Several leading manufacturers, in the automotive and other industries, have answered the government’s plea and indicated their willingness to offer their production facilities over for the manufacture of ventilators – but what are the challenges?
This is by no means a simple endeavour, and there will be many obstacles for the original equipment manufacturers (OEMs) to overcome very quickly in order to meet very demanding timescales. Cooperation, collaboration and pragmatism between those involved will be absolutely crucial for the success of this critical, live saving venture.
OEMs are likely simply to offer their facilities on a contract manufacturing basis on behalf of ventilator manufacturers for much needed production capacity. This model will be the quickest and least complex to apply, although not without many challenges.
Contract manufacturing often takes some time to implement, particularly in relation to unfamiliar product lines. OEMs will need to carry out a period of research and development to prove the concept that their facilities, and the skills of the work force, are viable in the manufacture of a very different type of product. Tooling will need to be developed or sourced, installed and tested. Processes must be designed and prototypes produced and thoroughly tested and validated before production can even begin.
There is little doubt that the knowledge of the OEMs’ highly skilled engineering staff will be transferable to the manufacture of these crucial medical devices, but there will be some considerable effort in getting to grips with unfamiliar technology. The OEMs will need to rely heavily on the co-operation of ventilator manufacturers to share key knowledge and information about their technology, manufacturing processes and supply chain for the venture to be a success.
“The OEMs will need to rely heavily on the co-operation of ventilator manufacturers to share key knowledge and information about their technology, manufacturing processes and supply chain for the venture to be a success.
Throughout, ventilator machine manufacturers will be keen to protect their technology, and that of their supply chain, to maintain their competitive edge when the need for contract manufacturing has reduced. From an intellectual property perspective, OEMs and ventilator manufacturers must protect themselves and their technology, while at the same time finding a way for this life saving venture to proceed.
Many essential components of the state-of-the-art ventilator machines are patent protected, particularly in respect of the control mechanisms to maintain oxygen pressure at the optimum level. A patent will protect the patent holder from any unauthorised manufacture, sale or supply of their protected technology within the country or countries covered by the patent. While the OEMs will look to source essential components from an authorised manufacturer within the supply chain, in doing so they and their suppliers will need to take care not to infringe any patents which protect systems, or to breach the terms of any patent licences. Ventilator manufacturers and suppliers must be open about any known patents or licences which could restrict OEMs’ ability to manufacture and supply ventilators.
“While the OEMs will look to source essential components from an authorised manufacturer within the supply chain, in doing so they and their suppliers will need to take care not to infringe any patents which protect systems, or to breach the terms of any patent licences.
Key to the contract manufacturing will be the transfer of know-how and highly secret information from the ventilator manufacturers which will need to be subject to very strict confidentiality obligations on the OEMs and their staff. Ventilator manufacturers themselves will be under confidentiality obligations with regards to their own suppliers, meaning cooperation through the entire supply chain will be important.
Where control systems are software driven, OEMs will need to ensure they have the appropriate licences in place to incorporate that software into the new products and supply to their customers. OEM engineering staff will need to quickly become acquainted with different technology to ensure the ventilators are operational in a life and death situation. Cooperation of the software providers will also be crucial.
The manufacture of medical devices such as ventilators is highly regulated, and in order to carry the necessary CE mark, products be manufactured to an approved quality system. Of course, OEMs are used to working to very high quality industry standards and already have their own robust quality systems in place. However, the OEM’s own quality system may not be deemed appropriate by the MHRA which is the regulator for the manufacture of medical devices, meaning the OEM must work to the quality standards of the ventilator manufacturer customer to be able to CE mark devices. This will also take considerable time to implement.
There is little precedent for the current situation. To date, there has not been any feedback from the regulator giving clarity as to how the contract manufacture of these products might be approved in such a short space of time. The government could pass emergency legislation to expedite the regulatory process, and we wait with interest to see how this proceeds.
Disclaimer
This information is for educational purposes only and does not constitute legal advice. It is recommended that specific professional advice is sought before acting on any of the information given. © Shoosmiths LLP 2024.