The difference between a promising MedTech idea and a successful product is often the quality of the decisions made along the way.
MedTech development has never been simple. But the environment in which product teams are operating is becoming considerably harder.
Products increasingly combine hardware, software, connectivity and data. Regulatory expectations continue to evolve. Human factors, cybersecurity, clinical evidence, reimbursement, manufacturability and sustainability can all influence development decisions.
At the same time, companies are under pressure to innovate faster.
McKinsey reported in 2025 that MedTech R&D spending was increasing at approximately 10% a year, while average time to market had risen to more than four years. Yet its research also found that companies in the top quartile for innovation performance achieved 40% higher revenue growth and twice the total shareholder return of their peers.
The conclusion is important.
Innovation still creates enormous value. But simply spending more on R&D is not the answer.
The organisations that perform well tend to be better at deciding what to develop, what to test, what to change and, critically, what to stop.
More governance does not necessarily mean better governance
As organisations grow, development processes inevitably become more structured.
Stage gates appear. Committees expand. Reporting increases. More functions become involved in approving decisions.
Much of this is necessary in a regulated industry.
But there is a danger.
Governance can gradually shift from helping teams make better decisions to helping organisations document decisions that have effectively already been made.
A project reaches a gate, the presentation is polished, the required boxes are ticked and development continues.
McKinsey has previously highlighted this problem, arguing that conventional stage gates can become ineffective when funding is rarely delayed or stopped. It advocates genuine “decision gates”, points at which management makes explicit investment and design choices based on the evidence available.
That distinction matters.
A gate should not ask:
“Have we completed this phase?”
It should ask:
“Based on what we now know, should we continue investing in this product?”
Those are very different questions.
Good development decisions start with good evidence
One of the biggest mistakes in product development is trying to eliminate uncertainty through discussion.
You cannot.
You eliminate uncertainty through evidence.
That might mean observing clinicians using an early prototype.
Testing whether a critical mechanism actually works.
Understanding the regulatory implications of a proposed architecture.
Putting a crude interface in front of users.
Investigating manufacturing constraints before detailed engineering begins.
Or speaking to potential customers before investing another £1 million in development.
The objective is not to perfect the product.
It is to identify the assumptions that could kill the product and test them as cheaply and quickly as possible.
That changes the role of prototyping.
A prototype should not simply demonstrate progress. It should answer a question.
The best teams actively look for reasons they might be wrong
There is an uncomfortable truth about innovation.
Once organisations invest enough time, money and reputation in an idea, stopping becomes increasingly difficult.
Teams naturally become advocates for their projects.
The business case becomes something to defend rather than something to challenge.
This is where independent thinking becomes extremely valuable.
Strong development teams continually ask:
What assumption are we making?
What evidence supports it?
What would have to be true for this product to succeed?
What could make it fail?
What is the fastest way of finding out?
This approach creates a very different development culture.
Instead of trying to prove that an idea works, teams actively try to discover where it does not.
Finding a fundamental problem after six weeks and £50,000 is a successful development outcome if the alternative is discovering it after three years and £5 million.
Bring the difficult disciplines forward
Many expensive development problems are created when critical disciplines enter the process too late.
Industrial design develops a concept.
Engineering makes it work.
Human factors tests it.
Regulatory reviews it.
Manufacturing tries to produce it.
Commercial teams then attempt to sell it.
That sequential model is increasingly difficult to justify.
The FDA’s current human factors guidance reinforces the importance of considering intended users, use environments and user interfaces as part of medical device development, with the objective of minimising use-related risks and ensuring devices can be used safely and effectively.
Human factors therefore cannot simply be a validation exercise at the end of development.
Nor should regulatory strategy, manufacturing or commercial thinking.
The earlier these perspectives influence design decisions, the greater the opportunity to change direction while change is still relatively inexpensive.
Give small teams big problems
There is another lesson larger MedTech organisations can take from their most successful innovation programmes.
Not every development challenge needs a large team.
In fact, some of the hardest problems are better tackled by small, experienced, multidisciplinary groups with a clearly defined objective and the authority to move quickly.
McKinsey’s interviews with leading MedTech R&D executives highlighted increasing reliance on cross-functional teams and strategic external partnerships. It also noted a fundamental challenge for larger companies: combining innovation with commercial excellence while allocating resources between new products and established portfolios.
This is precisely where focused external development teams can add disproportionate value.
Rather than replacing internal R&D, they can work alongside it.
A tightly integrated team can explore an opportunity, challenge assumptions, build prototypes, conduct user research and resolve difficult technical questions without requiring the organisation to mobilise a major internal programme.
It creates a protected space in which ideas can be tested quickly, while still operating within the regulatory and commercial realities of MedTech.
Separate exploration from execution
One process should not govern every stage of innovation.
Early development needs freedom to explore.
Later development needs discipline to execute.
Confusing the two creates problems.
Apply heavyweight development controls too early and potentially valuable ideas become slow and expensive to investigate.
Allow exploratory behaviour to continue too late and programmes become difficult to control.
Leading organisations recognise the transition.
Early development should be about learning:
Can we solve the clinical problem?
Will users adopt it?
Can we create a meaningful advantage?
Can it be manufactured?
Is there a viable regulatory route?
Does the commercial case stand up?
Once those questions have sufficient evidence behind them, development can progressively move towards controlled execution, verification, validation, industrialisation and regulatory submission.
Measure learning, not activity
Development dashboards frequently measure what teams have done.
Milestones completed.
Budget spent.
Design reviews held.
Prototypes produced.
These are useful operational measures, but they do not necessarily tell management whether a product is becoming a better investment.
A more powerful governance conversation asks what has changed.
Which major uncertainties have been removed?
Has technical feasibility increased?
Has user desirability been demonstrated?
Has regulatory risk reduced?
Has the commercial case strengthened?
What new risks have emerged?
What evidence would justify the next tranche of investment?
McKinsey’s analysis of high-performing MedTech organisations similarly points towards data-driven R&D management, with leading companies tracking a focused set of KPIs and challenging inconsistent assumptions rather than treating R&D as a management “black box”.
Faster development is really faster decision-making
Companies often talk about shortening development timelines.
That can easily be interpreted as asking engineering teams to work faster.
The bigger opportunity is usually elsewhere.
Reduce the months spent pursuing the wrong concept.
Resolve usability issues before detailed engineering.
Expose manufacturing problems before tooling.
Understand regulatory implications before architecture is locked.
Kill weak ideas before they consume significant resources.
And give strong ideas the resources and autonomy they need to move.
The objective is not speed for its own sake.
It is reducing the time between uncertainty appearing and a well-informed decision being made.
Where Maddison fits
At Maddison, we believe some of the most valuable development work happens before the answers are obvious.
We work with MedTech organisations as a focused extension of their internal teams, bringing together industrial design, engineering, human factors, UX and commercial thinking to tackle difficult development challenges.
Sometimes that means developing an entirely new device.
Sometimes it means rapidly exploring a technology or product opportunity before a company commits significant internal resources.
And sometimes it means challenging an existing programme to identify where a different approach could reduce risk, accelerate development or create a better product.
We are deliberately structured to stay close to the problem, close to the users and close to the people making the decisions.
Because successful MedTech innovation is rarely about having more ideas.
It is about creating the evidence that allows you to make better decisions about which ideas deserve to become products.
References
- McKinsey & Company and Russell Reynolds Associates, “Talent, tech, and team: The formula for medtech R&D success”, July 2025. Reports MedTech R&D spending increasing at approximately 10% annually, average time to market exceeding four years, and top-quartile innovators achieving 40% higher revenue growth and twice the total shareholder return of other quartiles.
- McKinsey & Company, “Value creation priorities shaping medtech”, 2024. Analysis of leading MedTech companies identifies innovation productivity, data-driven R&D management and clinical excellence among important drivers of performance.
- McKinsey & Company, “Make milestones matter with ‘decision gates’, stage gates with real teeth”, 2017. Examines the limitations of conventional stage-gate governance and proposes decision-oriented gates linked to genuine investment and product choices.
- US Food and Drug Administration, “Applying Human Factors and Usability Engineering to Medical Devices”, final guidance, August 2026.
- US Food and Drug Administration, “Content of Human Factors Information in Medical Device Marketing Submissions”, final guidance, May 2026.