Supporting SMEs through regulation and compliance
Phil Brown, director of regulatory & compliance, Association of British HealthTech Industries (ABHI), explains the launch of a new scheme designed to help SMEs through the regulatory and compliance processes.
In February, I was delighted to see the commencement of a new £7 million Health Technology Regulatory and Innovation Programme, a joint initiative by ABHI and CPI, funded by Innovate UK, that will support healthtech SMEs to navigate new regulatory processes.
Companies have until 12:00 on 31st May 2022 to apply for grants, and the programme will operate a rolling call, allowing for weekly review and distribution of funding. Up to £30,000 is available for each SME to spend with UK, European or global regulatory affairs providers in activities such as global submission support and preparation, technical road mapping, and guidance on regulatory standards.
Support for businesses is, of course, always welcome, but the health technology industry is unique in that it is primarily made up of small and medium sized companies, meaning that funding like this is hugely beneficial to those that may not necessarily have the internal resource to manage complex regulatory requirements.
At ABHI, we have around 320 members, and we are able to offer those companies with regular insights and practical guidance on regulatory change to support their own strategies. But we are very much aware that there are thousands of UK SMEs not within our membership who do not have this level of support. The beauty of this programme, therefore, is that it is open to all, and comes at a time of important change for the sector.
In Europe, the transition to the MDR and IVDR is very much underway, and in the UK, the MHRA is developing new sovereign regulations under what are very tight timelines for the post-Brexit market. This has created something of a perfect storm in terms of capacity within the regulatory system to support innovators with change. When we consider the new requirements for diagnostic companies, for example, whereby many will now need to go through the Conformity Assessment Body process for the first time, that question of capacity is even more acute. There is huge competition to secure technical expertise, so to be able to give SMEs a foothold in this environment, through financial help and understanding, is vital. After all, many of these innovations will one day go on to enhance, and even save, the lives of patients.
This programme, therefore, is built to support companies, both in terms of what milestones they need to reach to be compliant, and the detailed requirements along the way, for example, the data needed to develop a technical file, or clinical studies, and to ensure regulatory programmes include aspects such as post-marketing activities.
To be able to view regulation strategically, and part of a holistic business strategy, rather than a mere check box exercise, is another important ambition of the programme. As it will not only satisfy the immediate technical needs of a business but will future-proof innovations further down the line and will support a wider trend within the industry towards outcomes-based regulation.
From a practical point of view, the programme will provide SMEs, both ABHI members and non-members, with the ability to work with credible consultants and experts, to progress their regulatory strategy. The funding can be applied to several areas, ranging from global registrations, mock audits, and quality work, through to clinical and technical guidance and advice on reimbursement models.
ABHI will be providing a suite of training aids for SMEs to utilise in the form of instructional videos, and we will also be developing a report which details the current ‘health status’ of the regulatory landscape, both in terms of Europe and the UK. This work will also provide a useful exercise for our wider engagements with regulatory stakeholders, and to ensure the needs of SMEs are always considered.
The funding is offered to SMEs developing or supplying products in the medical device and diagnostics area, including in-vitro diagnostics. To apply to this programme, and for more information, companies should visit CPI’s website here.