Keeping a population healthy is a huge drain on government resources, and many health authorities are looking for ways to reduce costs. Over the last couple of years, drug delivery systems have been singled out for attention. Peter Roldskov, Global Process Business Development Manager at NNE Pharmaplan, explains why: “Traditional therapy forms are time-consuming and expensive to administer. An injection treatment, for example, consists of the drug, the vial or cartridge, the syringe and the nurse. It takes time for the nurse to give people the injection, it’s inconvenient for the patient and some authorities have to pay for patients to travel to the medical centre. So, medicines that patients can administer themselves will save healthcare authorities a huge amount of time and money.”

Incentives for self-care systems
As a result, governments are shifting focus to self-administered medicines – and they are dangling a lot of investment money in front of pharmaceutical companies as an incentive. This strengthens the business case for companies looking to develop self-administered medicines – and adding a self-care element to investment applications can open the avenue to more financial support. But the self-care trend also offers many other advantages to pharmaceutical companies.

For many pharmaceutical companies, low-price generics are difficult to compete against. But drug delivery systems can help research-based companies tap into a new source of customer loyalty. “For most patients, the actual medicine itself is not a pull. If it works, they are happy,” says Peter. “But if companies can really set their product apart from their competitors’, patients are more likely to choose it. The companies can do this by developing a self-administration device that patients like.”

Overall, there are now less new drug releases than before, and putting an established drug in a new delivery system offers companies the chance to re-launch existing medicines and extend product life-cycles. The company does not even need to overhaul the administration system each time. Often small changes – a new feature such as a memory module, for example – can make a huge difference to the patient, and boost sales.

This is made easier by the fact that, in general, it’s quicker to get regulatory approval to a change in an administration system than a change in the actual medicine. But how do companies know what people want?

What patients want
Peter is convinced that focus groups are the way forward – and not just with patients, but with doctors also. “For many of these medicines, it’s the doctor who recommends the product – and so customer research has to focus on both end-user needs and doctor preferences. This is the only way to develop a product that patients will want, and doctors will prescribe.”

Still, according to Peter, there are three basic elements that patients tend to look for: convenience, design and simplicity. “The medicine should be fast to administer – preferably less than 30 seconds – and it should be simple to do, without any rolling up of the trouser legs or fiddling with the packaging. Also, most people don’t like to treat themselves in public, so the design needs to be as unobtrusive as possible. And because keeping track of doses and treatment is difficult, people want a simple-to-use administration log built in.”

There are already self-administration systems on the market that have these features. For example, injection pens can include a memory function that keeps a log of previous doses and the time between treatments. Patches can be applied directly to the skin (and under the clothes) to invisibly administer a medicine. And remote-controlled catheters or pumps can be applied under the clothes.

Fast-tracking new administration system designs
But, in this new world where drug delivery system design drives sales and customer loyalty, pharmaceutical companies need to react quickly – and this can be a big challenge for production facilities. Traditionally, it takes four or five years to take a product from idea to production, and much of this time is spent designing, building and qualifying the production facility. So, to get their developments to market quicker, companies need to consider facility design much earlier in the process.

“It’s a massive advantage if a company can consider production processes while designing new drug delivery systems and modifications,” comments Peter. “But few companies have people in-house who are experienced in both. That’s where we can help. We have experience in process and facility design and device design – and bridge the gap between the two with Design for Manufacture (DFM). This strong link can reduce time, money and trouble later on in the project. If production and validation aspects are considered in the beginning and included in the DFM, companies optimise their production processes while designing devices – so they are ahead of the game when it comes to getting their product approved and on the market.”