DAI at 20: What two decades of uninterrupted manufacturing prove

20 years is a long time for any autoinjector to stay in commercial production. For DAI (Disposable Autoinjector), one of SHL Medical’s longest-running devices, those two decades have meant more than a product anniversary. They reflect sustained performance across more than 20 combination products, over 880 million cumulative units shipped, manufacturing across two continents, and uninterrupted commercial production through a period when the autoinjector market changed significantly.

20 years is a long time for any autoinjector to stay in commercial production. For DAI (Disposable Autoinjector), one of SHL Medical’s longest-running devices, those two decades have meant more than a product anniversary. They reflect sustained performance across more than 20 combination products, over 880 million cumulative units shipped, manufacturing across two continents, and uninterrupted commercial production through a period when the autoinjector market changed significantly.

The early years

DAI's story began when a multinational pharmaceutical company approached SHL Medical about a new kind of project: a drug-device combination product in an autoinjector format. At the time, neither company knew where the project would lead.

When the first DAI was launched two decades ago, autoinjector development was still less established than it is today. Many of the processes and regulatory expectations that guide drug-device programs today were still taking shape. 

SHL Medical had to solve two things at once: develop a reliable self-injection device and build the capabilities needed to support the program as it grew.

DAI went through multiple design iterations before reaching the three-step, button-activated configuration that would support decades of commercial manufacturing. Feedback from development and commercial use helped refine key parts of the device, including the activation mechanism.

“DAI represented an early milestone in autoinjector design at a time when self-injection devices were still far less established across the market. For SHL Medical, it also marked the beginning of our journey in self-injection system development,” says Markus Puusepp, Chief Growth Officer (CGO) at SHL Medical.

From the factory floor up 

As demand for DAI increased, the focus shifted from development to scalability. Production moved from manual assembly to higher-capacity automated manufacturing. That shift required tighter process control, closer alignment between design and manufacturing, and a more direct link between development and the factory floor.

DAI also went beyond one manufacturing site. Operations expanded from Taiwan to the US , bringing new layers of complexity related to cross-site coordination, knowledge transfer, and consistent execution across locations with different operational rhythms. Establishing these standards and sustaining them throughout years of active production is where industrial expertise was built.

That kind of execution is founded on people as much as processes.

“Long-term combination product programs depend on the experience and coordination of teams across functions over many years. Maintaining that alignment across sites is essential to supporting reliable large-scale production. That is where accumulated experience makes a real difference,” Puusepp adds.

What a 20-year journey proves

DAI’s 20-year journey shows what long-term execution in combination products requires: refining a device for commercial use, scaling production without compromising consistency, coordinating operations across sites, and maintaining supply reliability as programs and industry expectations evolve. It also demonstrates the enduring value of long-term collaboration in bringing combination product innovations from concept to reality.

Those capabilities were built through decades of active commercial manufacturing, and they continue to shape how SHL Medical supports combination product programs worldwide.