Developing medical devices with TRUMPF
Want to develop a medical device and need a strong partner at your side? We will be happy to review your requirements, develop suitable production concepts and optimise your production process.
Developing medical devices: what are the challenges?
The safety of patients is the top priority in medicine. For this reason, manufacturers of medical devices meet high quality requirements and regulatory specifications. In terms of production conditions and legal regulations, manufactures therefore face enormous challenges: in addition to suitable procedures for system specification, appropriate risk management is also required, among other things, to ensure that standards are met and medical devices are certified and approved. This requires in-depth expertise. Therefore, as a manufacturer, you need an experienced partner at your side to assist you in the development, production and approval of your product.
With different materials in production, it is also necessary to observe different geometric tolerances. It is then often necessary to reposition and fix the device in the production process.
It is now necessary to reduce manual processes in manufacturing - not only to improve efficiency and quality, but also to address the shortage of skilled workers.
As a manufacturer of medical technology, you must comply with, document and monitor regulatory requirements and standards. This also includes, for example, that your devices and components are traceable and your production systems are qualified according to FDA, DIN EN ISO 13485 or EU MDR.
Since the product life cycle of medical devices is long, production systems need to be scalable. In addition, the machines must perform reliably for many years with minimal downtime and low maintenance requirements.
Solution: how can TRUMPF support you in every phase of the product life cycle?
In this phase, you can let us know about the requirements of your product idea or device design - especially with regard to material, geometry as well as tolerances. We will then check the feasibility. To do this, we conduct application experiments, test different technology variants and run various test samples.
During subsequent consulting sessions, our technical experts will work with your team to find suitable development solutions. In this process, we also incorporate our knowledge from other industries in order to optimally benefit from possible points of synergy. When deciding on a particular development process, we then look at the advantages and disadvantages of the various technologies and finally develop a concept for the processes, the design and the required laser specifications.
In the development phase of medical products, we test and implement specific production concepts. In doing so, we primarily focus on the tolerances of the workpieces in terms of geometry and material surface, but also analyse possible risks.
At TRUMPF, we place particular emphasis on the development of robust processes in this step. This includes the reliability of production systems, active process and condition control and the monitoring of parameters. During the design process, we also ensure that it is suitable for manufacturing your medical devices. We also address the question of whether other accessory devices or auxiliary equipment are needed. Our technical knowledge from projects in other industries often comes in handy.
For the overarching strategy in medical device manufacturing, all factors - scalability, profitability, long-term availability of beam sources and components and the possible configurations of the systems - are equally important. It also comes down to the highest quality and minimal risk throughout the development process so that your products can ultimately look after the health and safety of people.
At this stage of the product life cycle, you as a medical device manufacturer need to define a risk class. You will also ensure compliance with legal requirements and regulatory standards for medical devices.
TRUMPF will support your company with our comprehensive expertise on the current EU directives and regulations. In addition, we help you to qualify your equipment and to test and verify your processes by providing documentation in accordance with the standards (FDA, EUDAMED systems). We also train your staff during this phase.
The series production of medical devices must ensure consistent results. For this purpose, integrated process control measures are applied. Process flow is given top priority and becomes the essential reference point for order management, data and resource management, and maintenance and repair. In networked production, it is also important to look at data interfaces (such as OPC-UA) and export functions.
In order to be able to monitor, service and maintain your systems independently, your employees should be adequately trained. Service agreements can provide a suitable framework for this.
If you want to integrate new medical devices in series production, TRUMPF can develop the specifications suitable for this together with you in the lab. We can also program the geometries of the new components if required. We will of course also support you in the subsequent validation, for example when you want to use new materials.
In the run-down phase of a medical device, you should think about how you can continue to use the production systems and technologies in your company in a meaningful way - possibly also for the production of other medical devices.
TRUMPF can check potential areas of use for you in the laboratory and advises you on all aspects of further use or product return. We offer comprehensive services for the phase-out phase: we clean up your software, overhaul the system, integrate new products or relocate the laser system to a new site. Of course, we also take care of the transport and requalification for you.
