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Extending the shelf life of your diagnostic assay and instrument

Complexities and timescales associated with developing a new platform often lead to companies launching under performing, over cost and unreliable instruments.

This adversely affects a company's reputation and, in the long term, reduces profitability and market share. Using the right balance of internal and external resources to develop an appropriate product, implement volume manufacturing, and deliver sales on time to capture market share is therefore critical.

Add in the increasingly complex technology, concurrent instrument and assay development and higher product quality requirements (needed to achieve assay sensitivity and selectivity) and you have a complicated development programme on your hands. The rush to commercialise new assays produces "first generation" instruments which are often just packaged laboratory solutions that are difficult to use and insufficiently robust for commercial launch adversely affecting a platform’s reputation. Costly field servicing and subsequent efforts to improve sensitivity and reliability without overhauling the product is often too little too late. 

The race to launch the first $1000 sequencer is likely to provide an interesting example. With many companies developing technologies; including Roche 454, Pacific Biosciences and Helicos, all with significant in-house development teams competing for a share of a significant market. Being the first to market but with a difficult to use unstable laboratory research platform will not win sustainable market share, especially as user expectations for instrument reliabilities grow. These instruments need to be suited to clinical laboratory and point-of-care use from day one if their wide spread adoption is to be realised and the forecast income stream delivered.

Looking further ahead, as diagnostic products mature the business requirements change, from a focus on product development, to the demands of low cost, high quality manufacturing. Being able to identify and resource supply chain and product development programmes that realise these ambitions through design, sourcing and partner selection are key for maximising profitability in a mature and competitive market. 

PA has helped many life science companies from start-ups to world leaders develop next generation assays and instruments and implement manufacturing solutions. Working alongside the client teams we have successfully navigated a path from instrument concept, through to product launch and beyond:

  • Auditing and identifying technology solutions to deliver against your business case

  • Developing breakthrough solutions including instrument and automation design.

  • Delivering fast tracked innovative product development

  • Implementing manufacturing and supply chain strategy.

  • Improving instrument performance and quality, and reducing field service costs. 

To find out more about strategies for extending the shelf life of diagnostic assay and instruments, please contact us now.

Contact
Mark Humphries
Product development and manufacturing
contact us now

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