In recent years, 3D printing technology has taken the world by storm. Its ability to create physical objects from a digital model has led to some amazing innovations, and one of the most exciting applications is in the medical field. 3D printing offers many advantages for medical device manufacturers, including faster prototyping, improved accuracy and decreased manufacturing costs.
Prototyping Medical Devices
Developing ground-breaking medical devices is heavily intertwined with improving patient care and outcomes in the healthcare sector. Rapid prototyping is a key element of this process, as it allows for the quick and iterative development of new products and services. In the past, prototyping a new device could take months or even years. However, with the advent of additive manufacturing technologies, this process can now be completed in days or weeks.
3D printing is an excellent fit for prototyping since it allows for nearly limitless shape options, doesn’t require tooling, and can generate components with mechanical properties that are very close to those created using conventional manufacturing techniques. Fundamental to this process is having the 3D CAD data available which is suitable and optimised for successful 3D printing, usually prepared by design engineers who have a good understanding of additive manufacturing technologies.
Developments in Additive Manufacturing
3D printing has experienced significant progress and development in the last 30 years and is continuing to revolutionise the way businesses and organisations approach product development. Recent advances in technology at the equipment level and in materials science have delivered substantial gains, with improved throughput, better performance and cost efficiencies in prototyping and factory floor production. The introduction of smaller scale affordable printer systems means the technology is now accessible to a wider user group.
Stereolithography (SLA) 3D printing is at the forefront of these new developments. Recognised as the first commercial rapid prototyping technology, SLA continues to gain traction over alternative additive systems, with designers, engineers and medical device manufacturers. Particularly because of the ever-expanding range of diverse materials and the capability to produce parts with precision accuracy, intricate details and smooth topography.
Biocompatibility and sterilisable 3D printing materials
Depending on the application, biocompatible and sterilisable parts may be necessary for the prototype development of medical devices. Today SLA offers the widest selection of biocompatible and sterilisable materials for healthcare and medical applications. These materials are specifically formulated to meet the requirements of medical regulations.
For example, Formlabs now has over 30 materials available, including various options that are compliant with ISO13485. Including – BioMed Clear is a medically certified biocompatible resin, strong, durable, and suitable for long-term skin or mucosal contact for parts that demand good wear tolerance and low water absorption and can be used for surgical planning and implant sizing tools. Tough 1500 resin is a robust material simulating the same strength and performance attributes as Polypropylene (PP). This is sterilisable and certified for permanent skin contact making it an ideal candidate for medical prototyping and testing of wearables and personal protective equipment. Elastic 50A is a soft and pliable material suitable for prototyping parts usually manufactured in silicone and without the need for tooling investment. Delivering clear flexible components rapidly and ideal for prototyping masks, handles, grips and gaskets.
Precision Accuracy and High Quality Surfaces
In the medical sector, even the slightest inaccuracies in a device can have disastrous consequences. For example, if an implant is even slightly too large or too small, it may cause serious complications for the patient.
Thankfully, additive manufacturing technology has greatly improved over the years. SLA 3D Printers are now capable of building parts to a tolerance below of 25 microns (-0.025mm) which is less than the thickness of a human hair, achieving higher levels of precision and accuracy when compared to conventional manufacturing practices. One of the major benefits of printing at these levels of resolution is seen in the high-quality surface finish that can be produced, resulting in very smooth parts which require much less post-processing and are similar in standard to an injection moulded component.
Decreased Manufacturing Costs
Additive manufacturing is often recognised for its ability to lower manufacturing costs. This is due to a number of factors, such as the elimination of tooling and the ability to print multiple parts from a single 3D CAD model.
Medical device manufacturers can realise even greater savings by using additive manufacturing for low volume production. With traditional manufacturing methods, the expenditure of a production run usually scales linearly with the number of parts produced. However, this is not the case with additive manufacturing, as the digital model can be used to produce an infinite number of parts. And in the digital age, this can be achieved with simultaneous manufacture carried out around the world at multiple sites without the need for tooling knowing all the parts will conform to the same specification. This brings with it many benefits including the ability to print and manufacture on-demand locally close to market – reducing transportation costs, timescales and environmental impacts by delivering directly to the end customer.
Our Medical Device Prototyping Service
For us, health care innovation is more than just a buzzword. It is critical to advancing patient care, improving outcomes and being able to adapt to an ever-changing industry. Getting to market rapidly with clinically important and marketable products is the challenge of medical device development. To enable Bluefrog Design to support clients fully on the journey from concept to manufacture, our comprehensive medical prototyping solutions help to optimise the product quickly so that it can be tested, approved, and verified efficiently before launch.
Our experience covers a wide range of projects, from medical devices to laboratory equipment, scientific instruments, drug delivery systems, surgical instruments, diagnostic tools and prosthetics. Produced in-house, we deliver medical prototypes that help you achieve the highest regulatory approvals. Manufacturing individual parts and low volume production components in biocompatible and compliant materials through advanced SLA 3D printing, CNC machining, injection moulding and vacuum casting.
This article was written by Medilink Midlands Member, Bluefrog Design