Professor Laurie Rowe, founder and director of Red Medtech, analyses the digital revolution in quality management and emerging technologies, and how it is redefining medical devices.
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As the medical device industry continues to evolve, we are witnessing a growing trend towards the adoption of digital solutions. From wearable devices to software applications and monitoring devices, and the advancing adoption of Artificial Intelligence innovations, this exciting and investable technology space is revolutionising the healthcare industry.
Digital solutions transforming quality management
One area where we are seeing an increasing demand for digital solutions is in Quality Management Systems (QMS). The US Food and Drug Administration (FDA) has announced its intention to align its quality system regulations with ISO 13485, recognising the global convergence of medical device regulatory authority expectations. Some of the country-specific systems in place have not changed over a number of years, if not decades, so it’s refreshing to see the FDA promote the harmonisation of international practices and process – especially for design and development. The adoption of eQMS platforms is helping medical device companies streamline their quality management processes, improve operational efficiencies, and meet regulatory requirements. We are seeing a huge increase in demand for eQMS solutions and it’s not surprising when you consider the efficiency gains that can be had – allowing your product engineering team to focus on creating innovative technical solutions and robust compliance content over paper-shuffling.
The role of automation in efficiency
Automation has long played a significant role in manufacturing and the continued evolution of smart software tools is further streamlining the product design and development process for medical devices. From rapid concept CAD sketching and complex test simulations including augmented reality to packaging labelling generation, automation is helping to reduce errors, increase efficiency, and ensure compliance. The developments in computer modelling are fantastic – not only are you able to generate and communicate ideas quicker than ever before, but the ability to easily share 3D models with non-engineers that they can explore virtually (rotate, zoom in, and view components in detail) means that end users feedback and iterative changes can be implemented much more efficiently. It is possible to create truly immersive experiences, which are a great boost for user-centric product design and the CGI level of renderings we are seeing nowadays is out of this world.
AI's impact on medical devices
We are also witnessing the adoption of AI and digital touchpoints within it to create highly innovative medical devices. AI is being used in the development of healthcare products by enabling advanced data analysis, predictive modelling, and automation. For example, it can help by analysing large volumes of information including medical data or biomarkers, identifying trends, and making accurate predictions for treatment planning and patient monitoring. In engineering design, we can use it to run complex simulations to explore the feasibility or robustness of alternative solutions and replicate physical testing. There is a magical combination of concurrent developments in the UK healthcare sector with industry and Universities working alongside collaborators under the NHS Transformation Directorate, and it makes for a really innovative space – supporting both research and practical interventions. AI is transforming the customer experience and revolutionising the healthcare industry. However, developing and regulating intelligent healthcare technologies also present their own set of challenges that need to be addressed and managed.
Ethical AI and collaboration
Collaboration and data sharing are crucial in ensuring that AI is used ethically, safely, and responsibly in industries that impact human lives. Citadel AI and the British Standards Institution (BSI) have partnered to ensure that AI used in healthcare becomes more reliable, transparent, and responsible. Through Citadel AI’s tools, BSI can measure AI compliance against technical standards, supported by in-depth technical analysis including fairness testing, bias detection, and robustness testing. From our direct experience of our Red Network, we are seeing that partnerships and collaborations are key in delivering successful projects – and it is great to see issues such as bias which could adversely impact usability and safety of products, is high on the agenda for these initiatives.
The future of AI in medical devices
AI is here to stay in medical devices, and its growing role in healthcare has significant implications for the future of medical device development. At Red Medtech, we help spin-outs, start-ups and established organisations on their development for compliance journey with expert and experienced consulting. Whether it's implementing a complete QMS for ISO 13485 certification, supporting design and development projects as part of evolving device designs with DHF documentation and practical guidance, or remediating Technical Files for compliance with changing regulations – we are here for you. At Red Medtech we are helping people, help people.
Frequently Asked Questions
What are some examples of medical devices incorporating AI?
Examples include robotic surgery systems, diagnostic imaging systems, wearable health monitors, and electronic health record systems.
This is an exciting space, when you consider the iterative nature of big data collection, analysis and application for new technologies. There are tangible benefits for patients and the healthcare industry – a massive potential in using medical engineering for good.
What is the difference between AI and automation?
Automation has the power of AI at its fingertips and mostly utilises conventional software to transfer data from one location to another. The big difference between AI and automation is that AI strives to mimic human thinking, while automation is all about working with data. In other words, AI "comprehends" data, while automation simply works with it.
AI and Machine Learning - are they the same things?
Artificial intelligence involves creating a machine that can replicate and imitate human intelligence, but Machine Learning goes further with a unique objective. Machine Learning is focused on teaching a machine – training it to master specific tasks and deliver precise outcomes by recognising and uncovering patterns.
How does AI improve the accuracy and efficiency of medical devices?
Medical devices incorporating AI can significantly improve the accuracy and efficiency of medical diagnosis and treatment. AI algorithms can analyse vast amounts of patient data, including medical imaging, lab results, and patient history, to identify patterns and make predictions that can aid in diagnosis and treatment planning.
For example, AI-powered medical imaging devices can analyse images in real-time, detecting anomalies and providing insights to physicians that may not have been visible to the human eye. This can help in early detection of diseases such as cancer and improve treatment outcomes.
AI can also help medical devices become more efficient by reducing the time and resources required for diagnosis and treatment. For instance, AI algorithms can analyse patient data and recommend personalised treatment plans, reducing the need for trial-and-error approaches.
It is clear that AI and digital solutions can revolutionise the healthcare industry by improving the accuracy of medical devices, leading to better help for patients. Well managed and regulated AI in medtech presents great opportunities – for example in complex areas such as rare diseases and conditions with multiple pathologies, as well as those with large patient populations.
What are the benefits of using AI in medical devices?
Medical devices incorporating AI offer several benefits, including:
- Improved accuracy: AI algorithms can analyse vast amounts of data and identify patterns that may be difficult for humans to detect. This can lead to more accurate diagnoses and treatment plans.
- Enhanced efficiency: AI can automate many tasks that were previously performed manually, such as analysing medical images or monitoring patients. This can save time and reduce the workload of healthcare professionals.
- Personalised medicine: AI can analyse patient data to identify individual risk factors and tailor treatment plans accordingly. This can lead to more effective treatments and better patient outcomes.
- Reduced costs: By improving efficiency and accuracy, AI can help reduce the cost of healthcare, making it more accessible to more people.
- Predictive analytics: AI algorithms can analyse patient data to predict potential health issues before they occur. This can allow healthcare professionals to intervene early and prevent more serious health problems.
Overall, the use of AI in medical devices has the potential to improve patient outcomes, reduce healthcare costs, and enhance the efficiency of healthcare delivery.
