Having the concept for a new, innovative and groundbreaking medical device is just the first step in many from idea to production and marketing. The process itself has several steps involved before even the prototype is developed.
In medical product design, which is in the early part of the process, taking the time to do things accurately and with input from all involved stakeholders is often a critical mistake. There are several other common issues that can develop over these initial months that can turn a great concept into a product that will never see production.
Not Addressing Feasibility
One of the most common issues that arise in the early concept stage is to fail to be specific enough regarding the needs of the patient and how the medical product, device or implant will address those needs.
When this is incomplete or inaccurate, it is impossible to complete a feasibility study to determine the market share for the product, the potential competition and an understanding of the products already on the market addressing the same need.
Not Working With Experts
Trying to create a medical product design without a design team with experience in the medical device field is an error that is very common with new companies. It can also happen in established companies when the in-house engineering and design team doesn’t take advantage of professionals actually developing prototypes and then ramping up to production.
Not Understanding the Validation Process
With medical devices, even in the pre-clinical stage, validation and verification of processing, including traceability of materials, will be an essential part of the reporting required to obtain permission.
Not knowing the specifics of how this verification will be completed as well as going through the design validation process are two other critical errors that can easily prevent a quality medical product design from getting approval.