During the development of medical devices and components, it’s crucial to validate the final product before mass production begins. Validation ensures that the plastic injection moulded device meets requirements and performs as intended.
Plastic injection rapid tooling offers an efficient solution for producing parts for clinical validation, especially for plastic medical devices. Creating prototypes at an affordable price point enables manufacturers to conduct necessary tests and validations before full-scale production begins. It ensures final product quality and safety, thus instilling confidence in regulators and consumers. Mould tools manufactured using the rapid tooling process can undergo full medical IQ/OQ/PQ validation.
The global medical devices sector is expanding rapidly. Worldwide, the medical devices market size was valued at USD 600.21 billion in 2023 and it is proposed to hit around USD 996.93 billion by 2032, with a CAGR of 5.8% from 2023 to 2032[1]. To keep up with demand, medical technology companies are looking in even more detail at their processes and one area of focus is that of validation.
The importance of validation in plastic injection moulding medical devices
In medical injection moulding, validation not only ensures that the final product consistently meets regulatory and quality standards but performs as intended throughout its lifespan. However, validation processes often include rigorous testing protocols, complex documentation, and collaboration across a range of stakeholders. Depending on the complexity of the device and the number of components within it, project timelines can be significantly increased due to validation process delays.
That is why production methods that speed up the product’s validation process are increasingly proving popular with producers. Once such process is plastic injection rapid tooling.
How can plastic injection rapid tooling services help with medical device validation?
Rapid iterations – rapid injection mould tooling offers more design flexibility and the option of quick design iterations. It involves technologies such as additive manufacturing (e.g 3D printing) and CNC machining and has shorter lead times than conventional tooling to create moulds and tooling inserts. This leads to faster iterative design improvements and validation cycles.
Design customisation and optimisation – Geometry, features and materials of the final production moulds can be replicated. This enables real-world manufacturing conditions to be tested during the validation process.
Material and process accuracy – The component material used in the new product development process can then be checked for compatibility with the final product requirements. This can include evaluating material properties, heat resistance, chemical resistance and durability. In addition component tolerances of 0.05mm +/- can be achieved.
Speed to market – faster than traditional tooling methods, the combination of 3D printing and CNC machining can significantly reduce lead times, facilitating quicker product development cycles and helping bring medical device products to market more quickly. Rapid tooling can reduce timescales from the usual 8 – 12 weeks to just 2 weeks, compared to traditional tooling methods.
Reduced waste and environmental impact – additive manufacturing methods of rapid tooling production significantly reduce waste, which has environmental benefits and, depending on the material used, can save on raw material costs. Tool inserts can be built up layer-by-layer using the additive method and then machined or finished precisely using the subtractive process.
Regulatory compliance – product design changes can be made more quickly and easily, offering flexibility to ensure that the finished components meet the highest possible quality and regulatory requirements.
The validation for medical devices can be challenging and require substantial resources, including personnel, equipment, and time. Balancing these resources effectively, while meeting project timelines and budget constraints can be a significant challenge for medical device and component manufacturers. However, the validation process can be improved by choosing the right medical plastic injection moulder.
OGM – our expertise in rapid tooling & validation for medical device manufacturers
We provide a comprehensive range of clean room injection moulding services for medical device manufacturers of equipment used by dentists, doctors, surgeons and other health professionals in hospitals, surgeries and clinics. From design for manufacture to medical grade rapid tooling, we will assist you in bringing your medical devices to market quickly and safely. Through our committed project management approach, we ensure smooth and productive collaboration by prioritising transparency, efficiency, and client satisfaction.
Validation for medical devices and components is one of the areas in which we are committed to excellence. Here’s more information about our validation services – https://ogm.uk.com/validation-services.
[1] www.Precedenceresearch.com, 14 Feb 2024