That’s Quality

The dimensions of medicalgrade, biocompatible plastics and polymers are critical for ensuring medical device functionality, quality and compliance. But what is best practice for their measurement, and how can manufacturers improve the management of quality data?

When using any measurement system to assess plastic medical components, if they operate in silos, key quality data can become isolated. While manufacturers can still collect the data required to validate parts, if systems are kept separate, they are unable to glean insights that can help improve medical device production quality, increasing the risk of unexpected defects or worse, recalls.

A quality management system (QMS) is essential for managing measurement data in line with industry standards. Industry 4.0 has introduced a solution to potentially siloing, by centering upon a datadriven approach that can help medical device manufacturers improve decision making and facilitate communication between their automated measurement systems.

The future of quality management works on these same principles — Quality 4.0 digitizes and connects the entire process from drawing to reporting. This approach removes the challenge of integrating data from fragmented sources, reduces human error and improves productivity. So, what does Quality 4.0 involve?

From Drawing To Final Product

Every plastic surgical component, device casing or housing begins with a conceptual drawing. Converting 2D drawings into functioning medical components traditionally required engineers to manually outline all the individual dimensions and create a ballooned image that acts as a guide when manufacturing the final product. As Quality 4.0 capabilities evolve, manufacturers are using automated solutions like High QA Inspection Manager to automatically populate First Article Inspection (FAI), Production Part Approval Process (PPAP) and Initial Sample Inspection Reports (ISIR).

By automating the ballooning process, medical device manufacturers can monitor process control more effectively, identify trends and reduce errors. This means healthcare facilities and other customers can be confident in the plastic part’s compliance and ability to meet the application’s needs. Automation also removes the risk of human error caused by engineers inputting the wrong data.

Following the ballooning stage, augmented reality (AR) systems like ARKITE can guide operators through the assembly process, by projecting instructions for them to follow. As well as reducing assembly error, this digitally confirms when every operation is complete and records data for full traceability.

Improved Visibility

Prolink SPC universal data collection and analysis software is a good example of manufacturers bringing all of their measurement data together. Prolink allows manufacturers to automatically collect data from any metrology or manufacturing system and outputs the results in the same format for reporting. This plug and play platform extracts real-time result data from any machine, enabling full visibility across multiple site locations.

Quality 4.0 provides medical device manufacturers with a 360-degree view, so they can use data generated insights to improve the production process.

Advances in technology ensure that testing and regulatory support for a wide range of devices and materials across the medical industry are constantly innovating.

Polymers are used extensively in the manufacture of medical devices and must meet demanding industrial requirements.

With devices being generally complex in geometry, material and chemistry, the work plans often need to be thought about carefully to ensure the tests performed give the truest evaluation of medical devices in use.

Companies such as Lucideon work to ISO, ASTM, and FDA standards, as well as novel methodologies with rationale when the standards are not adequate.

One of the most popular methods requested by medical device manufacturers is equivalence testing.

To undertake work in this area, a range of techniques and methods are utilized. These can include:

FTIR (Fourier Transform Infrared Spectroscopy) provides detailed information on the chemical structures within compounds. FTIR depends upon the absorption of infra-red radiation arising from the vibrational and rotational characteristics of dipolar chemical compounds and is a powerful technique for polymer identification.

DSC (Differential Scanning Calorimetry) is a thermoanalytical technique used to study the thermal transitions of a polymer. DSC yields a plot of temperature versus heat flow and provides information on thermal characteristics, thermal history, and curing performance of polymer samples.

TGA (Thermo-gravimetric Analysis) is a method of thermal analysis in which the mass of a sample is measured over time as the temperature changes, thus providing information on the bulk composition and thermal stability of polymers.

GPC (Gel Permeation Chromatography) determines the molecular weight and molecular weight distribution of polymers which are some of the most important characteristics of thermoplastic polymers; they have great impact on mechanical properties and processability.

SEM/EDX (Scanning Electron Microscopy/Energy Dispersive Analysis) provides detailed high-resolution images across the surface sample size measurement and can also provide elemental identification and quantitative compositional information.

It is important for clients to receive analysis and interpretation of test results, and not just the numbers.

Analytical interpretation and rationale support make equivalence studies more robust when they are able to clearly demonstrate why a method is chosen and show what the results mean for the materials and the manufactured devices.

Reasoning Behind Equivalence Testing

There is a growing trend from medical device manufacturers for equivalence testing. The reasons behind this are varied and include the desire to introduce new innovations or change suppliers.

Investigations as part of competitor analysis, which might be needed to help a medical device manufacturer retain their position in the marketplace, also draw on equivalence testing.

Another driver is a legacy from the pandemic; the material shortages and supply chain staffing shortages we saw during COVID-19 are still lingering.

As a result, new materials are being considered and equivalence testing needs to be implemented to ensure alternatives offer the equivalent performance attributes.

There is enhanced pressure across the industry to remove certain raw materials, and/or ingredients to meet new safety concerns and regulations.

Finally, ever changing market pressures to continually add functionality to existing products, in areas such as antimicrobial and antibacterial resistance, need to be addressed.

As a result of all these factors and more, medical device manufacturers might not only look at equivalence and analytical comparison, but also at alternative polymers and other materials. This is where polymer consultancy services can come into play. Addressing factors relevant to the medical device sector, they address the key areas of materials selection and characterization such as biocompatibility of new choices. The services also cover specific details, including how to process, clean, and sterilize the new materials.

Advanced materials are constantly evolving, improving, and transforming the medical device industry. For manufacturers, the options are there to test and challenge how they can be implemented into medical devices for long-term gains.