Medical devices are part of our everyday lives. Whether you’re taking an over-the-counter pregnancy test or using precise surgical instruments, you need these devices to work well. When the consequences of mistakes are much more severe, product developers must consistently put forth their best work. As such, there are certain mistakes and errors medical device developers know to steer clear of. Learn how these crucial products come to market with this rundown of the common pitfalls to avoid during medical device product development.
Overlooking User Needs
A product won’t work if the end user can’t actually use it. If a product is difficult to operate, too expensive for most target users’ budgets, or inefficient in a user environment, it won’t fulfill its purpose. Prioritizing the user and their needs means making a product that’s intuitive, efficient, and cost-effective. To do that, development teams must keep the end user in mind every step of the way. Medical device developers must consider user needs, such as the work they do, the environment they operate in, the tools they already have on hand, and more.
Not Prioritizing Quality Management
Quality management helps refine a product from a rough concept into an effective device. When development teams overlook or delay quality management processes, they risk putting an unsafe or ineffective product on the market. That’s why teams must think of quality management not as a one-and-done item on the to-do list but as a thorough and ongoing operation. It helps to work with an ISO 13485 certified company, as developers with this certification have demonstrated their commitment to quality, safety, and customer satisfaction.
Keeping Poor Records
All good businesses and business practices rely on thorough record keeping. A lack of notes—or poorly kept notes—can lead to missing information, communication errors, and slow, clumsy processes. That’s why poor records are one of the most important pitfalls to avoid during medical device product development. Good records improve efficiency, communication, and collaboration throughout any project. This diligence is particularly important during research and development tasks such as medical device manufacturing. Good record keeping enables development teams to communicate and collaborate effectively, examine mistakes, and find practical solutions.