Richard Coxon, director, life sciences, Dassault Systèmes, examines the potential ramifications of the UK’s Medicines and Medical Devices bill.
Early in September 2020, the Medicines and Medical Devices bill entered its second reading in the House of Lords. The bill addresses safety, the pace of innovation and the regulation of medical devices and medicines for the future in post-Brexit UK. These laws will govern the UK life sciences sector and establish a framework for innovation and early adoption of new therapeutics, attracting new investment and global interest in the UK while retaining the focus on safety and striving for excellent, patient centric health outcomes.
A new hope?
Once the formality of the new bill has completed, the UK life sciences sector has the opportunity to take advantage of the benefits that technology promises; and leap forward with virtual technology instead of doing everything in the real world. There is rising pressure from patients, the healthcare industry and policy makers for personalised healthcare with the patient at the centre. There is a strong need to lower the cost of medicines, have faster access and approval of new therapeutics, while at the same time reducing waste production and energy usage and of course ensuring safety first by complying with stringent regulations.
The technology landscape in life sciences is generally slower to change than in other sectors, this is in part because of the burden of this stringent regulatory compliance. However, with health technology innovating at pace and a fresh focus on the UK regulatory compliance framework, are we seeing the start of a change to embrace this innovation and technology and welcome a sea change in life sciences?
Shifting from the real to the virtual world
Take a look at other regulated industries and the impact of digital transformation over recent decades. For example, the aerospace sector has undergone a huge period of digital transformation, going from time consuming and high cost physical prototyping to full product development in the virtual world. The time and cost savings are enormous, and safety is maintained, despite the increasing complexity of aircrafts. Not to mention the reduction in waste and energy.
Imagine a life sciences sector where most of the development (clinical trials) is performed in the virtual world? Using virtual patients? With a wealth of technology at our fingertips, including advanced simulation, 3D design and virtual twin experience technology, the life sciences sector is in a place to overhaul how we think about therapeutic product development, and welcome in personalised medicine and devices.
Technology such as computational modelling and simulation, could enable the use of virtual models to benchmark the performance of a medical device, evaluate how each part interacts and performs and how the overall device is predicted to respond in real world circumstances. Such advances in virtual twin technologies have already reached the patient, we can experience true to life virtual models of the human heart, brain and more to help model medical device performance.
Information from these virtual models can help the entire manufacturing chain assess how to design, create and deliver the device so that it can provide the best performance at the lowest possible cost to the right patient. The regulatory bodies, such as the FDA, are already exploring this new virtual “clinical” evidence of the safety and benefits of medical devices.
As we increase our focus on implementing this virtual experience technology into life sciences, it will vastly accelerate all product development time, significantly reduce costs, and impact the real world by helping people lead healthier lives and ultimately save lives.
Breaking down the silos
When you take a holistic look at the sector, there are many key stakeholders involved to create a therapeutic product. From policymakers, to researchers, doctors and patients, they all play a vital role in the improvements and the health of patients, but unfortunately they often work in silos.
Product Lifecycle Management (PLM) can help to bridge gaps between the silos and help increase collaboration. PLM brings together research, development, testing, therapeutic delivery, commercials and reimbursement, and all other vital elements into a single digital environment. A joined-up flow of processes, communications and data will undoubtedly reduce time to market and the cost of development.
A well-implemented PLM solution also allows an organisation to streamline its decision-making, using past knowledge and know-how, together with a means to manage product innovation and quickly evaluate options to design, manufacture and supply the therapeutic product. This is also key in helping to manage globally distributed and geographically separated teams – something we need more than ever in the current COVID-19 climate.
Enhancing the patient experience
COVID-19 has also brought to light the power and speed possible through innovation. From the NHS Nightingale hospitals that took mere weeks to build, to having potential vaccines in development for the virus in a matter of months, we have proven we have the capabilities to transform better patient outcomes given sufficient urgency.
The recent bill highlighted that “availability and attractiveness are the twin pillars of the government’s strategy on medicines and medical devices, and the key themes of this Bill.” This means the UK wants to make new treatments available as early as possible to UK citizens, and for the UK to be the most attractive place for new treatments to be tested, rolled out and adopted. Getting this right will enable the UK to become a global centre of life sciences investment, thereby enabling the UK to lead the industry by adopting virtual and simulation technology to innovate the human experience, governed by a flexible and fully safe regulatory framework.
This innovation and virtualisation of therapeutic development will help deliver personalised medicine and medical devices, and achieve a more patient centric healthcare system; one that is focussed on accelerating better health outcomes and longer lives for every UK citizen.
