The transition from EU MDD (2007) to EU MDR (2017) has included an increase in expectations for...
At Home Diagnostic Equipment Poses Quality Challenges
The growth in popularity of at-home medical device diagnostic equipment has obvious benefits for consumers, but it has not come without risks. The well-publicized story of Theranos, a health technology corporation, and the deception involved in the company’s rapid explosion from unknown startup to a business valued at more than $9 billion has unfortunately cast doubt on this market’s future potential. Other companies, however, have already begun developing promising devices that can help patients diagnose illnesses and improve lives from the comfort of their own home. As this market grows, it is important that we learn from the mistakes made at Theranos and make product quality and consumer well-being our main priorities.
The concern of the quality community with improvement must extend to its own practices to ensure the safety of consumers. It is unfortunate but true that there will never be a shortage of companies and individuals willing to risk the health and well being of others in order to further their own interests. Recent changes to quality and regulatory standards will help close some gaps that had previously been exploited, but quality auditors and regulatory professionals must continue to be on alert and speak up if concerns are found. It is only with continuous vigilance that we can continue to advance the technology and convenience of medical devices and maintain the quality assurances that patients expect.