's why..

Any medical device will be judged against the standard of care. This is what is understood, practiced, and familiar.

Changing from this standard of care is a significant undertaking. Clinicians need to be trained. Patients need to be educated. Procurement needs to approve new suppliers. IT systems need to be updated. The list goes on and on..

So, if your medical device is going to be considered, the benefits over the standard of care must significantly outweigh the costs associated with this change.

The benefits are where you start - that is, the quantified clinical benefits over the standard of care. What is the clinical impact that you need to make to compel healthcare systems to change from what is currently practiced and known?

This is where the endpoint comes into play.


The terms endpoint and outcome are commonly interchanged. Outcomes are measurables that are tracked with a medical procedure. There can be intended health outcomes - such as survival, elimination of disease, or elimination of symptoms. There can also be unintended (or negative) health outcomes - such as infection, misdiagnosis, or death. Every medical procedure has both intended and unintended outcomes.

One of your primary jobs as a medtech innovator is to positively change an outcome. This change in outcome will most likely be evaluated through a clinical trial. When designing the clinical trial, the primary "endpoint" needs to be identified. This primary endpoint is a measurable event or an outcome of significance to a patient that determines if the intervention is beneficial. For instance, a primary endpoint for a life-changing surgical procedure could be a 15% percent increase in 6-month survival. A primary endpoint for a remote monitoring device could be a 20% decrease in hospital readmissions 30 days from discharge.

Achieving this target endpoint is the purpose of your medtech innovation. If this endpoint isn't meaningful to the healthcare community, then neither will be your device. Moreover, this endpoint needs to be meaningful enough to overcome the change resistance that will inevitably arise from any deviation in the standard of care.

So, before diving into concepts and prototypes, be sure that you are focused on the right endpoint. And be sure that this endpoint will satisfy the key healthcare stakeholders that will be affected by the change in care required by your innovation. Do the benefits of this endpoint outweigh the costs of change for these key stakeholders?

Once you have quantified and confirmed this endpoint, use it to drive and filter out potential solutions.

Start at the endpoint, and work backwards.



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