Knowledge Base

3D Printing for Medical Devices

3D printing has made a significant impact in the manufacturing sector. From aerospace industry to automobile engineering, and from medical field to education, 3D printing is making inroads as a viable option to traditional manufacturing. In the field of medical science, 3D printing is used in dentistry, surgical tools, anatomical models, prosthetics and prototyping of medical devices. For the purpose of this article, we will focus on the use of 3D printing for medical devices.

Medical devices are instruments or appliances that are used for better diagnosis, monitoring and treatment or alleviation of ailments. At home, medical devices like glucometer, blood pressure monitor, etc. help check parameters of chronic diseases like diabetes and high or low BP and help in avoiding unwanted emergency conditions. In hospitals, medical devices like defibrillators, ventilators, electrocardiogram machines, infusion pumps, etc. are extremely useful for monitoring patients with critical care needs. Some of the medical devices that can be 3D printed today include intraocular lenses, stents, surgical instruments, and so on. Of course, not all medical devices can be 3D printed yet.  However, as 3D printing technology and 3D printers improve in accuracy, more and more medical devices could be printed in the near future.

Since they interact with humans, medical devices are highly regulated by various government agencies. Before they are allowed to be manufactured, medical devices undergo numerous tests. Based on the risk they pose, medical devices are then classified as being low risk to high risk. The medical devices manufactured or permitted to be used in India are notified and regulated by the Central Drug Standard Control Organization. The current grades include:

  • Grade A: Low risk
  • Grade B: Low - moderate risk
  • Grade C: Moderate – high risk
  • Grade D: High risk

Medical equipment manufacturers are always on the lookout of processes and technologies that help them design better medical devices that are reliable, accurate, safer and cost less to manufacture. One technology that assists them in achieving this objective is 3D printing. 3D printing allows manufacturers to rapid prototype medical devices. From concept to design to prototyping, manufacturers can get to clinical trials faster with the help of 3D printing. For medical device manufacturers in India, this augurs well for their growth.

Did you know?
India is the 4th largest market for medical devices in Asia, among the top 20 markets globally. The current market size of the medical devices industry in India is estimated at Rs. 1100 crores ($11 billion), representing a sunrise sector of the Indian economy

The medical devices industry in India consists of large multinationals as well as small and medium enterprises (SMEs) growing at an unprecedented scale

The medical device sector has been growing steadily at a CAGR of 15% over the last 3 years. There are 750–800 domestic medical devices manufacturers in India, with an average investment of Rs. 2.3 - 2.7 crores ($2.3–2.7 mn) and an average turnover of Rs. 6.2 - 6.9 crores ($6.2-6.9 mn).

The medical devices industry in India is poised for significant growth with the market size expected to reach Rs. 5000 crores ($50 billion) by 2025. India is the 2nd largest PPE Kits manufacturer with production capacity 10 lakh+ PPE coveralls per day. To boost domestic manufacturing, the Government of India has launched Production Linked Incentive Schemes for medical devices.
[source: https://www.investindia.gov.in/sector/medical-devices]


3D Printing Technology

The 3D printing process, also called additive manufacturing or rapid prototyping, has been expected to change the manufacturing scenario for the advantages it offers. The 3D printing process includes the design of an item or object using computer software and the manufacturing of it with a 3D printer. In 3D printing, the product is built layer-by-layer. The layers are sliced by a 3D computer aided design (CAD) software, which determines how the layers will be constructed. At present, the various printing technologies include Stereolithography (SLA), Selective Laser Sintering (SLS), Fused Deposition Modeling (FDM), Digital Light Process (DLP), Multi Jet Fusion (MJF), PolyJet., Direct Metal Laser Sintering (DMLS) and Electron Beam Melting (EBM). While PolyJet 3D printers like those from Stratasys are the preferred choice for multi-material prototypes and pre-surgery models in anatomically correct detail directly from unique patient CT scans, DMLS and EBM are popular with medical device manufacturers.

Specific to the device manufacturing sector, 3D printing offer the following advantages:

  • It is possible to custom build small production volumes: 3D printing works by translating a CAD drawing into a 3D print file (usually .stl format) using appropriate software. Since it works directly, there are no moulds or costly tools involved in the design-to-print process. It is thus possible to produce a small quantity of medical device prototypes – even one. This is something that cannot be achieved by traditional manufacturing processes
  • Print complex shapes: 3D printing allows rapid prototyping with the shape, texture, and material properties of any medical device. It is therefore possible to optimize designs with complex geometries for final production
  • Rapid prototyping: 3D printing is popular for rapid prototyping. Since device design is an iterative process, 3D printers help save time between design iterations. This saves time for the manufacturers. There is yet another reason why 3D printing is gaining popularity with medical device manufacturers. Since government regulations can change anytime, they need to be extremely alert about implementing the changes. As 3D printers accept CAD output directly, it is easier for them to change minor designs. With traditional processes, manufacturers need an entirely different set of moulds and tools even for minor changes
  • Minimal inventory: Since 3D Printers can print exactly as per the need of the user, there is no need for ‘batch processing’ as in traditional manufacturing.  Consequently, there is no need to maintain a costly inventory
  • Wide choice of raw material: 3D printers accept a wide range of materials, thanks to advances in 3D printing technology. From plastics to carbon fibre and from metal to ceramics, the wide choice of raw material is simply amazing. As an example, take a look at the 3D printing material offered by Stratasys. This wide choice helps manufacturers choose the proper material for medical device prototyping.

Summary:
Medical devices are critical for better healthcare monitoring. In India and other countries, regulatory bodies are making norms stringent in order to improve patient safety. Rapid prototyping or 3D printing has an inherent advantage of being nimble and flexible. Medical device manufacturers are therefore increasingly turning to 3D printing for prototyping.