1. Miniaturisation isn’t always necessary
While miniaturisation is often a key goal, the workshop highlighted that smaller isn’t always better. In some implant categories, current sizes are sufficient, and further miniaturisation may offer diminishing returns. Instead, development efforts may be better directed toward improving mechanical or chemical stability and biocompatibility. Examples include orthopaedic implants or subcutaneous drug delivery systems, where space constraints are less of a concern.
2. Batteries remain a critical bottleneck
There is a continued need for better batteries in active implants, with two main challenges identified: battery capacity and charging time. These limitations are particularly impactful in implantable devices due to the burden they place on both patients and surgeons, whether through frequent recharging or the need for surgical replacement. While battery capacity can be partially mitigated by using larger or novel solid-state batteries, reducing charging time will require more radical technological development.
3. Materials innovation is driving the future
Advances in materials science are opening new frontiers for implant development, especially in neurotechnology. A notable example is InBrain Neuroelectronics, which is pioneering the use of reduced graphene oxide flakes as electrode material for brain interfaces. While regulatory hurdles remain significant, the potential performance gains are compelling: dramatically improved charge injection capacity, enhanced chemical and mechanical stability and reduced foreign body response, supporting long-term implantation.
4. Quality management starts early
A consistent takeaway was the importance of implementing a quality management system (QMS) early, especially for startups aiming for regulatory approval. Key practices include maintaining clear documentation of processes, ensuring traceability and establishing operating procedures aligned with regulatory expectations.
Interestingly, panellists noted that the FDA approval process is currently perceived as more navigable than Medical Device Regulation (MDR) and CE marking. The FDA’s structured and collaborative approach often makes it a preferred first step, even for European companies.
5. The end-user is key
Finally - although this should come as no surprise - there was broad agreement that successful medical device development starts and ends with the user. Too often, start-ups and academic spin-offs chase breakthrough technologies without fully considering real clinical needs. Addressing unmet clinical needs should be the guiding principle throughout R&D. This means prioritising surgeons (as key decision-makers) and patients (as end-users and beneficiaries). Their needs, experiences, and preferences ultimately shape product adoption and commercial outcomes..
In conclusion
The AIMD workshop provided a valuable platform to exchange ideas and stay aligned with where the field is heading. TTP is excited to continue to contribute to the evolving landscape of implantable medical technologies.
If you’d like to discuss how TTP can help bring your device to market, contact us.
About TTP's Neurotechnology device development team
From proof-of-concept studies to manufacturing scale-up, TTP's dedicated neurotechnology consulting services can help you rapidly engineer advanced neuromodulation solutions, guiding you every step of the way. With our multidisciplinary team of engineers, scientists and human factors designers, you can hit the ground running. Combining deep expertise with a proven track record in end-to-end product development, we will help you create technologies and devices that push the limits of what's possible in neurotechnology. Find out how our neurotechnology product development team can help you start strong and finish ahead.
TTP's Neurotechnology team is part of TTP's MedTech team. Learn more about TTP's approach to medical device design and development and our medical device consulting services.
