You Can Pay Me Now or Pay Me Later
Loran J. Paprocki
In the medical device industry, the cost of a single quality failure can eclipse the cost of a quality program.
The medical device industry is a high-stakes game. The risks are ominous in the possibility of financial loss due to products that are unsuccessful, or worse; products that fail in their function. Medical devices which are unable to meet their clinical requirements may result in harm, injury or even death to patients. The costs of entry to the market are proportionately enormous in terms of the required time, talent and treasure to bring a product to market and to generate a return on investment. In light of the dire nature of medical device failure, regulatory agencies such as the U.S. Food and Drug Administration (FDA), Health Canada and British Standards Institution provide guidance to ensuring the rigor of the quality of medical devices. While the regulatory guidance can be a valuable tool in ensuring that customer requirements are actualized by the finished device, the efforts of companies developing devices are typically slowed by those requirements. Companies who fail to invest resources to the execution of design quality systems take on the risk of negative impacts to revenue and to the lives of patients.
An early and notable example of the costs associated with ineffective quality systems is the failure of the Dalkon Shield. The Dalkon Shield was an intrauterine birth control device (IUD) whose location and reclamation was facilitated by an attached string. The manufacturer ignored internal concerns that the string might wick body fluids and lead to bacterial infections. The manufacturer, A. H. Robbins Company, had no internal experience with obstetrics or gynecology and relied upon the inventor of the device for their clinical input. A. H. Robbins' decision to disregard the infection concerns and to continue marketing the device was influenced by the early market success of the product as sales in the first year were in excess of one million units (Kastetter, 1999). The financial success was erased as the predicted wicking issue became reality; resulting in infections, septic abortions and death. Waves of resulting litigation included including a $7,500,000 punitive damage award for one of the cases (Kastetter, 1999).
While the Dalkon Shield litigation occurred in the early 1970's, the tough lessons have been repeated in more recent years. The error of placing short term financial gain over product quality impacted the design of hip replacements, with similar monetary consequences.
Stephens, D'Urso and Holmes (2006) tell the tragic story of Sulzer Orthopedics. Sulzer Orthopedics was the fourth-largest supplier of orthopedic implants. A year after the product launch of their hip replacement implants, complaint rates increased unexpectedly. North American Science Associates (NAMSA) performed analysis to detect possible causes for the complaints and discovered an oily residue on the hip joints. The residue could cause the impedance of the ingrowth of bone which was essential to a positive clinical outcome. The contamination issue was relayed to Sulzer Orthopedics who waited three weeks before announcing a voluntary product recall. A notification of the FDA followed three days later. The recall included around 40,000 units with an additional impact as similar contamination was found on their knee replacement implants. The subsequent recall affected 1,500 patients requiring the replacement of defective knee implants in 560 individuals.
Stephens et al. continue, noting the effects upon the patients that used Sulzer Orthopedics' products. Pain when moving, pain when seated for periods of time, inability to walk without the assistance of a cane, separation of the implant from the bone and lost wages were among their issues endured by the patients. Due to the time lag between the awareness of the issue and the isolation of product, at least one patient had a first problematic implant replaced with a second contaminated implant; requiring an eventual third operation. Lawsuits followed. Sulzer Orthopedics' first settlement offer was $750 million to all affected parties. Two weeks later, the conclusion of the first court case resulted in the awarding of more than $15 million dollars to three women. A few days later, Sulzer Orthopedics revised its initial settlement offer to reach $1 billion. The final settlement totaled $1.035 billion and was deposited into a trust fund just three years after the product launch.
History has repeated itself as Johnson & Johnson is currently in the courts over the performance of their hip replacement implants. Learning from Sulzer Orthopedics' lesson in the cost of litigation; Johnson & Johnson has increased its reserves for product-liability costs to $570 million in 2010 and has ear marked an additional $280 million for the potential medical costs of the recipients of Johnson & Johnson implants. The final cost of the design failure is expected to exceed $1 billion. (Rockoff & Searcey, 2011)
To return to the initiating event at Sulzer Orthopedics; the years of legal proceedings, the billion dollar settlement, untold lawyer's fees, lost business and crippling patient pain were all due to an oily contamination on the implants. Brown University (2007) notes that the contamination was created when Sulzer Orthopedics brought portions of the product manufacturing in-house. In an effort to cut costs, a change was made to the machining oils. The materials change resulted in the residue first detected by NAMSA. In reading the FDA's design control guidance below, the warning has been carried forward by regulatory bodies.
The later in the development cycle that the change occurs, the more important the validation review becomes. There are numerous cases when seemingly innocuous design changes made late in the design phase or following release of the design to market have had disastrous consequences. (FDA Center for Devices and Radiological Health, 1997, p. 41)
It is important to note that the previous examples of catastrophic device failures were not due to failures in manufacturing but failures in the creation or maintenance of the device design. Failures were designed in rather than built in to the device. Inadequate knowledge of the customers was apparent and insufficient consideration of design changes existed. Rather than increase the core knowledge of those areas the companies moved forward with the existing design. This horrific history led to the increased regulation of medical device design. The increased regulation has been a two-edged sword as it provides guidance for the proper assessment of design but it also creates a costly burden upon the entire industry as companies work to comply with voluminous requirements. To avoid the expenses involved in developing new products required to conform to higher levels of scrutiny, a majority of new products are created under the less stringent 510(k) clearance process.
The FDA regulates the medical device industry and may approve the sale of a medical device based upon its similarity to a device that was on the market prior to the existing regulation. These devices are commonly termed 510(k) devices as connection to the pertinent section of the Food, Drug and Cosmetic Act. Wizemann (2011) notes that while manufacturing issues account for 28.5% of 510(k) device recalls, device design issues account for 28.4% of the recalls. The high percentage of device failure due to design is alarming due in part to the fact that while manufacturing issues are typically transient, design issues are persistent. Where inadequate training of an assembler may cause the manufacture of a lot of defective product, an error in the device design will exist in every device that is produced and would not be stopped by end-of-the-line quality inspections.
Among design issues, Ward and Clarkson (2004) note that the main cause of device failure is user error. It is important to note that user error is not defined as simply being a mistake by a user. Rather, the concept includes that some mistakes by the user should be expected and avoided by the design of the product. If a user was instructed to cut the blue wire with the red stripe, but instead cut the red wire with a blue stripe, the effect is a user error due to the manufacturer's insufficient consideration for the user's ability to follow the instructions. While it is easy to put the scalpel in the hands of a surgeon and expect them to make the correct cut, it is an abandonment of Deming's first item in Profound Knowledge; the appreciation for a system. The ignoring of expected errors due to normal use is to ignore the reality of the customer's experience. In multiple studies of anesthesia procedures the frequency of user error as defined as incidents involving human error as a proportion of all incidents exceeded 70% with the rate as high as 80% in infusion pump studies (Ward & Clarkson 2004).
Fairbanks and Wears (2008) define the issue well when they state, "Technologies often fail to deliver their promised benefits when they are not designed in a way that matches the needs, cognitive processes, and environments of the intended users." (p. 519). This design input becomes more critical as the medical device user is increasingly the patient rather than the physician. Blood glucose monitors, telemetry devices, steroid inhalers and many other devices are used by individuals with wide ranging differences in intellectual and physical ability.
Rogers, Mykityshyn, Campbell and Fisk (2001) describe how a home-use blood glucose meter could claim three easy steps but rely on the execution of fifty two sub-steps to achieve a proper reading. Frustration would be expected in an elderly user with only a high school education. While 1.64 million Americans received Medicaid home care in 1995, that number exploded to 8.3 million Americans in 2004 and the trend is expected to continue (Story, 2010). This shift in the definition of the medical device consumer will continue with the aging of the population. Regulatory bodies have responded by generating guidance to the correct identification of the users of medical devices. The benefit of advance consideration of design features, and the relationship between risk management (the management of device failures which pose hazards to patients) and financial return, is noted in the FDA's design control guidance,
Risk management begins with the development of the design input requirements. As the design evolves, new risks may become evident. To systematically identify and, when necessary, reduce these risks, the risk management process is integrated into the design process. In this way, unacceptable risks can be identified and managed earlier in the design process when changes are easier to make and less costly." [emphasis added] (FDA Center for Devices and Radiological Health, 1997, p. 5)
Shah and Robinson (2007) list the expected financial fruit of ignoring the user's needs and abilities as including development costs, product failure and loss of sales and profits. In contrast to the earlier examples of massive settlements impacting a company's financial health, today's omens portend that the inability to consider the new users of medical devices will lead to a company that suffers the chronic ailment of substandard sales volume.
In the medical device industry, the cost of a single quality failure can eclipse the cost of a quality program. Past failures to understand fully the device and the customer has led to billion dollar settlements against the medical device companies involved. While the highly visible legal actions attract headlines, the current shift in the definition of the medical device user impacts the long term viability of products. Rather than suffering publicized recalls, the failure to capitalize on guidance to increase the usability of devices could lead to the quiet exit from the market by products which the user finds to be simply not worth the bother to use.
Brown University. (2007, Spring). Major recalls of organ replacement devices. Retrieved from http://biomed.brown.edu/Courses/BI108/BI108_2007_Groups/group05/pages/sulzer.html
Fairbanks, R. J. & Wears, R. L. (2008). Hazards with medical devices: The role of design. Annals of Emergency Medicine. 52.5, 519-521.
FDA Center for Devices and Radiological Health. (1997, March 11). Design control guidance for medical device manufacturers; This guidance relates to FDA 21 CFR 820.30 and sup-clause 4.4 of ISO 9001. Retrieved from http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm070627.htm.
Kastetter, T. E. (1999). Quality concepts and products litigation. The TQM Magazine, 11.4. 264.
Story, M. F. (2010). Medical devices in home health care. In S. Olson (Ed.), The role of human factors in home health care: Workshop summary (145-172). Washington DC: The National Academies Press.
Rockoff, J. D. & Searcey, D. (2011, July 8). Hip joints set off new rush to court. The Wall Street Journal, Retrieved from http://online.wsj.com/article/SB10001424052702303365804576432051261804910.html.
Rogers, W. A., Mykityshyn, A. L., Campbell, R. H. & Fisk, A. D. (2001, Winter). Analysis of a "simple" medical device. Ergonomics in Design pp. 6-14. Retrieved from http://www.hfes.org/WEB/Newsroom/Winter01EIDarticle1.pdf
Shah, G. S. S., & Robinson, I. (2007). Benefits of and barriers to involving users in medical device technology development and evaluation. International Journal of Technology Assessment in Health Care, 23.1, 131-137.
Stephens, K., D'Urso, S. & Holmes, P. (2006). The Sulzer hip replacement recall crisis: A patient's perspective. In S. May (Ed.), Case studies in organizational communication: Ethical perspectives and practices. (125-138). Thousand Oaks, CA: Sage Publications.
Ward, J. R. & Clarkson, P. J. (2004). An analysis of medical device-related errors: Prevalence and possible solutions. Journal of Medical Engineering & Technology. 28.1, 2-21.
Wizemann, T. (Ed.). (2011). Food and drug administration postmarket surveillance activities and recall studies of medical devices. In, Public health effectiveness of the FDA 510(k) clearance process: Measuring postmarket performance and other select topics: Workshop report. (pp. 5-21). Washington, DC: The National Academies Press.