Challenge

Take a wearable injector platform from proof-of-principle to FDA approval. The product had to be capable of delivering 2ml of Treprostinil drug over a 48-hour period with a high degree of accuracy, control and safety over a broad range of conditions.

Approach

Using our broad skills in electronics, mechanical engineering, software, design and human factors, Team Consulting harnessed a novel technology and met requirements of a precision drug delivery device. We also supported SteadyMed through the submission of a new drug application (NDA) to the FDA. As a company in the early stages of development, our client needed a partner who was flexible, cooperative and accommodating. As SteadyMed’s partner, it was also important to understand the pressures of a young company from investors, timelines and strict budgets.

Outcome

The final product is now in manufacture with a complete Design History File. It is with the FDA for approval.

At a glance

Client
SteadyMed Therapeutics (now United Therapeutics)

Sector
Drug delivery

Services
Mechanical design
Electronics
Software
Human factors
Industrial designProject management

Team staff on project
25

Wearable patch pump for continuous drug delivery

SteadyMed’s research team had developed a novel drug delivery systems based on an expanding battery: the e-cell. The company’s first drug device combination product candidate is known as Trevyent™ and was developed to treat patients with pulmonary arterial hypertension (PAH). SteadyMed’s single-use product is designed to accurately and continuously deliver a subcutaneous infusion of the drug treprostinil 24 hours a day, every day, with each Trevyent™ unit lasting 48 hours.

We were involved throughout the development process including full technical development and formative and summative human factor studies. We also managed a number of multi-national subcontractors and helped design manufacturing and test equipment. The final product is now in production and with the FDA for product approval.

Designing a body-worn device

We developed a simple aesthetic form of the device and designed it with the user in mind, reinforcing its strengths: comfort, discretion and ease of use.

The use of formative usability testing in the UK and US to better understand the needs of PAH sufferers was instrumental in achieving the correct design. 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.

Stephen Augustyn, Head of Mechanical Engineering Group

Working with early stage companies

Young companies can have financial and technical challenges to face. A development partner can be critical for a small company facing deadlines with crucial commercial consequences. We understand this responsibility, as well as the trust that our clients put in us. Working with SteadyMed we became an integrated part of its development effort.

Team Consulting also excels 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.

Multi-disciplinary development

The development of the Trevyent™ product crossed all disciplines at Team. We formed a core long-term team with members from all functions. The close integration of human factors, design and all the engineering disciplines was key to resolving the trade-offs and challenges of a complex and safety critical product.

Complex human factors

Testing a sophisticated device, within a group of users that are difficult to recruit, presented some challenges. To tackle this, Team developed a bespoke, remote controlled test device that could present the users with all the user-interfaces they could encounter in a realistic environment.

Our well-established network of recruiters and the experience of our human factors team helped overcome the challenges in this programme.

Kay Sinclair, Senior Human Factors Consultant.

Maintaining dose accuracy

With flow rates measuring a few μL per hour, accuracy and precision were paramount, while components needed to be low-cost and suitable for a disposable device. To achieve this, we developed a sophisticated closed-loop control system, providing robust and responsive delivery and rapid detection of infusion line obstruction.

Testing performance

A body-worn device is exposed to a wide range of environmental conditions: vibration, drop, rapid temperature changes , electromagnetic interference etc… So testing needs to be carried out to prove delivery accuracy across all conditions and maintain safety and performance. In parallel with the development of the device, we also developed a series of test methods and test equipment, to allow fast and accurate evaluation of the product’s performance.

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