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SaMD is a step forward in harmonizing healthcare
SaMD is a step forward in harmonizing healthcare

October 20, 2022

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In the modern world, technology has reshaped the healthcare industry by providing enhanced healthcare and managing it through innovation. Medical devices have grown in functionality and usability over time, with the overarching objective of providing patients with safe and accurate care.

 

With the fast advancement of software and a plethora of suitable hardware on the market, Software as Medical Devices (SaMD) has grown in popularity over time. SaMD enables consumers to utilize their own devices by separating the output and complex processing from the primary medical equipment. It is applicable to a broad range of technical platforms, such as medical device platforms, commercial "ready to use" platforms, and virtual networks.

 

In this article, we will look into SaMD and its current relevance, its advantages and challenges:

 

SaMD, therelated technology and use cases include:

The innovation in SaMD is revolutionizing healthcare by allowing people to be more engaged in their treatment process. The growing popularity of SaMDs is due to their effective usage in clinical practice: simplifying diagnosis, therapy, and health management for a specific patient as well as health care.

 

SaMD has expanded into new areas of utility, such as Image transmission from an ultrasound machine to the practitioner, Windows desktop tools for sleep problems, and Android and iOS apps for diabetic management. In addition to supporting "core" medical devices, SaMD has expanded into new areas of utility, such as:

  • Therapy adherence monitoring: The SaMD, coupled with the cloud, is hosted on a generic device such as a smartphone. This is a classic instance of bringing your own device (BYOD) to the patient. Information from an end medical device is sent to a smart device and then to the cloud where it is accessed by a medical professional.
  • Medical device processing of raw data: For instance, in EEG, the neuro equipment gathers patient raw data and delivers it to a PC. The desktop hosting program filters out extraneous noise and displays the appropriate EEG waveform.
  • Telemedicine or TeleHealth: It has enabled enhanced patient care by enabling early warnings and better treatment guidance of the most common conditions, such as stroke and heart disease.

 

SaMD challenges and solutions

It aims to ensure data security while retaining product performance and efficiency, yet, combining current product development approaches for the ever-changing internet with backend security is challenging. The SaMD concept has gained popularity, but it is not without its own set of obstacles that are characteristic of a standalone software product:

  • The sensitive data is available over the network by software that masquerades as a medical device. The goal is to ensure data security while retaining product performance and efficiency.
  • Security issues are particularly significant because of the variety of software developed for healthcare. Stakeholders, regulators, and other authorities at various levels must follow FDA requirements to expedite the approval of software developed for healthcare applications.
  • The internet is dynamic, and there is no way to eliminate security problems while still making your product responsive to the changing internet. The primary goal is to strike a balance between innovation and flexibility while protecting the user's data.

 

Solutions:

Upgrades to the host OS: It offers foolproof techniques for rigorous testing across a wide range of platforms. There should also be a smart notification system that alerts consumers to potential mistakes and issues.

Fixing bugs and handling criticism: The "time to correct" support in the cycle must be swift and precise.

TAT for problem resolution: Constant product enhancements based on customer feedback are an effective way to keep troubles at bay.

SaMD is a thriving sector, and new concepts emerge as more professionals enter the field. SaMD makers must also attempt to remain up to speed on continually changing laws to adjust their product. To build smart healthcare equipment without jeopardizing sensitive user data, developers must strike a balance between innovation and regulatory compliance.


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