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The Anatomy of a Successful Design Plan

                                                                                                                                                                                                                                                                


Are you interested in learning more about how to create a succesful design plan? Mr. Packard will be speaking on this topic at OMTEC 2014.

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Did your latest project plan begin with a bold idea and the hope to fill your booth at AAOS with innovation and excitement?

Did that project plan end with another line extension and the cold reality that your team was eight weeks late for the biggest event of the year?

Your project didn’t need to end that way, but you can console yourself in knowledge that most of your competitors had projects that slipped just past the deadline, too. If you want something to cheer about next year, you need to master the design and construction of medical device design planning. Every manufacturer must make design planning a core competency for survival.

MBA programs teach managers that it is more important to implement plans effectively than it is to develop the perfect strategic plan. Unfortunately, successfully developing innovative orthopaedic implants is not just about implementation. The pathway to regulatory approval is narrow, winding and filled with peril (and sometimes flying monkeys).

Step 1: Start with the End in Mind
The first key to a successful design plan is to “start with the end in mind.” Unfortunately, most design teams believe that the “end” is when you complete the design. The truth is that regulatory approval is the “end.” Once you understand this truth, you will begin to understand why most design plans are flawed. A design plan should end with a completed regulatory filing that has been reviewed and recommended for approval or cleared for market.

Therefore, in order to achieve this goal, I recommend organization of your plan milestones in accordance with the requirements for a 510(k) or the requirements of a Class III Design Dossier. Both of these submissions consist of similar summary technical documents or STEDs. Most companies complete the design verification and validation (V&V) testing phase, and then they begin furiously writing STEDs for submission.

Instead of writing the STED after you complete design V&V testing, try writing your STEDs before you complete design V&V testing. You may not have report numbers or test results, but you can leave blanks in your STED to fill in later—just like you would for a test protocol when you don’t know what the lot number is or the calibration identification number for the test instrument you will be using.

Step 2: Standardization
Instead of creating a new testing protocol for each design project, the best practice is to standardize your protocol for each test. By doing this, you eliminate the need to write a new protool and you increase the predictability and consistency of duration for each test. I like to think of the protocols as the spine of a design project. If your “spine” (i.e. – test protocols) is strong and properly aligned, your design project will have fewer delays.

Subject matter experts (SMEs) should be established for each type of design V&V testing that is required. A back-up SME should be identified for each of these tests as well. These SMEs have several important roles. The most important role is to maintain these standardized test protocols. This includes:

  1. Reviewing new and revised external Standards related to the testing,
  2. Educating other team members on important aspects and project risks associated with the testing, and
  3. Ensuring that protocols are appropriately applied and revised when needed.

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