| Did you ever hear the saying, “garbage in, garbage out?” Perhaps you’ve used it yourself at times, as when your teenager insists on writing their 20-page term paper the night before it’s due. Parents, having the benefit of decades of life experience, know that the outcome of a last ditch effort of this type will most likely not turn out well.
This wisdom also applies particularly well to the medical manufacturing process. The FDA is like the parent in this instance, mandating that Design Transfer Procedures be in place to avert the types of disasters which might ensue if the “garbage” philosophy were carried out. Meant to ensure that medical device designs are correctly translated into production specifications for manufacturing, Design Transfer Procedures keep those directly involved with the manufacturing process in check. It is absolutely vital that those involved in manufacturing receive accurate and complete information. Imagine what would happen if an engineer provided a manufacturer with faulty design information. Components could be made to the wrong specifications or of a material that proves toxic to the application. These errors range in negative effect from being costly in terms of dollars wasted to perhaps costing someone their life. A Design Transfer Procedure would ensure that a variety of mishaps do not occur during the transfer process. The procedure is typically overseen by the medical device company’s management. For example, a Design Transfer Procedure would lay out responsibilities of supervisors and managers to make sure the latest revision of electrical schematics, bills of materials, Gerber files, and quality testing procedures are received by the manufacturer of a device’s printed circuit boards. It’s important that the order is received in a timely manner so as not to hold up the manufacturing process. However, it’s much more important that the printed circuit board is made properly, the correct electrical components are placed on it in the correct orientation, and it is tested to make sure it doesn’t malfunction after assembly. Design Change Procedures basically ensure that when changes are necessary, the medical device company follows all the procedures for Design and Development Planning, Design Input, Design Output, Design Review, Design Verification, and Design Validation. Once the changes are reviewed, validated, verified, and approved, they can be incorporated into the original device design. This is where the Design Change Procedure must dovetail with the Design Transfer Procedure to make sure the correct information is provided to the company’s management staff in the procurement, manufacturing, product service, and warehouse departments. This is to make sure they can keep component vendors on track with the changes, maintain sufficient inventory of the changed components, put the right components in the device during assembly, and properly support repair technicians in the field. Yet another aspect of Design Controls promulgated by the FDA comes into play with the establishment of procedures for maintaining a Design History File (DHF). This DHF contains all documentation created during the life cycle of the project, meaning, movement from creation to completion and on into market introduction, sometimes beyond. DHF Procedure sets up protocols for collection and organization of information about the medical device design, starting with design documentation and covering the gamut from design changes, to validation testing, to design verification, and on to design review. All this is done to ensure that the initial product design was developed in accordance with the original design plan and overall product design requirements. _____________________________________________ |
Posts Tagged ‘design changes’
Medical Device Design Controls – Transfer, Changes, and History
Sunday, September 12th, 2010
Medical Device Design Controls – Planning and Input
Sunday, August 29th, 2010| Have you ever had the divine experience of remodeling a major-use room of your house? Was the general contractor you employed able to understand what you wanted, plan out the work according to your requirements, and finish the job to your satisfaction? Maybe you had the unfortunate experience of hiring one that forgot your requirements, made things up as they went along, and stuck you with a room that looked awful, violated building codes, and didn’t meet your needs.
Now imagine what would happen if a medical device company took this haphazard approach to designing new products. Suppose the company’s engineers ignored the input of regulatory, marketing, procurement, quality control, and manufacturing staff? What if they chose not to follow applicable industry standards for performance and safety? And what if they failed to check design calculations or test prototypes for errors before putting the device into production and introducing it to the marketplace? The result is likely to be unfavorable, just like your contractor forgetting that you wanted a black granite countertop, not a beige one. To help eliminate painful and costly scenarios such as these, the FDA requires that medical device manufacturers establish and maintain procedures to control the design of Class II and III devices, and even some Class I. This requirement for a system of design controls is part of the Quality System Regulation (QSR) under Title 21 of the Code of Federal Regulations. In case you’re not too familiar with the Code of Federal Regulations, Title 21 gives the FDA legal authority to regulate food, drugs, and medical devices in the United States. So what falls under the premises of FDA design controls? Well, the FDA requires that a medical device company develop procedures for:
For now, let’s focus on Design and Development Planning and Design Input Procedures. In the Design and Development Planning Procedure companies must carefully plan who will be involved in each phase of product development, as well as how they will interact, all in an effort to ensure that information flows and design requirements are met. The right pool of people would include design engineers, in addition to those employees responsible for making sure that regulations are complied with and those who are charged with securing intellectual property rights to the design. Then there are those who must acquire the physical materials required to manufacture the device and those who will do the actual manufacturing of it. Also, those responsible for quality control, marketing, sales, and product service should be involved. Perhaps others should be involved as well. Mind you, the Design and Development Planning Procedures are not set in stone. They must be regularly reviewed and updated as the project evolves. Now let’s talk about Design Input, which is another term for a design requirement. These inputs can come from inside or outside the company. An example of a requirement coming from within is when Marketing stipulates that the maximum manufacturing cost of the device should not exceed $150 in order to maintain an acceptable margin of profit and be most competitive in the marketplace. A design requirement coming from outside the company would include industry standards that make specific requirements, such as requiring that the device in question be designed to protect its electronics from radio frequency interference. Next time we’ll continue our discussion on medical device design by exploring Design Output, Design Verification, and Design Review Procedures. _____________________________________________ |
