Dangerous Virus, new Regulations
FDA regulatory intervention
As the primary regulatory body for medical devices in the United States, the FDA has taken a strong role to help quicken the development of available medical products to diagnose, treat, and combat the virus.
We have a vital mission to protect and promote public health and the FDA is closely collaborating with our domestic and international public health partners to mitigate the impact of the novel coronavirus that emerged in Wuhan, China," said FDA Commissioner Stephen M. Hahn, M.D.1
The FDA specified 7 ways it’s assisting:
- Facilitating the development and availability of medical countermeasures (MCMs) that can be used to diagnose, prevent, or treat emerging diseases.
- Providing regulatory advice, guidance, and technical assistance to sponsors developing investigational MCMs for emerging threat indications.
- Working with medical product sponsors to clarify regulatory and data requirements necessary to rapidly advance development of products essential to supporting response efforts.
- Providing review and feedback on development proposals including design and set-up of clinical trials for establishing the safety and efficacy of investigational products and data assessment.
- Protecting the safety of the nation’s blood supply and human cells, tissues, and cellular/tissue-based products for transplantation.
- Enabling access to investigational MCMs—when necessary—through an appropriate mechanism such as under an Emergency Use Authorization (EUA) or under expanded access mechanisms when the clinical circumstances warrant.
- Protecting consumers against fraudulent products 2
Medical device manufacturers are encouraged to use this landing page for up-to-date communications from the FDA.
Shortages lead to new policies
As demand increases, supply of certain medical devices to affected regions is becoming contrained. This is very evident for common medical supplies like respiratory masks. In fact, certain masks manufactured in South Korea are selling at 4.5 times the rate they did before the outbreak.3
We’re seeing increased demand for our respiratory protection products, and we’re ramping up our production worldwide, in China, around the world to meet that demand,” Mike Roman, CEO of 3M, makers of the popular n95 respiratory mask.
While evidence of price gouging hasn’t been observed, the South Korean government has enacted new polices to ensure it stays that way. New regulations impose punishments as high as 2 years in prison and a 50 million dollar fine for companies charged with hoarding materials to profit from the outbreak.
Stocks going up, and going down
While there is no cure, medical device company stocks have hit all time highs as companies in the travel and retail sectors fall. During cases of outbreaks, investors generally back pharmaceutical and medical device companies, and that appears to be the case here. The stocks of Chinese medical device companies like Shenzhen Mindray and Yichang HIC both reached record highs last week.
Innovation for Early Detection and Safe Treatment
Innovative solutions for early detection and safe treatment that minimizes the risk of spreading the virus have been developed by medical device companies across the industry.
Early and objective detection
With an incubation period of 2 to 14 days and varying severity of its symptoms, sensory detection of the coronavirus is dubious. That being said, early detection is vital to prevent the virus from spreading.
This has led companies like GenScript, VivaLNK, and Radiation Shield Technologies to develop objective forms of detection.
GenScript created a test that targets the RdRP gene, N gene, and E gene in the Wuhan-Hu-1 genome. Their solution has successfully detected the virus in samples, but has yet to be used in a clinical environment. Fortunately, GenScript has production capability and certification to develop test kits, so it may only be a matter of time until this method can be used by healthcare providers.
VivaLNK develeoped a wearable medical device patch that provides continuous temperature monitoring. Because one of the first symptoms is a fever, temperature can be the first sign of coronavirus infection. The VivaLNK sensor can stream temperature data to a variety of systems via SDK, so it’s highly effective in real-time analysis of patient data.
Radiation Shield Technologies, developers of radiation resistent Demron material suits, created a way to externally check hospital staff for signs of the virus. By wearing a Demron CBRN suit, hospital staff can be monitored for temperature fluctuations that indicate fever. In addition, Demron-lined transportation chambers for potentially infected patients can monitor temperature and be externally cooled.
Robotics to Protect Healthcare Staff
The best way to treat coronavirus is quarantining those who have it, limiting their exposure to the rest of the population. Limiting the exposure of healthcare staff is a best practice as well.
This has lead to a reliance on robotic care and short-range telehealth.
Infected patients at Hangzhout Hotel in China and Providence Regional Medical Center in the United States are being treated by robots equipped with a camera, microphone, and stethoscope. Tasked with administering treatment, conducting diagnostics, and delivering medication & food, robots protect hospital staff from tactical work that could lead to exposure, contamination, and spreading the virus. In addition, the robots deliver medicine 3 times as quickly as hospital staff could.
The nursing staff in the room move the robot around so we can see the patient in the screen, [and] talk to him” Dr. George Diaz told CNN, minimizing the exposure of staff to the virus.3
Robotics for Cleanup
Other robots, similar to those used in commercial applications like airplanes, are tasked with sanitation. These utilize a UV-c light to ensure surfaces in clinics do not carry the virus.
We’ll be tracking regulations related to coronavirus and the medical device industry. Stay informed by signing up for our newsletter below.