What 20 years of DAI means for the next combination product program
October 28 2026
Some of what determines a combination product’s success only becomes fully visible as development progresses into industrialization and sustained production. Development teams can plan for those demands, but experience from commercial programs provides something different: evidence of where challenges actually emerge once a product reaches commercial production.
That is one reason a device partner’s track record matters. The useful question is not simply how long it has been operating, but what previous programs have exposed, how those challenges were addressed, and whether those lessons feed back into the programs that follow.
DAI (Disposable Autoinjector) provides one of SHL Medical’s longest-running sources of that kind of experience. Across two decades and around 20 combination products, DAI encountered challenges that had no ready answer. Solving them contributed to capabilities that SHL Medical did not have in the same form before.
For a new combination product development program, the value of that history is having precedent for challenges that otherwise might otherwise become visible only later, at scale.
Solving a testing constraint
One example is testing. For years, DAI devices were verified with drug-containing primary container in place, consuming product and testing resources at scale. As DAI volumes grew, this became a practical constraint. So, SHL Medical developed a way to assess aspects of DAI functionality without relying on drug-filled primary containers for every test.
What began as a response to a specific DAI manufacturing challenge became one of the early container-free testing approaches developed at SHL Medical, and eventually part of how we approach testing more broadly. Today, SHL Medical supports Container Free Release testing alongside other testing and simulation methods, enabling customers to conduct quality-control batch release testing without pre-filled syringes.
Learning to move expertise
A second lesson emerged when DAI production expanded across manufacturing sites A validated manufacturing process is not defined by equipment specifications alone. Years of production also accumulate process history, troubleshooting knowledge, an understanding of critical controls, and practical insight into how variation presents itself during operation.
When DAI production expanded to the US, that knowledge had to become transferable. Equipment and specifications could be replicated directly, but reproducing the manufacturing capability required more than installing the same machinery. Process requirements had to be translated into documented workflows, system controls, training, responsibilities, and day-to-day execution that another site could apply consistently. The challenge was to make this accumulated manufacturing knowledge explicit while adapting its implementation to local roles, systems, and operating conditions.
DAI became one of the programs through which SHL Medical built and strengthened our cross-site autoinjector manufacturing and knowledge-transfer capabilities.
Building resilience into commercial supply
DAI’s commercial history also highlighted another challenge in maintaining long-term supply continuity. During the COVID-19 period, multiple DAI combination products were already in commercial supply. SHL Medical teams across functions, sites, and regions had to respond to changing constraints while keeping materials, capacity, production priorities, and customer requirements aligned. Through that coordination, DAI production continued and supply remained uninterrupted.
The experience of keeping DAI in supply during COVID-19 also sits within SHL Medical’s broader approach to global supply chain resilience. We established multi-sourcing strategies for critical raw materials, increased safety-stock levels for key materials, and further developed our business continuity management approach, strengthening the supply framework supporting DAI and other commercial programs.
How DAI strengthened SHL Medical’s combination product capabilities
These examples point to a broader part of DAI’s contribution. A long-running commercial program repeatedly encountered challenges that had no ready answer. The solutions developed in response often proved useful beyond the program that first required them.
Over 20 years, the approaches and capabilities developed through DAI became part of how SHL Medical works: the processes, the insights, and the hard-won experience that now inform how we develop, industrialize, and support combination product programs.
What the next combination product program inherits
The next combination product program developed with SHL Medical may have little in common with the DAI that first entered commercial production two decades ago. What carries forward is the context created by having already supported combination products well beyond development and into years of commercial use.
For pharma and biotech teams evaluating a device partner, that can be a more useful measure of experience than years in operation or installed manufacturing capacity alone. A development program eventually becomes a manufacturing and supply program, and the partner chosen at the beginning may still be supporting it many years later.
DAI’s 20-year history gives SHL Medical a long view of that lifecycle. Its commercial history has helped us identify questions worth asking earlier, before they become late-stage problems.
To discuss how SHL Medical can support your combination product program from development through commercial production, get in touch with our team.
This is the final piece in our DAI 20-year series. The earlier articles looked at the partnership that carried DAI for two decades, what its history says about proven device technology, and the manufacturing capability it built.
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