Regulatory compliance is essential to successfully developing, deploying, and commercializing a medical device. A single example of noncompliance, if it is egregious enough, may cause the Food and Drug Administration to terminate your ability to market a device in the United States.
Although very few companies go out of business due to noncompliance, it can cost millions or even billions of dollars. Noncompliance not only causes greater scrutiny from regulators, but also creates legal liability that may involve many thousands of patients.
Serious noncompliance can also lead to lengthy and highly-publicized recall processes.
Medical device executives are keenly aware of compliance as a cost center. Indeed, compliance is one of the major sources of overhead in the medical device industry – and in several other regulation-driven sectors. Yet, cutting corners is not a viable cost reduction strategy.
In the long run, when it is discovered – and it will be – the consequences are disastrous.
Let’s consider major noncompliance cases that rocked the United States:
Da Vinci Surgical System – Intuitive Surgery, Inc.
Since its introduction in 2000, the da Vinci robotic surgical system by Intuitive Surgical has had noteworthy compliance and legal issues. The FDA issued a warning letter to the company in 2013, raising concerns about its safety notification practices. Serious lawsuits have arisen since, including a class action suit alleging that investors were misled about safety concerns.
Failure to uphold quality standards often opens a company to product liability suits as well. A $300 million product liability suit related to da Vinci commenced in April, 2016 in California. The plaintiff claims that the device led to significant internal injuries when it was used by her doctor to perform a hysterectomy. Other major suits are working through the courts.
Metal-on-Metal Hip Implants – Johnson & Johnson, Inc.
Johnson & Johnson found itself at the center of one of the largest noncompliance cases in history when its metal-on-metal prosthetic hips were found to contribute to a range of symptoms, including chronic pain and elevated levels of chromium and cobalt in patient blood.
In November 2013, the firm was expected to pay $2.5 billion to settle related suits. In late 2016, it was hit by a devastating new verdict from a federal jury in Dallas, requiring it and subsidiary DePuy Orthopedics to pay $1 billion to six Pinnacle hip implant patients.
ABG II & Rejuvenate – Stryker Corporation
ABG II and Rejuvenate are two hip replacement products by Fortune 500 med-tech firm Stryker. Patients were required to undergo revision surgery due to fretting or corrosion of components. In 2014, Stryker set aside $1.42 billion to compensate patients. Stryker previously received FDA warning letters concerning its failure to maintain quality standards.
Avaulta Transvaginal Mesh – C. R. Bard, Inc.
C. R. Bard continues to face lawsuits related to alleged injuries suffered by transvaginal mesh patients. It was able to have 149 suits dismissed in 2016 and 75 more in 2017. In the wake of the controversy, the FDA reclassified pelvic mesh products to Class III, the highest level of scrutiny. The long-term effects on the industry remain unknown.
For Lasting Medical Device Success, Quality Management Comes First
To succeed in the U.S. and internationally, medical device companies must uphold the highest quality standards. To protect patient health – and your reputation – quality management must be planned, executed, and maintained at every step in the value chain.
Technosoft Innovations uses its unmatched expertise in the globally-recognized ISO 13485 quality management standard to simplify and streamline compliance. Starting from this firm foundation, companies are empowered to innovate and excel.
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