5 Considerations for Prototyping Orthopedic Medical Devices

Orthopedic medical devices can vastly improve the quality of life for people coping with orthopedic conditions like degenerative diseases or sports injuries. Some of these devices even save lives. However, despite the high demand for orthopedic devices in the medical field, designing and prototyping these devices is often a serious challenge. Design complexity, redesigns, prototype testing, and other engineering challenges can extend the amount of time you spend in the prototyping stage and could even stop your project in its tracks.

If entrepreneurs or medical companies want to create life-changing new orthopedic medical devices, they should streamline the prototyping process as much as possible. When you consider these five design and prototyping approaches, you may avoid some of these common setbacks.

The Challenges of Prototyping Orthopedic Medical Devices

The process of prototyping new orthopedic medical devices varies depending on what type of device you’re creating. Some of the devices that are in the highest demand are:

• Joint reconstruction
• Trauma fixation
• Braces
• Spinal
• Arthroscopic
• Orthobiologic

The prototyping phase is a time to think carefully about the design and come up with innovative engineering solutions long before you apply for FDA approval or move on to the manufacturing stage. In general, the more complex the medical device is, the longer it will take to finalize the design and the higher the total product development costs will be.

Moreover, new medical device designs often take far longer to develop compared to variations on an existing design. This is one of the main challenges of prototyping new orthopedic medical devices. Designers must be able and willing to put in the extra effort and time required to ensure the device design is as accurate, precise, and potentially safe as possible.

However, orthopedic medical device designers can mitigate some of these challenges when they partner with a product development team that has designed or worked with medical devices before. A third-party medical device manufacturer with experience in designing and prototyping medical devices can streamline a few areas of this process and help you create a high-quality design. There are five approaches you might consider to make the prototyping process more efficient.

5 Ways to Optimize the Prototyping Process 

To design high quality orthopedic medical devices that are truly life-changing for patients, you should try to optimize every stage of the design and prototyping process. But how? The methods you use will depend on factors, such as the complexity of your design, your budget, your timeline, and which tools or resources you have available. Still, there are five potential design and prototyping approaches you might consider when you design a new orthopedic medical device.

#1: Understand What Patients and Medical Professionals Need

Many orthopedic medical devices never make it out of the design stage, let alone into the manufacturing stage. When a medical device company or entrepreneur is stuck on the design step, it’s usually because they didn’t take enough time to thoroughly research the device before beginning the process. To avoid this, start by identifying:

• What the market is for this product;
• Whether there are similar devices on the market, and if so, how your design differs from these other devices;
• What the risks are for the device, including potential medical, mechanical, and manufacturing risks; and
• Whether the device will be familiar or unfamiliar to orthopedic medical professionals, particularly surgeons.

This process should start before you begin the design process in earnest. Performing detailed research and development on the front end will save you time and money on redesigns and multiple prototypes in the future.

#2: Use Rapid Prototyping

When companies design orthopedic medical devices, they often produce many working prototypes and computer models before finalizing the design and beginning the regulatory approval process. Prototypes and 3D models test the feasibility of the design before the company commits to this time-consuming and complex regulatory process.

For example, one major part of the prototyping process for orthopedic medical devices is the finite element analysis. During this step, engineers perform a full structural analysis of the prototype while considering factors like:

• Material feasibility and safety, including toxicity
• How the device transfers heat
• How fluid flows through or around the device
• Adaptation of the surrounding bone
• Wear over time

This gives engineers a sense of how the device might perform once it’s implanted. Any problems or risks at this stage have to be addressed before the design is ready for the next stage.

The best way to do this is to use a rapid prototyping methodology. Rapid prototyping tools allow orthopedic medical device designers to quickly test the physical and operational properties of the product. You can make and review multiple prototypes within just a few days or even test out multiple concepts at once to find the best engineering solution. Without rapid prototyping, this process would take many months and significantly delay your production timeline.

#3: Consider Using Rapid Tooling

Advanced prototyping tools like 3D printers, CNC machinery, and other types of rapid tooling are ideal for testing the feasibility of orthopedic medical device designs. Because this process is faster than conventional tooling methods, you can create multiple prototypes simultaneously or in quick succession to test out different designs or materials. Some of these tooling options are also more precise than manual tooling techniques, which is often important when designing and prototyping orthopedic medical devices.

#4: Hire a Product Developer with Medical Industry Experience

You can’t trust just any product developer to help you design and prototype orthopedic medical devices. Experience and knowledge of the medical industry are absolutely essential. A knowledgeable engineer can:

• Perform thorough research into the design: The engineer may help you identify important design details that will allow your orthopedic medical device to operate more safely and efficiently.
• Help you select materials and test them: Engineers that have worked on medical device designs before may be familiar with tests, such as the finite element analysis and can also perform more reliable quality control tests throughout the prototyping process.
• Work closely with you on redesigns: Because safety and quality is so important with orthopedic medical devices, designers often return to the drawing board multiple types during the design and prototyping stages. Engineers with some medical industry experience not only understand the need for redesigns but can also make this process more efficient. They can offer you a reasonable estimate for how long the design and prototyping process will likely take and will communicate with you if this timeline changes.

Having a professionally-designed prototype and detailed 3D model of your device could also make the regulatory and manufacturing processes run smoother in the future.

#5: Keep Detailed Design Records

The engineers you work with can keep detailed copies of every design and prototype iteration, including detailed 3D models. This enables you to return to old designs and make adjustments quickly. Not only could this improve the form and function of your final design and prototype, but it could also make it easier for you to apply for FDA approval in the future or make important changes to the design based on regulatory feedback. Having detailed models of the design is also an important step if you plan on patenting your design.

While you could create these designs yourself, it is often better to use professionally-drafted designs and models. That’s because engineers understand important details like tolerances, and they also generally have the most advanced CAD design tools available to them.

While these five considerations can make the design and prototyping process run more smoothly, the most important thing to remember is that your product requires its own unique process. A trusted product development company with experience in the medical field can help you find the right process based on your timeline and budget.

Why You Should Work with an Experienced Design Team 

Ideally, you should get in touch with an experienced product developer as early in the design process as possible. Having the product developer involved in the conceptual stage gives you the benefit of their skilled team of engineers. Not only can they help you identify the best materials to use and the form your device should take, but they will also make sure that those elements can be easily recreated by a third-party medical device manufacturer in the future.

Hiring an end-to-end product developer has many benefits. These companies are heavily involved from the design concept to the final prototype. Having all of these processes under one roof makes it easy to document everything and refine your design. They are as committed as you are to the process and fully understand all of the engineering challenges you need to solve. They treat you as a partner, not just a contractual obligation. In an industry as competitive and complex as the medical device field, partnering with an experienced and passionate product designer is invaluable.