Digital collaboration can help manufacturers resolve tension between innovation and regulation

Collaboration is key

Enigma was one of the earliest validations of computer science, the very start of the digital revolution that has accelerated into the 21st century and that we continue to experience at speed. It was also a case study in effective collaboration, with the government, military and academia combining to create a spectacularly successful invention to address a truly acute necessity.

Which brings us to the present day. In recent months, we’ve seen another powerful portrayal of Plato’s proverb, plus the benefits of co-operation, this time in the form of digital collaboration to co-create vaccines to combat the urgent threat of COVID-19. The UK’s most-used Oxford AstraZeneca jab, for instance, stemmed from the critical combination of government foresight and funding, vaccine research expertise at Oxford University, and the manufacturing capabilities of the Anglo-Swedish pharmaceutical giant.

Rapid regulation

We shouldn’t forget one other key player – the vaccine industry’s regulator. The Medicines and Healthcare products Regulatory Agency (MHRA) has been responsible for approving all the vaccines now licensed for use in the UK. Crucially, it has worked fast, through a regulatory process known as ‘rolling review’, which can be used to complete the assessment of a promising medicine or vaccine during a public health emergency.

Rolling review allowed MHRA scientists and clinicians to carry out rigorous, scientific and detailed scrutiny of all the available vaccine data on a staggered basis, as it became available from ongoing studies. The MHRA team reviewed data on issues such as efficacy and safety from pre-clinical laboratory studies, clinical trials, manufacturing and quality controls, product sampling and final vaccine testing, and also considered the conditions for safe supply and distribution. Part of the MHRA, The National Institute for Biological Standards and Control, conducts ongoing independent laboratory testing so that every batch of vaccine meets the required standards of safety and quality.

This type of rapid regulatory approval process highlights the vital role of digital collaboration, and the huge benefits to be gained from real-time, through-life data sharing – in this case, ultimately saving of thousands of lives.

Innovation versus regulation

Historically, regulation has rarely sat so comfortably alongside innovation. While most manufacturers rightly respect their industry regulators for the vital functions they perform – not least, squeezing out ‘cowboy’ competitors and sub-standard products – they also tend to regard them as a drag on innovation.

That’s because regulators limit manufacturers to doing only what they have approved. By definition, regulators favour narrow, restricted or ‘regulated’ behaviours and products. As a result, while these will invariably be trusted because they have been tried and tested, they also tend to evolve slowly. The regulators’ goal has been to keep things safe, often by keeping them the same.

Conversely, by definition, innovation means finding new ways to operate or solve problems, often by moving first and acting fast. Innovations won’t have been extensively tried, tested and approved. It adds up to an inevitable tension with regulation.

Resolving tension

As the MHRA’s regulatory approval of new vaccines so graphically demonstrates, a major step towards resolving this tension lies in digital collaboration between manufacturers and regulators.

The same goes for vaccine distribution. New vaccines have placed a host of fresh demands on distributors and healthcare systems, such as handling fragile vaccines carefully, storing them at the right temperatures, diluting them correctly, and administering them quickly. To address so many challenges, manufacturers need flexible distribution arrangements. Traditionally, they have faced regulatory hurdles, such as only being able to use existing distribution partners that have been tried, tested, audited and approved. Now, through digital collaboration – the sharing of real-time data to demonstrate safe, high quality distribution – manufacturers can be freed to react effectively to the needs of the marketplace.

The next steps

If, as a manufacturer, you could benefit from reinventing your relationship with your industry regulator, BSI can help you with the trust-building tools you’ll need. These range from audit or certification to good distribution practice (GDP), to standards like ISO 44001 for Collaborative Business Relationships and ISO 56002 for Innovation Management. Or you may need sector-specific certification, such as the Kitemark for IoT for makers of electronic devices and applications, and the Kitemark for BIM Objects for manufacturers of construction products.

Above all, we can act as an independent facilitator, with in-depth pan-industry expertise to lead debate and offer guidance, while remaining free from the shackles of specific technologies and solution providers.

The potential exists for digital collaboration to spread throughout manufacturing industry, reinventing the relationship between manufacturers and regulators by enabling real-time, through-life data sharing and rapid regulatory approval of everything from revised product specifications and production volumes to new suppliers and distributors. Now is the time to transform that potential into reality.

Necessity may be the mother of invention, but digital collaboration is the latest addition to the family.