Key themes from the Summit
1. AI and Automation in R&D
Johnson and Johnson and L&T Technology Services were among the attendees who delivered sessions dedicated to the transformation AI is having on design, testing and compliance in product delivery – whether that be in agentic AI application or using AI to digitise your QMS. These technologies promise faster development cycles and improved quality, but require robust strategies for validation and regulatory acceptance.
2. Cross-Functional Collaboration
It was great to see a focus on cross-functional collaboration at the AMDS. GE Healthcare emphasised the integration of software and hardware teams to deliver next-generation imaging technologies, whilst Fresenius Medical Care demonstrated how multidisciplinary collaboration accelerates patient-focused solutions.
Effective workflow development requires inter-departmental alignment and cross-functional collaboration. Interdisciplinary alignment, between engineering, regulatory, clinical and user experience teams, ensures that every stakeholder is engaged from concept to launch, promoting collaboration, accelerating development and minimising costs.
3. Digital Engineering and Simulation
Digital engineering and the use of simulation tools and in-silico models are becoming increasingly accessible and widespread, and play an essential role in many engineering disciplines. Generating innovative concepts using these tools can accelerate innovation by allowing engineers to model concepts, understand the constraints in each simulation and de-risk the development, prior to creating prototypes.
The role of computational modelling and in-silico trials in reducing reliance on physical prototypes was a focal point of Ansys’ workshop, in which they heralded this approach in cutting time-to-market while maintaining safety and compliance.
4. Global Regulatory Strategy
There was a definite emphasis on the importance of proactive regulatory planning at the AMDS. This was underscored by Zimmer Biomet’s plenary, “Navigating FDA Regulations and Ensuring Compliance in a Complex Medical Device Landscape”, and Smith & Nephew’s session on EU MDR impacts. Meeting the legal requirements for placing medical devices on the market requires a much broader view of the whole product life-cycle, covering not only the development but manufacture, clinical evaluation and post-market surveillance. It is therefore critical for companies that are aiming to scale globally to actively establish a regulatory strategy to avoid facing delays in their outputs.
5. Patient-Centric Design and Data Integration
Innovation must be intuitive and usable and as such, there is a noticeable shift in companies moving from a product-centric to experience-centric approach. Embedding usability engineering early in your development process is a surefire way to ensure your medical devices and digital health solutions are prepared for clinical evaluations. Integrating Voice of Customer work, formative and summative usability testing, human factors and risk-based design principles into workflows, creates closed-loop feedback allowing iterations to be insight-led, resulting in a better overall product.
Baxter International shared how engineering advancements and customer insights can align technology with real-world clinical needs. They used their case study on the Novum IQ Infusion Platform to demonstrate how competitive advantage can be delivered through improved patient outcomes.