Development of medical technology and devices - advanced engineering in an FDA (QSR) and ISO 13485 regulated environment
With our world class engineering teams in Cambridge UK and Boston, we design and develop innovative medical devices and technologies for the world’s leading companies and for innovative start-ups. We provide our clients with an unparalleled skill set – from product design, human factors and mechanical engineering, through software, electronics and wireless communications, to life science – enabling them to trust us with their most technically and commercially challenging projects. Our quality and project management systems, meet the FDA's QSR and are certified to ISO 13485, ensure that we can deliver to our clients' fast track and regulatory compliant development programmes.
We operate in five major sectors:
Drug Delivery Device Development
An unmatched track record in inhaler and injection device development. Our market-leading inhaler and injection devices include MDIs, DPIs, needle free, auto-injector and reconstitution developments. We specialise in the creation of breakthrough drug delivery devices from concept through to commercialisation.
Clinical Diagnostics and Life Science Instrumentation
If you are facing a tough technical challenge in your diagnostics product & technology development, we have the skills to help. In home use and POC we offer our unrivalled human factors skills and low-cost, high-performance sensor technology. In the laboratory, we focus on developing the core measurement engine and being the system integrator for complex instruments.
Surgical and Interventional Devices
Development of tomorrow’s sophisticated surgical tools and implanted devices demands proven multidisciplinary and clinically aware design capabilities. Our team focuses on advanced, next-generation surgical device development as well as breakthrough smart implant design and neuromodulation device development.
Wireless Medical Technology
We enable wireless communications in medical, health and wellness products. By combining world class capabilities in both wireless and medical product design, we can get you to market earlier. We have developed wireless medical devices for use both inside and outside the body, as well as having specialist experience in developing implantable antennas.
We enable our clients to grow, developing robust and profitable product portfolios with clear routes to market-leading positions. Combined with streamlining NPD processes we are able to deliver better outcomes from technology investments.
We bring multidisciplinary capabilities to all these areas – mechanical design, electronics and software, physics and mathematics – and are trusted by many of the world’s leading pharmaceutical and medical device companies to successfully enhance their product development capability.