The Key to Safe and Reliable Medical Devices

This is the transcript of an online event from October 2024. You can watch the full recording here.

Regulatory Landscape in Medical Device Manufacturing

Before diving into specific applications, let’s discuss the regulatory framework that medical device manufacturers must adhere to. Key regulations include ISO 13485, FDA’s 21 CFR part 820, and the European Medical Device Regulation (MDR). These standards aim to ensure the safety and quality of medical devices, making compliance a critical aspect for manufacturers. There is another blog article explaining the differences between these regulations.

Bruker Alicona’s role is to provide metrology solutions that help companies prove their compliance with these regulations. This involves designing systems that navigate the complexities of these standards and ensure traceability and quality.

The Rigorous MDR Standards

The MDR is the most stringent regulations, requiring extensive data and clinical evidence to ensure the safety and efficacy of medical devices. The Medical Device Regulation demands more data than the ISO standards, making it a tough framework for manufacturers.

Success Story: How does Zfx meet the MDR standards with the µCMM of Bruker Alicona

The Italian-based dental production company Zfx uses Bruker Alicona’s µCMM (micro-coordinate measuring machine) to meet these rigorous standards. Zfx, part of the global life science company ZimVie, specializes in dental prosthetics. They use the µCMM for comprehensive quality control, measuring components with specifications as tight as ±2 micrometers. The µCMM, equipped with a pick-and-place automation setup, operates 24/7, ensuring continuous compliance with MDR standards.

Lukas Breitenberger, CEO of Zfx, shares insights into their quality assurance processes. They distinguish between prototype releases and daily input checks, using the µCMM to measure form tolerances, position tolerances, and dimensional checks. The high automation capabilities of the µCMM allow Zfx to run measurements overnight and on weekends, optimizing their workflow and ensuring high-quality standards. Watch the full success story of the Zfx quality assurance in this video or read the case study.

Zfx quality assurance dental prosthesis measurement crown abutment fixure — Werner Weithaler, Sr. Engineering Manager & Lukas Breitenberger, CEO of Zfx

For perfectly white teeth: the implant is more than just the crown

There are several parts to be measured in dental prosthesis production, but the most critical ones are the abutment and the fixture. The abutment, which holds the crown in place, requires precise measurements to ensure a tight fit. In the recording you see how the µCMM is used to measure the critical contact surfaces of the abutment, ensuring angles, distances, and parallelism parameters are met.

The fixture, which is implanted into the jawbone, also requires precise measurements, particularly for surface roughness. The µCMM’s high-resolution 3D data sets allow for accurate evaluation of these parameters, ensuring good osseointegration and biocompatibility.

quality assurance for dental prosthesis — Abutment of a tooth implant

quality assurance for fixtures - measurement of geometry roughness — Fixture of a tooth implant

Navigating the Precision Challenges of Knee Implant Measurements

Knee implants consist of three main components: the femoral component, the polyethylene insert, and the tibial component. Each component presents unique measurement challenges. Let's focus on the tibial and the polyethylene component.

Tibial Component

The tibial component in a knee implant is a critical part that fits into the lower bone (tibia) and provides a stable base for the polyethylene insert and femoral component, ensuring proper alignment and load distribution in the knee joint. This part features various parameters, including roughness on the contact surface and polished areas that are optically challenging to measure. The µCMM is used to create high-resolution data sets for evaluating these parameters, ensuring the component’s longevity and performance.

Polyethylene Insert

The polyethylene insert, which bears the load of the body, requires precise surface measurements to prevent wear. The FocusX, equipped with One Click Roughness, quickly measures the surface parameters, providing instant results.

measurement of the poyethylene insert of a knee implant

Tackling the Complexities of Bone Screw Measurements

Bone screws, used in orthopedic surgeries, present a significant measurement challenge due to their complex helical surfaces. The InfiniteFocus G6, with its Advanced Focus-Variation Sensor, creates high-density 3D data of these screws. This allows for accurate evaluation of parameters such as pitch, angles, and distances, ensuring the screws meet the quality standards required.

Not quite the Screwdriver you need for your IKEA Nightstand: Surgical Tools Ensuring Precision and Safety

Screwdrivers used in orthopedic surgeries are another important application in medical technology. These tools must fit perfectly with bone screws to prevent slipping and potential injury during surgery. Imagine a scenario where a surgeon is screwing a bone screw or a plate onto a bone; the last thing you want is for the tool to slip and cause damage to surrounding tissues. This makes the precision of these tools absolutely critical.

During the measurement process, the screwdriver is placed onto the InfiniteFocus G6, and a Real3D measurement is set up. This involves creating a high-resolution dataset that can be evaluated in the MetMaX software. The software allows for detailed analysis of the tool’s geometry, ensuring that all critical functional parameters are met. This meticulous process ensures that the screwdrivers meet the necessary precision and safety standards, preventing any potential mishaps during surgery.

For more information on Bruker Alicona’s medical applications, visit their dedicated medical technology page. If you have specific measurement challenges or need further assistance, don’t hesitate to get in touch with our team.