. 2021 Feb 16;55(4):646–655. doi: 10.1007/s43441-021-00263-2

Table 4.

Key considerations and barriers in collaboration on health products development.

Considerations	Barriers
● Strong and cross-sector collaborations (e.g. academia, patient-representative bodies/charities, regulators and industry) ● Early engagement and communication with stakeholders ● Patient and public involvement ● Availability of funding ● Recruitment and availability of appropriate expertise ● Stakeholders’ aligned strategies and common purpose ● Flexibility in considering different stakeholders’ perspectives ● Transparency ● Perspectives of end users well captured and integrated into the research design ● Training available related to the research being conducted ● Adapting to changing regulatory environment	Legal barriers ● Intellectual property (IP) concerns and ownership ● Data sharing, access agreements and confidentiality ● Difficulty agreeing terms for contracts between academia and industry (e.g. data sharing) Structural barriers ● Differences between regulatory requirements between Europe, the UK and US ● Differences in regulatory requirements for CT products and medical devices ● Uncertain regulatory guidance around AI and ML algorithms ● Multiple levels of clearance/review in regulatory agencies ● Lack of capacity from MHRA regulatory, specifically in the medical devices area ● Conservatism or ‘old school’ thought process prevalent among companies and agencies ● Insufficient funding to support a full research project Other barriers ● Lack of information sharing between MHRA and NICE ● Lack of trust between health systems (e.g. NHS) and pharmaceuticals ● Language barriers encountered in contracts which delays the research process ● Potential conflict of interest as an impediment/prevention from collaboration taking place (e.g. inability of third-party independent organisations to accept money from industry) ● Excessive time needed to reach collaborative agreement ● Excessive workload as barrier to CPD and career development ● Cultural differences

Considerations

Barriers

● Strong and cross-sector collaborations (e.g. academia, patient-representative bodies/charities, regulators and industry)

● Early engagement and communication with stakeholders

● Patient and public involvement

● Availability of funding

● Recruitment and availability of appropriate expertise

● Stakeholders’ aligned strategies and common purpose

● Flexibility in considering different stakeholders’ perspectives

● Transparency

● Perspectives of end users well captured and integrated into the research design

● Training available related to the research being conducted

● Adapting to changing regulatory environment

Legal barriers

● Intellectual property (IP) concerns and ownership

● Data sharing, access agreements and confidentiality

● Difficulty agreeing terms for contracts between academia and industry (e.g. data sharing)

Structural barriers

● Differences between regulatory requirements between Europe, the UK and US

● Differences in regulatory requirements for CT products and medical devices

● Uncertain regulatory guidance around AI and ML algorithms

● Multiple levels of clearance/review in regulatory agencies

● Lack of capacity from MHRA regulatory, specifically in the medical devices area

● Conservatism or ‘old school’ thought process prevalent among companies and agencies

● Insufficient funding to support a full research project

Other barriers

● Lack of information sharing between MHRA and NICE

● Lack of trust between health systems (e.g. NHS) and pharmaceuticals

● Language barriers encountered in contracts which delays the research process

● Potential conflict of interest as an impediment/prevention from collaboration taking place (e.g. inability of third-party independent organisations to accept money from industry)

● Excessive time needed to reach collaborative agreement

● Excessive workload as barrier to CPD and career development

● Cultural differences