What 20 years of DAI reveal about drug-device partnerships

In 2023, a new combination product launched on SHL Medical's DAI (Disposable Autoinjector) technology. The first DAI product had launched almost two decades earlier, and in the years in between, DAI remained in commercial production.

For a pharma company, selecting a device partner can mean entering a partnership that extends well beyond development and launch. A combination product can stay on the market for well over a decade. Across that time, the device brings continued requirements around production, regulatory activities, lifecycle management, and periodic new programs.

Much of what determines whether the right partner was chosen becomes visible only in later years.

That is what makes DAI's commercial record worth reading closely. Over the two decades that DAI has been in production, self-injection has moved from an emerging category toward an established part of drug delivery. It is now used increasingly by patients outside clinical settings as chronic disease and biologic therapies have grown.

An autoinjector technology that has held its place across that shift has been tested by many of the conditions that arise over a long commercial life.

An early position in an emerging autoinjector category

DAI's story starts in 2001, when autoinjectors were still relatively new and the future scale of self-injection was far from settled. SHL Medical took an early position in that space, working with a US-based multinational biopharmaceutical company to develop an autoinjector-based combination product.

The device that came out of that work, a spring-powered, button-activated autoinjector built around a pre-filled syringe, reached commercial use in 2006.

DAI's first launch demonstrated that the technology worked and could be produced at commercial standard. On its own, though, a first launch shows only that a device partner can deliver against one set of requirements at a single point in time. What a pharma company usually needs to understand is what happens over the far longer period that follows.

What happened after the first launch

In DAI's case, the first commercialization led to further projects based on the same technology. Over time, a single product grew into a broader family of devices. As DAI's portfolio expanded, SHL Medical and our partner moved from managing one program to running several development and production streams at once.

This is the part of SHL Medical's track record that speaks most directly to a device decision. When a customer comes back for one product after another, the relationship gets tested in ways a first launch never reaches. DAI shows that SHL Medical can keep delivering as the work expands across several programs at once.

A record that holds as requirements change

Each combination product can bring different requirements around drug formulation, device presentation, handling, regulatory pathway, and patient population. That is why the range DAI has covered says more than the number of products alone.

Over its commercial history, DAI has supported around 20 combination products across a range of therapeutic areas, including rheumatoid arthritis, anemia, migraine, dyslipidemia, and osteoporosis. Today, more than 880 million units of DAI devices have been shipped worldwide.

A record of that breadth suggests that DAI's underlying technology, along with the autoinjector manufacturing and quality systems behind it, has held up across varied products and clinical requirements. DAI's commercial history has not been limited to its early years either, with the most recent combination product built on its technology launched in 2023.

DAI's continuity speaks to a specific consideration in any long-term drug-device relationship: whether a device partner can continue supporting commercial production years after the initial launch.

What long-term autoinjector production requires

Two decades of DAI are easy to read as the record of one successful device. The more useful way to read them, however, is as the record of a successful partnership: one that began with the first commercial program, expanded into successive projects and a broader scope of collaboration, and continued to support commercial production as requirements and market conditions changed.

Sustaining that continuity over time is a more meaningful measure of a device partnership than any single approval or launch.

Next in the series: 20 years of proven technology, on how one device architecture kept adapting across therapies and successive generations of design.

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