CERTIFIED: ISO 9001 | ISO 13485 | ISO 27001
CERTIFIED: ISO 9001 | ISO 13485 | ISO 27001
5 Common Pitfalls to Avoid when Doing a Medical Device Proof of Concept
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Can a medical device proof of concept (POC) help validate your ideas and ensure that your product meets market needs before full-scale development? Absolutely.

By following these principles, you can ensure that your POC remains efficient, focused, and useful for addressing key questions before moving into full-scale development.

Ensure that your medical device proof of concept (POC) is successful by avoiding these common pitfalls:

1. SET CLEAR GOALS

Without clear goals, the POC can drift and lose focus. Defining the objectives early on allows for more structured and effective progress, though goals can evolve as necessary.

HOW WE HELPED

For a drug delivery system, the first POC goal was to confirm whether the technology was feasible. After proving that, a second POC focused on optimizing the user workflow. Having clear, specific goals for each POC phase helped ensure timely completion without drifting into full product development​.

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2. STICK TO SHORT TIMELINES

A POC should be fast and iterative, focusing on quick learning and adjustments. Keeping the POC phase short prevents it from merging into broader development.

HOW WE HELPED

For a Bluetooth communication system in a cardiac lab, the team worked in one-week sprints to test signal interference. This rapid, iterative approach allowed them to address problems quickly without committing to lengthy development cycles​.

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3. AVOID INVOLVING TOO MANY STAKEHOLDERS

Involving too many people at different stages can lead to delays and confusion. Keep the team small and focused on the specific goals of the POC.

HOW WE HELPED

In a digital microscope project, the POC phase involved nearly everyone in the company, from engineers to customer service. This wide involvement slowed down decision-making. The team later reduced the stakeholders to a more focused group for each POC, which significantly sped up the process.

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4. MANAGE EXPECTATIONS

It's important to communicate that a POC is not the final product. Sometimes, stakeholders may assume that because a POC works or looks complete, the product is ready.

HOW WE HELPED

In a POC for a cardiac instrument mobile app, the marketing team mistakenly thought the app was nearly ready for release because it looked polished. However, it was just a prototype without backend functionality or regulatory approval. Setting clear expectations early will help align everyone on the status​ of the project.

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5. AVOID MIXING POC WITH PRODUCT DEVELOPMENT

Trying to reuse or merge the POC directly into the product development phase can lead to confusion. The POC is for rapid discovery, while product development requires a more structured approach.

HOW WE HELPED

In a novel cardiac instrument project, the client initially tried to apply product development processes to the POC phase. This approach slowed things down. Once the POC was separated from full product development, the team could quickly iterate and test different interaction models.

CLIENT CASE STUDY
Keep reading our POC Series

5 Critical Ways that Leading MedTech Organizations use Proofs of Concept prior to Development