Getting Started

The most often asked questions at PDC meetings are:

  • What is the overall design paradigm to follow when developing a new device?
  • How do I know if there is a market in the pediatric device arena for my idea?
  • How do I find out if someone else has already thought of my idea?
  • How do I file for intellectual property protection for my idea?
  • What is the FDA regulatory process?
  • Where can I find start-up money for my invention?

There are many sources to answer these questions. We have selected those that we feel are most appropriate for the development of medical devices for children. We will explain the procedures associated with each process or agency and provide selected links to their web sites for additional information.

Device Design Process

The medical device design process, as with other design processes, can be broadly divided into six areas:

  1. Market
  2. Design specification
  3. Concept design
  4. Detail design
  5. Manufacture
  6. Sell

There are many different ways to go about each of these issues. We feel that the best place to start is an article made available by the National Institute of Health. It was written in England by a group of engineers. The content of the article gives a good description of the overall process to follow in the design of a new medical device.

The design process for medical devices is highly regulated to ensure the safety of patients. This paper will present a review of the design process for implantable orthopedic medical devices. It will cover the main stages of feasibility, design reviews, design, design verification, manufacture, design validation, design transfer and design changes.

Although the article deals with orthopedic devices, the basic principles and questions asked would fit for any device use evaluation, design, regulation review and manufacture.