Patient-Controlled Drug Delivery

Janssen

One-Press

Background

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.

Value Delivered

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

Project Scope

Insight & Strategy, Industrial Design, Packaging & Communication, Human Factors, Prototyping & Evaluation, Mechanical Engineering, Manufacturing Support, Design Transfer

Project Scope

Insight & Strategy
Industrial Design
Packaging & Communication
Human Factors
Prototyping & Evaluation
Mechanical Engineering
Manufacturing Support
Design Transfer

The device has to feel simple, intuitive and non-intimidating if it is to improve the patient experience.

Human-Centred Inclusive Design

We mapped out the complete patient journey from pre-injection to disposal through a series of targeted research activities. By understanding the overall experience, we identified key areas for development – and this was critical to the success of the product.

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

By involving our mechanical engineers in the concept design phase, early prototypes replicated activation force, needle shield movement and audible clicks, mimicking real device interactions and feedback.

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.

Because One-Press doesn’t look or feel like a typical injection device, user anxiety is immediately reduced. It’s not intrusive and the whole experience becomes far less intimidating.

Engineering a Platform Device

Compatible with many different drug formulations

Engineering a robust device for high volume manufacture and assembly is a difficult and highly regulated process. However, our technical expertise and industry experience enabled us to design the sophisticated mechanical interactions required without knowing the specific characteristics of different drug formulations.

To create a flexible and safe platform technology, it was necessary to identify and solve several critical challenges.

Engineering 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.

Engineering Challenges

Controlling Syringe Assembly Forces

As the needle guard is a critical component of the primary container sub-assembly, the axial force applied during One-Press assembly must be tightly controlled to maintain container closure integrity and avoid damage to the seal.

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.

Engineering Verification

Prototype Tooling

To evaluate all fit, form and function interfaces, our network of approved suppliers produced low volume injection mould tooling within four weeks. The high-quality moulded parts are made from final specified materials to ensure testing was completed to a high level of accuracy.

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

Packaging and Communication Material

Creating ‘frustration-free’ packaging helps to build the patients’ confidence from the beginning.

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 results were conclusive, identifying clear usability improvements over regular autoinjectors and a more positive patient experience.

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.