The IVD Instrument Design and Engineering Landscape is Shifting
Over the last two decades there have been numerous technology breakthroughs including thermodynamics, optics, microfluidics, fluorescence detection and high precision motion control to serve the challenges of automation within many biological applications such as hematology, PCR, immunology and microbiology.
In the past, the significant challenges for designing in vitro diagnostic (IVD) products were to replicate labor-intensive activities through automation, maintaining the precision and quality of human skills while dramatically increasing throughput, thus justifying the development investment. Later, new diagnostics challenges required technology breakthroughs to enable instrument systems to carry out tests and assays that lab technicians could not achieve manually. Sample volumes have reduced, temperature controls have become more precise, micro-particles and cell counting require the best engineering solutions to allow biologists access to a new range of data. But with these technological advances, instrument complexity has risen while at the same time there has been significant pressure to maintain instrument prices.
In parallel with the increasing technology challenges, the industry has also witnessed further changes such as more scrutiny on risk management by regulatory bodies, the gradual rise of the Point of Care industry and the associated rise in instrument production volumes, and gradual expiry of key patents such as many associated with PCR. While this shifting landscape may be perceived by some as further constraints on business, other instrument developers and contract manufacturers see it as a great opportunity to add lean design principles to their repertoire.
Lean design principle, the Toyota heritage
Toyota has been a global leader in the field of applying lean principles, initially created around manufacturing, to their design process. Jeffrey Liker’s book 1, 2: The Toyota Product Development System is considered a leading reference in this domain, in which he provides insights into identifying lean principles successfully applied to the production line, and translating these to the design and development process. Liker challenges companies to look for areas of waste in the development process and suppress these, focus energy on areas of value-add, and use key indicator metrics to measure continuous improvement. Liker is a great advocate of using Value Stream Mapping as a foundation stone for continuous improvement in product design
Lean design at Invetech
At Invetech, we have been increasingly integrating lean processes into our instrument development activities. One leader of this activity is Paul Tsironis, Director Electronics Design, Global. Paul brings over 13 years of lean design training from his past experience at Toyota City, Japan and the Toyota Technical Centre in Melbourne Australia. Paul’s experience includes optimizing design and development of automotive wiring harnesses and associated components for vehicles produced in over 13 countries, including managing multinational suppliers in the process.
Paul’s expertise means he is now a key proponent for developing lean design principles and processes within Invetech. Structured re-use of components, concurrent engineering and early part manufacturing establishment are some of the tools and processes that are now commonly in use within the wider Invetech design and engineering teams.
A simple but powerful example of the application of lean principles was observed during a recent “Kaizen” at Invetech, dedicated to rationalizing the selection of bar code readers. At any one time, the Invetech development team might be working on five to 15 different diagnostics and life science instrument development projects. Most of these devices feature bar code reader technology which can take many shapes and forms, depending on the application and the performance required. The output of this Kaizen was to identify a common model and brand with broad performance characteristics from a preferred supplier list. The successful outcome of this Kaizen means our engineers can now immediately identify a barcode reader for ongoing instrument development projects into the near future. The procurement team takes care of the supplier establishment, managing supplier quality as well as potential obsolescence issues. Savings include optimization of supplier base, economies of scale, reduced testing and better management of inventory. According to Paul, “The impact on time to market is proving significant. Through avoiding re-design and the need for systematic reliability testing, this one focused activity has had a significant effect on reducing development effort. While the automotive industry remains ahead of the more complex or lower volume IVD industry, applying these lean principles is producing quantifiable advantages for our customers.”
Conclusion: lean design, the new best practice
Lean principles allow design teams to deliver better reliability at a lower effort, especially for the part of the design that is not core to the OEM technology. This frees up time and energy for the design teams to focus on what the OEM client expects the most from Invetech: innovating around their core technology.
While technology expertise and innovation remain key to the IVD automation industry for the near future, the opportunity for instrument design firms and contract manufacturer to rationalize their design approach using proven lean design principles is now imperative.
Ludovic Labat is Global VP, Design and Engineering and Contract Manufacturing at Invetech. He holds a doctor in materials science from the University of Le Havre, a Master of Science of Energies (Research) and a bachelor's degree in applied physics.