Company: UK company designing, manufacturing, and distributing its range of medical devices
Industry: Medical Devices
Revised manufacturing agreement to support quality management system and standards
Introduction
This UK company creates and manufactures its own range of medical products for distribution throughout a number of territories including the UK, Europe, US, Canada, and Australia. The company has specialist knowledge and extensive experience within a particular field to enable it to design innovative healthcare solutions. The client was undertaking an assessment of its own quality management system and would be subject to audit. It, therefore, needed for an experienced lawyer to liaise with its external medical device consultants, and to prepare a suitable manufacturing agreement in good time for the overseas manufacturer to both review and agree to the agreement, thereby enabling the client to have it in place in readiness for its audit and corresponding assessment deadline.
The (Pain Point)
The client has a team of highly experienced and qualified technicians that innovate and design new healthcare solutions in respect of the company’s range of medical devices. In order to legitimately manufacture and distribute its products it is required to comply with a number of regulatory frameworks as relevant for its various market territories. As part of its regulatory compliance it must establish and maintain an effective quality management system that encompasses its various work environments and business relationships. Such quality management system is independently assessed for its effectiveness and suitability. This includes an assessment of its documentation including relevant commercial contracts.
The Challenge Faced
The client recognised that whilst its documentation, systems and processes were compliant, it still strives for excellence and wanted to not only ensure it maintained a suitably comprehensive and effective quality management system, but to do so by maintaining its lead in the marketplace due to the extent of regulatory compliance it has and wishes to continue to achieve. It was therefore conscious that there were particular improvements that it anticipated and wished for these to be expressed within a new manufacturing agreement.
Due to the impending deadline of the audit, the client needed for a suitably qualified and experienced lawyer to be able to work quickly and efficiently with its external medical device consultants, as well as to create, negotiate, and conclude a comprehensive and technical manufacturing agreement. This project also needed to be completed within a very short timescale
Why Chosen
The client had worked with me in the past, and whilst existing legal advisors were involved in the business, the client wanted someone who was able to get up to speed quickly and without fuss, to establish relationships and an effective line of communication, and to be available during the project window in order to complete this part of the project with minimal distraction. The client trusted me to be able to complete this project within time.
The Response
Whilst the external medical device consultants prepared for audit completion, it was necessary to work in tandem with them to create the manufacturing agreement. Key personnel had direct contact details for me and accessibility was not frustrated by “office hours”. It was agreed with the client that working out of hours and at weekends would likely be required to complete on time, and this was factored in with the availability of other key personnel. It was observed that phone calls rather than email exchanges would often offer a more productive resolution when challenging hurdles arose.
Overall Results
- successfully passed its audit;
- did not receive any “advisories” in connection with its manufacturing agreement;
- identified a few gaps in its quality management system when reviewing against the new manufacturing agreement and was able to more effectively accommodate changes quickly;
- had in place a suitable and much more comprehensive manufacturing agreement.
- Know how to prioritise, and clearly understand what you are ultimately seeking to achieve
- Use an experienced and qualified lawyer who is able to quickly establish relationships, can set out sensible and clearly defined objectives, and who is an effective communicator able to prepare, negotiate, and conclude business agreements in a timely manner
- Use a lawyer who puts their client needs first, is readily available, responsive, capable, and will see the deal through