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.

Two More Lessons On Requirements

On the path to helping our clients achieve success with their medical device developments, here are two more lessons we have learned about requirements.

Lesson 3: Focus on what-not-how

Perhaps the biggest potential mistake in the design process is to focus prematurely on the "how" characteristics in the requirements document. The attention early on should be on what the product does, achieves or could be. Don't focus on how it will achieve it. The requirements should focus on the what-not-how of the product.

One way to support success in this area is to make sure requirements and specifications are "independent" measures and not dependent measures. For example, in a potential medical device, actuation rate would be an independent variable that would depend on the design of the mechanism and power source that powers the actuation. These how's should not control what your medical device could achieve.

Lesson 4: Release and track changes

Requirements change. The goal is to make sure that changes are clearly communicated to the design team in order to facilitate success. We quickly complete a requirements document and release it. Any changes that occur go through an approval process, and the act of changing and disseminating the revised requirements document is an effective communication tool. We make it easy for clients to design, communicate and reach their ultimate goals.

At PADT Medical we work closely with clients to help in every aspect of getting their idea to market, including developing medical device requirements that enable success.

Two Lessons Learned on Requirements

On the path to helping our clients achieve success with their medical device developments, here are two lessons we have learned about requirements.

Lesson 1: Capture them

From the moment you begin discussing the details of a new product, begin describing its requirements and specifications. There are many creative ways to gather these. The key is to "set the trap" and start recording. This is a mindset and reaction. When you hear of a requirement, capture it by recording it on the fly into a document. We'll get this information into the Product Requirements Document. Over time you will have an impressive list of requirements that you can review to create clarity on the goals.

Lesson 2: Don't get distracted

It's easy to get distracted by focusing on the organization of the requirement document, the wording of requirements or going out of scope and focusing too early on the specifications. We help our clients avoid this. The goal should be to capture the requirements and refine them later. One thing to keep in mind is that there is no ideal organizational method, so don't get hung up on that. Also, specifications can remain unclear until significant development testing is conducted. Don't get too excited about defining detailed specifications before their time.

The requirements process can seem onerous, and so at PADT Medical we work closely with clients to help in every aspect of getting their idea to market, including developing requirements that enable success.

Medical Device Requirements vs. Specification

There is occasional confusion when discussing what it means to establish "requirements" for a medical device project. The word is so generic that few people agree to its meaning. One thing we have found to be helpful is to define the difference between a requirement and a specification.

We define a requirement as a medical device characteristic that would be described by the end-user or customer. It is typically a general statement of "want" about the product. We define a specification as a "metric" that measures how well that requirement is satisfied.

In an ideal world, each customer requirement would have a single measurable specification. For example, the customer might state that the medical device must be lightweight. The obvious specification (or metric) would be product weight. This is something that we can measure in the lab, compare to a competitive product and track over the course of development.

So a requirement uses customer language and a specification uses engineering language. We'll be discussing four lessons we have learned about requirements in our next posting.

Making it Easier: Requirements

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!

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!

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.