Why the decisions you make today could determine the cost, risk and commercial success of your next medical device.
What if the biggest mistake in your next medical device programme happens before your engineers have even started?
Not during testing.
Not during regulatory approval.
Not when manufacturing costs exceed expectations.
But months earlier, when a handful of seemingly sensible decisions establish the direction of the entire development programme.
A product architecture is selected. A technology is specified. A form factor is agreed. A manufacturing approach is assumed.
Everyone moves forward.
The problem is that these early decisions can quietly determine much of the cost, complexity and risk that follows.
And once significant resources have been committed, challenging them becomes increasingly difficult.
The uncomfortable question for MedTech leaders is this: are you making the right decisions early enough, or simply making them quickly enough to get development started?
1. The hidden cost of early assumptions
Every medical device development programme begins with assumptions.
About the clinical need.
About the intended user.
About the technology.
About manufacturing.
About the regulatory pathway.
About what customers will actually pay for.
Some assumptions are supported by evidence. Others are based on experience, precedent or the way things have always been done.
The danger is that assumptions can become specifications long before they have been properly challenged.
Consider a connected diagnostic device.
The development team selects a sensor technology that performs exceptionally well in laboratory testing.
The electronics architecture is designed around it. The enclosure follows. Software development begins.
Six months later, representative user testing reveals that the device is difficult to position correctly, compromising measurement reliability.
The sensor works.
The product architecture doesn't.
Correcting the problem may require changes to the enclosure, electronics, software and verification plan.
Was this really an engineering failure, or a decision-making failure that happened much earlier?
The earlier a fundamental assumption is challenged, the more options remain available to address it.
2. Design freedom decreases as commitment increases
At the beginning of development, almost everything is possible.
Different technologies can be evaluated.
Alternative product architectures can be explored.
User workflows can be challenged.
Manufacturing approaches can be compared.
But as development progresses, those choices become increasingly constrained.
Tooling investments are made.
Suppliers are selected.
Interfaces are established.
Verification activities begin.
Regulatory documentation accumulates.
Changing direction becomes more disruptive and potentially more expensive.
This is particularly important in MedTech, where design changes can affect risk management, usability engineering, verification and validation.
ISO 14971 establishes a lifecycle approach to medical device risk management, while IEC 62366-1 addresses the usability engineering process and associated use-related risks.
The implication is straightforward.
Early design decisions should be informed by the complete product lifecycle, not simply by what is technically easiest to develop.
For leadership teams, that raises an important question.
How much time does your organisation spend exploring alternatives before committing to a development direction?
And how does that compare with the time spent correcting decisions later?
3. Technical feasibility is not commercial viability
A technology can work beautifully and still make a poor product.
It may be too expensive to manufacture.
Too complicated to assemble.
Too difficult to use.
Too large for the intended environment.
Too dependent on specialist components.
Or insufficiently differentiated from existing solutions.
Yet development teams can become deeply invested in proving technical performance before these wider questions have been answered.
This is where a broader design perspective becomes valuable.
Rather than asking only whether something can be built, the team needs to understand whether it should be built in that particular way.
Can we achieve the same clinical benefit with a simpler architecture?
Could a different form factor improve usability and reduce manufacturing costs?
Are we engineering functionality that users don't actually need?
Could an alternative technology reduce regulatory or supply chain risk?
Does the proposed product deliver enough value to justify its likely cost?
These are not questions that slow innovation.
They help direct investment towards the strongest opportunities.
4. The real value of early prototyping is learning, not proving
Prototyping is often viewed as a way to demonstrate that a concept works.
But its greatest value may be in revealing why an idea doesn't work, before too much money has been spent pursuing it.
An early prototype doesn't need to look like the finished product.
It needs to answer an important question.
Can the intended user operate the device correctly?
Does the proposed mechanism deliver the required performance?
Is the form factor practical?
Can the product be assembled efficiently?
Does the clinical workflow make sense?
What happens when the device is used outside ideal laboratory conditions?
A simple physical model, functional rig or interactive interface can expose fundamental weaknesses before detailed development begins.
The objective should be to reduce uncertainty, not simply demonstrate progress.
Are your prototypes designed to validate your assumptions, or to challenge them?
There is a significant difference.
The first approach risks reinforcing an existing direction.
The second creates opportunities to discover something better.
5. Human factors should influence the first design decision
One of the most expensive assumptions in medical device development is that users will behave as expected.
They often don't.
Clinicians work under pressure.
Patients have different physical capabilities.
Home-use environments are unpredictable.
Training may be limited.
Devices are handled, cleaned, stored and maintained in ways that designers may not anticipate.
The FDA's guidance on human factors and usability engineering emphasises understanding intended users, use environments and user interfaces to reduce use-related risks.
Yet usability is still sometimes treated as something to evaluate after the technical architecture has been established.
By then, important decisions about size, shape, controls, displays and workflows may already be difficult to change.
What would happen if the intended user experience shaped the technology selection, rather than the other way around?
A different sensor location might improve reliability.
A simpler interface might reduce training requirements.
A redesigned workflow might eliminate an entire development requirement.
An ergonomic improvement might make the difference between occasional use and routine adoption.
These are not cosmetic considerations.
They can fundamentally influence clinical performance and commercial success.
6. The challenge isn't always capability. It's perspective.
Most established MedTech companies have highly capable engineering and development teams.
But internal teams operate within existing structures, product architectures, established technologies and competing priorities.
That creates a natural tendency to build on what is already known.
Sometimes that is exactly the right approach.
But when a programme involves a new technology, an unfamiliar user requirement or an unresolved product challenge, existing assumptions can become limiting.
Who in your organisation has the freedom to question the brief?
Who can explore a completely different architecture?
Who can challenge whether the proposed solution is the right one?
And who has the time to build and test alternatives before the programme becomes committed to a particular direction?
This is where a small, experienced external team can add disproportionate value.
Not by replacing internal expertise.
But by bringing fresh thinking, multidisciplinary experience and the freedom to explore difficult questions without disrupting core development activities.
Sometimes a few weeks of focused exploration can reveal an alternative that would otherwise have remained undiscovered.
The value isn't simply in moving faster.
It's in making sure you're moving in the right direction.
7. Five questions to ask before approving your next development programme
Before committing significant resources, MedTech leaders should challenge their teams with five questions.
1. Have we defined the real problem?
Are we responding to a validated clinical or user need, or developing a solution around an interesting technology?
2. Have we explored genuinely different solutions?
Has the team compared alternative technologies, product architectures and workflows, or simply refined the first credible concept?
3. What assumptions could invalidate the business case?
Which uncertainties around performance, usability, manufacturing, regulation or commercial value would have the greatest consequences if proved wrong?
4. What is the fastest, least expensive way to test those assumptions?
Could a focused feasibility study, early prototype or user evaluation provide the evidence needed before committing to detailed development?
5. Are we measuring progress by activity or by reduced risk?
Does each development milestone increase confidence that the product can be manufactured, approved, adopted and sold?
These questions won't eliminate uncertainty.
But they can prevent uncertainty from becoming an expensive surprise.
Better decisions before bigger investments
At Maddison, we believe some of the most valuable work in medical device development happens before the detailed engineering begins.
When the problem is still being defined.
When alternative approaches remain possible.
When assumptions can be challenged without major disruption.
And when experienced designers and engineers can explore what might work, rather than simply deliver what has already been specified.
Our approach combines industrial design, engineering and human factors expertise with a practical understanding of medical device development and commercial realities.
We work alongside MedTech organisations to explore difficult challenges, develop and test concepts quickly, and establish a stronger foundation for subsequent development.
Sometimes that means creating a new product architecture.
Sometimes it means finding a simpler way to solve a complex problem.
And sometimes the most valuable outcome is identifying why an idea shouldn't progress in its current form.
Because good development isn't simply about getting things right.
It's about discovering what's wrong while you still have the freedom to change it.
One final question
Think about your current development pipeline.
Which programme would benefit most from challenging its fundamental assumptions before another six months of engineering investment?
That could be the most valuable conversation your team has this year.
Maddison. Design That Means Business.
References and further reading
- FDA, Applying Human Factors and Usability Engineering to Medical Devices (2016). Guidance on understanding intended users, use environments and use-related risks.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-usability-engineering-medical-devices - ISO 14971:2019, Medical Devices: Application of Risk Management to Medical Devices. International standard covering systematic medical device risk management throughout the product lifecycle.
- IEC 62366-1:2015+A1:2020, Medical Devices: Application of Usability Engineering to Medical Devices. International standard covering usability engineering and use-related risk.
- FDA, Quality Management System Regulation (QMSR), effective February 2026. Incorporates ISO 13485:2016 by reference into the US medical device quality management framework.
https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr - European Union, Regulation (EU) 2017/745, Medical Device Regulation. Requirements for medical device safety, performance, risk management and conformity assessment.
https://eur-lex.europa.eu/eli/reg/2017/745/oj - McKinsey & Company, The Business Value of Design (2018). Research examining associations between design performance and business outcomes across multiple industries, supporting the wider commercial importance of design-led decision-making.
https://www.mckinsey.com/capabilities/mckinsey-design/our-insights/the-business-value-of-design