How AI/ML is Revolutionizing Medical Device Industry

By Dash Technologies Inc., October 18, 2021
Reading Time: 10 minutes

AI is estimated to increase sales by around $120 billion in the healthcare industry alone by 2028. This growth will most likely be focused on artificial intelligence and machine learning-based software as a medical device (AI/ML-based SaMD).


1. Introduction
2. The State of Clinical Trials
3. The Relation between AI/ML
4. Challenges for AI/ML within Medical Devices
5. How are AI/ML Transforming Medical Devices?
6. Medical Areas Where AI/ML Apps are Active
7. What is a Medical Device Trusted Manufacturer?
8. The Final Say…


There are numerous AI/ML applications in medical devices, and business executives & experts are searching for insight into the effect of this technology.

  • Currently developing AI applications in major industries.
  • Common trends in efforts to innovate, their impact on the future of healthcare.
  • Applications that seem to provide healthcare professionals the highest value.

The State of Clinical Trials:

Patients now have to examine the government’s clinical trial database themselves unless they already know of a trial through their health professional or anybody they know. The reviews for inclusion and exclusion criteria will next be carried out thoroughly, as stated in the process map below from CB Insights.

The Relation between AI/ML:

Artificial Intelligence (AI) is a popular term used to cover all human-like intelligence and display computers but does not necessarily distinguish between particular words, such as machine learning, deep learning or natural language processing (NLP).

AI may be divided into primary and sub-sections of study, as illustrated in the following image.

Source: AI Mind Map Medium Blog

Machine Learning (ML) is one of the elements of AI, which is highly promising in healthcare and medical devices.

The application of AI built using smart algorithms is ML. As the system receives additional data, the machine learns from it without depending on rule-based programming.

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Challenges for AI/ML within Medical Devices:

For organizations to remain compliant with laws and regulations like HIPAA compliance and GDPR, proper access, storage and data security is of most significant priority for the effective implementation of all systems.

Overcoming compliance challenges might be made even more challenging if other variables like existing software and infrastructure to manage data from a variety of platforms and networks can be resolved.

How are AI/ML Transforming Medical Devices?

AI definitions exist in various ways, each with different characteristics. However, what we are concentrating on today (based on the 2018 AMA AI Board Report):

• Artificial intelligence represents several computing techniques that generate systems that carry out activities that typically require human intellect.
• Automatic image recognition, processing natural languages and machine learning include, but are not limited to.
• However, AI/ML is a more suitable phrase that reflects the increased capacity of human clinical decisions when paired with these computational methodologies and systems.


AI/ML technology can change healthcare through the generous quantity of information produced daily during healthcare delivery. The manufacturers of medical devices use these technologies to improve healthcare and to develop their goods. Getting acquainted with real-world use, experience and performance improvement are significant benefits in AI software development.


Medical imaging is also one of the most popular AI applications For example, an AI diagnostic system, which identifies diabetes and macular edema in patients autonomously.

Medical Areas Where AI/ML Apps are Active:

There are already several devices that may be generally categorized under the following categories using AI/ML technologies:

  • Radiology is one of the main fields of AI/ML usage, whether interpreting the scans or other information such as MRI or ET.
  • Oncology in a wide range of applications, such as mammograms.
  • Robotic surgery .
  • Neurology (in brain atrophy screening)
  • Management of endocrinology and diabetes.
  • The fractional flow rate score for coronary artery disease, ECG analysis, etc., are estimated using cardiology AI/ML.
  • Internal medication (e.g., AI/ML for liver ion concentration evaluation).

What is a Medical Device Trusted Manufacturer?

So what is a trusted manufacturer by FDA?

  • First of all, a trustworthy manufacturer must guarantee that a quality system is effective and proactive. The primary quality areas in which attention is focused are:
  • Design controls and documentation are necessary to verify how the manufacturer ensures the safety and efficiency of a system or device.
  • Verification and validation of the design establish that the manufacturer’s construction is meant to work for the end-user.
  • Risk management to ensure the identifying and implementation of all applicable risks.
  • Iterative design reviews make it possible to detect risks and failures faster and reduce overall corrective measures or errors in the field.

Several more aspects are essential to being a ‘trusted manufacturer.’

  • Ability in all design phases to follow excellent AI/ML techniques.
  • Ensure all algorithm modifications are implemented by pre-specified objectives and by any relevant protocols of changes.
  • Trusted manufacturers should document how both pre/post-release the system is learned.
  • Ensure the integrity of the reference algorithms.


The Final Say…

As a significant benefit for software, AI/ML’s capacity to learn from the actual world is outsized in all the industries it touches.

A plethora of available healthcare data and the increasing big data analytics have made the healthcare industry more AI/ML-permeable. As with the medical industry, their integration into other business areas contributes to strengthening and advancing technology throughout time.

There are numerous AI development companies in the USA  with qualified, interested and dedicated experts who contribute to the growth of these technologies.

Let’s speed your medical device to market. We will help you with the entire lifecycle from concept to launch. Dash Technologies is happy to assist! Please get in touch with our experts now for more details.

About Dash

Dash Technologies Inc.

We’re technology experts with a passion for bringing concepts to life. By leveraging a unique, consultative process and an agile development approach, we translate business challenges into technology solutions Get in touch.

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