Case Study – Systems 2

A UK-based company specialising in DNA purification had started their development programme overseas to take advantage of development incentives. The result was a prototype instrument that was over-size, had high parts cost and did not address the ergonomic requirements or fulfil the technical specifications.

The Requirement :

• To redesign the prototype instrument to the marketing requirements.
• To design for manufacture.
• To complete a cost reduction exercise.
• To redesign system components to meet specification.
• To make the instrument modular to allow for serviceability.
• To complete the software development.
• To complete the consumables development.

The Commercial Constraints :

• The HMI interface had to be retained.
• The tooling for the consumable had to be retained.
• The reaction vessels had to be retained.
• The redesign was to be constrained to those elements that did not meet the specification.
• The transfer price of the instrument was to be commercially viable.
• The purification sequence was defined and was to remain unaltered thus eliminating further validation costs.

The Market Constraints :

• The instrument was to be bench-top.
• The instrument should address the ergonomic requirements of the user.

The Solution:

ITL redesigned the automated DNA purification instrument to a contemporary design that performed the purification assay protocol as defined by the Client. The essential elements of the original prototype were retained, whilst reducing the cost and size of the unit. The instrument was designed into modules for serviceability and the software development was taken over and completed by ITL. We then liaised with the specified moulding company to make modifications and design changes to the disposables to ensure that they were fit-for-purpose and easily handled on the instrument. ITL then went on to generate the regulatory documentation and guide the instrument through the relevant regulatory compliance testing before entering the Manufacturing phase. In addition Operators’ and Service manuals were produced and service training completed.