Tuesday, June 17, 2008

Who Needs A Product Development Process?

One of the ways we add value to our customers to help them understand the Product Development Process (PDP). Established medical device companies have proven PDP's that have been tested and refined through numerous product developments. Small and early stage medical device companies often enter into a development program without the benefit of an established process. This is where we can help. PADT Medical has an established and refined PDP that we utilize with companies that do not have one of their own.

A well defined PDP provides a high level road map that helps development teams understand how to navigate the medical device development process. Our PDP satisfies the FDA Design Control regulations while at the same time providing the efficiency and flexibility that meets the needs of companies developing innovative new medical devices. There are always surprises, detours, and hurdles in development. The PDP is the all important tool thats keep a program on track and the focus on the finish line.

When we meet with prospective clients, one of the first things we try to understand is where the medical device is on the product development roadmap. We have found that having a one-page overview that highlights the development phases, documentation, and procedures is an invaluable tool for communicating progress to-date and the work remaining.

Here is a link to PADT Medical's one-page PDP overview.

If you are developing a new medical device and you are unsure about the steps required to take your concept to market, feel free to contact PADT Medical. We can help you understand the process and provide tips on how to avoid some of the most common pitfalls encountered by device developers. In the coming blog posts, we will elaborate on various pieces of the PDP that we use at PADT Medical.