09/16/2024 | News release | Distributed by Public on 09/16/2024 07:01
By Professor Alejandro Frangi, Bicentennial Turing Chair in Computational Medicine at the Royal Academy of Engineering
In Silico Methods drive scientific innovation by leveraging computer simulation instead of biological testing. This innovative technology facilitates discoveries though complex data analysis connecting a wide variety of tools from biology, computing, and mathematics (Translational Bioinformatics in Healthcare and Medicine, 2021).
This article explores how virtual trials can make medical innovations safer, more efficient, and more widely accessible.
As we stand on the brink of a new era in medical technology, the importance of robust scientific evidence to ensure the safety and efficacy of novel medical interventions cannot be overstated. Traditional methods, such as bench testing and animal studies followed by clinical trials, have served us well but often fall short in predicting rare side effects that only emerge after widespread use. Bench testing is limited in reproducing human physiology with accuracy; animal testing raises concerns on animal welfare and may not reliably predict human responses due to biological differences (source); and human clinical trials are regarded as the gold standard but are costly, time-consuming, and ethically complex.
The limitations of traditional methods are widely recorded in academic research, making the potential of In Silico Technologies a groundbreaking approach and a beneficial addition to the development of medical technology globally.
The human and financial implications of late-stage medical device failures can be devastating, and extensive human testing is often impractical, especially for paediatric patients, rare diseases, and hard-to-reach ethnic groups.
Computational Medicine, or In Silico Medicine, leverages the power of engineering, mathematics, and computational sciences to revolutionise our understanding and treatment of human diseases. In silico trials (IST) utilise computer-based trials with populations of digital twins (virtual patients) to simulate and predict clinical outcomes of medical devices. This innovative approach allows for an exhaustive exploration of potential risks and failure modes before any physical trials commence, significantly enhancing patient safety and reducing the time and cost associated with bringing new medical technologies to market.
The consolidation of in silico evidence is set to transform health and life sciences research, development, and regulatory processes. For first mover countries, this presents a unique opportunity to lead the way in health and life sciences, driving economic growth and providing citizens with early access to cutting-edge healthcare products. However, the journey is not without challenges. Regulatory harmonisation, in silico evidence integration in regulatory pathways, and effective cross-sector collaboration are critical hurdles that must be overcome to realise the full potential of in silico trials.
Regulatory bodies in the UK, US and EU are already recognising the value of in silico trials, establishing frameworks to support their integration into the medical device approval process. International harmonisation of regulatory standards is essential to facilitate the global adoption of in silico trials, ensuring that his new form of evidence is recognised and accepted across different jurisdictions while meeting the same or more stringent safety standards than today.
The future of medicine lies in the successful implementation of in silico trials, and this requires a concerted effort from all stakeholders. Cross-sector collaboration and international harmonisation of regulatory science are paramount. By fostering partnerships between academia, industry, regulators, and policymakers, we can ensure that the necessary technical, regulatory, and ethical standards are met. This collaborative approach will pave the way for a new era of medical innovation, ultimately accelerating the delivery of innovative solutions to patients while upholding the highest safety standards
When applied to medical devices testing, In Silico Technologies allow us to:
1. Use advanced computer models early in the development process
2. Simulate device behaviour under various conditions before physical testing
3. Identify and resolve potential issues early, saving time and money
4. Enhance device safety and performance through virtual optimisation
Therefore, In Silico Technologies can use detailed predictive models and virtual patient populations to test medical devices. This approach offers several advantages as it provides a controlled and reproducible testing environment, it more accurately replicates real-world conditions and patient variability, and it generates robust data for regulatory submissions and clinical decisions.
The FD-PASS study (source) illustrated the power of In Silico Trials. The flow diverter performance assessment (FD-PASS) in-silico trial modeled the treatment of intracranial aneurysms in 164 virtual patients with 82 distinct anatomies simulating both normotensive and hypertensive patient phenotypes using a flow-diverting stent. Computational fluid dynamics were employed to quantify post-treatment flow reduction. The predicted FD-PASS flow-diversion success rates mirrored those previously reported in three clinical trials or registries (PUFS, PREMIER and ASPIRE). This in-silico approach enabled a broader investigation of factors associated with insufficient flow reduction than what was feasible in a conventional trial. The findings demonstrated that in-silico trials of endovascular medical devices could replicate the results of traditional clinical trials to a 5% accuracy and perform virtual experiments and subgroup analyses that are challenging or impossible in conventional trials, thereby uncovering new insights into treatment failure, such as in the presence of side branches or hypertension.
Adopting a simulation-first approach enhances traditional methods by addressing potential issues early through virtual testing, reducing patient harm and trial failures, and improving cost-effectiveness and efficiency in device development. This approach also enhances safety and reliability from initial design to post-market monitoring.
As such, In Silico trials represent a significant leap forward in medical device development. By harnessing the power of computational modelling and simulation, we can create safer, more effective medical devices more quickly and at lower cost. This approach promises to revolutionise healthcare, leading to more equitable access to cutting-edge medical technologies and ultimately better outcomes for patients in the UK and worldwide.
As we embrace this digital transformation in medical innovation, we're not just changing how we develop devices - we're paving the way for a new era of personalised, efficient, and safer healthcare for all.
The UK is home to emerging technologies that have the power to revolutionise entire industries. From quantum to semiconductors; from gaming to the New Space Economy, they all have the unique opportunity to help prepare for what comes next.
techUK members lead the development of these technologies. Together we are working with Government and other stakeholders to address tech innovation priorities and build an innovation ecosystem that will benefit people, society, economy and the planet - and unleash the UK as a global leader in tech and innovation.
For more information, or to get in touch, please visit our Innovation Hub and click 'contact us'.
Emerging technologies will be debated and explored at our annual Tech and Innovation Summit, taking place on 6 November. This campaign week will directly feed into the themes discussed at the Summit.
techUK's flagship Tech and Innovation Summit returns to traverse the extraordinary and ground-breaking discoveries made possible by the application of emerging and transformative technologies.
Find out more about how to get involved!
This webinar explored how future advances are set to influence the development and adoption of web3 technologies and artificial intelligence.
This webinar explored how these technologies are expected to intersect and what opportunities this will create for businesses.
#UnleashInnovation - techUK's Technology and Innovation programme is excited to host its innovation campaign week, as part of the Unleashing Innovation campaign, from 13-17 May.
Sign-up to get the latest updates and opportunities from our Technology and Innovation and AI programmes.
techUK's sprint campaigns explore how emerging and transformative technologies are developed, applied and commercialised across the UK's innovation ecosystem.
Activity includes workshops, roundtables, panel discussions, networking sessions, Summits, and flagship reports (setting out recommendations for Government and industry).
Each campaign runs for 4-6 months and features regular collaborations with programmes across techUK.
This campaign explored how the UK can lead on the development, application and commercialisation of space technologies and ultimately realise the benefits of the New Space Economy.
These technologies include AI, quantum, lasers, robotics & automation, advanced propulsion and materials, and semiconductors.
Activity has taken the form of roundtables, panel discussions, networking sessions, Summits, thought leadership pieces, policy recommendations, and a report.
Get in touch below to find out more about techUK's ongoing work in this area.
This webinar explored the space industry of tomorrow and panellists spoke about what steps the UK can take to become a superpower across a broad spectrum of emerging and transformative space technologies.
This event explored how the UK can improve access to growth capital for space SMEs looking to scale.
Click here to view the event recording, speaker slides, and written summary.
This sets out the key technologies, industries, enablers and actions that will make future UK leadership in space a reality.
Hear from Agri-TechE about how space technologies are supercharging innovation in agriculture.
In our first video interview of the series, learn about Reaction Engines and how they're leading on innovation.
Published in advance of techUK's Supercharging Investment in Space event.
The changes are a welcome boost for UK companies seeking a space license.
A guest insight published in advance of our "Lessons from Yorkshire" space clusters webinar on 5th December.
Learn about how the CAA is at the forefront of driving UK innovation through space regulation.
Senior Programme Manager, Emerging Technologies
Senior Programme Manager, Emerging Technologies
Rory joined techUK in June 2023 after three years in the Civil Service on its Fast Stream leadership development programme.
During this time, Rory worked on the Government's response to Covid-19 (NHS Test & Trace), school funding strategy (Department for Education) and international climate and nature policy (Cabinet Office). He also tackled the social care crisis whilst on secondment to techUK's Health and Social Care programme in 2022.
Before this, Rory worked in the House of Commons and House of Lords alongside completing degrees in Political Economy and Global Politics.
Today, Rory leads techUK's emerging technologies activity across everything from immersive, web3, AI and robotics to space, gaming & metaverse.
This involves co-running techUK's flagship Innovation campaign, managing four series (including the 'Meet the Innovators' interview series), and launching 4-6-month 'sprint campaigns' on transformative technologies and sectors.
Email:[email protected]LinkedIn:https://www.linkedin.com/in/rorydaniels28/This campaign has explored how the UK can lead on the development, application and commercialisation of the technologies set to underpin the Gaming & Esports sector of the future.
These include AI, augmented / virtual / mixed / extended reality, haptics, cloud & edge computing, semiconductors, and advanced connectivity (5/6G).
Activity has taken the form of roundtables, panel discussions, networking sessions, Summits, and thought leadership pieces. A report featuring member case studies and policy recommendations is currently being produced (to be launched in September 2024).
Get in touch below to find out more about contributing to or collaborating on this campaign.
This webinar explored the gaming industry of tomorrow and asked what steps businesses can take to lead in the development, commercialisation, application and adoption of the key emerging technologies that will underpin it.
On January 31 techUK was delighted to collaborate with Shoosmiths on this web 3.0 and metaverse event.
Click here to view the event recording.
This webinar explored the key technologies behind the future of Esports in the UK and asked what more the UK can do to lead on their development and application.
What's round the corner at intersection between emerging tech, gaming and regulation?
Contribute a case study for techUK's first Gaming and Esports report by 25 July.
Find out how Sharkmob are promoting a healthy UK innovation ecosystem.
Read Shoosmiths' key reflections from techUK's Exploring the future of Esports webinar.
Senior Programme Manager, Emerging Technologies
Senior Programme Manager, Emerging Technologies
Rory joined techUK in June 2023 after three years in the Civil Service on its Fast Stream leadership development programme.
During this time, Rory worked on the Government's response to Covid-19 (NHS Test & Trace), school funding strategy (Department for Education) and international climate and nature policy (Cabinet Office). He also tackled the social care crisis whilst on secondment to techUK's Health and Social Care programme in 2022.
Before this, Rory worked in the House of Commons and House of Lords alongside completing degrees in Political Economy and Global Politics.
Today, Rory leads techUK's emerging technologies activity across everything from immersive, web3, AI and robotics to space, gaming & metaverse.
This involves co-running techUK's flagship Innovation campaign, managing four series (including the 'Meet the Innovators' interview series), and launching 4-6-month 'sprint campaigns' on transformative technologies and sectors.
Email:[email protected]LinkedIn:https://www.linkedin.com/in/rorydaniels28/Running from July to December 2024, this campaign will explore how the UK can lead on the development, application and commercialisation of web3 and immersive technologies.
These include blockchain, smart contracts, digital assets, augmented / virtual / mixed / extended reality, spatial computing, haptics and holograms.
Activity will take the form of roundtables, workshops, panel discussions, networking sessions, tech demos, Summits, thought leadership pieces, policy recommendations, and reports.
Get in touch below to find out more about contributing to or collaborating on this campaign.
Find out more about how to get involved!
This webinar explored how future advances are set to influence the development and adoption of web3 technologies and artificial intelligence.
This webinar explored how these technologies are expected to intersect and what opportunities this will create for businesses.
This webinar explored how key emerging technologies will shape the future military operating environment.
Click here to view the event recording.
On January 31 techUK was delighted to collaborate with Shoosmiths on this web 3.0 and metaverse event.
Senior Programme Manager, Emerging Technologies
Senior Programme Manager, Emerging Technologies
Rory joined techUK in June 2023 after three years in the Civil Service on its Fast Stream leadership development programme.
During this time, Rory worked on the Government's response to Covid-19 (NHS Test & Trace), school funding strategy (Department for Education) and international climate and nature policy (Cabinet Office). He also tackled the social care crisis whilst on secondment to techUK's Health and Social Care programme in 2022.
Before this, Rory worked in the House of Commons and House of Lords alongside completing degrees in Political Economy and Global Politics.
Today, Rory leads techUK's emerging technologies activity across everything from immersive, web3, AI and robotics to space, gaming & metaverse.
This involves co-running techUK's flagship Innovation campaign, managing four series (including the 'Meet the Innovators' interview series), and launching 4-6-month 'sprint campaigns' on transformative technologies and sectors.
Email:[email protected]LinkedIn:https://www.linkedin.com/in/rorydaniels28/Our annual Campaign Weeks enable techUK members to explore how the UK can lead on the development and application of emerging and transformative technologies.
Members do this by contributing blogs or vlogs, speaking at events, and highlighting examples of best practice within the UK's tech sector.
#UnleashInnovation - techUK's Technology and Innovation programme is excited to host its innovation campaign week, as part of the Unleashing Innovation campaign, from 13-17 May.
#SuperchargeUKTech - techUK's Technology and Innovation programme is excited to have hosted its innovation campaign week, as part of the Supercharging Innovation campaign, between 18-22 September.