A sensor alone does not make an implant “smart.” It is the interplay of mechanics, electronics, software, power supply, materials, and risk management that results in a product that functions reliably inside the body.
An interview by Bayern Innovativ with Dr. Harald Unterweger on smart implants, microsensors, and bioresorbable materials has raised a number of development questions for us—questions that inevitably come up at some point in every medical device project. Smart implants are often described in grand terms: autonomous systems, intelligent therapies, artificial intelligence, and continuous data streams from the body. We currently see their concrete benefits in a more down-to-earth context, namely in monitoring and decision support.
An implant can measure stress, provide insights into the healing process, or reveal changes that are difficult to assess from the outside. This gives doctors a better basis for making decisions. For patients, a reliable measurement reduces uncertainty.
A sensor alone does not make a smart implant
From our perspective, an implant does not become “smart” simply by having a sensor built into it somewhere. The sensor is only one part of a larger system. Mechanics, electronics, software, power supply, materials, housing, sterility, biocompatibility, and risk management must all work together.
At first glance, a pressure sensor on an osteosynthetic implant seems manageable. However, the development process reveals just how many interdependencies are involved.
The measured value must be recorded. The reference must be accurate. The calibration must be appropriate for the application. The signal must remain readable over time. At the same time, the sensor technology must not compromise the implant’s actual function.
Inside the body, factors such as moisture, tissue, temperature, movement, forces, and time all come into play. These conditions make sensor technology in implants particularly challenging. Drift, noise, assembly-related factors, and temperature behavior also play a role.
A system that performs well on a test bench must also function under real-world conditions. Good development therefore begins early with many questions:
Which measured variable is truly relevant?
How is energy transmitted?
What data leaves the system?
How is a malfunction detected?
What assumptions underpin the evaluation?
What evidence does the product need before the next step makes sense?
Decisions That Must Be Made Early in the Development Process
With bioresorbable materials, this approach becomes even more important. An implant fulfills its purpose and then degrades in a controlled manner. For patients, this can eliminate the need for a second procedure. In terms of development, this creates a close interplay between material, geometry, surface, degradation rate, and mechanical safety. A material that degrades changes its behavior. Its strength decreases over time. The load must be appropriate for the healing process. A screw in a high-stress bone area poses different challenges than a temporary implant subjected to lower mechanical stress.
AI-driven optimization and additive manufacturing help evaluate variants more quickly, create geometries, and highlight conflicting objectives. Nevertheless, the team remains responsible for development. An algorithm can provide suggestions, but the medical device requires traceable requirements, professional testing, and documented decisions.
In practice, it’s not the best-looking idea on the screen that counts.
Another point raised in the interview is energy supply. For sensor-only systems, passive approaches can be useful—for example, when energy is supplied from an external source. As soon as actuators, pumps, or active therapy come into play, energy requirements increase significantly. Energy harvesting from motion, temperature, or biochemical gradients is particularly useful for smaller energy needs.
From our experience with wearable and mobile systems, we know how early this issue needs to be addressed in the system architecture. Runtime, aging, heat, form factor, and security are difficult to correct later on.
The issue of data is just as sensitive. When measurement values are transmitted from the body, we’re talking about health data. A direct cloud connection may seem technically convenient, but it requires clear answers regarding access, security, responsibility, and failure behavior. An external interface is always a risk factor in a medical device.
Our assessment?
Smart implants are the result of a combination of factors: the right measurement parameter, a robust design, a suitable power supply, intuitive software logic, durable materials, and thorough documentation.
Wir übernehmen nicht jeden Trend in den Entwicklungsalltag. Wir prüfen, was technisch sinnvoll ist, was regulatorisch tragfähig wird und wo ein Kunde früh Klarheit braucht.
Wenn dieses Thema aktuell in Ihrem Projekt auf dem Tisch liegt, sprechen wir gerne darüber.
