Unlocking Innovation Through Early Human Factors Engagement

In the race to develop cutting-edge medical devices, manufacturers often focus intensely on technical innovation and regulatory compliance. Yet many promising products still fail to gain traction in the market or require costly redesigns late in development. The missing ingredient? A deep understanding of the human element from day one.

Early integration of user journey and behaviour mapping isn't just a nice-to-have - it's increasingly becoming the differentiator between medical devices that transform healthcare and those that gather dust. Human Factors has the ability to help identify the next breakthrough in medical technology by putting users at the centre of innovation.

The Hidden Cost of Late-Stage User Research

Medical device development is already an expensive proposition. The development of a Class II 510(k) cleared medical device cost is approximately $30 million, with the development and engineering costs comprise approximately $2-5 million of this total[1]. What many manufacturers don't account for is the additional cost of addressing usability issues discovered late in development:

• Medical devices that fail post-launch typically do so because of user adoption issues, not technical failures

• Estimated 98 000 avoidable deaths per year [2]

• Redesigns identified during verification and validation testing can typically add 4-6 months to development timelines

• FDA rejection due to use-related safety concerns can cost companies millions in additional development and delay market entry by years

What is User Journey and Behaviour Mapping?

User journey mapping goes beyond traditional market research by documenting not just what users say they want, but how they actually interact with devices in real-world contexts. This methodology involves identifying trends and performing robust analysis in order to create visual representations of:

• The complete experience a user has with a device, from initial awareness through long-term use

• Pain points and workarounds in current solutions

• Emotional and cognitive states during device interaction

• Environmental factors that influence device use

• Differences between intended and actual use patterns

Behaviour mapping specifically examines observable actions users take when interacting with medical devices, identifying discrepancies between how designers expect a device to be used and how it's actually used in practice.

Unlike focus groups or surveys, these methodologies reveal hidden opportunities that users themselves may not articulate because they've normalized pain points or aren't aware of possible solutions. These opportunities can be utilised to understand gaps in the market, drive innovation, and build robust user requirements.

When and How to Incorporate Human Factors Researchers

The ideal time to bring in Human Factors expertise is before the first concept sketch is drawn. Human Factors researchers should be integral team members during:

1. Opportunity identification phase - When exploring unmet needs in the market

2. Concept development - When defining core functionality and use cases

3. Early prototyping - When testing initial user interfaces and workflows

4. Throughout development - As the product evolves and becomes more refined

While adding these resources does increase early development costs, the ROI becomes evident through reduced redesign costs, faster regulatory approval, higher adoption rates, and stronger market differentiation. Companies that integrate Human Factors early typically see 40% fewer changes during verification and validation testing.

A previous ClariMed case study on HIV injection device development exemplifies this approach, where early patient interviews revealed both practical usability preferences and crucial emotional needs that significantly influenced the final device design.

The Competitive Advantage of Human-Centered Innovation

As medical devices become increasingly sophisticated technically, the greatest opportunity for differentiation lies in the human experience. Devices that seamlessly integrate into users' lives - whether they're patients, caregivers, or healthcare providers - will outperform those that prioritize features over usability.

The next breakthrough medical device won't just be technically superior - it will be fundamentally designed around human needs, behaviours, and contexts. And that breakthrough will come from companies that recognize Human Factors research not as a regulatory checkbox, but as the foundation of meaningful innovation.

The question isn't whether you can afford to integrate user journey mapping into your development process. It's whether you can afford not to.

Put Users at the Center of Your Next Innovation

ClariMed's Human Factors experts help medical device companies integrate user research from day one—reducing development costs, accelerating regulatory approval, and ensuring market success.

Schedule a consultation to discover how early Human Factors engagement can transform your development process.

References

[1] StarFish Medical, Cost to Develop Medical Devices July 2020 White Paper

[2] Institute of Medicine. (2000). To Err is Human: Building a Safer Health System. National Academy Press.