The Role of Prototyping in Medical Device Development
Medical device development is a multi-step process. Proving that your preliminary concept is possible is a critically important phase in bringing your new medical device from idea to reality.
The word “prototype” is almost ubiquitous these days, and used across many different industries, but it can mean very specific and different things depending on your goals and your product. HDA Technology’s approach to prototyping is integrated into our product development approach and focused on feasibility. We wanted to use this article as an opportunity to unpack everything you can and should expect in the prototyping phase of your medical device manufacturing journey.
What is Medical Device Prototyping?
A prototype can be defined as the preliminary or original example of an idea, concept, or plan that has not yet reached fruition. The word can be broken in two – proto meaning “the first of” and type referring to the item or idea.
Prototypes can have many different uses. They can validate an idea or test a theory, clarify the requirements for designing or manufacturing something, prompt feedback from stakeholders and investors, and be used for evaluation of function and identification of design flaws. Prototyping refers to the process or phase of prototype creation and testing. In medical device development, there are a few different ways that prototyping can happen.
First, prototyping can be seamlessly integrated into your full development process. That is to say, as an organic part of the design phase of medical device development and manufacturing, a prototype is created to test for the feasibility of functionality, production, safety and certification issues, closeness to the original vision, and, ultimately, manufacturability. Second, prototyping can be a service or independent phase offered. Prototyping services imply selling 3D printed mock-ups, rapid turn manufacturing, and physical prototyping.
As is the case with all development and manufacturing firms, HDA engages with prototyping in the former way: it is an organic part of our process. We focus on proof of concepts, which are chiefly concerned with the feasibility and manufacturability of your product.
Types of Prototypes
Prototypes can range from low-fidelity to high-fidelity and can be categorized in a number of different ways depending on what production needs you are prioritizing. HDA Technology generates proof of concepts when appropriate, and also builds full functioning prototypes on the way to pilot production. A range of prototypes that can be relevant to you depending on your product goals.
Proof of Concept (Low Fidelity)
A proof of concept (PoC) is meant to offer a basic representation of your device’s shape or functionality. It’s cost effective and often used to demonstrate and evaluate the feasibility of manufacturing your product for your stakeholders or investors.
Full-Functioning Prototypes (Mid Fidelity)
A full-functioning prototype mimics the detailed functionality of your device – how it operates and in different conditions. You can use full-functioning prototypes to test your device’s performance and consumer or buyer usability. While a PoC is not really meant to be used in the “real world”, full-functioning prototypes can be applied to different situations to gauge the device’s realistic performance.
Product Equivalent Prototypes (High Fidelity)
Product-equivalent prototypes are the last phase of prototype creation. This type captures all the features of your final product, including design, user features, and function. This is the closest thing you will have to your final product and is used for final rounds of testing. Product-equivalent prototypes are used when you are transitioning from small-volume production to mass- or large-volume production.
Prototypes can be further typified into categories like feasibility prototypes, sketches, and diagrams (abstract representation of the final product), rapid models (prototypes focused on the form and fit of the device), and working models (prototypes focused on the function of the product).
Medical Device Prototype Development: Steps for a Proof of Concept
As discussed, a PoC is a preliminary way to demonstrate that your device idea, new technology, or novel design improvement has the potential for real-world application. The idea of a PoC is simple. As the originator of your new idea, it may be easy for you to understand or envision how it’s going to work.
But when you come to explain it to others – whether it be your investors, business partners, or manufacturers – their eyes glaze over. If you can simplify your idea, ideally with a visual aid or demonstration, you are now able to communicate your vision directly and practically. This opens up opportunities not only for feedback from others but for reflection and refinement of your idea on your part as well. As applied to potential investors, a PoC may also lead to additional funding!
PoC development is an integrated part of HDA’s workflow and happens early in the development process. A PoC can help validate the basic concept of your device, forecast how much manufacturing will cost, verify the expected results of your product, identify risks associated with your product, and facilitate feedback from stakeholders and investors. PoC can also be valuable in research and development contexts, where a novel technology must be tested before a medical device is designed around it.
It’s always important to remember that the form of your PoC changes depending on your priority needs.
Validating the Basic Concept of A Device
You may already have a clear picture of what medical device you want to develop, but not a lot of confidence that your vision of this device will work. HDA will mock up what is called a PoC Demo. To do this, we could use commercial off-the-shelf (COTS) components, various lab equipment, and crude fixturing to create the effect that you are hoping to achieve with your final device. This product will not be fully functional – it will be a concrete, physical device that the client will be able to see and engage with to clarify their vision. This will also help us refine our approach to the product’s development and manufacturing.
Facilitate Feedback from Stakeholders and Investors
In a different case, you may be a startup needing to prove to potential investors that your vision for your device’s function is possible. As a result, the PoC we develop will not need to look pretty or even accurate to its final form, but rather needs a degree of functionality; design and fabrication will be tailored to achieve minimal, non-clinical function without committing to the full scope of the device’s design and appearance.
One of our clients once secured a major investment by verbally describing what they wanted to build to investors while showing them a block of wood with a hole drilled in it, a crank made out of a pencil, and some fishing line. The resulting startup was very successful.
Further Research and Development
PoC development is also a good fit for research and development efforts, where the method by which to achieve a novel medical procedure is being tested. An example of HDA’s experience with this kind of PoC is our work with a very high-performance special purpose electro-cautery system. We were tasked with developing new technology for a novel tissue-cutting application.
This was a PoC focused on approach and method; the design of the medical device wasn’t important! Only after we developed a functional mockup of the trial technology was the development of a medical device greenlit.
HDA makes it a priority to support you if your investors need to discuss the device’s technical specifications with us at this PoC stage.
From Prototyping to Regulatory Approval
HDA prides itself on embedding high-quality and regulatory standards into its process and ethos as a company. That being said, our prototyping work is primarily focused on PoC; because PoC are not human-use devices, FDA regulations are not a significant concern at this stage of the medical device manufacturing process. Furthermore, when developing a PoC, our focus is to figure out how to accomplish a functional goal, or how to illustrate your vision of the product. At this stage, regulatory compliance would add considerable cost and time that may be redundant if the PoC demonstrates that an idea is unfeasible or must be altered. As a result, designing for regulatory compliance becomes practical after the PoC phase, and moving into pilot production.
Every new idea needs to be tested before it’s manufactured. HDA Technology conducts proof of concept testing for all of our clients as a natural part of our high-quality development and manufacturing work. If you have additional questions about what HDA’s prototyping process looks like, or would like to request a consultation, you are invited to get in touch.