Ultimate Guide to Medical Devices Prototyping Machining

medical device manufacturing

In 2017, the global additive manufacturing market was valued at $6 billion and was expected to reach $26 billion in 2022. The market then grew, and in 2020, the industry boasted of a market valuation of US$15.4 billion. Experts estimated a growth of CAGR 21.8% at the time, which would propel the market to a revised size of $61.1 billion by 2027.

That spells massive growth, and if you haven’t joined the train yet, well, here you are. There’s always a start.

Additive manufacturing is especially gaining momentum in designing and developing medical devices. Medical devices prototyping machining is now used to cross unimagined barriers. Devices that were merely science fiction 10 years ago are now a living reality. This detailed guide will give a comprehensive outlook of what medical device product prototyping entails. We’ll also see some top applications of CNC machining in the medical industry.

What is a Medical Product Prototype?

A medical product prototype is simply an original design after conceptualization and designing. The product prototype is a simple replica of early models that engineers can later use for test runs. It acts as the “proof of concept” that can be shown to investors, manufacturers, or even probable customers to give them a feel of the end design.

A medical product prototype shifts us from the realm of theory to reality. This way, we’re better suited to add new functions and improve the product’s efficiency without compromising precision. Manufacturers can interact with the product through augmented reality and 3D printing to alter the product’s size, shape, and dimensions. Prototyping, also called materialization, dramatically minimizes the cost of production and errors in the final product.

Use of 3D Printing in Medical Prototyping

One outstanding feature of 3D printing is that you can use it to manufacture parts for any medical equipment as well as actual complete devices for medical end-use. This art comes in handy, especially in cases of emergency or specialized and individualized care where mass-produced medical products don’t fit or suit some patients.

Designers working alongside manufacturers and medical practitioners have quickly developed new inventions and existing medical devices. The technology has been used to make devices such as stents, diagnostic carts, arthroscopy, orthopedic surgery support systems, drug delivery systems, endoscopy devices, vision testing systems, cryotherapy devices, cardiovascular and vascular access devices, Doppler ultrasound devices, and the list goes on.

Additionally, 3D printing has found usage in creating medical models and prototypes of the human anatomy. This enables practitioners to not only examine visual models of human body parts (e.g., bones, heart, and joints) but also pinpoint the problem and plan a strategic treatment. Surgeons today use 3D printing in planning out their surgeries.

As if that were not enough, on-demand medical prototyping has successfully been used in replacing or augmenting human anatomical body parts. It is not uncommon to see consumers with artificial hands or legs or even a bone implant. Patients with broken limbs or internal structures now have 3D models implanted to act as brace or support structures.

Medical Instrument CNC Machining

Medical devices, especially complex ones, require tight tolerances. This is especially possible with CNC machining. The industry is headed towards miniaturization and micro-machining, where the parts and devices made will eventually become smaller and smaller with higher efficiency.

For instance, MIT working alongside Harvard’s Brigham and Women’s Hospital is working on a 3D-printed ingestible capsule. Patients who need long-term care can ingest the pill, which delivers a discrete amount of drugs into the patient’s body. The tablets are self-powered and can survive in the stomach for up to 1 month and probably transmit wireless information to the physician. That leads us to our first common application for CNC machining in medical devices.

Medical Implants

When it comes to medical implants, the orthopedic implant just has to work once the surgery is complete. Most times, it’s a matter of life and death; thus, high precision is needed. As such, it may take extended periods stretching up to 18 months for the final design to be completed. These implants should carry two main features for their performance to be approved: biofunctionality, which is a prime consideration for plastic implants, and biocompatibility, an underlying factor for metallic implants.

Examples of implants include artificial bones made of titanium, artificial hip sockets, and in dentistry to recreate the size and shape of cavities. Manufacturers need to work on shorter machining time spans to achieve economies of scale in mass production.

Machined Surgical Instruments

Surgery may involve sophisticated instruments. With the development of technology today, it is possible to achieve this with high-precision CNC machining. However, manufacturers must pass general guidelines and safety standards before such instruments are used on patients. In the US, medical machinists must comply with requirements from the FDA, International Organization for Standardization, and the International Electrotechnical Commission.

Some typical surgical tools developed through CNC machining include plate benders, biopsy tubes, electronic tissue ablation devices, and fluid management and monitoring systems, among others. When designing these instruments, we generally advise our customers to;

  • Make it easy to clean, especially if it comes into contact with body fluids.
  • Make it easy to hold for surgeons during surgery.
  • Keep it simple for anyone who might use it.
  • Use a standardized color combination to communicate to users intelligently.

Machined Parts for Electronic Medical Equipment

There is an increased demand for electronic medical components across the health industry. Such parts need to have a nonexistent margin of error as any mistakes can cause irreparable damage or death. These parts also need to be biocompatible. It is also vital to comply with the set standards of regulatory bodies when designing such equipment.

Most of these electronic medical components are used in imaging. They include MRI scanners, CT scanners and monitors, ultrasound equipment, and heart rate monitors. However, most of these devices only have some of their components made through CNC machining. These parts may include buttons and levers, switches, and electronic casings and housings.


Developing features on the scale of microns is possible through high precision cutting to achieve extremely tight tolerance. Some of these miniature devices need high operational speeds at times in the order of thousands of RPM. This complexity in design reduces the margin of error. Some tools that need micromachining include pediatric ventricular assist devices (VADs), screws, pacemaker parts, stents, tubes, catheters, and chips. That said, much research still needs to be done on microfluidics to achieve test on-chip and organ-on-chip apparatuses.


As already said, developing these medical devices calls for top-notch standards since we are dealing with lives. Luckily, dealing with expert CNC machinists will minimize degrees of errors enabling you to meet the guidelines and requirements of regulatory bodies. We work with you from the product ideation stage until we formulate an end-to-end solution that meets your needs. Contact our dedicated team if you have any inquiries and concerns about CNC machining various medical devices.