With the introduction of the MacBook, iPod, iPad and various iPhone iterations, Apple has proudly touted that its tech innovations have “changed everything” and “changed everything again.” Apple is poised to create yet another new segment in its path of innovation, as the company is currently in talks with the FDA to classify its latest technology, the iWatch, as a Class I or even Class II medical device. As such, it’s safe to say the tech giant is changing things once again, and has an opportunity to set an example for other manufacturers along the way.
Due to the fact that iWatch has the ability to capture, store and transmit many vital signs based on thresholds set by a health care professional, Apple claims that its regulated, wearable iWatches could be used to monitor patients and eventually integrate into patient health records. Getting clearance from the FDA means Apple will have broader appeal of who they can target for sales, but also means that Apple, as a medical device manufacturer, will have many new regulations to comply with and considerations to make.
While the technology may be user-friendly, low-cost and allow health care providers to offer more personalized care and advice to patients, what is the risk if the iWatch malfunctions? For example, if the iWatch reports healthy blood pressure levels but the wearer is actually in danger of – and goes into – cardiac arrest, Apple could find itself in the middle of a pretty serious product liability lawsuit. False positives or the patients/users making wrong decisions based on an erroneous display of measured elements can also be quite adverse, and even fatal.
DNA analysis company 23andMe knows this all too well, as the FDA recently forced the company to end the sale of its personal genome services (PGS). According to the FDA’s cease and desist letter1, “Some of the uses for which PGS is intended are particularly concerning…because of the potential health consequences that could result from false positive or false negative assessments… For instance, if the BRCA2-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist.” Apple, presumably, will want to avoid receiving a similar cease and desist letter at all costs. This can be done through the use of sophisticated software, extensive testing and managing ongoing activities with quality management software (QMS) to help ensure compliance with necessary safety regulations, in addition to streamlining and tracking product audits to find and remedy issues before the iWatch hits store shelves.
Not only does Apple claim the iWatch’s ability to make health assessments and recommendations, its recent hire of hardware developer Nancy Dougherty has spurred rumors that the device could come equipped with sophisticated sensors that are capable of tracking kidney and liver function, measuring electrolytes, and determining the amount of sugar in the blood in real time. According to Zeev Zalevsky, of Israel’s Bar-Ilan University, who studies blood sugar–monitoring devices, “Glucose is the holy grail of diagnostics.3” What’s more – since diabetics are most at risk for plummeting blood glucose levels at night while they are asleep, wearables like the iWatch could be an indispensable tool to alert users of such instances. That said, an iWatch with these monitoring features would not be a toy or a fashion statement – it could easily be the difference between life and death for someone suffering from diabetes or another life-threatening disease.
Before the ubiquitous tech leader officially becomes a manufacturer of medical devices, it’s important for the company to think through the extensive regulatory and compliance demands ahead and have the processes and systems in place to become and remain compliant with industry regulations while ensuring quality is upheld throughout the iWatch’s entire life cycle, and be capable of training employees for such challenges. While Apple may be no stranger to customer complaints, as the company moves into the more heavily regulated world of medical devices, complaint management will be more crucial than ever. Don’t like the color of your iPhone? Oh well, buy a designer cover. Does your iWatch shock you when you sweat? That’s an issue that could prove harmful, and Apple will need to remedy it quickly. Complaint management software will be vital in identifying, logging, responding to and analyzing customer complaints and implementing QMS to assign responsibility and accountability for tasks is paramount.
Additionally, a QMS could help manage employee trainings to ensure compliance with government and industry regulations, in addition to maintaining a standard of excellence in controlling the training initiative. Centralized, comprehensive training records provide proof of compliance and an accurate reflection of training needs, while integration with quality-driven actions such as corrective action and preventive action (CAPA) plans and change control ensures that any additional training required due to events are enforced and carried out.
Without a doubt, Apple has shaken up the tech market in recent years, blazing the trail for new companies to follow suit. Apple is known for its attention to detail, product quality and reliability, however, not in the medical device industry where there is constant scrutiny by governmental regulatory bodies. In its pursuit for Class I or Class II medical device approvals from the FDA, it’s vital that Apple set an example for others by ensuring absolute quality, compliance and safety; otherwise, it and other medical device manufacturers could face the possibility of lawsuits and become iBankrupt.
2 The BRCA gene test is a blood test that uses DNA analysis to identify harmful changes (mutations) in either one of the two breast cancer susceptibility genes — BRCA1 and BRCA2 [http://www.mayoclinic.org/tests-procedures/brca-gene-test/basics/definition/prc-20020361]