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4 Steps to Defining Your Clinical Outcome

clinical strategy market driven innovation technology development Apr 20, 2022
4-steps clinical outcome

Hey – Eric here.

Here are 4 steps on how to clearly define the clinical outcome that compels adoption of your new medical device.

Today’s issue of Medtech Mindset takes about 3 minutes to read.


If you are growing a medical device business, a big part of your mission is to improve the health and well-being of a patient population. Demonstrating a clinical outcome is evidence that you have succeeded in this mission. Additionally, it’s typically required to gain clinical acceptance and healthcare adoption.

The right clinical outcome should focus a device design. It ensures that design priorities, testing processes, and other de-risking activities are placed on the most critical interactions.

Unfortunately, most companies avoid the topic of clinical outcomes until late in the game – often only after a device design has been frozen.

Why does this happen?

Engineering and clinical teams are disjointed.

Typically, these functions are separate and siloed in large organizations. And in smaller organizations, a clinical function may not even exist during early stages of development.

Other reasons that companies avoid defining clinical outcomes include:

- They may think clinicals are unnecessary in a 510(k) pathway.
- They may think that clinical feedback and endorsement is all that is needed.
- They may think a novel technology will be enough to drive adoption.

These reasons lead companies toward a difficult realization when their medical device reaches the market.

If your company experiences any of these issues listed above, fear not! The following steps may get you and your team back on-track with a compelling clinical outcome.

Step #1: Define a specific patient population.

They key term in step #1 is “specific.” You need to define a small subset of your clinical indication that experiences very poor outcomes.

Why will this matter?

Because targeting a population with poor baseline outcomes will a.) make demonstrating your clinical outcome more feasible and b.) will reduce the size and cost of a clinical study.

Step #2: Focus on the negative (not the positive)

After you have defined sub-populations of your target clinical indication, study the standard of care (SOC), and determine the negative health outcome that result from problems associated with the SOC.

These negative health outcomes could be infections, repeat procedures, readmissions, mortality, etc. Research the average incidence rate of these negative health outcomes for the sub-population and expanded patient populations.

Why aim for a negative health outcome rather than a positive one?

Negative health outcomes are much more linkable to economic outcomes – another key driver of new medical device adoption. You want to improve clinical outcomes, of course. But most often, creating a compelling ROI for customers is the best way to make this happen.

Step #3: Define the anticipate improvement

Define the anticipated incidence rate that you aim to achieve. Review this expected improvement with members of the clinical community to understand the minimum threshold that will need to be achieved to overcome SOC inertia and adopt a new solution.

Step #4: Determine clinical study size and cost

After you have defined the baseline and anticipated incidence rates related to the negative health outcome, conduct a basic power analysis to evaluate the sample size that will be required. There are several online sample size calculators that can help with this process, such as THIS one.

After you determine the sample size, estimate the approximate costs of the clinical study. These costs will depend on enrollment, procedures, routine follow-ups, and other factors. Depending on the size and cost of the clinical study, you may need to rerun Steps 1-4 to determine alternative patient populations, negative health outcomes, incidence rates, and study size.

(Even if your medical device will not require clinical studies for regulatory clearance, it is highly likely that a post-market study will be required to define superiority over the standard of care. So, it is critical for you to understand the ballpark size and cost of this study.)

That’s all for this Wednesday's Medtech Mindset. Just a simple tip to help you with this key medtech topic.

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See you again next week.



P.S. Have another medtech topic that is challenging you? Reply to this email and tell me about it! Perhaps it will make its way into a future Medtech Mindset issue.

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