Developing a user centred drug delivery device – considerations and 5 key steps to take

Published: May 2022

Patient self-administration of medication at home is increasingly in demand and becoming more diverse. This brings many benefits such as lowering the burden on primary care facilities; reducing healthcare costs; providing patient independence and freedom. With the COVID pandemic further influencing behaviours and habits, this is likely to shape the drug delivery industry for years to come.

Empowering patients in this way means flexible usability of a drug delivery device, within both healthcare and home environments, is critical for future drug programmes and treatments with patient centricity key to the R&D process.

Here are some of the key considerations:

Ease and convenience of administration
Optimising safety and efficacy while minimising potential user errors
Flexibility for different drug formulations & volumes
Eliminate the use related barriers to adoption
Ensuring repeatable pharmacokinetic performance in patient administrations
Identify the primary container platform as early as possible

Developing an innovative and intuitive drug delivery device which factors in all these considerations requires know-how in usability, human factors, industrial design, and engineering. Below are five steps we recommend you take.

Know the market

User research to generate valuable insights is critical for creating a human-centred inclusive design. It can be easy to think only of HCPs as the main users of a device with patients, who ultimately benefit from the treatment, being overlooked. Every stakeholder should be identified at the outset, and the complete patient journey mapped out through a series of targeted interviews and research activities. By identifying the various stages and environments of care, from the onset of symptoms all the way through to complete recovery or adjustment to a new way of life, you can capture all user needs accurately within formal design inputs, hence setting the project off on the correct path for concept development.

Conduct human factors testing

With user requirements now driving design direction, multiple concepts should be developed, and an iterative process of prototype, test and refine adopted to quickly learn from real users. This qualitative research strategy will support concept down selection through rapid design iteration. The insights and experience gained from these studies will also further consolidate the requirements.

At Shore we involve our mechanical engineers at the concept design phase to create prototypes to that can replicate the key device characteristics of every individual project (activation forces, audible clicks, needle shield movement, dose indicators, etc). This approach means that our early stage human factors testing is as comprehensive and informative as possible, providing evidence on which concept(s) should be taken forward into engineering.

Engineer a flexible solution

Device developers need to overcome many design and engineering challenges when transforming the selected concept direction into a design suitable for high volume manufacture and assembly. This is a highly regulated process which must consider things such as the primary container, filling lines and logistics around worldwide distribution, without losing the design intent to meet the user needs. The selected molecule must be contained and protected, and with more pharma companies looking for the flexibility of a platform device, the engineering design must be able to adapt to specific characteristics of different drug formulations without compromising the usability of the device.

A good example of such challenges is highlighted on our work on the One-Press Self Injection Device. The engineering team at Shore had to accommodate syringes with multiple fill volumes and viscosities, so we developed innovative over-moulded friction pads that simulated the stroke resistance of a full syringe. It was also imperative to control syringe assembly forces to maintain container closure integrity, without risking the integrity of needle guard removal via the cap. Detailed FEA and Tolerance Analysis allowed us to comply with a large variation in tolerance within the system, without compromising the necessary forces required to remove the cap, and in tandem the needle shield.

Controlling syringe assembly forces in our self-injection device

Create a positive out of box experience

Packaging is an integral part of the product experience, protecting the device and presenting it to the user correctly. Creating ‘frustration-free’ packaging helps to build patients’ confidence from the beginning. As such, every aspect of the packaging and out-of-box-experience should be considered as an opportunity to reduce patient anxiety – from easy to open tabs, to the friendly, instructive graphics in user guides.

The packaging should be both environmentally friendly and cost-effective, protecting the product from potential damage. By ensuring the final packaging can be manufactured using existing facilities will create a smooth transition to mass production.

Enhance confidence with training

Training products and demo devices play an important role in improving patient confidence, as well as maintaining drug regimen, fostering a better understanding of the treatment and minimising potential user errors. These reusable devices can replicate the appearance, feel and delivery force experienced when administering a real drug product

As well as designing user-centred drug delivery devices for our Customers, Shore can further support the commercialisation of a new molecule by developing and supplying robust, reusable training products and learning assets, making it easier for HCPs and patients to adopt new therapies and drug delivery devices.