Our process makes it easier for innovators to take their concepts to market. One factor is how we work with clients to develop clear "requirements" in the beginning of every project. It's one of the keys to our clients' success.
In our experience, unclear design requirements are the most frequent source of misdirection in a project. When time-to-market is critical, a detour in the project development path can significantly threaten the life of a product.
This is why at PADT Medical we make requirements a requirement. No joke! The good news for our clients is that we guide them through it, so rather than an onerous process, it's one they recognize as value-adding and on the path to success.
There is a reason why ISO, MIL Specs, textbooks, and other professional publications insist on starting with defining and documenting design requirements. When this "best practice" is skipped the cost to the program is realized in the end.
There are numerous books and sources available to describe the process of collecting customer requirements. A book we refer to is "Product Design & Development" by Ulrich and Eppinger. The FDA Quality System Manual also offers some good insights into some of the questions that should be asked when collecting requirements. We highly recommend becoming familiar with the Requirement Engineering in order to successfully develop new products.
Don't worry: we'll take you through the requirements process and whatever it takes to succeed!
Thursday, March 20, 2008
Thursday, March 13, 2008
Track Record of Success
We thought we'd start by providing some background on us. First of all, I'm Scott Klopfenstein, and I'm a project manager at PADT Medical. I'll be joined in this blog by others on the team who are similarly dedicated to your success.
It takes an experienced and balanced development team to develop new medical and biomedical devices. The regulated medical device market imposes unique requirements and challenges on those who are developing new products. Our clients have told us that working with people who understand these challenges is essential to their success.
Developing this expertise is one of the key drivers behind PADT Medical. We are totally dedicated to our clients' success.
We are a specialized group within Phoenix Analysis & Design Technologies (PADT) that is dedicated to medical device development. PADT has been involved with medical device programs from 1994 with the goal of becoming the premier engineering services company in the Southwest.
Our experience and expertise are instrumental in helping our clients succeed. We also provide other support that we'll be discussing as we go along that sets us apart from all others.
As you consider working with companies to help bring your innovations to market, be sure to evaluate their level of experience in medical devices. Ask these questions: (1) What percent of their business is related to medical devices, and (2) do they have a mature quality system?
If the company has a track record of success in medical devices and their quality system is reportedly QSR compliant, then evaluate them further to see if they are good fit. We always aim to be a great fit with our clients!
It takes an experienced and balanced development team to develop new medical and biomedical devices. The regulated medical device market imposes unique requirements and challenges on those who are developing new products. Our clients have told us that working with people who understand these challenges is essential to their success.
Developing this expertise is one of the key drivers behind PADT Medical. We are totally dedicated to our clients' success.
We are a specialized group within Phoenix Analysis & Design Technologies (PADT) that is dedicated to medical device development. PADT has been involved with medical device programs from 1994 with the goal of becoming the premier engineering services company in the Southwest.
Our experience and expertise are instrumental in helping our clients succeed. We also provide other support that we'll be discussing as we go along that sets us apart from all others.
As you consider working with companies to help bring your innovations to market, be sure to evaluate their level of experience in medical devices. Ask these questions: (1) What percent of their business is related to medical devices, and (2) do they have a mature quality system?
If the company has a track record of success in medical devices and their quality system is reportedly QSR compliant, then evaluate them further to see if they are good fit. We always aim to be a great fit with our clients!
Thursday, March 6, 2008
Getting Started
Welcome to the PADT Medical Devices blog. Our purpose is to provide useful information about the development of medical devices to emerging medical device companies that are commercializing new products.
Our entire team at PADT Medical is focused on reducing time-to-market by utilizing computer simulation and rapid prototype testing to quickly converge on design solutions. This enables our innovative clients to better achieve design goals, implement manufacturing and more rapidly take their concepts to market.
In the coming posts we hope to provide commentary, tools, and tips that highlight how we help make this possible.
Our entire team at PADT Medical is focused on reducing time-to-market by utilizing computer simulation and rapid prototype testing to quickly converge on design solutions. This enables our innovative clients to better achieve design goals, implement manufacturing and more rapidly take their concepts to market.
In the coming posts we hope to provide commentary, tools, and tips that highlight how we help make this possible.
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