“Quality assurance” is a somewhat nebulous concept for people outside of industries like manufacturing, but in heavily-regulated industries like medical device production and manufacturing, quality assurance, or QA for short, is a fact of day-to-day life. Specifically, it forms the top level of a three-tiered quality stack:
- Quality Assurance (QA): The process by which companies ensure outsiders that their products meet expected or required quality standards.
- Quality Management System (QMS): An established set of practices to build and maintain quality assurance.
- Controls (QC): Practices within a quality management system that identify and fix problems and roadblocks to quality.
Few industries need to be more meticulous about quality assurance than the medical device industry. Here’s why a thorough approach to QA is essential to aspiring medical device entrepreneurs.
Medical devices companies depend heavily on consumer confidence, an economic indicator that expresses consumers’ feelings of optimism or pessimism about the economy, an economic sector, or an industry.
The health of the medical device industry is deeply dependent on consumer confidence. Consumers jealously guard their right to make decisions about their medical care, including what devices get used in their care.
Economists associate an increase in consumer confidence with an increase in aggregate demand, which increases the market value of the products in question. Meanwhile, decreases in consumer confidence correlate with decreases in aggregate demand, resulting in the lower market value of goods.
Consumer confidence is more about perception than reality. It takes time to build consumer confidence, and not much time at all—one disaster, in some cases—to evaporate it. Quality assurance, therefore, is not just about PR, although a medical device company should be upfront about and proud of scrupulous adherence to quality control—it certainly can’t hurt.
No, quality assurance is also crucial for its role in preventing the kinds of accidents that destroy consumer confidence. For this reason, consumer confidence dovetails with the next reason quality assurance matters—consumer safety.
Ensuring consumer safety in the medical device industry is no laughing matter. Medical devices may be used for any number of functions where lives hang in the balance, from monitoring the blood sugar of diabetics to assisting regular cardiac function. The vast majority of such devices are complex pieces of medical equipment. It practically goes without saying, but for ethical reasons, the need for rigorous controls to protect consumer safety cannot be overstated.
What goes into making safe medical devices?
- Clinical Research. The safety of medical devices can best be supported by data generated in clinical trials. Regulations and clinical study practices vary from market to market, limiting medical device companies’ ability to do all the necessary clinical research in-house.
For this reason, most medical device developers and manufacturers partner with clinics to act as third-party, neutral research arms. The role of these clinical research organizations (CRO) is to ensure the integrity, safety, and compliance of the necessary clinical trials.
Post-Market Surveillance. Attention to consumer safety does not stop at the clinic. Medical device companies must take a proactive approach to post-market surveillance of product performance to monitor consumer safety, as well as comply with regulations (more below).
Human Factors. Some of the biggest threats to consumer safety from medical devices come not from fault in the devices, but from human error in the operation or application of the devices. It falls to the medical device manufacturer to do everything possible to reduce the chance that human error in the use of the device could cause injury to the subject patient or failure of the device.
This is often a function of engineering, troubleshooting, and risk management—manufacturers have to allow for the possibility that the device will be used not only correctly, but incorrectly, and account for consumer safety in both circumstances.
Post-market surveillance and clinical research are both components of regulatory compliance, the third reason quality assurance is essential for medical device companies.
Befitting the great public trust placed on them to protect public safety, medical device companies face some of the stiffest regulatory burdens of any industry in almost every country or jurisdiction.
Attention to public confidence and public safety are almost afterthoughts—regulatory controls basically assure the application of strong quality management systems, or else the medical device company in question won’t remain in business very long. They may not even survive to put the first product on the market.
- US medical device companies must comply with standards set by the US Food and Drug Administration (FDA). These regulations include attention to “good practices” (GxP), including good manufacturing practices (GMP), good clinical practices (GCP), good laboratory practices (GLP), and good distribution practices (GDP). Medical device companies in other countries or jurisdictions may have other regulatory authorities to comply with.
- ISO 14971 is an internationally-accepted standard of risk-management implementation, promulgated by the International Standardization Organization to help establish uniform quality assurance standards for various industries. Most medical device manufacturers in the US, Canada, and Europe will have to comply with ISO 14971 to establish adequate risk management practices and confirm them with regulators.
IQ OQ PQ.
- Most medical device manufacturers and developers rely on sophisticated equipment in their operations. IQ OQ PQ is a quality control stack meant to ensure proper installation of that equipment so its output can be relied upon.
“IQ” refers to “installation qualification”—delivery and installation per manufacturer standards with adequate operational conditions (power, temperature, etc.). “OQ” refers to “operational qualification”—making sure the equipment functions within manufacturer-established parameters. “PQ” refers to “performance qualification”—validating the equipment’s function under production conditions.
According to this Dickson IQ OQ PQ guide, areas where the efficacy of a product could impact consumer safety, as is the case with medical devices, are particularly important for this process.
For all of these reasons, quality assurance is essential to the medical device industry and the companies that produce remarkable advances in medical device technology. Every company interested in changing the world with breakthroughs in device-based healthcare needs to pay careful attention to quality control through the implementation of a robust quality management system.