The Anatomy of a Successful Design Plan

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.

Step 3: Monitoring, Measurement and Data Analysis

“What gets measured gets done” is a popular management saying attributed to several famous authors, but the concept of quantifying and analyzing quality issues prior to setting quality objectives is the foundation of Quality Assurance and ISO Quality Management Systems (see Clauses 8.2.3 and 8.4).

Some design and development managers track accuracy of project completion dates, but this degree of measurement is too crude. I like to think of design metrics as being equivalent to patient data in a clinical study. You need more than patient age for your study reports, and effective targeting of design planning improvement efforts requires knowledge about the deviation from plan for each task in the overall project schedule.

Deviations can be tracked in Gantt charts by the project manager, but the best person to report on the date of task completion is the person responsible for the subsequent task. This will ensure that any transfer delays between tasks are captured.

In order to adequately analyze the overall timeliness of design project tasks, a software database is recommended. This will allow you to make the following types of comparisons:

1. Sorting and ranking of tasks by duration
2. Actual vs. planned duration for each task
3. Variability for each task type between projects
4. Correlations to product type and task duration or variation
5. Correlations to vendors and duration or variability
6. Correlations to seasonality and delays

Step 4: Establish Quality Objectives

Once you have data and data analysis for each of the tasks required to complete design projects, your next step should be to establish quality objectives for the design and development teams to improve their processes.

Your first inclination might be to pick your longest tasks and to make those tasks shorter. However, experience has taught me that the longest tasks rarely offer huge opportunities for shorter timelines. Instead of focusing on the longest tasks, target tasks with the greatest variability. Variability in duration of tasks disrupts subsequent tasks, and variability may result in changes to the critical path of the project. If you can eliminate the variability of tasks, you can reduce buffer lead time in your over- all project and launch dates will become more predictable.

For assignment of these quality objectives, consider assigning each V&V testing SME to monitor and report on the progress of the quality objectives for the task(s) they own.

The SMEs may also consider updating the standardized work instructions to include sections for:

1. Planning and preparation (see Step 5)
2. Preferred vendors
3. Monitoring and measurement of the testing process
4. Quality objective reporting
5. Process for initiating corrections/corrective actions

Step 5: Adopt & Adapt SMED Techniques

In the lean manufacturing world, there is a process improvement tool called “Single-Minute Exchange of Die” or SMED. SMED techniques are tools that allow a manufacturing machine to switch from one product to another with extremely little downtime. The basic concept is to take steps of the setup for the next product and perform many of those steps prior to stopping production of the previous product. Adjustments made to tooling and equipment while the equipment is not operating are called internal setup, and adjustments made to tooling on a cart while the equipment continues to run are called external setup.

You can apply SMED techniques to design V&V tasks, as well. If you take each verification and validation task and break it down into smaller tasks, you will identify tasks that can be performed prior to starting the actual design V&V testing. Here are some examples of preparation tasks that can begin before samples are ready for testing, with estimates of time saved:

1. Preparing shipping paperwork and packaging – 1 day
2. Protocol writing – 1-2 weeks saved
3. Review and approval of GLP protocols – several days
4. Requesting quotations and obtaining purchase orders – several days
5. Reserving testing dates – days to weeks, depending upon lab workload
6. Selecting labs with faster reporting and/or electronic reporting – several days
7. Performing testing in-house – days to weeks
8. Performing test method development on prototypes – several weeks

SMEs for each test should be trained on lean manufacturing principles. This will give them the tools to analyze each testing task for opportunities to perform preparatory tasks in advance and to eliminate queue and batch waiting time whenever possible. As these opportunities are identified, process flow charts for the improved process should be documented in standardized work instructions for each type of test.

Step 6: Continuous Improvement

As your company develops new products and your design process changes, the weakest link of your design process will also change. Therefore, SMEs and design project managers need to continue monitoring the duration of each task and analyzing the results against the data for previous projects. When you make changes to your design procedures, you also need to evaluate the impact of the changes upon existing projects. Whenever you make a change to a procedure or testing protocol, it is important to define which current projects will implement the change and which projects will use the prior version.

Finally, once the variability of your design project planning is reduced to a sufficient degree, you may be able to establish target durations for each task as well as upper and lower control limits for the variability in duration of each task. This degree of design process control is unheard of in medical device development. However, the automotive industry has demonstrated that it is possible to launch a new product every year at the same time with 100 percent confidence. Imagine the competitive advantage that being able to guarantee a new product each year for AAOS would give your company over the competition.

Robert Packard of Packard Consulting is a regulatory consultant with 20 years of experience developing products and managing projects in the medical device, biotechnology and pharmaceutical industries. His experience includes research, product development, operations management, manufacturing engineering, equipment design, regulatory affairs, quality assurance and fundraising. Mr. Packard’s passion is training others. Specific questions about ISO 13485 Certification or Quality System training can be directed to him at rob@13485cert.com.

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