Medical devices and instruments

The development of medical devices is one of most heavily regulated activities in all of engineering. A medical device can be certified and sold in the EU or the US only when it meets and has followed all applicable regulatory requirements and guidance. Errors in the development process can be commercially terminal for small companies and start-ups. Maddison helps its clients to navigate this minefield. Our team is well-versed in implementing the following standards that govern the development process of medical devices:

ISO 13485: Quality management systems.
ISO 62304: Medical device software development.
ISO 62366: Human factors.
ISO 14971: Application of risk management.
ISO 61010: Safety requirements.

Build-test-learn loops

Maddison applies its “Build–test–learn loops” process and its “demo or die” philosophy to medical device development. We ensure that the client’s budget goes as far as possible, rapidly and judiciously building and improving a series of working prototypes to realise the final device.

The image shows working prototypes resulting from a build-test-learn loop of Zedscan™

ZedScan™

Zilico’s first to market device. ZedScan™ uses Electrical Impedance Spectroscopy (EIS) to differentiate between normal, pre-cancerous and cancerous tissue on the cervix according to its electrical properties. Maddison was brought in to support the product development including usability, industrial design and product engineering.

Xstrahl

The requirement was to redesign Xstrahl’s superficial orthovoltage medical X-Ray system. The need was to design a new imaging head system to be far easier for the user to manage and manipulate, whilst also reducing cost.

Maddison devised a concept using an electro-mechanical braking system operated by a single hand trigger to provide smooth, multi-axis movement with one hand.

Maddison completed both the industrial design and engineering for the head unit, built and assembled the first prototypes to test. The result was an ergonomic treatment arm with simple to operate, smooth movement.

The London eye project

Maddison helped invent a surgical tool for clinical trial for the implantation of a specially engineered patch of retinal pigment epithelium cells, derived from stem cells, to treat people with sudden severe sight loss from wet AMD. The work was conducted for the London Project to Cure Blindness, a partnership between Moorfields Eye Hospital NHS Foundation Trust, the UCL Institute of Ophthalmology, and the National Institute for Health Research (NIHR).

SurePulse

SurePulse approached Maddison to collaborate with their in-house team to develop their technology into a commercial medical device. Accurately assessing a baby's situation in a timely manner is crucial for medical professionals and obtaining an accurate heart rate reading plays a vital role.