Research & Development

Research & Development

A new approach: changing working practices to ensure a timely launch


Plexus is a global leader in complex product design, manufacturing, supply chain and aftermarket services. Constantly upgrading and improving their processes, the company relied on cross-department cooperation when developing a machine to aid diagnoses of the Human Papillomavirus (HPV), as Oliver Mihm, regional president EMEA explains

Whatever its area of expertise, all manufacturers are beholden to time constraints. Hitting a well-planned deadline can, at its best, ensure market share for an innovative and robust product that benefits its target market. Missing a deadline means a delayed product for higher cost and may deny a product the opportunity to shine by hitting the market early. It is therefore no surprise that manufacturers increasingly liaise with each other to streamline their manufacturing processes, with teams from multiple Original Equipment Manufacturers (OEMs) collaborating with an Electronics Manufacturing Services (EMS) provider in the name of a collective objective.

This cooperation drives positive change, facilitating efficient innovation in any industry. A more efficient manufacturing process means better products for the customer, faster, and in fields like medtech efficiency is genuinely empowering those in the profession to save lives. This then has a knock-on effect for the patient, their relatives, and the staff who care for them.

The particular problem of HPV

A powerful example of the impact that manufacturing can have on medical progress is the machinery used to diagnose the Human Papillomavirus (HPV), found in around 99 per cent of cervical cancers. Certain types of HPV are known to cause cell abnormalities and cancer in women, and testing for HPV can predict the type of infection that may lead to cancer before these abnormalities can be seen. With thousands of women diagnosed with cervical cancer every year – 3,200 cases in the UK alone according to Cancer Research, or nine women every day – it is clear that streamlining the diagnostic process increases the likelihood of early detection and, ultimately, saves lives.

As such, healthcare and life science OEMs are continually developing equipment that will automate the tedious and repetitive motor functions needed to perform this test. As an example, one such manufacturing objective was the design and development of a non-assay system that performed the de-capping, re-capping, and sample prep functions that form part of the test process. This product would replace the lab technicians required to manually perform these tasks, reducing human error whilst accelerating the overall process. The manufacturer’s goal was to release the product within a two-to-three-year window, guaranteeing a timely arrival on the market.

Preparing to innovate

Cost effectiveness and product/process improvements were high on the agenda, as previous equipment was not always entirely fit for purpose. Lab technicians had been known to develop carpal tunnel issues due to the number of caps they had to remove and replace. As the process itself was changing, teams and communication pathways would need to be established before beginning design and manufacturing to ensure that the infrastructure needed for solving problems was in place.

The process began by identifying which teams would work together to ensure maximum efficiency. A complete design team was put into place that would cooperate with the customer’s small-scale internal team, boosting productivity whilst retaining the internal team’s expertise. Meanwhile, the industrial design partner’s team worked directly with the customer’s marketing team, and the mechanical, electrical, and software teams collaborated directly with technical engineers on the customer’s design site.

As face-to-face collaboration is key, weekly meetings were arranged alongside regular visits to the customer’s site. This ensured that there was a full understanding of the task workflow that operators had to carry out before automation was introduced.

Together, the teams were able to examine the final design objective from the very beginning. They collaborated to incorporate all of the customer’s various ideas to include existing design aspects into the system while optimising time to market.

Making it happen

Once all objectives were fully fleshed out and identified, and logistical infrastructure was confirmed, the execution phase began. The time-to-market strategy used, while effective, placed some restrictions around which components could be incorporated into a system. Selecting components that have a proven track record ensures a greater reliability and less testing. However, this could also mean that components are difficult to integrate into a single system, as they are not purpose-built for their specific role.

The diagnostic system being developed in this case was an extremely complicated design, containing a huge range of components: internal bar code readers, shakers, de-cappers, pipettors, heaters, reagents, and buffer solution handles, all alongside 29 axes of motion. On top of this, the system used a Programmable Logic Controller that meant a UI designed using C# coding with XAML files, and a SQL Server database that interfaced with a UI, had to be developed.

The expertise of the design teams, alongside the collaborative and communicative manufacturing structure in place, allowed them to cooperate and overcome the logistical difficulties of both the machine being built and of the time-efficient structure chosen at the beginning of the project. An important feature of this was advanced supply chain problem solving, which was necessitated by the complexity of the product.

Advanced supply chain problem solving involved introducing multiple vendors, so materials could be sourced and components pre-assembled. Some key components in this case were specifically selected by the customer, and at points where the system did not totally meet the technical requirements, it was necessary to work with both customer and vendor to keep component specs updated and ensure system functionality. As the project evolved regularly in the initial stages, confidence testing was crucial, allowing the product to be reimagined and redefined while still meeting requirements and expectations.

Oliver Mihm

Overseeing the entire process was a collaborative effort. The Design and Development, Manufacturing, and Supply Chain Solutions teams oversaw all deadlines, whilst cooperating closely with the customer to ensure efficiencies. The teams benefitted from routine management meetings, with emphasis placed on close contact and an open and welcoming attitude to communication. Through direct involvement with testing and prototype trials, the Design team was able to iterate the design as new improvements of requirements were identified. Being able to communicate direct feedback on prototypes – and trial/test them – was hugely beneficial to refining the user experience.

The results of change

Overall, this approach enabled the customer to hit its targeted timings, allowed the assay system to enter commercialised equipment and establish a portion of the market share for HPV testing by entering the market within the requested period. Through this success, the end customer received significant benefits from the project by obtaining a machine that facilitated a quicker sample handling process and significantly reducing the opportunity for human error and workplace injury.

About the author

With well over 100 years experience between us, we've been around the editorial and medical blocks a few times. But we're still as keen as any young pup to root out what's new and inspiring.

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