Developing medical equipment is different from any other type of product development for many reasons. Creators face more regulations with their products. They also have a smaller pool of potential clients to deal with, in most cases. Finally, and most importantly, these medical device creators have a higher duty of care than other product creators.
There is a higher level of trust needed to develop medical products, whether they aid in treatment, provide life-saving care, or help students learn. At Pacific Research Laboratories, we’ve had the opportunity to work on a wide range of these products. As a result, we’ve gained some unique insights into how they differ in the development stage.
Three Lessons Learned in Developing Medical Equipment
One of the highest goals someone can aspire to in creating products is to train the next generation of medical professionals. While working with Dr. Frederick Lippert on the development of Sawbones, we were able to gain a lot of insight into that process. Here are three of those discoveries.
#1: Define the problem in detail
Dr. Lippert discovered an issue with practical training for hopeful orthopedic doctors. These individuals had to work a lot with the human skeletal system, but were often limited to skeletal molds that were for display purposes only. While this was helpful, it didn’t help these students gain the experience of drilling into and working with actual bones. Most of the models were expensive and didn’t allow for a lot of student interaction. By detailing the problem, Dr. Lippert was able to create a solution.
He worked with Pacific Research Laboratories to develop an accurate model that wasn’t just anatomically correct—it also replicated the feel of real human bones. With it, those in training could practice a wide range of surgical procedures on a model that gave them an understanding of what it was like to work with the real thing.
In medical equipment manufacturing, it’s crucial to outline the problem, but that’s only the first step. The creator needs to break down exactly why it’s a problem so they can use those issues to inform their design process.
#2: Think beyond the product
Medical devices are sophisticated, and unlike most products, their use won’t be immediately apparent. The instructions for product use are just as crucial as the device itself. While working on the product, the creator also needs to consider their companion materials like:
- Instructional videos
- Assembly and use directions
- Product brochures
- Care instructions
- Storage recommendations
Medical products may require additional care that other products do not. As they’re creating these products, inventors need to take careful notes to allow their customers to use them for their intended purposes.
#3: Consider alternate uses
While Sawbones’ initial design helped orthopedic surgeons to practice medical procedures, that wasn’t its only use. Medical providers could intentionally fracture it to study patterns and how they occur. They could also use it to explain conditions to patients using a working model. Some could inform on ideas and placement for surgical devices like artificial discs or joints.
By understanding all the different uses for their products, leaders at Sawbones were able to develop an entire catalog of products designed for different applications. They expanded their product line to reach a much wider audience of medical professionals, from those in research and development to the general practitioner trying to explain a treatment plan for their patients in the office.
By reviewing all the potential uses of a product, creators can discover entirely new ideas that help them reach a wider audience. That can both diversify their offerings and aid them in preparing for FDA approval, as some medical devices will require specific permissions based on their use.
Precision is a Requirement in Medical Equipment Creation
One thing that any creator needs to remember is that medical equipment creation requires expert precision. This isn’t always easy, even when the creator has a strong understanding of human anatomy. A difference of only a fraction of an inch can result in an inaccurate model that doesn’t work as intended. While it might be tempting to outsource prototyping and product development to a low-cost overseas provider, the loss of accuracy and precision will cost them in the long-run.
Developing medical equipment is something best done with a partner with specific medical field experience. They’ll understand the need for precision and will have gained a lot of insight from previous projects on how to help creators solve problems. Patients and practitioners put a lot of faith in manufacturers to create designs that work as intended. The right partner can guarantee that trust isn’t misplaced.
PRL’s engineers have dozens of manufacturing options available to help you solve any challenge facing your product: CNC machining, custom tooling, 3D printing, thermoplastic molding, reverse engineering, and more. No matter what stage your product is currently at, we can create it and optimize it for manufacturing.