DESIGN AND DEVELOPMENT PLANNING OF MEDICAL DEVICES

DESIGN AND DEVELOPMENT PLANNING OF MEDICAL DEVICES

Developing a new device and introducing it into production are very complex tasks. For many
new devices and associated manufacturing processes that use software, these tasks are further
complicated because of the importance of software, and the possibility of subtle software errors.
Without thorough planning, program control, and design reviews, these tasks are virtually
impossible to accomplish without errors or leaving important aspects undone. The planning exercise
and execution of the plans are complex because of the many areas and activities that should be
covered. Some of the key activities are:
• determining and meeting the user/patients requirements;
• meeting regulations and standards;
• developing specifications for the device;
• developing, selecting and evaluating components and suppliers;
• developing and approving labels and user instructions;
• developing packaging;
• developing specifications for manufacturing processes;
• verifying safety and performance of prototype and final devices;
• verifying compatibility with the environment and other devices;
• developing manufacturing facilities and utilities;
• developing and validating manufacturing processes;
• training employees; • documenting the details of the device design and processes;
and,
• if applicable, developing a service program.
To support thorough planning, the QS regulation requires each manufacturer to establish and
maintain plans that describe or reference the design and development activities and define
responsibility for implementation
The plans should be consistent with the remainder of the design controls. For example, the design
controls section of the quality system requires a design history file (DHF) [820.30(j)] that contains or
references the records necessary to demonstrate that the design was developed in accordance with
the:
1. approved design plan, and
2. regulatory requirements.
Thus, the design control plans should agree with, and require meeting, the quality system design
control requirements. One of the first elements in each design plan should be how you plan to meet
each of the design control requirements for the specific design you plan to develop; that is, the design
plans should support all of the required design control activities. Such plans may reference the
quality system procedures for design controls in order to reduce the amount of writing and to assure
agreement.
Interface
Design And Development Planning section 820.30(b) states:
“The plans shall identify and describe the interfaces with different groups or activities that provide,
or result in, input to the design and development process...”
If a specific design requires support by contractors such as developing molds, performing a
special verification test, clinical trials, etc., then such activities should be included or referenced in
the plan and proactively implemented in order to meet the interface and general quality system
requirements. Of course, the interface and general requirements also apply to needed interaction
with manufacturing, marketing, quality assurance, servicing or other internal functions.
Proactive interface is a important aspect of concurrent engineering. Concurrent engineering is
the process of concurrently, to the maximum feasible extent, developing the product and the
manufacturing processes. This valuable technique for reducing problems, cost reduction and time
saving cannot work without proactive interface between all involved parties throughout all stages of
the development and initial production program.
Structure of Plans
Each design control plan should be broad and complete rather than detailed and complete. The
plan should include all major activities and assignments such as responsibility for developing and
verifying the power supplies rather than detailing responsibility for selecting the power cords,
fuseholders and transformers. Broad plans are:
• easier to follow;
• contain less errors;
• have better agreement with the actual activities; and
• will require less updating than detailed plans.
Over the years, several manufacturers have failed to follow this advice and opted for writing
detailed design control procedures. They reported being unable to finish writing the over-detailed
procedures and were unable to implement them.
Regardless of the effort in developing plans, they usually need updating as the development
activities dictate. Thus, the QS regulation requires in 820.30(a) that the plans shall be reviewed,
updated, and approved as the design and development evolves. The details of updating are left to the
manufacturer; however, the design review meetings are a good time and place to consider, discuss
and review changes that may need to be made in the design development plan.