Full development of PatchPump® platform technology

SteadyMed Ltd

Challenge
To take a wearable injector platform technology from proof-of-principle to manufacture.

Approach
We are developing the existing technology towards an approvable and manufacturable product, assisted with usability testing in the US & UK.

Outcome
Following thorough product development, a number of development stage units have been manufactured ahead of regulatory submission.

Specialty pharmaceutical company SteadyMed Ltd came to Team to help take the PatchPump® wearable injector pre-filled with a therapeutic drug, from proof-of-principle to an approved drug product that is small, discreet, waterproof and easy to use.

Conceived as a platform technology, PatchPump® is designed to be highly customisable, and is intended to deliver volumes greater than 2mL over a period of minutes for bolus delivery or a number of days of continuous infusion depending on the needs of the particular therapy and disease state.

The first drug device combination product candidate, based on the company’s PatchPump® platform, is known as Trevyent® and is being developed to treat patients with pulmonary arterial hypertension (PAH).

SteadyMed’s single-use Trevyent product is designed to accurately and continuously deliver a subcutaneous or intravenous infusion of the drug treprostinil 24 hours a day, every day, with each Trevyent unit lasting 48 hours.

 
Our approach

The project has required us to employ our broad skills in electronics, mechanical engineering, software, design and human factors in order to harness a novel technology and support SteadyMed through to submission of a new drug application (NDA) to the US FDA.

SteadyMed’s research team had developed a novel expanding battery, the ECell, which powers itself to drive a piston against a flexible drug container to administer liquid drug. SteadyMed wanted support and technical leadership from us to turn the technology into an approved, manufacturable product, according to tight timescales and rigorous regulatory standards.

As a company in the early stages of development, SteadyMed needed a partner who was flexible, cooperative, accommodating and used to working with young companies to meet tight timelines and strict budgets. It was also critically important to SteadyMed that their partner possessed expertise and a history of execution in the key disciplines of human factors, engineering and design.

Development sketches of patchpump

Our first job was to look at the architecture and structure of SteadyMed’s proof-of-principle PatchPump® device. We proposed a number of refinements in terms of construction, sensor type and electronics architecture, and confirmed SteadyMed’s confidence in the technology and initial design.

We developed an uncomplicated aesthetic form for the device, reinforcing its strengths of comfort, discretion and ease of use.

PatchPump development render

As with many projects of this nature, we also managed a number of multi-national sub-contractors on SteadyMed’s behalf and worked with the client’s teams in Israel and California to evaluate and select the most appropriate manufacturing partners.

As well as full development, we also undertook formative usability testing in the UK and US to better understand the needs of PAH sufferers. From the outset, it was important to ensure that the pre-filled, pre-programmed Trevyent drug product was easy to use. We have made the process of drug administration from Trevyent very simple, offering patients just three steps to operate.

The project posed several difficult technical challenges, many of them related to meeting the tight requirements for delivery accuracy across a range of conditions – including vibration and drop, rapid temperature fluctuations and electromagnetic interference. With flow rates measuring a few μL per hour, accuracy and precision were of paramount importance but still had to be achieved with low cost components suitable for a disposable device.

A sophisticated closed-loop control system was developed, providing robust and responsive delivery and rapid detection of infusion line occlusions. We have successfully addressed all of these challenges.

In parallel with the development of the device and working closely with the SteadyMed team, we also developed a series of test methods and test equipment, to enable fast and accurate evaluation of the PatchPump®’s performance.

 
Outcome

Development stage Trevyent units have now been manufactured and, working with SteadyMed, we will soon be undertaking stability studies and design verification testing ahead of submission of an NDA to the US FDA.

As well as Trevyent for PAH patients, we are developing a PatchPump® device based on the same ECell technology that includes integrated and automatic cannula insertion.

patchpump-on-body

 
From our client

“We reviewed a number of proposals from top-tier product development consultancies for this project and concluded that Team had a unique combination of world-class expertise in design, human factors and engineering.”

“They also excel at the essential ‘softer’ skills, such as being supportive, accommodating and flexible. We had an ambitious vision with this project, and our decision to work with Team has resulted in a highly effective collaborative effort. We couldn’t be happier with the end result.”

Jonathan Rigby, President & CEO
SteadyMed Ltd