If you’re reading this, there’s a good chance you’re interested in medical device prototyping for some reason. Perhaps you’re considering building a model of a medical device idea. Or maybe you just want to learn more about prototyping medical devices. Whatever the case, you’ve come to the right place. This guide walks you through the essential things you need to know about medical device prototyping.
How Is Prototyping Used in the Medical Device Industry?
Prototyping plays a critical role in the medical device industry. It allows medical device development companies, designers, and healthcare professionals to design and develop new medical devices. Below are some of how prototyping is applied in the medical device industry:
Build medical device design
Medical device developers leverage prototyping to build designs for new devices and bring their concepts to life economically. They use cheap prototypes to get their ideas off the ground without spending too much money during the conceptualization stages.
Gather user feedback
Once the developers have designed the prototypes, they will take them to the next stage where potential users provide valuable feedback. The developers use the feedback to improve the designs.
Test functionality
Prototyping plays an important role when it comes to testing the functionality of medical devices. The developers use functional medical prototypes to test performance and safety before the device goes into scale production.
Secure investment and approval
It is the last step of the prototyping process in the medical device industry. Medical device developers present high-quality medical devices to regulatory bodies for approval. They may also submit the prototypes to investors and potential partners to secure funding.
How to Prototype a Medical Device?
Prototyping medical devices involves several steps, right from conceptualization to the final approval stage. Let us look at each one of these steps:
● Concept development: The medical device prototyping begins with creating 3D CAD models and 2D files for material, quantity, tolerance, finishing, and other requirements for the prototype.
● Prototyping method selection: The next stage is choosing the ideal prototyping technique to produce accurate and stable prototypes. Many techniques are available, including CNC machining, 3D printing, vacuum casting, rapid tooling, and reaction injection molding. It usually depends on the project demands for selecting the proper techniques.
● Building the prototype: This is where the real action happens. The developers build a basic prototype in alignment with the core functionality and feasibility of the concept. After building the basic prototype, they progress to a more advanced and highly refined model that can be used for clinical trials.
● Testing functionality: This stage entails assessing if the prototype works as intended. The developers use the feedback to make improvements.
After the tests reveal flaws and factors to improve, the above process will be repeated until the design is ready for production.
Medical Device Prototyping Techniques
There are several medical device prototyping techniques, each with its advantages and considerations. Let us look at some of the most common techniques for prototyping medical devices:
CNC Machining
It is an automated subtractive manufacturing process that medical device developers use for creating prototypes. The CNC machine removes material from the workpiece to get the desired shape. CNC machining is highly accurate and can create intricate designs. It is used to make plastic and metal medical device prototypes or low-volume runs.
3D Printing
3D printing is another popular and versatile technique used for medical device prototyping. It prints 3D models layer by layer. 3D printing can handle intricate designs that CNC machining cannot realize.
It can be used to manufacture various medical devices, such as prosthetics, braces, and surgical instruments. Doctors can utilize 3D printing to manufacture medical devices that perfectly match the patient's body based on their specific condition, making the treatment more precise and convenient.
Vacuum Casting
It is how vacuum casting works — a liquid resin mixture is poured into a silicone mold created from a three-dimensional printed master pattern. This medical device prototyping technique stands out for producing prototypes in low volume economically.
Rapid Tooling
As the name suggests, rapid tooling is applied to quickly build low-volume prototypes that closely resemble the final product. It uses quick molds, dies, or patterns to produce prototypes and end-use products within a few weeks.
Reaction Injection Molding
Reaction injection molding (RIM) is exactly what its name says — injecting a fast-reacting liquid mixture into a heated mold. This process combines speed, affordability, and the ability to produce intricate geometries. RIM is ideal for making medium- and large-sized plastic enclosures for medical devices.
Sheet Metal Fabrication
This method involves shaping thin sheets of metal to create 3D designs. The developers use processes such as cutting, bending, and forming to create the desired designs. Sheet metal fabrication is only applied when the medical device prototype requires metal components with a wall thickness of less than 6mm.
How Can a Company Optimize the Design and Prototyping Phase of Medical Device Development?
Early User Integration
A good place to start is to involve potential users, such as doctors, nurses, and patients, early enough. Get their feedback on initial concepts to ensure the design addresses real needs and is user-friendly.
Stage-Appropriate Prototyping
Start with low-cost, low-fidelity prototypes such as cardboard and foam to test core functionalities. As the design evolves, progress to more detailed prototypes for user testing and refinement.
Use Digital Tools
Utilize computer-aided design (CAD) software to create and modify designs virtually. It allows for faster iteration and reduces costs.
Concurrent Engineering
Encourage collaboration between design, engineering, and regulatory teams throughout the medical device prototyping process. It avoids late-stage design changes due to compliance issues.
Rapid Prototyping Techniques
Consider techniques like 3D printing or CNC machining for faster turnaround times, allowing for quicker design validation and testing cycles.
Conclusion
Medical device prototyping has truly changed the healthcare landscape over the years. It has enabled a wide range of stakeholders in the healthcare industry to accelerate the development of new medical devices. Medical prototypes have helped to improve patient outcomes, reduce costs, and enhance safety.
FAQs
1. What materials can be used in medical device prototyping? And can the materials be the same as the final product?
A variety of materials are used in medical device prototyping, depending on the device's function and stage of development. Some common options include plastics, metals, and resins.
In the prototyping stage, most materials can be the same as the final product.
2. What finishing is available for medical device prototyping?
The finishing options for medical device prototypes depend on the chosen technique and desired outcome. Some finishing options available include polishing, sandblasting, painting, silk screening, laser engraving, powder coating, and anodizing.
3. How long will it take to create a medical device prototype?
The time to create a medical device prototype varies depending on several factors including the design complexity, prototyping technique, and material availability. The general lead time would be 7 days.
4. How can I protect the intellectual property of my medical device design?
Here is what you can do to protect the intellectual property of your medical device design:
● Non-Disclosure Agreements (NDAs): Have anyone involved in the prototyping process sign NDAs to protect confidential information.
● Patents: Consider filing for a patent to secure intellectual property rights for your design. Consult with a patent attorney who can advise you on the patenting process.
● Trade Secrets: Maintain secrecy around specific design details that give your device a competitive edge.
