A drug and its device can no longer be considered separate entities, and for a product to become successful, the device needs to function as far more than just an afterthought. Ian Anderson, director of innovation at Bespak, explains how the company works in tandem with its pharma partners to create safe, reliable and highly useable devices.
Now, more so than ever, drug development can prove a frustrating task. Forced to navigate a succession of regulatory hurdles, pharmaceutical companies must insure themselves against the possibility of failure. This entails finding partners across the supply chain that are equipped to do the same.
Above all, they need resilient device manufacturers. With changeable timelines and no guarantee of the drug's success, device manufacturers must support their pharmaceutical partner, no matter what the outcome.
One company rising to the challenge is Bespak. A global supplier of drug delivery devices for injectable and inhaled products, this UK-based organisation creates more than 500 million devices each year. With many of the world's top pharma companies as customers, it is the leading supplier of devices to sufferers of asthma and chronic obstructive pulmonary disease.
Nor is its role confined to manufacturing. With services spanning from pilot schemes to the clinic, Bespak boasts long experience in design, development and industrialisation, providing expertise at every step of the process.
Of course, despite its prowess as a contract manufacturer, Bespak holds minimal influence over a drug's eventual approval. As a tier-I supplier to the industry, the company would flounder if tethered to the fates of specific pharmaceuticals. Bespak's success hinges on its flexibility - the ability to develop adaptable devices with wideranging applications.
"Because we own the intellectual property (IP) of our devices, we can take our technology and modify it," explains Ian Anderson, director of innovation. "If the drug fails, it fails; but we still have the IP and the know-how to develop a device for another drug. So, we develop a platform technology that we can use across a variety of pharmaceuticals, and aren't dependent on a single drug for success."
With a dedicated innovation team, whose job it is to translate the raw idea into a marketable product, Bespak believes in getting involved as early as it can. This isn't always feasible - a drug nearing completion may require a last-minute device - but generally the intention is to partner at the initial stages, while the scope is still fluid.
"The drug and the device are not independent entities anymore," explains Anderson. "They're seen by regulatory bodies such as the FDA as a combination, and so they have to work as a combination, taking the end-user's needs into account."
While human factors are often viewed as regulatory hurdles, Bespak sees the situation in a more positive light. Through addressing usability early in the development cycle, the company believes that an emphasis on patient needs can become a USP. It therefore talks to all relevant groups about what they're looking for in a device - quizzing patients, healthcare professionals and the pharmaceutical industry alike.
Importantly, this applies even before the drug becomes a reality. For Bespak, it is more about working with a concept of what the drug might entail. How viscous does it need to be? How stable is it? Is it a Newtonian fluid or does it have a unique rheology? Do patients want a smaller needle, in the case of an injectable device? Because most devices are targeted at a single condition, understanding the specifics of the patient group is key.
This applies no less when the intended users are more varied. Should the device be used across a range of therapies, it is crucial to understand the breadth of opportunities on offer. After all, there is no easy way to incorporate new sets of needs once certain elements have become fixed.
"We need to make sure that patients are satisfied by the experience of using our devices," says Anderson. "That extends to where they're going to store it in their house, where they're going to use it, and whether they have to administer it in public. All of these things come in the process of development."
The pharma partner's needs are just as central. While technical considerations gain the limelight, commercial considerations are never far away, the supply chain is carefully analysed and logistical considerations given weight. This means exploring the probable distribution network and the nature of the cold chain. Such aspects, overwhelmingly, are addressed from the outset.
"We alter our device to make it suitable for all those elements," says Anderson. "Our pharmaceutical partners are satisfied because the device fits the market, but there is also an element of specificity."
Once the manufacturing process gets underway, the emphasis switches to maximising the stability of the device, creating ease of assembly and minimising effort for the pharma partner. Bespak often asks for an ideal delivery profile, rather than simply working towards a target delivery time, so there are plenty of factors to consider when it comes to meeting the brief.
Technically, the challenge is to ensure the device works impeccably every time. With many devices being disposable, the device needs to function without a blip as soon as it is out of the box. Bespak thus supports its theoretical analysis with an intensive testing procedure.
"We establish the tolerance boundaries and know when tolerance build-up will result in a major failure - in the sense that the device won't deliver the drug - or whether it's more of a grey area, where the device starts to perform less well," explains Anderson. "And we make sure we don't go near either of those edges when we manufacture our devices."
Equally, there is an emphasis on reducing time to market. Given the present financial climate, there can be little scope for delays. Bespak therefore focuses on efficiency, allowing customers' products to be developed, tested and manufactured at speed and with minimised risk.
The end goal in all of this is securing regulatory approval. As with all such products, the drug-device combination must pass through a welter of regulatory and clinical trial processes to be given the go-ahead. Bespak works with its pharma partner to meet these standards, no matter how exacting.
"We work with several regulatory authorities to really understand what they want," explains Anderson. "So talking to them is key, and making sure that when we do tests and trials of our device they meet the expectations of the end market."
Today, Bespak is reputed as a stable and highly competitive device manufacturer, with an eye towards future growth opportunities. It is estimated that, for every second that passes, 1,000 patients across the world are using a Bespak device - a number that looks set to grow as Bespak devices are used to treat more medical conditions.
Anderson believes that, as time goes by, the drug delivery market will follow several trends.
"Everything will become simpler," he says. "The market doesn't really want complexity - it wants simplicity of use, simplicity of design and simplicity of the supply chain. But at the same time, it wants sophistication, allowing users to get much more out of a device.
"Finally, there will be a push to reduce waste in the whole system, so while a lot of medical devices are large, bulky and disposable, the tendency will be to miniaturise them. If they still have to be disposable, they can potentially gain reusable elements. These are the kind of trends we're tracking at the moment."
Tuned in to both future possibilities and present demand, Bespak continues to cement its status as a leading player in the field. This is reinforced through the loyalty of its existing customer base, who value Bespak most of all for its ability to sharpen their own competitive edge.