Article Hunter

Norwegian-based pharmaceutical company Photocure had identified the need for a new, large-area PDT lamp that could be used in combination with its proprietary pharmaceutical VisonacTM for the treatment of moderate to severe acne.

With time to market and cost of development as key issues, the company recognised that a highly focused development programme would be required. The aim was to achieve a production-ready device for planned Phase III clinical trials starting in the first half of 2009.

Photocure chose Sagentia as its development partner due to the company’s track record in the medical device sector, its ability to offer a rapid concept to manufacture development programme and the assurance that Sagentia could offer through its accreditation to ISO 13485 (the medical device quality management standard).

The fully developed lamp – known as Aktilite® CL512 – comprises two light panels with 512 light emitting diodes that deliver a controlled dose of red light. The panels can be adjusted to treat either the face or flat areas such as the chest or back. A mobile trolley stand and articulating support arm are used to position the lamp over the treatment area.

Based on Photocure’s IP and product requirements, Sagentia undertook a complete concept to manufacture product development programme comprising analytical modelling to identify the best technical concept; all mechanical, electronics, software and optical development work; validation and optimisation of advanced design concepts with clinical stakeholders; the establishment of an extended production supply chain, notably in the Far East; approvals testing for EU and US regulatory requirements; and finally transfer to production using Photocure’s existing European sub-contract manufacturer.

Photocure’s brief called for a large area PDT lamp that could provide uniform illumination of the whole face. To meet this need, Sagentia developed a 3D optical model to simulate illumination across the entire face and investigate the performance of different product concepts. Sagentia’s 3D model was able to determine that full face illumination could be achieved using just two angled lamp panels rather than the three to five previously considered necessary.

At key points during the development programme, Sagentia solicited feedback from clinical / nursing professionals to ensure that user requirements were correctly identified and validated. This included one-to-one clinician interviews, focus groups to explore the range of product concepts and usability workshops to validate prototype designs.

One of the primary reasons for the rapid and successful conclusion of the project was Sagentia’s ability to manage and co-ordinate a multi-disciplinary in-house team of engineers, scientists and technologists, many of whom had direct medical device development experience. This extended from initial product conceptualisation through to the establishment of a Far East network of suppliers. Sagentia’s expertise in this area enabled the company to build a supply chain for low volume, high quality mechanical parts at 40 per cent of the cost of equivalent European items.