The medical device industry is undergoing rapid change, and, to paraphrase a famous cable fantasy series: change equals chaos, and chaos can be a ladder. As technology drives innovation, medical devices evolve to become more intelligent and more interconnected, expanding the Internet of Medical Things (IoMT).

Unlike their predecessors, interconnected medical devices communicate through one or more electronic interfaces with multiple devices. These interfaces offer powerful functionalities, but the medical device industry faces new challenges with increasing digital interconnection. Regardless, the market for digital interconnection is surging, and Deloitte Consulting estimates that by 2025, the market for interconnected medical devices will increase from $15 billion to $52 billion.

Digitally interconnected medical devices use their interoperability to connect with other devices and exchange data. They can issue commands to complete an action, such as administering a drug or performing therapeutic action. When devices are interoperable, they can connect and share information through a wireless or hard-wired connection. Examples of device interoperability include how we can use our smartphones to make payments and program televisions through a digital assistant such as an Amazon Alexa.

A medical innovation created to help people with diabetes control insulin administration that recently had to clear FDA regulations was an integrated Continuous Glucose Monitor (iCGM). Its creators integrated the iCGM with other compatible medical devices and electronic interfaces (such as automated insulin dosing systems, insulin pumps, blood glucose monitors, and other electronic devices used for diabetes management), simplifying patient treatment.

While these interfaces offer powerful functionalities, they also present new risks.

Because the technology is new, the regulatory pathways for these interconnected devices are uncertain. Predicate devices are few and far between, which removes the shortcut of 510(k) submission from the table.

Manufacturers of interconnected medical devices will likely have to undergo the De Novo process. This risk-based classification process provides a premarket review pathway for new devices with a low-to-medium risk profile. The FDA established the De Novo process to encourage innovation, reduce regulatory burden, offer more component flexibility, and increase the number of device choices.

A Brave New World

The interoperability of medical devices promises significant advances for global health. We have already seen the explosion of mobile health apps and their usefulness, but smartwatches and phones are only the beginning.

The digital health data generated by electronic medical records, new sensors, medical imaging, and low-cost gene sequencing is the key to medical innovation and will improve the quality of life of millions of people all over the world. In combination with artificial intelligence, cloud computing, and big data analytics, this wellspring of data is paving the way to better diagnostics, personalized treatments, and early disease prevention.

What Are the Risks Associated with Interconnected Devices?

For one, the healthcare industry is increasingly a target for cyberattacks and hackers.

This is partially because patient data is valuable, and medical devices are currently easy to hack. In addition, the pandemic-era emergence of telemedicine has exponentially increased the volume of patient data shared remotely with countless healthcare providers – and this data is not always secure.

Meanwhile, privacy concerns are just the tip of the iceberg. Consider the cautionary tale of a baby born in Alabama with severe brain injury who died due to incorrect care while her hospital struggled with hijacked system operations. The system failure was caused by a ransomware attack that allowed hackers to hold an entire hospital in another country hostage, resulting in an infant's death. This sophisticated thuggery is a surging, multibillion-dollar worldwide cybercriminal industry.

With ransomware attacks on the rise, no health care network or hospital is safe.

To use connected medical devices safely, organizations need an overall risk management strategy to ensure the security of sensitive data and keep hackers at bay. By utilizing the three main strategies below, they can increase the security of interconnected medical devices and support patients, clients, and consumers more effectively:

  • Use risk assessments to identify and implement critical security controls in applications, focusing on preventing application security defects and vulnerabilities.
  • Enable red team services and penetration testing to assess how well an organization might perform at each stage of a cyber attack
  • Implement security operations solutions: A Security Operation Center (SOC) is a centralized function within an organization whose task is to continuously monitor and improve an organization's security posture. Leveraging people, processes, and technology, the SOC prevents, detects, analyzes, and responds to cybersecurity incidents.

Increased interoperability is driving rapid innovation in myriad ways, and connected medical devices have endless promise for developers and consumers alike. However, with ever-evolving technical standards and regulatory policy, you need a medical device manufacturer who understands how to address the FDA’s requirements and can help you plan your product development efforts and premarket submissions.

At the Vanguard of Medical Device Manufacturing

Before introducing a new product, you must first evaluate existing ones in the FDA marketplace and create a production and market introduction strategy roadmap. A medical device contract manufacturer integrates design, regulatory strategy, and manufacturing processes to deliver quick, practical solutions and overcome any challenges along the way. We pay special attention to quality assurance for medical devices to avoid the aforementioned pitfalls, developing your technology for ultimate market success. This approach often shortens the overall FDA approval runway for our clients.

 

Author's Bio: 

Author:

Arthur Deptala

LinkedIn

CEO of Pathway NPI

I'm the CEO of Pathway NPI, where we're impacting the evolution of healthcare by streamlining medical device development, manufacturing, and commercialization.

Specifically, Pathway NPI partners with early-stage medical device companies, enabling them to leverage our umbrella of certifications, audits, and manufacturing technologies to expedite their time to market while focusing exclusively on selling their product. This solution in turn allows better use of startup capital and compresses the startup time frame.