Eastyoke project managers have led a number of projects for the development of new medical devices and associated consumables for US and European biotechnology and healthcare businesses. NPD / NPI programmes in this sector have included the development of point of care and laboratory diagnostic equipment, personal devices such as inhalers and injectors, and surgical equipment and implantables.
We are experienced in the development, industrialisation, regulatory approval and market introduction of Class I, II and III devices and we understand the associated quality standards such as ISO 13485. In particular, we have people who understand many of the critical enabling technologies associated with this sector, including plastic injection moulding, automated assembly, packaging and safety critical control systems.
A recent assignment involved the development of a diagnostic breathalyzer device for the detection of the volatile organic compounds associated with a specific type of lung disease. We supplied an interim project manager with experience of the regulatory compliance issues associated with new product development within this sector. The device is currently undergoing clinical trials in British hospitals.
Pharmaceutical Process Engineering
Our client, a bioscience / biotechnology corporation with expertise in plasma-derived therapeutics and drug development, asked Eastyoke to supply an interim project manager to oversee the expansion of its UK manufacturing facilities. The site manufactures chemical intermediates for the pharmaceutical industry and it was critical to ensure that production was not disrupted during the expansion.
The scope of the project included included design, construction and installation of a reactor hall, mezzanine floor, clean rooms, prep labs, stores, reactor vessels, mixing tanks and associated building services.
Eastyoke’s project management contractor was responsible for the oversight and coordination of the civils and process engineering contractors, consulting engineers and CDM coordinator, as well as liaison with the client’s management and stakeholders.
We have project managed the development of analytical instrumentation for the healthcare, environmental monitoring, food and chemical process industries. We understand the associated regulatory regimes, quality standards and, in particular, we are very familiar with GxP requirements.
One of our most recent assignments in this area involved the development of chemical agent detectors for use in homeland security applications. We supplied an interim project manager whose task was to ensure the product met the expectations of a very demanding customer while also fulfilling the business objectives of the supplier.