Clinical laboratories are facing growing challenges as they try to keep up with increased demand for personalized medicine and complex diagnostics. They require reliable diagnostic instruments that can handle high volumes, do not need specialist operators, and are easy to maintain.
According to HiArc, a company with 45 years of experience in the field, bringing new diagnostic devices from prototype to production is complicated by several hidden bottlenecks. Tony Lacroix, Director of Control Systems at HiArc, and Jerry Sevigny, Director of Systems Engineering at HiArc, highlighted some common pitfalls in the transition from concept to commercial product.
A frequent mistake is moving too quickly through the early stages of development. “Time ‘saved’ in the concept phase often results in multiplying delays later,” said Lacroix. He emphasized that identifying technical risks and confirming product needs during the concept stage can prevent costly redesigns later on.
Another issue is unclear or incomplete requirements at the outset. Teams sometimes skip converting general product requirements into detailed technical ones. This can lead to misaligned expectations and design choices that increase cost or complexity unnecessarily.
Manufacturing considerations should be addressed early as well. Involving manufacturing teams during initial planning helps ensure that designs are practical for large-scale production and maintenance over time. Small oversights—such as missing access points for wiring—can cause significant problems if not caught early.
Lacroix shared an example: “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%.”
Sevigny described another case where incomplete assay development led to difficulties: “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.”
The article concludes that successful scale-up requires structured communication among all stakeholders throughout every phase—from initial concept through commercialization—and stresses that careful upfront planning leads more reliably toward commercial success.
