Cost cannot be measured with diagram

I recently read an advertisement in your journal titled “ResMed v. 3B/BMC” and was dismayed by the lack of facts related to a statement made regarding the “approximate direct manufacturing cost: $7.00” for a full face mask with headgear.

Having worked in the field of sleep medicine since 1991 as a senior level executive, and having owned and operated sleep facilities offering both diagnostics and durable medical equipment, I find the claim that a full face mask of even mediocre quality could be manufactured for that price very misleading. Key elements were missing in the ad: There was no mention of costs associated with FDA submission, regulatory and compliance, the new medical excise tax, tooling, engineering and patent filings, not to mention the cost of managing a sales force, warranty claims and providing educational support to clinicians and patients.

The total cost of manufacturing a high quality medical device, one which patients deserve and clinicians need to improve outcomes and adherence, is complex and certainly not getting any less expensive. “Medical grade” silicone (as defined by Dow Corning) is most commonly used in CPAP masks and is the widely accepted industry practice—the gold standard. USP Class VI biological testing, tissue cell-culture testing and 90-day rabbit intramuscular implantation testing with histopathology are performed to insure biocompatibility. Additional tests sometimes include skin sensitization, pyrogenicity and hemolysis. Additional costs and safeguards should be taken to ensure patient safety when developing nasal mask interfaces. The expense to conduct these tests and others associated with good manufacturing practices should be factored in when discussing the cost of a product.

Manufacturers providing high quality medical products such as full face masks, CPAP devices and accessories have to comply with rigorous standards and use only the highest quality materials when providing devices that come in direct contact with a patient's skin or are used to support or augment his or her breathing patterns. The cost of quality cannot be measured with a simple exploded diagram of parts used to make a product. The medical industry is undergoing a multitude of changes on many levels and the future of health care, on a global basis, will continue to evolve as long as there are manufacturers that are willing to take the high road.

At InnoMed Technologies, I'm proud to say that we take great pride as an American-based medical manufacturer in following the standards and guidelines given to us by the regulatory bodies. In turn, this has enabled InnoMed Technologies to develop world-class products, albeit the costs are much higher than what was represented in the advertisement. Innovative medical device and true patient care is derived from manufacturers that look at all aspects of managing a company long-term and are not purely focused on the cost of parts.

—Ron Richard, CEO, InnoMed Technologies