Today, clinical labs are challenged on multiple fronts with resource constraints, efficiency pressures, and increasingly complex diagnostics that support personalised medicine. Labs need reliable, high throughput diagnostic instruments that don’t require specialists to operate and are easy to maintain. They seek walk-away solutions, as they expand capacity to meet rising demand.
Bringing complex, high-performance diagnostic instruments to market requires strict adherence to a proven ‘concept to commercialisation’ process: design, development, integration, testing and manufacturing. Yet oversight or inexperience during the early phases can make scale-up difficult, or even impossible.
As the promise of innovation meets the realities of regulated clinical testing, diagnostic developers can encounter more hurdles than necessary on their path to market.
With 45 years’ experience in designing and engineering complex diagnostics and medical devices, HiArc has helped bring dozens of products to market successfully.
In this article, Tony Lacroix, Director, Control Systems and Jerry Sevigny, Director, Systems Engineering, at HiArc spotlight some common, real-world engineering and manufacturing gaps that impact the transition from prototype to production in diagnostics and they provide practical advice for ensuring design-for-manufacturability from the start.
Go slow to go fast
A common mistake in diagnostic development is rushing the concept phase. Some teams carry out only a high-level investigation, or impose arbitrary time limits. Time ‘saved’ in the concept phase often results in multiplying delays later.
The concept stage is important because it is when technical risks are identified, product needs are confirmed, and feasibility is tested. Missing or compressing this phase can result in costly late-stage redesigns, schedule overruns and performance compromises.
Confirming product needs
For development to run smoothly, all stakeholders must be aligned on clear, written product and systems requirements from the outset.
Best practice involves converting product requirements into technical requirements – but some teams try to skip this step. This is a critical mistake. Requirements must be validated, clarified, and, when necessary, challenged.
For example: a developer may specify that an instrument must operate from 18°C to 30°C at up to 85% humidity – a difficult environment due to heat dissipation and condensation control. Experienced engineers would question whether the specified ranges are truly necessary, since keeping them broad might add significant cost and complexity.
Testing feasibility
A frequent pitfall is failing to involve manufacturing and engineering early in the concept phase. These teams play a key role in identifying viable production processes, assessing component manufacturability, and evaluating how fabrication methods will influence system performance.
Design choices should also reflect the intended production volume. Building five units versus 5,000 units requires different tooling, components and investment structures. Early clarity about this avoids expensive redesigns when transitioning from prototype builds to scaled manufacturing.
Design for manufacturability
Projects run more smoothly when manufacturing is embedded early in the requirements phase. The manufacturer’s voice is essential for ensuring that designs can be built efficiently and maintained over their lifecycle.
For example, engineers might overlook creating access points for wiring or tubing – a small detail that can significantly affect assembly and serviceability. Early manufacturing input ensures such issues are addressed while changes are still low impact to the project.
Real-world examples
Tony Lacroix: “We had a program that was planned for a three-to-five month concept phase. Based on what we found, the concept took over a year. The result of that, however, was that the program was able to move through the remaining phases quickly without many issues because we had been able to identify the key challenges early and make the changes we needed to the design before we started down the wrong path.
“That instrument ended up going into manufacturing quickly too and then there was a heavy ramp up on production. This happened during COVID-19, so production increased well beyond what was originally planned. Luckily, as we had manufacturing tightly involved in the beginning, we were able to meet those higher quantities.
“The instrument forecast increased by 55%. We were able to rapidly mobilise to support the increased demand and ultimately increased instrument production by 309%.”
Jerry Sevigny: “A number of years ago, we got involved on the manufacturing side of a desktop device that did point of care testing in the doctor’s office. As we were building the devices, the developers were trying to get the chemistry in the three reagent cartridges working. They got two out of the three cartridges working very well, but the third one, they had tremendous trouble with the chemistry. It just did not work. They decided to go back and to change to traditional chemistry, which meant the whole detection system in this instrument had to change.
“So we put a new detection system in and they got it to work on the original two cartridges, but still not the third. The problem was that the assay was developed at the same time as the instrument, and they thought they had everything aligned and one part wasn’t. The assays should have all been finalised, tested and verified on prototype hardware, before starting production.
“As manufacturers, we were trying to develop an instrument based on what the customer said the technical requirements were to run the assay. But as the assay was still not stable, it was an impossible task and, in a case like this, the longer it goes into the development process, the harder it is to change.”
Scaling up smoothly
Experience shows that building complex diagnostic instruments requires constant, structured communication between all stakeholders, from concept through commercialisation. Challenges will always arise, but beginning with a disciplined ‘phase‑zero’ concept review helps identify potential issues early so necessary adjustments can be made before they become costly.
Schedule pressure is a universal reality in MedTech, but ‘go slow to go fast’ often proves the most efficient path. Investing early time in requirements, feasibility and manufacturability consistently results in faster, smoother and more scalable progression to commercial success.
