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HealthTech industry Update | Access and Diversity in Clinical Trials

Physicians from underserved communities into research through a reimagined model, we can impact better health outcomes rooted in quality data that allows us to thrive from more diversity and better representation while providing patients with greater access to new care options.

🧑‍⚕️🧑‍⚕️🧑‍⚕️Clinical research partners must intentionally expand their reach to include investigators serving the people within these diverse and often underserved communities. This should be non-negotiable and integral to every research project plan.

To do so it is needed to:

🧑‍⚕️Building trust

🧑‍⚕️Empowering investigators

🧑‍⚕️Maintaining relationships with investigators

Conclusion is

🏥providing investigators with a strong infrastructure, top-notch support with day-to-day boots on the ground, and powerful, continuous training makes for solid and successful relationships. 

🏥A reimagined model will impact better health outcomes rooted in quality data that allows us to thrive from more diversity and better representation while providing patients with greater access to new care options.

https://medcitynews.com/2023/05/access-and-diversity-in-clinical-trials-requires-supporting-the-investigators/

Knowledge Database | The right IOT Operating System for your IOT product

The question is not which is the best in the world, it is the selection which one fits the best to your product. The first decision is which IOT functionality you are aiming:

  • IOT data collection, connectivity, remote controlled
  • IOT data collection, connectivity, immediate decisions, controlling
  • IOT data repository and IOT analytics

Here some overview of typical Operating System types for industrial use according function, with useability:

Embedded OS | IOT data collection, connectivity, remote controlled

This type of operating system is typically designed to be resource-efficient and reliable. Resource efficiency comes at the cost of losing some functionality or granularity that larger computer operating systems provide, including functions which may not be used by the specialized applications they run. Depending on the method used for multitasking, this type of OS is frequently considered to be a real-time operating system.

To be used in case of:

  • Embedded computer systems
  • Small machines with less autonomy
  • Device examples: Controllers, Smart Cards, Mobile devices, sensors, Car ECUs, M2M devices, …..
  • Compact and extremely efficient
  • Limited resources

Products commonly used:

  • INTEGRITY (RTOS)
  • VxWorks.
  • Linux, including RTLinux, Yocto (Linux distribution for IoT), MontaVista Linux
  • Embedded Android
  • iOS
  • Windows CE
  • MS-DOS or DOS Clones
  • Unison OS

Real time OS | IOT data collection, connectivity, immediate decisions, controlling

A RTOS is an operating system intended to serve real-time applications that process data as it comes in, typically without buffer delays. Processing time requirements & OS delay are measured in tenths of seconds or shorter increments of time. A real-time system is a time-bound system which has well-defined, fixed time constraints. Processing must be done within the defined constraints or the system will fail. They either are event-driven or time-sharing. Event-driven systems switch between tasks based on their priorities, while time-sharing systems switch the task based on clock interrupts. Most RTOSs use a pre-emptive scheduling algorithm.

To be used in case of:

  • deterministic nature of behaviour
  • Real time event handling and priority driven state / event coupling
  • specialized scheduling algorithms
  • Clock interrupt handling

Products commonly used:

  • INTEGRITY (RTOS)
  • VxWorks
  • Windows CE
  • DSP/BIOS
  • QNX
  • RTX
  • ROS
  • FreeRTOS (emb.)

Server OS | IOT data repository and IOT analytics 

A server operating system (OS) is a type of operating system that is designed to be installed and used on a server computer. It is an advanced version of an operating system, having features and capabilities required within a client-server architecture or similar enterprise computing environment. Some of the key features of a server operating system include:

  • Ability to access the server both in GUI and command-level interface
  • Execute all or most processes from OS commands
  • Advanced-level hardware, software and network configuration services
  • Install/deploy business applications and/or web applications
  • Provides central interface to manage users, implement security and other administrative processes
  • Manages and monitors client computers and/or operating systems

To be used in case of:

  • Virtual machine
  • Virtualization
  • large server warehouses
  • Micro Service based

Products commonly used:

  • Windows Server 
  • Mac OS X Server
  • Red Hat Enterprise Linux (RHEL)
  • SUSE Linux Enterprise Server
  • Debian, Ubuntu
  • CentOS
  • Gentoo
  • Fendora
  • ROS

Thaumatec has got a lot of experience with Operating Systems during the execution of many projects which required OS tuning. We helped the clients with PoC investigation, OS porting projects and product development to have the right OS in place.

HealthTech industry Update | Better Data Quality Means a better future for Public Health

Public health is heavily dependent on collecting and sharing accurate patient data. 

Standards for data collection and interoperability can move the needle toward better health data, but it is up to healthcare organisations.

Unfortunately, persistent data-quality issues beginning at the provider level continue to undermine population health. 

These include:

➡️ Inaccurate and incomplete patient records.

➡️ Duplicate patient records. 

➡️ When patient records are inaccurate or incomplete

➡️ Inconsistent data stored in disparate systems across different institutions. 

➡️ Outdated reporting for purposes of health equity and SDOH measures. 

Modern data platforms allow healthcare organisations to:

 💪Improve return on investment in their data

 💪Aggregate data access

 💪Free up staff time and resources with better tools and processes

 💪Enhance health equity and SDoH initiatives

 💪Be better prepared for the next public health crisis.  

Here some more information and an overview:

https://medcitynews.com/2023/06/better-data-quality-means-a-better-future-for-public-health/

If you would like to see or search more interesting posts, check our KNOWLEDGE DATA BASE | BLOGPOST DIRECTORY: https://thaumatec.com/knowledge/

Healthtech Industry Update | Digital Technology in Heart Health Care and Monitoring for Cardiac Patients

The Cardiac world has changed

in the last decade in many ways, digital technologies enable patients to obtain care closer to the home and doctors will diagnose cardiovascular disease earlier to assist carers, families, friends and patients undergoing and recuperating for major heart surgeries and rehabilitation processes.

Main focus

is on a holistic recovery journey with cardiovascular technologies and all equipment and methods for speed up detection and treatment for predictive checks, enabling more safe surgery, improving healing cycle, providing online resources, support and counselling of the patients.

There are trials ongoing with Artificial Intelligence and chatbots, big data, analytics and much more using a system framework and developing solutions using:

➡️ Big data that Cardiovascular Disorders can be detected

➡️ Artificial Intelligence and Therapy of cardiovascular disease

➡️ Alexa capabilities and voice technology for support

➡️ Apps for Telemedicine to consult periodically or fast the medics

Here some more information and an overview:

HealthTech Industry Update | New Framework to Evaluate Digital Health Products

The framework, which evaluates the evidence for digital health products, seeks to provide hospitals, payers and trade organizations with a clear set of steps they can use to determine whether or not a digital health product is evidence-based and therefore suitable for their company to adopt.

The framework includes four steps

🧑‍⚕️Screen the product for failure to meet your organization’s absolute requirements

👨‍⚕️Apply an existing evidence assessment framework

🧑‍⚕️Use the Evidence Defined supplementary checklist

👩‍⚕️Produce actionable, justifiable recommendations

Advantages

🩺Careful evidence assessment can mean the difference between identifying critical evidence flaws and failing to do so.

🩺This can, in turn, impact countless patients, by dictating whether patients get access to digital health interventions that are effective and safe.

🩺Difference between medication adherence and nonadherence

🩺Resolution of affective symptoms and chronic emotional struggles

📖Here the MedCity News article:

https://medcitynews.com/2023/06/digital-health-evidence/

If you would like to see or search more interesting posts, check our KNOWLEDGE DATA BASE | BLOGPOST DIRECTORY: https://thaumatec.com/knowledge/

Knowledge Database | Medical reimbursement in EU

Important topics are identification and application for procedure codes and device codes in each European country and applications for inclusion in each country’s reimbursement catalogues and reimbursement lists.

Reimbursement Landscape in Europe – Important is to understand the current reimbursement environment in Europe, relevant for your medical device:

  • Clarify the relevant type of coding systems and guidelines
  • Locate any specific reimbursement mechanisms that could be utilized by the device, 
  • Identify the main decision makers
  • Developing a Winning

Reimbursement Planning for European Decision Makers – Develop the required evidence for European decision makers:

  • Value Story
  • Economic Model
  • Clinical Data
  • Decision Makers’ Feedback 

Implementation – conduct the following activities

  • Billing Guide
  • Reimbursement Applications
  • Pilot Projects
  • Other Funding Options

here more insight by MEDIClever: 

https://mediclever.com/medical-device-reimbursement-europe-eu.php

If you would like to see more interesting posts, visit our whole knowledge database: https://thaumatec.com/knowledge/

Knowledge Data Base | Europe Healthcare Systems and Reimbursement

If Europe wants its citizens to be healthy it must innovate more to deliver better healthcare, to more people in a more efficient manner.

Here an overview about the different Healthcare systems in Europe with some data and comparison on spendings and following topics:

  • Healthcare System Characteristics and Coverage/Insurance
  • Different models e.g. in UK and Germany
  • Country to Country variations in provision and care
  • Different willingness and ability to pay for innovations

If you would like to see more interesting posts, visit our whole knowledge database: https://thaumatec.com/knowledge/

HealthTech Industry Update | Dignose Diseases Via Retinal Scans

AI analyses photos of the eye that were taken with a retinal camera. These analyses are meant not only to screen for eye disease, but also those located throughout the body. 

In fact, the AI can help clinicians screen for more than 140 eye and systemic conditions — some of them cardiovascular and neurological

The company Optain has gained an initial seed investment of $12 million and is an AI company meant to enable earlier disease detection and prevention through retinal imaging.

Some background:

👁️ there are a lot of camera companies out there that can shoot an image through the eye and look at the back of the eye, blood vessels, lesions, the optical nerve and various other features. 

👁️ But not a lot of companies are very good at looking at that from an artificial intelligence and deep learning scenario to figure out which disease states we can predict or screen for by assessing those features.

👁️ The eye can often be a window to a person’s health

👁️ most clinicians lack non-invasive diagnostics and screenings that focus on the eye

👁️ adding a camera to Optain’s product could address this problem

Technology aspects:

📷Technology is based on technology developed by Mingguang He, an Australian clinician researcher

📷Eyetelligence’s technology

📷Eyetelligence’s AI was trained on third party cameras

📷Robust and flexible $15,000 cameras in optometry space

It’s difficult to say when Optain will clear regulatory hurdles and be able to enter the U.S. market, but Dunkel predicts this could happen in 2025. 📷💪

Here the Article by MedCityNews : https://medcitynews.com/2023/05/northwell-retinal-scan-eye-diagnosis-ai/

HealthTech Industry Update | Machine Learning Prediction Model for Inflammatory Bowel Disease

Machine Learning Prediction Model for Inflammatory Bowel Disease Based on Laboratory Markers. Working Model in a Discovery Cohort Study. The Authors aimed to create an IBD machine learning prediction model based on routinely performed blood, urine, and fecal tests.

by Sebastian Kraszewski 1, Witold Szczurek 2, Julia Szymczak 3, Monika Reguła 3 and Katarzyna Neubauer 4*

*Author to whom correspondence should be addressed.

Inflammatory bowel disease (IBD) is a chronic, incurable disease involving the gastrointestinal tract. It is characterized by complex, unclear pathogenesis, increased prevalence worldwide, and a wide spectrum of extraintestinal manifestations and comorbidities. Recognition of IBD remains challenging and delays in disease diagnosis still poses a significant clinical problem as it negatively impacts disease outcome. The main diagnostic tool in IBD continues to be invasive endoscopy.

Based on historical patients’ data (702 medical records: 319 records from 180 patients with ulcerative colitis (UC) and 383 records from 192 patients with Crohn’s disease (CD)), and using a few simple machine learning classificators, we optimized necessary hyperparameters in order to get reliable few-features prediction models separately for CD and UC.

Following methods have been used and topics checked

  • The k-Nearest Neighbour
  • Gradient Boosting Classifier
  • Random Forests
  • Support Vector Classifiers
  • Majority Voting
  • Best Classifiers and Most Important Predictors
  • Model Robustness
  • Web Application Integrated Model

Here the full article and results published by Journal of Clinical Medicine:

https://www.mdpi.com/2077-0383/10/20/4745

HealthTech Knowledge | HealthTech Standard highlights: IEC and FDA

IEC medical standards series are for basic and functional safety of medical electrical equipment and validating optimal usability of devices. The FDA Standards Recognition Program evaluates consensus standards for appropriateness for the review of medical device safety and performance.

Important International Electrotechnical Commission standards

IEC 60601-1-11:2015 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems for use in the home healthcare environment.

IEC 62353:2014 applies to the testing of medical electrical equipment and medical electrical systems, hereafter referred to as ME equipment and ME systems, or parts of such equipment or systems, which comply with IEC 60601-1:1988 (second edition) and its amendments and IEC 60601-1:2005 (third edition).

IEC 62304 is a functional safety standard that covers the safe design and maintenance of software. It provides processes, activities, and tasks to ensure safety. It applies to the development and maintenance of medical device software when the software is itself a medical device.

And here is an important standard from the USA, not to forget if you have to develop e.g. medical devices for this market.

FDA Standards are supplied by the United States Food and Drug Administration (FDA or USFDA), which is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods, and feed and veterinary products.

More information about FDA and the Investigational Device Exemption (IDE) process is topic for another THAUMATEC Knowledge Databse blog post:

https://thaumatec.com/knowledge/blog-posts/healthtech-industry-update-from-the-idea-to-a-medical-device/

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