Whitepapers

First things first: navigating risk in medical device development

Successful medical device development isn’t just about innovation - it’s about managing risk at the right time.

Identifying and addressing critical risks early isn’t just good practice; it’s essential for avoiding costly delays and ensuring long-term success. Most R&D leaders already know how to manage risk in medical device development. But when deadlines loom and teams are under pressure to show progress, good risk management often becomes a “we’ll deal with it later” issue. And that’s when late-stage redesigns, manufacturing dead-ends, or usability blind spots come back to bite. This paper isn't to teach you how to manage risk – you’ve got that already - but to help you do it more deliberately, with better language and structure to guide tough calls and trade-offs across various stages of the product development process - so you can move forward with confidence.

Download the e-book: First things first: navigating risk in medical device development

In this guide, we offer simple, practical guidance on common challenges and how we manage risk at all stages of medical device development:

1.   How to identify and address risks early – Strategies to tackle critical design and manufacturing challenges before they become costly roadblocks.

2.   How to balance risk and reward in product definition – Defining a target product profile (TPP) that maximises value while minimising unnecessary risks.

3.   How to use technical studies to de-risk innovation – How feasibility studies can help validate key requirements and prevent expensive late-stage redesigns.

4.   How to implement progressive testing for smarter decision-making – Insights into structuring testing at different development stages to ensure confidence in your design.

5.   How to plan for manufacturability from the start – Best practices for integrating manufacturing considerations early, ensuring a smoother path to production and scale-up.

By focusing on the right risks at the right time, you can reduce uncertainty, avoid unnecessary delays, and keep your development on track.

Download the e-book today to explore these strategies in more detail.

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Discover practical strategies for managing risk at every stage of medical device development.

Download the 'First things First - Navigating Risk in Medical Device Development' e-book

Get practical tools for making better risk decisions at every stage of medical device development in this e-book by using the form below.

Last Updated
April 9, 2025

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