Scottish Health Innovations Ltd

The Multifocal Imager

Multifocal-Lo-resThe Multifocal Imager 3GEN is the product of fifteen years research experience  gained in the investigation of more than 6,000 patients. The system was developed by David Keating a medical Physicist and Stuart Parks a Clinical Scientist at Gartnavel Hospital, Glasgow and was launched in the Summer of 2009 by Scottish Health Innovations Ltd (SHIL).

The innovation
The retinal imaging device. Utilising complex software, the system interprets electronic signals sent from the retina. These signals are used to create a detailed retinal map to help diagnose and monitor a number of retinal problems.

050352-080218-HC-Multifocal-ERG-(1)The Multifocal Imager System combines the use of software and hardware that produces a combined spatial and temporal information on the visual function. The defualt mfERG and mfVEP full M-sequence test takes eight minutes to perform sixteen thirty minutes

Step 1 – Establishing the Market and the Clinical Demand
When the inventors behind the Multifocal Imager came to SHIL the system had already been in development for some time. Help was needed to make the system commercially available. Before agreeing to support the product SHIL carried out thorough analysis including market research and competitor analysis to understand the clinical need for the product and validate the inventors belief in the product.

050352-080218-HC-Multifocal-ERG-(15)Step 2- Identification of Product Developers
Due to the nature of the product further software and hardware development was required to make the product commercially viable. SHIL engaged with local company Wideblue (www.wide-blue.com) who created hardware solutions to improve the original electronics design and added firmware features that optimise signal filtration and minimise the loss of test data. Product demonstrators were built for marketing samples and clinical testing.

Step 3- Manufacture
SHIL opted to become the legal manufacturer of the Multifocal Imager a Class IIa medical device. To market the product directly, SHIL successfully attained accreditation to ISO 13485:2003 and CE certification of the multifocal Imager 3GEN by route II.

080532-090803-HC-PackagingSHIL continues to engage with Wideblue who supply the components for the product as well as working with other local companies who provide packaging and marketing materials for the finished product.

Step 4-Route to Market
SHIL sells the Multifocal Imager directly. The product is available to European customers after being launched in the Summer of 2009 and approval for the FDA has been applied for to make the product available in the USA.
 

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