We designed and tested over 100 improvements to our client’s instrument in just five months, enabling rapid iteration and scaled-up production. In addition, our team manufactured 45 units and generated the device history records needed to gain a CE Mark.
Senior Consultant Sergio Malorni shares seven principles we apply when conducting technology due diligence, whether for rights acquisition or investment in the company which owns the target technology.
What should we make of the Medicines and Healthcare products Regulatory Agency (MHRA) updating its guidance for licensing e-cigarettes as medicinal products?
We share some powerful lessons from our established approach to inclusive design that could help when entering the $19bn FemTech market.
We undertook the end-to-end development of the system’s hardware and communications backbone. We designed, built, and tested the system components and implemented Asian based manufacturing for a market trial in 300 apartments, all in just 12 months.
Getting medical devices regulated to international standards is not easy. Rose explains how this process could be made much simpler.
We designed and manufactured an ingenious connected sensor to prove the monitoring technology to market leaders in home automation. The unrivalled performance and ease of use of the sensor, together with positive trial results led to a successful new product launch.
Drug delivery devices can be notoriously tricky to use, so our technology enables improved studies that can distinguish use error from drug performance. This allows developers to focus investment correctly, reduce costs and accelerate a new treatment’s journey to market.
The aim was to disrupt the diagnostics market with a lancing system that would significantly improve the patient’s experience. Our development and regulatory teams helped our client launch the first FDA & CE approved device for fully automated, virtually pain-free lancing.
Unilever identified an opportunity to trial a new business model and an innovative food service dispensing system for their leading ice cream brand. We provided end-to-end support to design, develop, and build 50 connected devices which were scaled up and pilot launched in outlets across Europe.
We were asked to resolve the difficult engineering and manufacturing issues that were jeopardising this novel inhaler’s launch. Our team identified and resolved the problems, validated the design and production tooling so Voke could gain CE approval and enter volume manufacture.
As the review of ISO 11608 approaches completion, Steve Augustyn outlines the changes device manufacturers and designers should anticipate.