Medical Manufacturing And The Healthcare Device Industry

Medical manufacturing used to be relegated to test tubes, syringes, scalpels and similar tools of the medical profession, but as technology has evolved to play a bigger role in medicine, manufacturers of medical equipment are having to reevaluate their approach to the production of devices and equipment.

 

Thanks to advances in digital technology, today’s medical equipment includes more robust networking capabilities than ever before, leading manufacturers to rely heavily on IT professionals to accomplish more and stay ahead of the competition.

What’s Involved In The Manufacturing Of Medical Devices?

Medical technology manufacturer standards vary based on the type of device being produced as well as the requirements of the specialization or space in which the device or equipment will be used.

The manufacturing process for medical devices tends to follow the standard flow of risk analysis, conceptualization, design, development, prototyping, testing and final product launch.

The difference in today’s manufacturing environment is that certain medical devices may need to undergo additional scrutiny by medical boards, state governments, federal agencies and other entities involved in approving medical devices for use.

In the United States, the Food and Drug Administration (FDA) Federal Food, Drug and Cosmetic Act lays out specific requirements for the manufacture of medical devices that emit radiation.

Credit: Xia

Even if a medical technology manufacturer was not directly involved in the design of a device that is subject to this act, the manufacturer of the device in question will still need to adhere to the guidelines.

The Latest Advances And Biggest Concerns In Medical Device Manufacturing

Among the biggest concerns in the design and manufacture of connected medical devices that utilize digital technology is security. As a rule of thumb, if something has a microchip and is connected to the Internet, it is susceptible to being hacked.

Because so much of today’s medical technology is connected through various intranets and the greater Internet, manufacturers are having to reevaluate design choices and adjust security feature offerings to secure equipment against cyber attacks.

Additionally, patient privacy is of great importance when collecting and transferring data regarding health and healthcare. Electronic protected health information (ePHI) regulations restrict the sharing of patient health information electronically across unsecured networks and platforms.

This means that medical devices involved in the gathering and disseminating of critical patient health data must be in compliance with ePHI and standard Health Insurance Portability and Accountability Act (HIPAA) regulations.

Despite these challenges, medical technology manufacturing is bringing some amazing innovations to the forefront of medicine. 3D printing, for example, has opened up new avenues for medical manufacturers as tools and device components can now be produced on-the-fly using files downloaded from or sent across the Internet.

This has helped to speed along innovation among researchers and developers of medical technology since the traditional barriers of time and space have been broken down between design professionals, medical consultants and manufacturers.

Additionally, machine learning and artificial intelligence (AI) are providing healthcare professionals with faster access to data analysis than ever before. AI can evaluate diagnostic imaging results and aid in the diagnosis of someone who is suffering from broken vertebrae, internal organ damage, diseases like cancer and more.

Manufacturing Medical Devices For Patient Use

Another interesting development that has come from the evolution of technology in medicine is the growth of patient-focused care at home using medical devices.

Telemedicine allows doctors and specialists to receive data gathered from wearable technology that a patient uses at home. This data can be analyzed using smart technology and reviewed by medical professionals to arrive at a diagnosis and prescription.

As such, manufacturers are having to rethink the use-case scenario of each device during the design and production phases. What may work well in a clinical setting or hospital may not work so well in a patient’s home.

Furthermore, design choices factored into the manufacturing process include how easy the device is to transport and ship, how easy it is to use, what networking features are required to interface with telemedicine systems and more.

Article Sources:

https://www.mobihealthnews.com
https://www.nsmedicaldevices.com
https://www.sme.org
https://www.mddionline.com
https://www.fda.gov

 

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