To Launch or Not to Launch
Quality pros help streamline medical device development and eliminate last-minute conflicts
by Les Schnoll
with the enactment of the Quality System Regulation (QSR), 21 CFR 820, in 1996, the world of research and development changed significantly for many medical device manufacturers.
Then, in 1997, when the process of design controls came under the auspices of the Food and Drug Administration (FDA), that world changed even more. Activities such as risk assessment and management, design transfer and documentation of activities in a design history file (DHF)—once only known and implemented by relatively few progressive organizations—became regulated and thus became the basis of many FDA Form 483 findings and warning letters. The use of a product development process (PDP) in the FDA-regulated world was born.
To ensure compliance with the requirements for design controls defined in the QSR, companies should use a structured PDP with well-defined degrees of freedom that instills discipline into the complete product life cycle without sacrificing creativity.
In this scenario, actions required to take an entire product offering from conception to commercialization are structured in a hierarchy. The hierarchy arranges these actions from phases (the highest level) to steps to activities and finally to tasks (the most specific). Phases divide product development into stages, and each phase has a unique theme and set of deliverables.
Early phases emphasize concept formation, product definition and project planning; later phases focus on development, verification, rollout and maintenance of the defined product. Careful planning and flawless execution are desirable attributes of all phases. The PDP process I describe here is comprised of five phases.
Phase 0—concept research: The concept research phase is initiated through the use of an approved concept project proposal. This starts the PDP but precedes the use of formal design controls.
The purpose of this phase is to identify new market opportunities, determine and prioritize customer needs, and conduct a high-level, rapid, assumption-based evaluation of the opportunities to assess their strategic fit.
The concept research phase concludes with management approval of an integrated business plan for the project. This document is updated at the conclusion of each phase. Once approved for phase 0, the team may begin phase 1 activities and the initiation of design control.
Phase 1—definition and planning: The definition and planning phase initiates the design control activities. The first step in this process is the establishment of a DHF. The purpose of the definition and planning phase is to define a whole product offering and complete the project plan. Key deliverables from this phase include the formalization of the customer requirements and product requirements specifications. It is in this phase that the design requirements specification is prepared.
Phase 2—design and development: The purpose of this phase is to design and develop the whole product offering and the supporting processes. The key deliverable is a complete design and development activity that delivers a product that is ready for verification and validation testing. Design changes beyond this phase are handled using the appropriate document control procedures.
Phase 3—verification and validation: The purpose of phase 3 is to verify and validate that the entire product offering and its supporting processes are robust and comply with the design requirements specifications and the customers’ specifications before making the product commercially available.
All regulation, code, standards and product safety approvals must be obtained by the end of this phase. Although orders cannot be accepted and customer shipments cannot be made until phase 4, demand-building activities may be initiated in anticipation of commercial release.
Phase 4—commercialization: The purposes of phase 4 are to deliver the product to customers in a controlled manner and to gather performance feedback on products that are commercially distributed. Full-scale launch of the product, including the release of evaluation equipment, coordinated mass communication to customer and the release of final pricing information, is initiated in this phase.
A commercial release notice is developed and distributed to indicate commercial availability of the product. In support of the product launch, manufacturing operations are ramped up to support full-scale production. In addition, a postlaunch evaluation is conducted to assess the overall success of the product versus the original targets. The core team exits the project at the conclusion of this phase and transfers product ownership to the supporting organization.
Steps and activities
The levels that are below phases within the structured process are steps that consist of multiple activities and are used to manage the progress of product development. Steps are the primary planning and scheduling mechanism to ensure all aspects of the whole product are considered.
The levels below steps within the structured process are activities and define in more detail how a step is performed. These consist of a number of tasks and describe the day-to-day work individuals do to complete their activities. Tasks can be thought of as work-scheduling units at an individual level.
Collectively, the structured whole-product process provides the basis for decision-making, project scheduling, resource planning, process measurement and continuous improvement.
Certain elements of the design control requirements are initiated by phases. In general, these elements continue through the development process and are maintained through the change control process.
Table 1 contains the design control elements that are initiated in each phase. In general, these elements continue through the development process and are maintained through the change control process.
The PDP should be flexible and scalable; that is, it should be generic, comprehensive and applicable to all projects at each phase level. Some steps and activities may not be applicable to all projects, however, and the process should be flexible enough to allow for these differences.
At the end of each phase, the project team tailors the process for the next phase by identifying and justifying steps, activities and deliverables that will not be applicable to its project. This is documented in the design and development plan for the next phase. This process is shown in detail in Figure 1.
In addition to documenting and defining a logical approach to commercialization of new or modified medical devices, the PDP also reduces the potential conflicts between functional groups, such as marketing and quality.
I’m certain that each of us has experienced—at least once—debates and accusations that quality is delaying the launch of a product. In today’s environment of quality acting as a strategic business partner (rather than as the quality cops), the use of a PDP only enhances that relationship. Quality and regulatory personnel should be members of any project core teams, and their early input into the PDP will eliminate most of the eleventh-hour conflicts prior to launch.
The company’s management team bears the responsibility for ensuring the process is implemented and followed. While there are always exceptions to the phased-gate approach shown in Figure 1, they need to be exactly that—exceptions.
Core teams should understand that their failure to meet all requirements in the applicable phases of the process will preclude their ability to move forward. This way, any delays that impact product launch are the responsibility and the ultimate result of the core team’s failure to follow documented procedures.
It’s clear that the ability to launch a product on a timely basis is key to the success of a company. What is typically not so clear is whether the product is ready to launch. An effective PDP, tailored to the needs and products of the company, is a useful and proven method to address the second issue. A great deal of work is required to implement a PDP, but the rewards will be immediately apparent.
Les Schnoll has 30 years of experience in industries regulated by the Food and Drug Administration and is currently vice president of quality, regulatory affairs and operations for ThermoGenesis Corp. in Rancho Cordoba, CA. He is a senior member of ASQ and an ASQ certified quality engineer, auditor and manager. A member of the U.S. technical advisory group to International Organization for Standardization technical committee 176, Schnoll wrote The Regulatory Compliance Almanac (Paton Press, 2001, 2008).