Patient-Controlled Drug Delivery
We have enjoyed a successful 15-year partnership with Janssen and were delighted to be asked to develop the company’s new patient-controlled platform device.
The project posed several complex challenges, not least the need to address patient anxiety and needle phobia and ensure that the final design did not look like other injection devices on the market.
Our solution is an intuitive and non-intimidating subcutaneous injector for self and caregiver administration of biologic drugs. It is suitable for a range of drug viscosities and enables patients, specifically those with limited manual dexterity due to Rheumatoid Arthritis or impaired eyesight, to self-administer their medication confidently and successfully.
We were responsible for all areas of this full-service project, from initial research and feasibility through to the transfer of the verified design to full production.
- Enables self-injection at home with audible and visual feedback
- Inclusive design is suitable for different user groups
- Helps patients with limited hand dexterity and poor eyesight
- Allows patients to decide how fast and with how much pressure to deliver their medication
- Reduces anxiety from needle phobias
- Administers a large range of drug volumes and viscosities
- Looks and feels like no other injection device on the market feedback
Packaging & Communication
Prototyping & Evaluation
Human-Centred Inclusive Design
An iterative combination of sketching and model-making helped to communicate initial ideas based on the user requirements identified in our research. Adopting the principles of ISO 62366, we could empathise with the physical limitations attributed to severe Rheumatoid Arthritis, build this into our designs and undertake preliminary user testing.
Informed by Early Market Studies & Insights
This approach meant we could then carry out qualitative research with HCPs and patients, helping us gauge both the acceptance and usability of emerging concepts and determine the most appropriate design direction.
Crucially, our findings identified that needle phobia was a key issue for patients, confirming that an intuitive, friendly, and safe design should be central to the product’s DNA.
Engineering a Platform Device
To create a flexible and safe platform technology, it was necessary to identify and solve several critical challenges.
Low Volume Syringes
Firstly, the design had to accommodate syringes with multiple fill volumes and viscosities to ensure compatibility with different drug formulations.
For lower fill volumes, we designed over-moulded friction pads that simulated the stroke resistance of a full syringe. These pads interact until the plunger hits the low fill volume syringe syringe stopper, creating a consistent force throughout the injection.
We tested the behaviour of the friction pads varied across different environmental conditions and used this data, together with FEA analysis, to optimise our design.
Controlling Syringe Assembly Forces
Conversely, because the device has to grip with enough force to pull off the needle guard when the cap is removed, the design of the puller had to comply with large variations in tolerance.
Detailed FEA and tolerance analysis helped to define the necessary forces. And to ensure a further level of control at production, automated gauges verify that the assembly force of the syringe is within out set limits.
We then conducted a full engineering evaluation and testing against the design requirements and test protocols in our on-site test suite.
Creating a Positive Out-Of-Box Experience
Every aspect of the packaging and out-of-box-experience was considered an opportunity to reduce patient anxiety – from easy to open tabs, to the friendly, instructive graphics in the Quick Start Guide.
The packaging, both environmentally-friendly and cost-effective, protects the product from potential damage. Importantly, we made sure it could be manufactured using existing facilities, creating a smooth transition to mass production.
One-Press is fully compliant to ISO 11608, ISO 23908, FDA Document 934 and contains an ISO standard 1.0mL prefilled syringe with a rigid or rubber needle shield.
Validated by Human Factors Studies
The device enables patients with limited manual dexterity and impaired eyesight to self-administer and control the speed of their medication successfully.
As it’s easy to use and particularly suited to dispensing large molecule and high viscosity drugs, One-Press has more than doubled the success of self-administration compared to autoinjectors.
One-Press is used for multiple drug programs around the world and was awarded the prestigious Medical Design Excellence Award.