Surgical Device Repair Excellence - Page 4

IMS Surgical Device Repair Excellence

Expertise of IMS R&D / Engineering Team

Training and Expertise of IMS Technicians

Quality of Materials Used in Repairs

Quality of IMS Repairs

The IMS Quality System

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Quality of Materials Used in Repairs

Specifying and Purchasing Component Parts:

In all areas of manufacturing, the concepts of private labeling and component outsourcing are common and well accepted. What do these concepts mean?

Private labeling is where one company manufactures something that another company buys, puts its name on it, and sells it as its product. Examples of private labeling can be seen in the automotive market. Collaborations between automotive companies allow for the same basic vehicle to be sold by more than one company, with only cosmetic differences existing between the vehicles.

Component outsourcing occurs when a company buys parts from other manufacturers that it then uses in the final assembly of its product. This is an economically wise practice, because a company does not have to own all of the equipment necessary to produce every part in a finished product. Below are two examples from the consumer electronics industry:

• 1 out of every 7 television sets in the world has a picture tube that comes from the same manufacturer ¹
  
  
• 60% of telephones worldwide have internal components that come from the same manufacturer ²

In the case of the television, there are approximately 60 different brands sold in the United States³. It would be economically unfeasible for all 60 of these companies to produce the picture tubes for their televisions. They can purchase the picture tubes from a company that has particular expertise in making the tubes, and thereby create a quality product.

Both of these concepts - private labeling and component outsourcing - occur throughout the surgical device industry as well. As an example, 4 out of the 7 major rigid endoscope companies do not manufacture the scopes they sell. They privately label scopes made by other manufacturers. Does this compromise the quality of the finished product? Absolutely not. These companies sell high-quality scopes that are widely used throughout every surgical specialty.

It is important to realize, however, that the patents for the vast majority of today's surgical rigid endoscopes expired over 20 years ago. This is a major reason why companies can participate in private labeling and component outsourcing.

It is also important to realize that manufacturers and private labelers do not have exclusive access to high quality components for surgical device manufacturing and repair. Just as they buy components - and even finished products - from other manufacturers, IMS buys high quality components - often from the same manufacturers. We specify and purchase component parts from these manufacturers that are equal in function to any part being replaced.

The companies that produce and/or refine the materials used in medical devices are, in most cases, well established and well known in the medical equipment industry. For example, materials such as optical glass, medical grade stainless steel, and medical grade adhesives come from a few large manufacturers. Like the scientists and engineers at IMS, these manufacturers all have clear, globally accepted definitions of medical standards and medical grades.

IMS works with the world's best and most reputable component manufacturers to buy the highest quality parts used in repairing devices - so that the device meets its original performance standards. As an example, IMS maintains a monthly rod lens inventory valued at over $1.5 million - all purchased from the four leading optical glass manufacturers worldwide.

Advanced Component Engineering™ ("ACE")

Optical and mechanical tolerances are standardized and part of any standard engineering education. The engineers at IMS have extensive education and experience in the field of surgical devices. In the case of surgical endoscopes, the expiration of most patents covering these devices occurred over 20 years ago. The design of many internal rigid endoscope components has changed little in that period of time.

Using sophisticated equipment, IMS engineers utilize Advanced Component Engineering™ to precisely measure all optical and mechanical dimensions. Material properties are also quantified to ensure overall performance meets the original performance standards.

With such equipment as the EndoBench™ (Lighthouse Imaging Corporation), Autocollimator (TriOptix Corporation), and precision measuring microscopes, IMS engineers measure parameters of illumination, imaging, and material properties for original, properly functioning endoscopes and their various component parts. This helps to guarantee that parts evaluated through the IMS Advanced Component Engineering™ program conform to the original performance standards as intended by the device manufacturer.

More: Quality of IMS Repairs »

¹ www.philips.com, 4/2003
² www.philips.com, 4/2003
³ www.bizrate.com, 4/2003

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