This article has been taken from The Gen newsletter - Spring 2009. Click here to download the pdf.
Norwegian based pharmaceutical company Photocure identified the need for a new, large area photodynamic treatment (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. Photocure chose Sagentia as its development partner due to our track record in the medical device sector, our ability to offer a rapid concept to manufacture development programme and the assurance we could offer through our accreditation to the medical device quality management standard ISO 13485. Based on Photocure’s IP and product requirements, Sagentia undertook the complete 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; approvals testing for EU and US regulatory requirements; and 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, we developed a 3D optical model to simulate illumination across the entire face and investigate the performance of different product concepts. Our 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. 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. Clinical trials are due to commence in 2009.
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