The rapid evolution of the minimally invasive and electrophysiology landscape has pushed engineering teams to find methods for accelerating and improving the device development process.
Though there are many things that can be done to accomplish this task—such as using a holistic approach to device design—prototyping is a straightforward, but effective tool that can be used to boost the development process and decrease time-to-market.
In this post, we’ll talk about the benefits of medical device prototyping is and how you can use it to better your device development process.
What is medical device prototyping?
When Thomas Edison said, “I have not failed. I've just found 10,000 ways that won't work,” he neatly summed up what prototyping is and how it works.
Prototyping is the process of creating a rudimentary version of a product for the purpose of visualization and conceptualization.
In general, prototypes fall into two broad categories: functional and non-functional.
Functional prototypes enable people to get a sense of the basic form and functionality of the product.
In the medical device world, a prototype of an electrosurgical connector and receptacle that can transmit data or power when plugged together would be an example of a functional prototype.
Non-functional prototypes are used to provide people with a non-digital representation of the product.
A 3D printed connector and receptacle that do not transmit data nor power, but show design efficacy, is an example of a non-functional prototype found in the medical device realm.
It’s important to note that when it comes to medical device prototyping, a functional prototype is not one that can be used in the market—it is not a final product, but a functioning example that can be used to develop a better version of the final product.
How does prototyping improve the medical device development process?
He defines an MVP as follows:
[T]he minimum viable product is that version of a new product which allows a team to collect the maximum amount of validated learning about customers with the least effort.
Similar to Deming’s Plan-Do-Check-Act cycle, the MVP method follows a path like this:
- Determine the product features/characteristics
- Create the minimum functional product that has those features/characteristics
- Introduce it to your team and customers
- Gather feedback and use it to improve the product
The purpose of an MVP is to collect real-world data about a product so that it can be improved before a full-scale release.
This is the same reason a device prototype is so valuable: It allows you to put your idea into people’s hands and collect feedback, input, and validation.
Aligning your team.
Trying to get your colleagues and higher-ups to conceptualize your device drawing in exactly the same way you do is a near-impossible task.
This can lead to miscommunication that can not only impact project deadlines, but also result in wasted time and resources from pursuing an idea that was not quite right to begin with.
Nothing gives a team a single idea to work from better than a device prototype.
Beyond getting your team members on the same page, a device prototype enables you to find design flaws and get a glimpse of the production process to see if any steps can be changed, combined or even removed.
Hearing the voice of the customer.
Though your device prototype can’t be used by end-customers (e.g., doctors, nurses, surgeons, etc.), it gives them a way to physically interact with your device and provide valuable input before you expend resources pushing the device through the development process and into production.
In short, a device prototype enables you to clearly communicate your device concept with stakeholders to identify problems and opportunities early on—streamlining your development process and saving your organization time and resources that may have been wasted pursuing a flawed concept.
What options exist for medical prototyping?
Just as there are many different types of medical devices, there are many ways to create a medical device prototype.
For energy-driven devices (“electric devices”), the prototyping method you use depends on whether you want your device prototype to be functional or non-functional.
Below is a high-level overview of the common prototyping methods used to create energy-driven device prototypes.
3D printed prototypes are typically non-function and used to conceptualize a design.
The rise of 3D printing has accelerated the development and production of device prototypes—which is perfect for teams that rely on quick, frequent iterations to push their designs through the device development process.
Using 3D printing, objects of almost any shape or geometry can be produced from a 3D model or electronic data source, such as an additive manufacturing file (“AMF”) or computer-aided design (“CAD”) file.
When it comes to medical device prototyping, the two most popular forms of 3D printing are:
- Stereolithography. A process whereby liquid material is converted into solid parts via layering and photopolymerization.
- Fused deposition modeling. A process whereby layers of plastic are created via a thermoplastic extrusion process.
Computer numerical control (“CNC”) machining is typically used for advanced prototypes that require tight tolerances and a specific material.
The process for creating a prototype with a CNC machine consists of taking a solid block of metal or plastic and shaping it with a CNC mill based on a set of coded instructions.
In the later stages of the development process, it can be useful to give people a sense of what they will actually experience when the product is released.
Screw machining consists of running metal through a screw machine to produce precision prototypes for connector pins.
Combined with a machined component, screw machining is a viable way to show how a connector will actually look, feel, and function.
Photochemical machining (“PCM”), also known as photo etching, is a process that uses chemical milling to corrosively machine away selected areas of sheet metal to create a part.
When it comes to medical device prototyping, PCM can be useful for creating metal prototypes at a low cost.
For metal prototypes that require a precise, smooth finish, laser cutting can be a viable option.
Laser cutting utilizes a coded program and high-output laser to shape material (typically metal) to specific geometry.
To learn more about the different medical prototyping methods, download our free medical device prototyping ebook.
How can you incorporate prototyping into your device development process?
Fortunately, the medical prototyping process has evolved significantly over the past 20 years to the point where prototypes can be created much more efficiently.
Creating prototypes that allow you to strategically validate and test your design can be quite challenging.
In order to do so, prototyping must be explicitly designed into the development process.
Though it is possible to do so on your own, the learning curve can be steep as it requires knowledge of the different prototyping options, design controls, material science, and many other fields.
When trying to incorporate prototyping into your device development process, we recommend working with a medical device engineering and prototyping expert.
To develop a deeper understanding of the prototyping process and the different prototype options available to you, download our free medical device prototyping ebook.