The use of project templates in medical device development
Cynthia A. Berg, PMP
Micro-Rel is a wholly owned subsidiary of Medtronic Incorporated, founded in 1973. Micro-Rel reports annual sales of $100 million and has 980 employees in Tempe, Arizona. Micro-Rel is a fully integrated supplier performing R&D, new product development and full manufacturing of final products and their major subcomponents. The largest percentage of product goes into the manufacture of heart pacemakers, and are microprocessor-based, involving both hardware and software development. Micro-Rel's organization supports both Medtronic and non-Medtronic customers.
The combination of pressures that are unique to our industry includes:
- FDA regulatory influence, including the need to register any “significant” change in existing approved products
- The need for ISO compliance
- The use of global teams
- Increased international competition (increasing need for speed to market)
- Cost pressures (government revamping of the health industry as well as the opening of the Third World markets).
Project Templates in New Product Development
A project template is a specific and repeat-able format for the purpose of uniformly describing processes, plans, and other documentation. Following this template results in a reliable product with a defined development trail. The results of this process are open to review by government or management agencies.
While the use of project templates is not new to the field of project management, when applied to our industry, specific issues become apparent. Being in a highly regulated industry, and subject to rapidly changing market pressures, we are sensitive to documentation requirements. We maintain histories, recipes and templates detailing the development process for each of our products as permanent auditable files.
Micro-Rel's “Micro Circuit Development Protocol” is an example of a new product development (NPD) template. We created it as a guide to the NPD process as well as to ensure compliance to Federal Drug Administration requirements for Implantable Pulse Generators. Our template arose from the need to prove both that we have a defined process for the development of new products and that we have a repeatable and successful process. This minimizes any potential of future development failures.
One of the major benefits of a template for project management is that it provides an audit trail and verifies product efficacy and conformance to requirements. The template formalizes all milestones and qualification or review requirements of regulatory agencies prior to formal product approval and release for market.
Another important benefit is that it provides inexperienced project team leaders a structured discipline and a basic work breakdown structure. Typically project managers at Micro-Rel have no formal training in project management. They became project managers as a result of doing a good job in another discipline (the accidental project manager syndrome). Training, if accomplished at all, is typically a process of trial by fire.
Micro-Rel implemented its NPD template in 1991; prior to then we had been doing “freeform” project management. Each project leader created a new management and development model each time we developed a product. The process was often equally stimulating, frustrating, and time consuming. Development cycle times from design to first implant sometimes stretched to three years. By the time we received FDA approvals to market our product in the United States, the technology and design were no longer leading-edge. We needed to examine what we could do to compress our development-to-market cycle time, as well as our ability to ease the FDA review process. Our answer to this strategic challenge was to reevaluate our project management process and change the structure of our organization to support project management.
The first strategic decision involved changing our organizational structure. Traditionally we had operated in a functional structure with project leaders that solicited cooperation on projects from functional manufacturing and design departments. The process was tedious, time consuming and unreliable. Success was due more to personal dynamics than strategic imperative, and certainly not a consistent and repeatable process.
In order to establish a structure to support NPD, Micro-Rel established dedicated project teams that contained a member from each of the major functional disciplines (product, design, and test). These teams were co-located to establish a team identity and to increase information flow and cross-functional learning. Concurrent engineering on these projects by geographically dispersed teams mirrored the organizational structure and learning at Micro-Rel. This common environment elevated the local experience to a global level. Although the project teams operated in a projectized group, the balance of our company remained operating in a functional or weak matrix structure.
At Micro-Rel, in the Bradycardia Pacing Business, there are currently three dedicated project teams, and at any given time these teams are shepherding two to three new products. Since we have embraced dedicated project teams and implemented our development protocol (as well as other project management standard practices) we have seen our development cycle time shrink from years to 14 months.
NPD Template (Micro Circuit Development Protocol)
The second major strategic response to the need for shortened cycle times and quality development was the “Micro Circuit Development Protocol” (Micro-Rel's NPD template). The goal of our template was to establish a standard for developing products. We acknowledge that each product is unique and some portions of the template may not apply, and therefore we allow for project-level adaptation of the template. By following the template on a development we knew that our products followed a consistent design, documentation and verification process. As a result, we hoped to create a model for NPD that was more efficient in the ability to meet both customer and regulatory requirements.
Our NPD template starts with a work breakdown structure that identifies all major milestones in each stage of the development process for the product as well as each subcomponent of the product. The milestones include major decision-making points as well as formal review requirements. This ensures that we locate and correct any errors in design as early as possible in the development cycle, thus preventing costly redesign and rework loops.
Following the NPD template provides an outline or overview of the general operating requirements and overview of project management principles that govern NPD at Micro-Rel. It details the record keeping requirements as well as requirements for change control system and supporting documentation. There is a section detailing general project planning guidelines that include recommendations on good project management practices (including risk analysis and resource identification), and a summary section to discuss review requirements (who, what and when).
The NPD template then continues through each “generic” stage of NPD. Each stage contains the following information:
- Responsibilities—who is responsible? (a responsibility matrix by function or job title)
- Requirements to start—what must be completed prior to this stage?
- Activities—what actions need to be performed?
- Deliverables—what is the outcome of the activities performed?
- Reference documents—all associated specifications that may impact the parameters or scope of the activities in this section.
In addition to the NPD template, Micro-Rel has a supporting document that is also responsible for our ability to expedite our product through all the subsequent stages of the manufacturing and development. This document is an informal guide created by a cross-functional group of production planners and administrators who were looking for a way to accelerate the transition of new products into full production. This development guide focuses on the requirements of the manufacturing facilities and functional operational needs to efficiently build prototypes and ramp-up to full production levels. The document contains a glossary of area-specific terms to establish a common language. It contains a guide of typical manufacturing flow as well as explanations and samples of all documentation required. It also includes a list of key contacts in each area (by job title). All engineering staff have a copy to help them orient their work and align with manufacturing requirements.
The main pitfall of relying on a template for NPD lies in the potential to stay with the familiar formula and squelch innovation. The dynamic of NPD lies in innovation: the melding of new ideas and technologies into concrete products. We believe that part of innovation is borne from the process of NPD. The process and the product exist in mutual symbiosis with each spurring on the other.
Figure 1. PONC as Percent of Total Budget
You might ask “can you separate the creation of the product from the process of the product?” By following a formulated process, the developer ensures conformance to reporting requirements and expects to achieve higher efficiencies and performance levels. By defining the process have we stifled new ideas by continuing to “think within a box”? Are we challenging our product to reach new heights, or are we riding in a cart being pulled by a horse with blinders on, following the same path we have always taken? The difference depends on the degree of flexibility in the template. There needs to be enough flexibility to encourage technology innovation, while maintaining structure to guide the management processes. The template is a tool to obtain a goal, not the goal itself.
To prevent creative stagnation and process obsolescence, as well as template flexibility, we believe it is essential to construct a review board to periodically examine the development template. This review board should consist of members directly involved in the product development process as well as some members involved in other areas who can remain detached and objectively question the practicality of our processes.
The review should not only examine current process and possible efficiencies, but also strive to benchmark other companies. In our industry, because of the highly proprietary nature of the products, it is not possible to benchmark at the detail level. Comparisons are made to similar processes at other companies apart from the products. If there are companies that manufacture products similar to product subcomponents, there is potential to leverage off their experience in that section of similar manufacturing and design.
Figure 2. Prototype Performance Improvement Trend
A process of continual review and feedback avoids stagnation in the model and encourages continual improvement.
Micro-Rel has demonstrated that the strategic use of new project development templates is essential for companies who are looking for efficiencies. Improvements occur both in conformance to requirements (whether they be regulatory agency's or owner-contractor's) and in reduction of NPD cycle times. An important aspect of this is in bringing non-practitioners up the project management learning curve. Since many product managers are practicing engineers, it is important that we provide them tools to be successful in a new discipline (documentation, milestones, cost and budget, and time management). We have achieved measurable results in the following areas:
- Compression of development cycle times (from 36 months in 1990 to 14 months in 1995, design to market release)
- Increase in number of products being developed concurrently from four in 1990 to nine in 1995
- Elimination of price of non-conformance (PONC) in NPDs (from 3 percent of development budget in 1990 to 0 percent in 1995) (see Figure 1)
- Ease for internal transition of new products from prototypes to full production
- Improved speed coming up the learning curve, starting with higher product performance measures from the initiation of the product (reduced scrap and rework) (see Figure 2).
Our story is an example of a whole company supporting the future of NPD. Embracing the discipline of project management through the application of a template, dedicated project teams and support of functional operations has had measurable benefits.
Increases in successful development (as measured by PONC and cycle time) of both new product and process technologies demonstrate the benefits of having a flexible structure in place to guide the development process. The structure itself, coupled with appropriate support systems, does not stifle but rather enhances creativity. It allows team members to focus on the creative portions of a project as opposed to continually recreating the management processes of project management and support of the corporate structure. ■
Cynthia A. Berg, PMP, is a business analyst for Micro-Rel Inc. She holds an M.B.A. in finance from Arizona State University.
PM Network • March 1996