How Medical Lead Users Can Accelerate MedTech Innovation

How Medical Lead Users Can Accelerate MedTech Innovation

Developing medical device innovations is a lengthy and costly process. A company’s shareholders place time pressure on the firm’s stakeholders, such as CEOs, CTOs, and product owners, to launch the product on time, within the planned cost frame, and finally meet profit expectations. High MedTech development costs, time pressure, strict regulations, and market uncertainty make the innovation process extremely challenging.

Dr Venesz developed a method that enables decision-makers to overcome these challenges and better fulfil firms’ shareholder expectations. His method provides an opportunity for firms to speed up the innovation process, reduce risk and uncertainty, and lower development costs and time.

In his work (published in a high-impact scientific journal), he states that the key to success is the engagement of appropriate medical doctors. Involving such practitioners highly enhances the innovation process: they identify real market needs, propose fitting solutions, collaborate during product development and testing, and most importantly, able to influence the market and change clinical protocols. In sum, appropriately identified medical doctors (called medical lead users) enable the market success of a newly developed MedTech product.

This article provides essential information for decision-makers about medical lead users, their identification and engagement, and the benefits for firms applying the method.

The full published research article is available here: https://doi.org/10.1016/j.jik.2025.100677

Who Are Lead Users?

The term "lead user" was originally defined by Professor Eric von Hippel (MIT). Two attributes identify lead users:

1. Ahead of Market Trends: they recognise trends much earlier than the majority of the market.
2. High Expected Benefit: they feel high expected benefit from solving those needs.

These individuals often create their own prototypes, but in the case of complex products like medical devices, they must collaborate with manufacturers to co-develop and launch the innovation.

Practical experience shows that not all practitioners are suitable to become medical lead users. According to Dr Venesz, only those who possess a specific set of personal characteristics. These are what he calls medical lead users.

Why Medical Lead Users Drive MedTech Market Success

Medical lead users possess seven personal characteristics that enable them to make an impact at different stages of the new product development process. The impact, and its intensity, varies across stages as the below Figure shows. 

The line “Average (AVG2)" indicate an important fact: the market diffusion stage is where medical lead users make the strongest impact. In other words, a medical lead user can significantly impact on market acceptance, influence clinical adoption, and change protocols. These are the critical steps for firms seeking to meet their KPIs and strategic sales goals.

Seven Characteristics Every Medical Lead User Must Have

Dr Venesz’s in his research identified seven traits that distinguish appropriate medical lead users:

1. Expert-Level Professional Knowledge: deep domain expertise developed over at least 10-15 years.
2. High-Level Technical Knowledge: ability to propose feasible solutions and provide technical feedback.
3. Experimenter Mindset: strong motivation to test, refine, and improve prototypes through hands-on work. They usually have small workshop at home. 
4. High Level of Collaborative Attitude: willingness to share their tacit (and of course explicit) knowledge through practical exercises.
5. Advanced Communication Skills: uses clear, simple communication with engineers; avoiding complex or metaphorical expressions that are hard to understand.
6. Social and Professional Connectedness: strong networks for early feedback, influence others, and market promotion.
7. Formal Authority: senior roles and respected status that enable them to influence protocols and adoption decisions.

These characteristics emerged through 38 interviews with MedTech developers and manufacturers who successfully co-developed products with medical lead users and achieved market success. 

We’ve developed a practical Medical Lead User Checklist to help firms assess candidates early in the innovation process, and practitioners can use it for self-assessment as well.

Practical Examples: Real Success Stories

Building on these real-world insights, we mention two success stories how Ergomedic has supported MedTech innovation:

• Surgical Implant Product: the client asked us to investigate why they were not successful in selling their high-end, well-designed surgical implants. After carefully analysing their business model and processes, we identified that the people they were engaging lacked the authority to implement the solution into clinical protocols. Following a series of interviews and targeted investigations, we identified the right medical lead users, as well as practitioners who had daily contact with those decision-makers and were able to influence the influencers. These lead users, due to their formal authority, were able to integrate the solution into clinical protocols. As a result, the firm experienced substantial growth in orders, revenue, and profits.
• AI-Based Eye Diagnostics Tool: a MedTech startup developing AI-powered eye diagnostics partnered with Ergomedic to validate their go-to-market approach. We discovered that the medical practitioner involved lacked some of the seven key personal characteristics of a medical lead user. We also recognised that their go-to-market strategy was not well established. As a result, we returned to the market research phase, followed by redesigning the product and developing a new go-to-market strategy. Since the device required MDR / 510(k) (FDA) approval, we supported the client by connecting them with regulatory experts from our network. A few months later, we received very positive feedback: the market welcomed the service, and the sales process was progressing well.

These examples demonstrate the importance of early and consistent involvement of medical lead users, and also show the complexity of challenges firms often face in MedTech innovation.

How Ergomedic Helps MedTech Innovations Succeed

At Ergomedic, we help MedTech companies achieve their market goals by applying our 20 years of experience at this domain and published research findings.

We address three key phases of the innovation journey:

• Product Discovery: identifying real clinical needs, validating opportunities, and testing early concepts with medical lead users.
• Product Design: creating user-aligned, clinically validated, and compliant product solutions.
• Go-to-Market: building appropriate strategies based on market specialities, establishing professional networks, and supporting early adoption.

Our approach ensures that the problem is considered comprehensively in order to achieve firms’ market success as expected. 

Business Value for Decision-Makers

By implementing these insights into everyday practice, your MedTech firm can achieve significant benefits:

• Faster Time-to-Market: shorten development time and accelerate regulatory readiness.
• Reduced Cost (Increased Profitability): minimise unnecessary investment and lower risk.
• Higher Product-Market Fit: align product design with real-world, validated user needs.
• Flowless Market / Clinical Acceptance: strengthen early adoption and protocol integration.

By engaging medical lead users in your innovation process, you can build a long term sustainable competitive advantage over your rivals.

If you are thinking of developing a new product but are not sure exactly what, applying the medical lead user method could offer an appropriate solution.

Start Your MedTech Growth Journey

We are ready to share our knowledge, experience, and resources to support your success. 

If you are ready to accelerate your MedTech innovation, partner with Ergomedic. Let's bring your product vision to market, and beat your rivals. 

Contact us today.

Ergomedic: Designing MedTech Products. Delivering Go-to-Market Success.

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