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Medtech Business Review | Thursday, July 06, 2023
In the healthcare industry, innovation, collaboration, and proactive measures are vital for ensuring the safety of patients, protecting sensitive information, and maintaining high standards of care.
FREMONT, CA: In recent years, the healthcare industry has faced unprecedented challenges that have compelled industry leaders to adapt and innovate. The need to overcome labor issues, cost increases, raw material supply disruptions, and heightened demand has driven a wave of reshoring manufacturing capacity, building contingency in the supply chain, and pursuing sustainable improvements. FTI Consulting explores the industry's hurdles, with many changes expected to impact policies, resource availability, and accepted practices.
One notable trend is the growing preference for remote work. Even before the COVID-19 pandemic, a significant portion of the US workforce, approximately 16 percent, embraced remote work. However, this number skyrocketed to an astonishing 71 percent during the pandemic. A 2022 study by the Pew Research Center revealed that 59 percent of Americans who can work from home choose to do so most of the time. Unfortunately, the healthcare and manufacturing sectors have limited opportunities for remote work, leaving many employees without this option.
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Despite the challenges, the outlook for the healthcare industry remains positive. However, there is a pressing concern regarding the availability of skilled technicians to meet the projected demand. A substantial number of programmers and machinists are approaching retirement age, while the societal emphasis on college degrees has diminished the number of young workers entering the skilled labor field. Cybersecurity poses a particularly acute concern in the healthcare industry. Patient's personal health information (PHI) is increasingly vulnerable to cyber threats due to the sensitivity of the information and the increasing use of digital technology in diagnostics, record storage, treatment, and practice management. Recent data breaches have underscored the magnitude of the problem, with financial losses and exposed records on the rise. Traditional centralized information security measures are insufficient to protect medical devices, leaving them vulnerable to attacks. The consequences of cyberattacks can lead to poor patient outcomes, longer hospital stays, and increased mortality rates. As medical devices become more advanced and diverse, prioritizing cybersecurity is crucial to safeguard patients' information and treatment.
The multi-layered supply chain of medical devices adds another layer of complexity to cybersecurity. Manufacturers often rely on multiple vendors for various components, making ensuring uniform and sufficient cybersecurity measures throughout the device's lifecycle challenging. The FDA provides guidelines and regulations, while medical device manufacturers (MDMs) identify risks and vulnerabilities associated with their devices. However, compliance with minimum safety thresholds does not guarantee security, and keeping up with technological advancements remains a challenge for regulatory bodies.
An alarming finding indicates that around 70 percent of medical devices, such as MRI machines, heart rate monitors, and medication pumps, run outdated and unpatched operating systems with critical vulnerabilities. This exposes the industry to potential breaches and cyberattacks, highlighting the urgent need for comprehensive security measures.
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