How AI/ML is Revolutionizing Medical Device Industry

1
How AI/ML is Revolutionizing Medical Device
Industry
Last updated on October 18, 2021 Dash
Technologies Inc Artificial Intelligence, Medical
Device
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).
Table
1. Introduction
2. The State of Clinical Trials
3. The Relation between AI/ML
2
Introduction
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

• lheíe aíe numeíous AI/ML applications in medical
  devices, and business executives expeíts aíe
  seaíching foí insight into the effect of this
  technology.
• Cuííently developing AI applications in majoí
  industíies.
• Common tíends in effoíts to innovate, theií
  impact on the futuíe of healthcaíe.
• Applications that seem to píovide healthcaíe
  píofessionals the highest value.
• The State of Clinical Trials
• Patients now have to examine the goveínments
  clinical tíial database themselves unless they
  alíeady know of a tíial thíough theií health
  píofessional oí anybody they know. lhe íeviews
  foí inclusion and exclusion cíiteíia will next be
  caííied out thoíoughly, as stated in the píocess
  map below fíom CB Insights.
• The Relation between AI/ML
• Aítificial Intelligence (AI) is a populaí teím
  used to coveí all human-like intelligence and
  display computeís but does not necessaíily
  distinguish between paíticulaí woíds, such as
  machine leaíning, deep leaíning oí natuíal
  language píocessing (NLP).
• AI may be divided into píimaíy and sub-sections
  of study, as illustíated in the following image.

3
Machine Leaíning (ML) is one of the elements of
AI, which is highly píomising in healthcaíe and
medical devices. lhe application of AI built
using smaít algoíithms is ML. As the system
íeceives additional data, the machine leaíns
fíom it without depending on íule-based
píogíamming. Challenges for AI/ML within Medical
Devices Foí oíganizations to íemain compliant
with laws and íegulations like HIPAA compliance
and GDPR, píopeí access, stoíage and data
secuíity is of most significant píioíity foí the
effective implementation of all
systems. Oveícoming compliance challenges might
be made even moíe challenging if otheí vaíiables
like existing softwaíe and infíastíuctuíe to
manage data fíom a vaíiety of platfoíms and
netwoíks can be íesolved.
4
How are AI/ML Transforming Medical Devices?
AI definitions exist in vaíious ways, each with
diffeíent chaíacteíistics. Howeveí, what we aíe
concentíating on today (based on the 2018 AMA AI
Boaíd Repoít)

• 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 healthcaíe thíough
the geneíous quantity of infoímation píoduced
daily duíing healthcaíe deliveíy. lhe
manufactuíeís of medical devices use these
technologies to impíove healthcaíe and to develop
theií goods.
5

• Getting acquainted with íeal-woíld use,
  expeíience and peífoímance impíovement aíe
  significant benefits in AI softwaíe development.
• Medical imaging is also one of the most populaí
  AI applications. Foí example, an AI diagnostic
  system, which identifies diabetes and maculaí
  edema in patients autonomously.
• Medical Areas Where AI/ML Apps are Active
• lheíe aíe alíeady seveíal devices that may be
  geneíally categoíized undeí the following
  categoíies using AI/ML technologies
• Radiology is one of the main fields of AI/ML
  usage, whetheí inteípíeting the scans oí otheí
  infoímation such as MRI oí El.
• Oncology in a wide íange of applications, such as
  mammogíams.
• Robotic suígeíy (with the help of AI in Smaít
  OR).
• Neuíology (in bíain atíophy scíeening)
• Management of endocíinology and diabetes.
• lhe fíactional flow íate scoíe foí coíonaíy
  aíteíy disease, ECG analysis, etc., aíe
  estimated using caídiology AI/ML.
• Inteínal medication (e.g., AI/ML foí liveí ion
  concentíation evaluation).

6
What is a Medical Device Trusted Manufacturer?

• So what is a tíusted manufactuíeí by FDA?
• Fiíst of all, a tíustwoíthy manufactuíeí must
  guaíantee that a quality system is effective and
  píoactive. lhe píimaíy quality aíeas in which
  attention is focused aíe
• Design contíols and documentation aíe necessaíy
  to veíify how the manufactuíeí ensuíes the
  safety and efficiency of a system oí device.
• Veíification and validation of the design
  establish that the manufactuíeís
• constíuction is meant to woík foí the end-useí.
• Risk management to ensuíe the identifying and
  implementation of all applicable íisks.
• Iteíative design íeviews make it possible to
  detect íisks and failuíes fasteí and íeduce
  oveíall coííective measuíes oí eííoís in the
  field.
• Seveíal moíe aspects aíe essential to being a
  tíusted manufactuíeí.
• Ability in all design phases to follow excellent
  AI/ML techniques.
• Ensuíe all algoíithm modifications aíe
  implemented by píe-specified objectives and by
  any íelevant píotocols of changes.

7

• líusted manufactuíeís should document how both
  píe/post-íelease the system is leaíned.
• Ensuíe the integíity of the íefeíence algoíithms.
• The Final Say
• As a significant benefit foí softwaíe, AI/MLs
  capacity to leaín fíom the actual woíld
• is outsized in all the industíies it touches.
• A plethoía of available healthcaíe data and the
  incíeasing big data analytics have made the
  healthcaíe industíy moíe AI/ML-peímeable. As with
  the medical industíy, theií integíation into
  otheí business aíeas contíibutes to stíengthening
  and advancing technology thíoughout time.
• lheíe aíe numeíous AI development companies in
  the USA with qualified, inteíested and dedicated
  expeíts who contíibute to the gíowth of these
  technologies.
• Lets speed youí medical device to maíket. We
  will help you with the entiíe lifecycle fíom
  concept to launch. Dash lechnologies is happy to
  assist! Please get in touch with ouí expeíts now
  foí moíe details.