Medical Product Design Tips

Medical product design requires its own unique approach, particularly from a plastics manufacturer's perspective.

Unlike many products designed for consumers, medical products inherently demand tighter tolerances and consistent performance. In addition to the usual quality concerns, doctors and surgeons have particular needs and expectations. Failure in any of these areas could in fact have a dramatic impact on their reputation, to say nothing about liability concerns.

As with any product design, the design concept should start with the focus on the end-user and work its way back to the designer. Each aspect along the chain is critical to an effective medical product. One common mistake many unfortunately make is to leave the entire project in the hands of the designer to allow them to work independently, or with minimal input from the key people along the value chain, from inception to completion.

During the product design stage, selecting the right suppliers to build a long term relationship with is critical. The right supplier should be able to review the design and offer non-biased input on the manufacturability of the product.  A supplier should be approached with the intent of having them help find solutions for making the most cost-effective design possible, rather than just supplying a quotation. Good suppliers will also have sufficient experience in addressing the many concerns specific to medical product manufacturing. For example, an experienced manufacturer should be able to suggest design modifications, in some cases, that could decrease the tooling investment significantly. 

Material Testing

For example, a company has a robust medical product design that will meet FDA Requirements and is both aesthetically and ergonomically pleasing, but the design requires some custom plastic components. Typically the cost of plastic parts are much less expensive than metal parts, but the tooling cost can be significantly more.

How to purchase a mold from the right supplier is also a very important factor. Experienced plastic suppliers should know that the mold design for plastic medical components is critical; where the mold is parted and gated (where the plastic enters the mold to begin forming the part and where the mold halves separate). It's also an important aspect when the part ends up on a medical instrument, especially if it is visible.

Some of the often overlooked, critical individuals along the value chain include:

Precision Components

The assembly and automation team
These individuals specify how the product will be assembled and what automation will be required. Those directly involved are often able to provide valuable information regarding part variation and can provide input regarding the potential for both fallout and production rates. For example, members of the automation team might recognize specific areas in the manufacturing process where the quality of the finished part can benefit from automation, and perhaps identify other areas where it is unnecessary, or cost-prohibitive. These people involved can provide valuable input on the assembly process or product design both to simplify it, and to reduce the rate of failure.

 The component suppliers: The various suppliers of the components that make up the finished product can often contribute valuable information and recommendations to an effective design.

Catalogue items: An experienced distributor will be able to recommend item options, addressing concerns regarding pricing, the availability of the item, and product consistency from lot to lot.  They should also be able to offer alternative solutions and understand what the impact of the product being replaced or discontinued altogether.

Custom metal products: Finding a metal product supplier who is well-seasoned in the many different processes in their industry, for your particular application is just as critical as finding an experienced plastic component manufacturer.

Platsic Resin

Custom plastic products: A well-seasoned plastics supplier will be able to understand how easily the components can be manufactured, and what process would be the most cost-effective so that they satisfy all safety and quality requirements.

Raw material supplier: Specifying the right material for the components to meet safety guidelines, durability and manufacturability from the start, is crucial. Changing materials at later stages can affect critical dimensions that have an impact on the form, fit, or even the function of the product.
 
Once the medical product design is complete, the next challenge is the planning stage, which requires diligent management of the supply chain. This is a critical requirement which many companies often overlook. Too often, buyers will either micro-manage the suppliers into failure, or work toward the other extreme and fully abandon their responsibility to the supplier.  Either extreme often results in fingerpointing which leads to a loss in productivity and additional problems.

Polypropylene head immobilizer

An effective project manager or Planner must possess the talent and skill to be able to hold suppliers accountable by delegating the proper authority and responsibility so they can work toward a common goal. The biggest, the most popular, or the cheapest supplier is not always the best supplier for a given component. This is often illustarted by professional sports teams that try to buy a team of the most talented players and do not end up on top by the end of the season. Selecting the right suppliers before the project is even launched is critical.

For additional information, please contact Promold Plastics.

Rick Puglielli (President, Promold Plastics)