The MI Share project brings digital circularity to medical instruments
A team from bwcon research gGmbH is aiming to combine circularity and digitalization in MI Share, a project funded through the Invest BW program. The project is looking at how digital processes can be applied to medical instruments. As well as bwcon research, the project consortium taking on the challenge of this digital transformation process includes the Hahn-Schickard-Gesellschaft, Heilbronn’s Nanoedge GmbH, and Tuttlingen-based Glaser GmbH.
The medical instruments in the MI Share project include things like scalpels, vocal cord retractors, holding instruments and all types of right-curved and left-curved cutting instruments used for procedures such as tumor removal. If used in minimally invasive surgery – a technique that is becoming increasingly common – these instruments must be extremely small. The cutting instruments’ blades are just 6 mm long and are, for example, operated through a tube with an inner diameter of 0.8 mm containing a 0.6 mm diameter traction cord. While this miniaturization offers significant benefits, it also brings new challenges, not least the cleaning and sterilization process.
Thinking like a customer instead of a manufacturer
“In our view, when you embark on a digitalization project like this, you must start by establishing the ‘job to be done’ by the item being digitalized, even if this may initially seem rather abstract”, recommends Dr.-Ing. Jürgen Jähnert, Managing Director of bwcon research gGmbH. The “job to be done” approach is the brainchild of the late Harvard professor Clayton M. Christensen. It is based on the fundamental idea that the focus should not be on the manufacturer’s product and product feature perspective, but on the product benefits as described from the customer’s point of view. According to Jähnert, “It is from these product benefits that clear requirements can subsequently be extrapolated for the technology, the engineering process and the product operating and operator model”.
The upshot is that innovation is not driven solely by the technology, but also by customer benefits. This approach is reflected in the monetization concept. Over the entire product life cycle, the customer pays significantly more to use the product than the revenue generated by selling it. What bwcon research is seeing is that the industry has not yet fully taken this mindset on board and is still pursuing a predominantly technology-driven, product-centric approach. Many of today’s leading companies like Apple or Google – including the S&P 500’s six most valuable companies – were early adopters of the customer-centric approach.
The focus on the “job to be done” means that service providers have to pay far more attention to their products’ entire life cycles than in the past. Changing conditions over the course of a product’s life cycle can often result in changes to the service and thus new commercial opportunities with the customer. As a result, value creation shifts from pre-sales to aftersales, where significantly higher revenue can be generated from the customer. However, there is no hiding from the fact that this approach calls for more liquidity and that traditional lenders often add a high risk premium for loan applications involving this type of model. But if the banks fail to adapt to the new situation, in the medium term they could end up losing their role as lenders to SMEs. A business that is able to finance the transition described above will be far more resilient than a purely product-focused company in times of crisis.
A paradigm shift from producer to operator
An approach that considers the entire product life cycle implicitly creates a different incentive system in companies and requires employees to embrace significant changes. One important aspect of this change is that the producer becomes the operator of their own product. This calls for the sales team to work much more closely and at a far more detailed level with the customer. In the old model, there was an incentive for sales reps to sell the biggest possible version of a device. But in the producer-as-operator model, their job is to offer the smallest possible version of the device that meets the customer’s needs. In the past, once a product was sold, the seller had no interest in how the customer used it.
However, if the producer is operating the product, this will need to change. There is also an impact on product engineering. If a company operates its own products, then as the operator it is responsible for the maintenance costs. This will generally lead them to produce more durable, higher-quality products that minimize the time and costs associated with maintenance – it is no longer the customer who picks up the bill if a product fails unexpectedly. Material use also comes into the equation. It goes without saying that producers will take their devices back at the end of the product life cycle. This means that they will pay more attention to how difficult it is to recycle the materials they use. A digital twin documents how the device is disassembled and how the different materials are separated and sorted.
If the “job to be done” approach is applied consistently, sustainability is achieved at no extra cost. In its previous incarnation as a device manufacturer, the company had an incentive to sell a new device once the warranty expired (and had little to gain from including recycling and the attendant costs in the development process). But in its new incarnation, the company wants its products to have a longer lifespan, and will thus take matters like circularity, waste and recycling much more seriously.
A circular approach to medical instruments
The MI Share project team systematically analyzed the medical instruments’ life cycle using the “job to be done” approach. The main challenge is to design medical instruments that are not single-use products. The solution is an advanced sterilization process that allows a cutting instrument, for example, to be used until it needs to be reconditioned because it can no longer properly perform the “job to be done”, in this case cutting. With this in mind, the team developed an intelligent cycle counter that records cleaning cycles in a way that makes it possible to calculate the number of incisions performed. The counter is read during every sterilization process. In addition, the surface finish of the instruments has been improved to reduce bacterial adhesion. This extends their service life and means that sterilization can be carried out more reliably by a central sterilization facility, for example.
A digital workflow controls the primary circular process between the sterilization facility and the operating room, while a digital twin records the cycles and controls the secondary circular process between the manufacturer, who reconditions the instruments, and the sterilization facility, which returns the reconditioned instruments to the primary circular process.
The cycle counter developed by the project provides the data needed to decide whether a medical instrument remains in the primary circular process or must enter the secondary circular process for reconditioning. This means that batch numbers are a thing of the past – each individual instrument gets its own digital ID that corresponds to its digital twin.
Ultimately, this means that the virtual world – in this case the data in the digital twin that has been collected by the cycle counter – controls the physical world of the real medical instruments.
The real challenge is changing mindsets
While the MI Share project addresses an extremely challenging reference scenario, the bwcon research team and project partners are confident that the basic approach and paradigm shift will be replicated elsewhere. This is because, if systematically implemented, they offer the incentive of achieving circularity at virtually no extra cost. The challenge isn’t really a technological one – the technology is readily available. The real challenges will be the change of mindset, the new way of cooperating with other actors, how senior management navigates uncertainty, and of course ensuring that the company has the skills needed to implement this type of concept in the first place. In other words, it’s the soft issues that can be the hardest nuts to crack in the innovation process!
Contact
Dr.-Ing. Jürgen Jähnert (author)
Managing Director
bwcon research gGmbH (Stuttgart)