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HealthTech Knowledge Guide | ‍Top 10 Advances in Medicine

These advances have directly contributed to the significant rise in global life expectancy, nearly tripling it from just 28.5 years in 1800 to 72.6 years in 2019.

TOP 10 Medical Advances

1. Antibiotics: Revolutionizing the treatment of infections

The discovery of antibiotics stands as one of the most critical advances in medical history. They were discovered in 1928 when Alexander Fleming returned home from vacation to find a petri dish on his workbench filled with a strain of mold that was not only thriving but also limiting the growth of bacteria.

2. Vaccines: Preventing deadly diseases

The fact the word vaccine derives from the Latin word for cow is no coincidence, given Edward Jenner’s discovery in 1776. He observed milkmaids who’d been exposed to the relatively mild cowpox virus developed an immunity to the more serious smallpox virus. His discovery led to the development of the smallpox vaccine, and 179 years later, in 1977, smallpox was eradicated (and remains the only disease ever to be entirely eradicated).

3. Anesthesia: Transforming surgical procedures

Prior to the mid-1800s, surgical procedures were limited due to the excruciating pain patients experienced. This changed in 1846 when William TG Morton used ether to anesthetize a patient for surgery. The drugs used to anesthetize patients for surgery have come a long way since these early days. Techniques have also been refined and, when used in combination with new technologies, have resulted in significant gains in patient safety.

4. X-rays and Medical Imaging: Advancements in non-invasive diagnostics

Before the advent of medical imaging, physicians relied on their sense of touch, observations, and the patient’s account of their symptoms to diagnose them. The discovery of X-rays by William Conrad Roentgen in 1896 revolutionized diagnostic medicine based on his experimentation with electric currents and glass cathode-ray tubes. The potential of his discovery in the diagnostic process was immediately recognized, with Glasgow Hospital opening its first radiology department just a year later.

5. Germ Theory: Small changes make a big impact

The introduction of anesthetics in 1844 meant that doctors could attempt longer and more complex procedures. However, post-surgery infection rates were soaring, along with mortality rates, limiting progress since scientists had no explanation for what caused infection until French microbiologist Louis Pasteur developed germ theory in 1861.

6. Organ Transplantation: Saving lives through organ replacement

The first successful kidney transplant was performed by Joseph Murray in 1954. While it had been attempted before, this was the first time the patient survived the surgery. By 1968, surgeons successfully completed pancreas, liver, and heart transplants, with the first heart-lung transplant in 1981.

7. Genetic Engineering: Unlocking the secrets of life

The discovery of the double helix structure of DNA by James Watson, Francis Crick, and Rosalind Franklin revolutionized molecular biology. The development of a map of the human genome has been vital in predicting and understanding the incidence of many diseases. While this information is already used to screen and create interventions for at-risk groups for conditions for which they may have a predisposition, the potential is even greater, with the possibility of personalized medicine and gene therapies close to becoming an everyday reality.

8. Heart Surgery: Pioneering cardiovascular interventions

The first coronary artery bypass graft (CABG) was performed by Dr. Rene Favaloro in 1967 when he took a vein from his patient’s leg and used it to bypass a blocked coronary artery. This innovative procedure restores blood flow to the heart muscle and relieves the symptoms of angina and the likelihood of a heart attack.

9. Antiseptics: Enhancing Sterilization and infection control

Joseph Lister’s development of antiseptics significantly improved infection control in surgery and beyond. Concerned with the high mortality rate following surgery, Lister began experimenting with different techniques to prevent infection, developing the antisepsis system in a home laboratory while working with his wife and assistant, Agnes.

10. Insulin: Saving millions of lives daily

Thanks to insulin, a diagnosis of type I diabetes is no longer a death sentence, but prior to 1922, children diagnosed with type I diabetes were expected to live for just one and a half years, and adults less than ten. The discovery of insulin by Sir Frederick G Banting, Charles H Best, and JJR Macleod at the University of Toronto meant that those with diabetes could live a relatively normal life.

Honorable Mentions

Several other medical advances came close to making our top ten and definitely deserve some recognition!

Epidemiology

Hippocrates considered the connection between the environment, host factors, and disease development around 400 BC, and Joaquín de Villalba first used the term epidemiology to explain these connections in the late 1700s. However, it was John Snow who meticulously mapped the incidence of cholera in London in 1854, tracing the source of the infectious disease to specific water pumps while illustrating the importance of applying statistical analysis to the outbreak of disease, outcomes, and behaviors.

3D Printing

When Chuck Hall first developed 3D printing in 1983, few could have imagined its medical applications. Thirty years later, the technology enables scientists to print the scaffolds for organs, prosthetic limbs, and medications. With the technology still very much in the early stages, the future applications of 3D printing in healthcare have incredible potential.

Artificial Intelligence (AI)

Artificial intelligence is already making its mark in many aspects of medicine. It’s assisting medical professionals in diagnosing and treating illness, with its potential seemingly limitless to the extent that it’s likely to be a permanent fixture on future top 10 lists. The current challenges involve overcoming the ethical issues around how much control machines have over the diagnostic and treatment process and ensuring accuracy.

Conclusion

It takes many pieces of a puzzle to see the bigger picture. While every little piece of knowledge improves our ability to diagnose and treat illness, these top ten medical advances have more than left their mark by drastically improving the life expectancy and health outcomes of millions of people. With so many rapid technological advancements, scientists can better understand, investigate, and develop treatments, building on these discoveries to improve health outcomes globally.

Here the details of the osmosis article:

https://www.osmosis.org/blog/2023/07/10/the-top-10-medical-advances-in-history#:~:text=The%20discovery%20of%20antibiotics%20stands,limiting%20the%20growth%20of%20bacteria.

HealthTech Industry Update | Medicine delivered by drones to Medical Deserts

Last time we talked about what the medical deserts are, and how technology can alleviate them.
This time our topic is how to enable healthcare access and improve outcomes in rural communities, and urgency through faster and more efficient transport of critical medical supplies. One possible way of transport and supply medical deserts is to use drones. Because of fast evolution of the related technology, the capability, and safety of drones is fast improving too.

Trials with special drones explore the potential for several use cases:

➡️ between medical facilities

➡️ to patients directly

➡️ in emergency cases

➡️ diagnostics via computer vision and AI

➡️ with a lot of safety features, not to harm anyone

➡️ Launching systems

There are a lot of trials in US, UK and many other countries ongoing and I think soon it will become more and more usual to have this systems commercial operational.

Here an example for a trial in UK:

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

Healthtech Industry Update | United Nation Goals for HealthTech ideas Impacting Good Health and Well Being

Innovations in healthcare and wellness span a range of technologies. Traditionally speaking, healthcare data and information have usually been collected and stored neatly for many years now, albeit in paper form.

The digitization of health data and information, known as eHealth, opens the door for applying analytics and informatics techniques to vast amounts of patient and hospital data.

INNOVATIONS IN HEALTHTECH

The digitization of health data and information, known as eHealth, opens the door for applying analytics and informatics techniques to vast amounts of patient and hospital data.

Partly or completely, it is business-as-usual issues that hinder countries in efficiently delivering public services, which in turn slows the progress of the UN-SDG program.

With the gradual standardization of data collection systems, innovators have a multitude of options for developing technology-driven health and wellness solutions.

Here the HealthTech areas and the description:

3D IMAGING

Medical imaging is at the heart of many patients’ diagnosis and treatment. Good imaging can help clinicians spot the earliest signs of an emerging medical condition. The more accurately we capture and model images of our bodies, the better the chances of detecting diseases early. This is life-saving for many patients.

3D imaging technologies potentially address this SDG’s challenge: faster detection of major diseases like malaria and tuberculosis, and in turn, a faster diagnosis. There is an urgent need for efficient diagnostic solutions as many patients suffer undue financial hardships in search of better healthcare.

3D PRINTING

The broad applications of additive manufacturing, also known as 3D printing, in the field of healthcare are bioprinting tissues or organoids, printing surgical tools, printing patient-specific surgical equipment, and customized prosthetics. The possibility of printing bones and implants that mimic human biology opens the door for customized solutions based on each unique disability.

3D printing makes healthcare cheaper for those who are in the most pain. The number of people suffering from disabilities requires high quality and more personalized solutions for truly comfortable lives. The very fact that such solutions already exist is enough for increased investments in this technology.

AUGMENTED REALITY

The work of a surgeon is very time-sensitive, as the patient’s health and life are often on the line. Augmented Reality (AR) overlays high-quality visualization, or 3D objects, onto real-world surroundings, creating a potent medical tool. This includes an overlay of CT-scans over the patient’s body, reconstruction of tumors in AR, and much more.

According to the UN, 40 percent of the world has fewer than 10 doctors for every 10,000 people. Augmented reality helps the industry in addressing this shortage by efficiently training many more doctors. At the same time, AR helps surgeons perform their tasks more accurately with less time spent on it.

BIG DATA & CLINICAL ALGORITHMS

The majority of health data is collected passively, that is, patients are not logging their details, but rather the points of healthcare services log the data. Image recognition software combined with machine learning helps clinicians to diagnose diseases using patient images and records such as photos, test results, x-rays, and other medical images.

The targets set by the UN to achieve the goal of good health for all requires doctors to get empowered to deliver an efficient, swift, and accurate diagnosis. To be able to achieve some of the targets by 2030, like ending epidemics of malaria, tuberculosis, and other neglected diseases, we need algorithms trained to spot diseases and detect anomalies faster.

BLOCKCHAIN

When it comes to healthcare, blockchain technology offers a unique tamper-proof electronic medical record (EMR) management system with higher privacy and interoperability. Though commonly associated with blockchain, these features are vital for improving access to healthcare for millions of people around the world. Trustless collaboration offers a way out of today’s messy healthcare networks.

The UN believes that concerted efforts are required to achieve universal health coverage and sustainable financing for health, to address the growing burden of non-communicable diseases. Blockchain technology opens the door for reduced complexity in health information exchanges (HIE) and exchanging electronic health records (EHR).

INTERNET OF MEDICAL THINGS

By monitoring an individual’s vital signs and automatically adjusting the amount of drug to be delivered, drug delivery systems help the patients to stay within a safe range, preventing abnormal dosing situations. Automatic drug delivery systems consist of a wirelessly connected implanted medical device and an external drug delivery device.

There is a greater risk of damaged medication when it gets compromised by exposure to temperatures beyond its safe range. Smart sensors monitor the environment temperature and conditions and alert users if they are close to a critical point or if medications already get spoiled. Such efficient technologies are necessary for improving access to healthcare – essential for achieving this SDG.

MOBILE HEALTH & DIGITAL BIOMARKERS

Biomarkers are bodily indicators that are measured to determine the condition of a patient. Cholesterol levels are biomarkers for potential cardiac diseases. Mobile Health, or mHealth, uses a combination of biosensors, wearable devices, and digital biomarkers that constantly monitor the user’s data, alerting them when the biomarker levels are abnormal.

Tuberculosis (TB) remains a leading cause of poor health and death. Though some of the results are encouraging, there are still large gaps in detection and treatment and the UN believes the pace of progress will not be sufficient to achieve the targets. Such digital monitoring technologies accelerate the process of detecting TB, which plays a major role in the ensuing treatment.

REMOTE CARING TECHNOLOGIES

Using artificial intelligence (AI), along with remotely connected monitoring devices, allows medical practitioners to efficiently analyze data from patients and improve their healthcare. For people with chronic diseases, implanted monitors combine characteristics of therapeutic and monitoring devices such as pacemakers, blood indicators, monitors for metastasis. This ensures there is sufficient data for remote doctors to analyze and prescribe treatment.

Remote caring devices have the potential to address the pressing challenge of helping those affected by neglected tropical diseases. The UN estimates that over 1.5 billion people suffer from such diseases and the numbers have improved slightly, mainly because of improved surveillance. Remote caring also allows a few doctors to monitor, diagnose, and suggest treatment for a large number of patients who are in dire need of healthcare.

NANOTECHNOLOGY

Nanotechnology, along with nanomedicine, considerably accelerate the developments in regenerative medicine, drug delivery, and vaccine efficiency. Novel concepts allow patients with organ failures or severe injuries to get artificial skin, bone, cartilage or other tissues.

The ability of nanomedicine to provide targeted slow-release vaccine delivery improves vaccine efficacy and in turn, the intended outcomes. This will prove vital in the UN’s efforts to support research and development of essential vaccines for several diseases in developing countries. Improving vaccinations plays a major role in ultimately achieving the goal of providing universal affordable healthcare.

PERSONALIZED MEDICINE

The latest artificial intelligence (AI) and machine learning technologies help identify patterns within genetic datasets so that computer models can make predictions about an individual’s odds of developing a disease or responding to interventions. Predictive analytics for personalized medicine enables doctors to make decisions based on demographics, biomarkers, genetics, and drug levels to provide patients with a personalized dose.

By 2030, the UN aims to substantially reduce the number of deaths and illnesses from hazardous chemicals, air, water, and soil pollution and contamination. Depending on a person’s immunity, environment, and habits, these types of pollution may have different effects on different people. Personalized medicine provides the opportunity for catering to the varying factors that affect patients and providing them with individual treatment.

ROBOTICS

The ability to manipulate a sophisticated robotic arm by operating controls combined with AR provides surgeons with better chances for successfully completing complex surgeries. Rehabilitation robots, equipped with sensors and advanced interaction control systems, continuously monitor and adapt their support to the state of the patient. Service robots are designed to assist clinical staff with logistical tasks and deliver supplies, medications, and meals by combining AI and advanced indoor navigation systems.

The UN estimates that more than 55 percent of countries have fewer than 40 nurses and midwifery personnel per 10,000 people. Combined with the shortage of doctors in several countries, robots present a unique opportunity for rapidly expanding health services. By allowing robots to take up repetitive and menial tasks, it frees up valuable time for medical practitioners to focus on essential and complex tasks in healthcare.

VALUE-BASED HEALTHCARE

High prices for some generic drugs in recent times have once again raised the question of shifting to value-based healthcare practices. Though spoken often in terms of healthcare payment, it includes some other important aspects of healthcare that need reforming. From fostering collaboration between science and research and patient needs to improving healthcare stakeholder relationships, the industry begins a slow and tedious shift into fair health practices and affordable health products.

The UN aims to achieve universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines for all. Value-based healthcare models and services have the potential to accelerate the pace of progress for this target.

VIRTUAL REALITY

Today, treatments for chronic pain using drugs have harmful side effects and prove to be ineffective in the long term. Virtual Reality (VR) offers a way for patients to undergo therapies that distract them from thinking about pain and facilitates a more natural pain relief procedure. In addition to such treatments, VR is useful in training practitioners and bringing about awareness about almost all health topics.

The UN targets significant reductions in the numbers for suicide, tobacco-related deaths, and other forms of substance abuse and addiction. VR is one of several technologies in development to reduce user dependency on these substances. By working on infrastructure obstacles, countries will benefit from stronger societies with low mental health concerns.

WEARABLES

Active smart fabrics memorize the shape, display a сhameleon effect, regulate temperature, resist water, absorb vapors, and heat the fabric. Medical-grade textile is capable of capturing millions of signals on the skin and unlocking a wide range of biometric insights including heart rate, respiratory rate, temperature, breathing, stress, movement, acceleration, and hormone levels.

According to the UN, inadequate and unsafe drinking water, sanitation, and hygiene are linked to more than 800,000 deaths globally. Along with air pollution, millions of lives are affected every year simply because of where people live or certain aspects of their lifestyle. By continuously monitoring a user’s health information, wearables facilitate the detection of illness and conditions faster, allowing the user to seek help before it is too late.

MENTAL HEALTH

There is a range of mental health remedies and treatments that vary in utility and complexity, depending on the individual’s condition. Some of them are simply for relaxation, deep breathing, and other techniques to help manage stress and anxiety. In more severe cases, AI, AR, and VR-based mental health programs provide clinicians with valuable methods and tools for diagnosing and treating major depression, anxiety disorders, and cognitive and memory problems in adolescents, adults, and senior individuals.

However, suicide remains the second-highest cause of death among people aged 15 to 29 globally, according to the UN. As more practitioners get involved in developing the tools necessary to combat complex mental health issues, families and societies must also develop healthy communication with their children to help avoid falling into the mental traps that get triggered by everyday events.

WOMEN’S HEALTH

Many women lack access to healthcare services. In order to democratize health services for women, solutions like female health chatbots provide users with fast, accurate, and affordable health information directly from experts – instead of getting it from the internet. According to statistics, breast cancer is the most common cancer in women worldwide – and early detection is the key to successful treatment.

The UN realizes that expanding access to modern contraceptive methods is essential to ensuring universal access to sexual and reproductive health-care services. A decline in adolescent fertility rates is also a welcome milestone. In general, empowering women with information to understand sexual health and its effect on their lives will help millions of women make informed, important life decisions.

MATERNAL HEALTH

The postnatal period is the most critical and yet the most neglected phase in the lives of mothers and babies. Most maternal and newborn deaths occur during this period. Smartphone apps assist new mothers by guiding them through this important time, helping to save them and their babies’ lives.

The UN estimates 303,000 women around the world died due to complications of pregnancy and childbirth in 2015. Important milestones have been reached for this target, with over 81 percent of live-births happening in the presence of a skilled attendant. More research on reproductive and maternal health topics will go a long way in addressing these preventable deaths.

INFANT CARE

Health monitoring systems for infants, based on wireless communications, prove to be reliable and efficient for both parents and doctors to help ensure better infant care. Such systems monitor parameters such as body temperature, pulse rate, and movement of an infant, and relay this information to the parents in real-time.

The UN estimates that more than 5 million mortalities for children under the age of 5. A majority of these deaths are preventable and more than half happened within the first month of life, considered the most crucial for child survival. With better monitoring, health tracking, and streamlined health management systems, technology can potentially save the lives of millions of infants.

SENIOR CARE

The senior people of society often suffer the most because of changes in pollution levels or technology. Health technologies designed for senior members of the society are similar to those for infants. Connected devices and wireless data transmission help caregivers keep a closer eye on their seniors, with real-time alerts and notifications.

While the UN does not single out this category of people in the goals, they are very much included in the sustainable development goal of ensuring good health for all ages. As populations grow, medical institutions must innovate to find ways to address every patient. Such senior care technologies can potentially reduce this burden while making their lives a lot easier and safer.

WHAT’S NEXT?

The Sustainable Development Goals are designed for all stakeholders in society. Healthcare institutions all over the world have pressing issues to deal with. Adopting and collaborating with intelligent technology will significantly boost the quality of health services.

Patients see increasing opportunities to monitor their health in more efficient ways, detect abnormal conditions, and access targeted treatments. Even healthy people now find innovative and simple ways to maintain a nutritious diet and exercise regularly – essential for preventing several diseases.

The growing number of startups and companies aligning their offering with the Sustainable Development Goals is an encouraging sign. All stakeholders must do their part in helping achieve these goals.

Here the full Article from StartUs Insights with Healthcare Innovation Map and 30 selected startups:

https://www.startus-insights.com/innovators-guide/30-healthtech-startups-impacting-good-health-well-being/

HealthTech knowledge guide | Medical device connectivity

Medical device connectivity is the establishment and maintenance of a connection through which data is transferred between a medical device, such as a patient monitor, and an information system. The term is used interchangeably with biomedical device connectivity or biomedical device integration. By eliminating the need for manual data entry, potential benefits include faster and more frequent data updates, diminished human error, and improved workflow efficiency.

Medical devices may be connected on wireless and wired networks. Wireless networks, including Wi-Fi, Wireless Medical Telemetry Service, and Bluetooth, provide more ubiquitous coverage of connectivity, allowing uninterrupted monitoring of patients in transit. Wired networks are fast, stable, and highly available. Wired networks are usually more costly to install at first and require ongoing costs for maintenance, but allow connectivity of the organization in a closed environment.

Interoperability of devices

Adherence to standards ensures interoperability within a network of medical devices. In most cases, the clinical environment is heterogenous; devices are supplied by a variety of vendors, allowing for different technologies to be utilized. Achieving interoperability can be difficult, as data format and encryption varies among vendors and models. The following standards enable interoperability between connected medical device.

CEN ISO/IEEE 11073 enables the communication between medical devices and external information systems. This standard provides plug-and-play interoperability between devices, and facilitates the efficient exchange of data acquired at the point of care in all care environments
IEEE 802.11 a/b/g/n are standards for implementing a wireless local area network (WLAN) in 2.4 GHz and 5 GHz frequency bands, utilizing the same basic protocol.

Regulatory organizations and industrial associations, such as Integrating the Healthcare Enterprise (IHE) initiative and Continua Health Alliance, are working towards standardized vendor-neutral device integration systems. The IHE provides a single set of internationally harmonized medical device informatics and interoperability standards as a unitary reference point for the industry. The IHE collaborates with Continua Health Alliance regarding data exchange protocol and device specializations.

The IHE Patient Care Device (PCD) Technical Framework Volumes 1-3 defines the established standards profiles, such as the integration, transaction and semantic content profiles respectively for complete, enterprise-wide integration and interoperability of health information systems.

Several profiles have applications in medical device connectivity including the following:

[DEC] Device Enterprise Communication – supports publication of information from point-of-care medical devices to applications such as clinical information systems and electronic health record systems, using a consistent Health Level Seven version 2 (HL7 v.2) messaging format and device semantic content or DICOM profile.
[ACM] Alarm Communication Management – ensures the right alarm with the right priority to the right individuals with the right content.
[DEC-SPD] Subscribe to Patient Data – supports a filtering mechanism for data transaction.
[PIV] Point-of-care Infusion Verification – supports communication of a 5-Rights validated medication delivery / infusion order (from Bar Code Medication Administration (BCMA) system, also known as Barcode Point of Care (BPOC) system, to an infusion pump or pump management system
[RTM] Rosetta Terminology Mapping – is based on the ISO/IEEE 11073 semantic standards converting vendor specific terms into harmonized standard terms. It uses a set of tools (Excel spreadsheets & XML files) to map the proprietary semantics communicated by medical devices to a standard representation using ISO/IEEE 11073 semantics.
[IDCO] Implantable Device – Cardiac – Observation (IDCO) profile – specifies a mechanism for transmission, and processing of discrete data elements and report attachments associated with cardiac device observations.

Medical Device Integration Software

Hospitals have many different makes and models of medical devices. Each department has different types of devices, and rarely does an entire hospital run the same brand device. Because of the large number of devices, and the varying formats that data is exchanged (RS-232, HL7, Bluetooth, WiFi), Medical Device Integration software has become a critical component to integrating this vital patient data.

Positive Patient Identification and Connectivity

Patient confidentiality can be compromised when the device data is transmitted to the wrong electronic health record. A positive patient identification at the point of care can be ensured through bar-code identifiers and radiofrequency identifiers.

Bar-code Identification – Patient data is encoded within a bar-code on the patient’s identification bracelet. Device identifying data is encoded within a bar-code attached to the device. Scanning the patient bar-code in conjunction with the medical device bar-code, ensures a patient-device association.
Radiofrequency Identification – Patient and device identifying information is encoded within an RFID tag. This information is detected, and the clinician is prompted to confirm the patient-device association. RFID is a more efficient method of positive patient identification when there are multiple devices in use.

Security Issues in Medical Device Connectivity

Security issues may arise in medical networking for many reasons. The following is a list of security challenges particular to medical devices:

Medical devices often operate with commercial central processing units, operating systems, or off-the-shelf software, which place them at risk of cyber threat.
Due to tight regulations surrounding medical devices, upgrades to software and security installations must be approved by the manufacturer, resulting in delays.
Device operating systems are often early generation and may no longer be supported.
Homogenous device environments facilitate rapid spread of computer virus.
Devices may have limited memory, necessitating the use of scaled back versions of operating systems, making it more difficult to utilize common security software.

Relevant organizations

Association for the Advancement of Medical Instrumentation(AAMI)

Health Level 7(HL7)

CEN/TC 251

ISO/TC 215 (Health Informatics)

HealthTech Industry Update | New wearable medical sensors

Self-powered sensors are key to more accurate, continuous health monitoring.

The researchers of Penn State like Huanyu “Larry” Cheng, Dorothy Quiggle Career Development Assistant Professor of Engineering Science and Mechanics are working to improve health monitoring by creating wearable sensors that collect data for clinicians while limiting discomfort for patients.

They are working on novel components and approaches to develop such devices as:

wearable head scanners
needle-free glucose monitors
wearable antennas
printable electronics.

The sensors are

made with flexible electronics
capable of monitoring patients’ physical motions and chemical signals in their sweat, skin
more to help diagnose or inform treatment plans
and the key is to make devices sustainable, resilient and self-charging.

Self-powered, rechargeable wearables

Developing flexible, economical sensors is one thing but powering them is another.

Although self-charging power units for stretchable energy harvesters already exist, they are expensive to fabricate, heavy to carry and they suffer from low and unstable output power.

Here graphene material could help. It can harvest energy from motion, such as human body movements, and store it as electrical energy in micro-supercapacitors and as other types of wearable sensors, the self-powered device can measure users’ vital signs such as pulse, temperature, electrocardiogram, blood pressure and blood oxygen.

Tissue paper for pressure readings

Tissue paper decorates presents, protects breakables and, thanks to the research team, it can monitor blood pressure and respiratory conditions. A wearable sensor that detects blood pressure and movement can use a small skin patch built from inexpensive, widely available tissue paper. The wireless device adheres comfortably to a user’s forearm and reads blood pressure by measuring the dilation and constriction of a blood vessel in the wrist.

A sensor for humid environments

Most wearable sensors use superhydrophobic materials to repel water, but they have limited flexibility and often degrade quickly in humid environments.

To solve that problem you could combine superhydrophobic materials with Joule heating, where electric current passes through a conductor to produce heat. The heat provides continuous moisture resistance, even when the sensor is in an environment with 99% humidity.

The result is a new flexible pressure sensor that is able to withstand high degrees of humidity. The details were made available online ahead of the March issue of Chemical Chemical Engineering Journal..

Outlook

“We don’t know where inspiration will strike — tissue paper, lotus plants, motion power and more have all proved fruitful sources,” Cheng said. “From discovery to research to application, our team is enjoying the challenge of creating the next generation of medical devices.”

Here the link to the full interesting article of Penn State – Pennsylvania State University https://www.psu.edu/news/engineering/story/new-research-advances-wearable-medical-sensors/

HealthTech Knowledge Guide | Barrier-free software

The term “barrier-free” is familiar to many, particularly when referring to buildings, public spaces, workplaces, or means of transport, and it indicates that these areas are accessible to everyone without assistance from others. As digitalization progresses, however, this term is also being used with increasing frequency in the IT world.

But just what does barrier-free software actually mean? And why is it so important? What guidelines and laws are in place, and what does an accessible system look like from a practical point of view? Read on to learn the answers to these questions.

1. What is barrier-free software?

In terms of software operation, accessibility means that users can operate and use the program to its full extent that people with disabilities will not experience any disadvantages, substandard functionality, or other barriers when using the product

2. Why is barrier-free software important?

Accessible software that is integrated seamlessly into the company’s operations ensures equal opportunities for all (potential) employees.

Accessible, barrier-free programs enable all individuals to have access to a job. They are characterized by the fact that their structure, formatting, and coding do not exclude anyone and can be used equally by people with and without disabilities. As such, they are becoming a pivotal tool for implementing our fundamental rights. Article 3 of the Basic Law for the Federal Republic of Germany states that “no one […] shall be discriminated against on the basis of disability.”

With that in mind, accessibility represents the challenge of making it possible for everyone to work in the most optimal way possible. This ultimately also serves to the benefit of the company itself. Bringing equality to the work environment fosters the potential of each individual while also encouraging collaboration among the entire staff.

3. Explaining the legal framework: When is software deemed barrier-free or accessible?

The simple answer is that software is considered to be barrier-free if every person can use it without restriction.

But that still leaves a lot of room for interpretation. As a result, there are international guidelines as well as national laws that make the entire matter more concrete.

Web Content Accessibility Guidelines (WCAG)

The WCAG is a set of international guidelines for barrier-free web content. They state that “…web content must be perceivable, operable, understandable, and robust.”

The Equal Opportunities for Persons with Disabilities Act (BGG: Behindertengleichstellungsgesetz)

The German Act on Equal Opportunities for Persons with Disabilities has been in force since 2002. Since 2016, the regulations are no longer limited to software and websites, but also extend to apps.

The Act on Strengthening Accessibility (BFSG: Barrierefreiheitsstärkungsgesetz)

This Act transposes the EU’s European Accessibility Act (EAA) into German law.

IAccording to the directive, all products and services must be barrier-free by 2025. This includes both the hardware and the operating software.

4. A barrier-free software for publishers and associations contains

The web-based application Xpublisher is used to create, manage, and publish magazines, journals, books, technical documentation, and other publications in a number of different output formats and channels. All work steps feature both a high level of automation as well as barrier-free operability.

The user interface

Layout and Design

The user interface and the features are designed to be logical, hierarchical, and easy to follow and the program components are easy to read and have high-contrast colours.

Usability

The system can be operated either using a keyboard alone or with an on-screen keyboard, maximum screen magnification, zoom in on the content seamlessly for better viewing.

Screen reader

A screen reader allows blind users or users with severely impaired vision to read the content using a Braille output device.

Graphic design

Graphical elements and images have descriptive text that screen readers can read. The well known alt tags for images on websites are one example of this.

Certifications

Very few web applications in Europe that meets the stringent requirements for barrier-free web content according Web Content Accessibility Guidelines, WCAG 2.1 – AA.

5. Barrier-free software: From theory to practice

The law gives publishers, associations, and businesses until June 28, 2025 to convert to barrier-free systems in order to foster equality for people with disabilities and their inclusion in society and the workplace.

But why wait when the relevant programs are already available today?

Here the full article by Xpublisher:

https://www.xpublisher.com/en/news/barrier-free-software

Healthtech Industry Update | Can AI augment Empathy and Compassion in Healthcare?

With the advent of the latest technologies and software, including generative artificial intelligence (AI), virtual reality, ChatGPT, and others, organizations are racing to find purpose and use for these new tools in fear of losing relevance in the marketplace.

The healthcare industry, that inherently is responsible for the lives and touchpoints of care of many populations across the globe is moving towards digitizing healthcare which currently demands:

greater discernment
true impact
improved quality
and reduced cost

The areas where AI is currently applies are:

interactive and customized patient experiences,
facilitated or eliminated administrative tasks in hospital or
facilitated or eliminated administrative tasks in provider workflows
improved access to healthcare.

But what is with empathy and compassion?

Empathy and compassion go hand-in-hand. Evidence increasingly validates that exhibiting empathy in a healthcare setting, including providers, professionals, social care workers, etc., has shown results of higher satisfaction levels, and better health outcomes for patients.

Compassionate care is also highly regarded by patients and can help providers determine appropriate care plans that focus on the unique patient’s needs based on their care story. Compassionate care can also strengthen physician-patient relationships as trust is established throughout care.

Patients value compassionate and empathic concern as much as, if not more than, technical competence, when choosing a physician, yet empathy and compassion among healthcare professionals is sometimes seen to decrease over time, especially during training and clinical practice.

In combatting time and labor constraints, AI has proven to
simplify workloads,
maximize time
offload repetitive or organizational tasks from an already over-burdened workforce.

In regard to emotion, empathy or compassion, AI has also progressed to be able to recognize and respond to emotional distress.

Experts debate AI cannot replace human empathy, specifically in a healthcare setting and with empathy being key to the successful treatment of patients, yet a recent JAMA Internal Medicine report found ChatGPT’s patient-provider communication skills were rated higher than that of their physician counterparts, including on the empathetic scale.

How AI can help augment empathy and compassion:

The healthcare industry should prioritize a patient’s experience with compassion and empathy within healthcare rather than just looking at the outcomes. Through this, when using AI tools to augment and improve compassionate and empathetic care, we can ensure high standards are met with each interaction.
Our human impact on the consumer experience needs to be at the forefront of our care as we look to improve performance. Health teams feel a sense of responsibility towards their impact on a human’s lived experience.

This is a foundational element to a better company culture where healthcare systems and organizations are better able to impact patient outcomes and assure the intersection of AI and empathy is beneficial for all.

What is the current state:

Yet to conclude that AI and artificial empathy will evolve enough to completely replace physicians/healthcare workers, or the human side of healthcare is to misrepresent the issues at hand and the possible solutions. To digitize healthcare and lean on the emerging technologies is to find the opportunity within the relationship between machine and human to augment humans’ ability to be human – to empathize and provide the compassionate touch to care.

Here the full article from MedCity News:

https://medcitynews.com/2023/11/digitizing-healthcare-can-ai-augment-empathy-and-compassion-in-healthcare/

Healthtech Knowledge Guide | Questions about the FDA and Approvals in 2023

In order to bring a medical product onto the market, medical standards are necessary to guarantee effectiveness, reliability, usability, safety, security and sustainability for the population. Getting from the product idea to approval and the finished product is a long journey with questions that need to be clarified, especially at the beginning of the journey. The MDR and IDR standards apply to Europe and the FDA is responsible for the USA.

Here are answers to some basic FDA questions and information mainly for European health technology companies looking to enter the American market.

The United States Food and Drug Administration (FDA or US FDA) 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, caffeine 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 & feed and veterinary products.

https://www.fda.gov/

Is FDA more strict than Europe?
The CE Mark in the European Union and the FDA approval process in the United States both perform the same functions, namely assessing the safety and efficacy of new devices. Despite the differences in the CE Mark and FDA approval systems, there are no more product recalls in Europe than in the United States. What about food? While America’s food is federally regulated, Europe’s food is not. All food in the 27 countries that make up the European Union is regulated by the European Food Safety Authority. The EFSA has much stricter food regulations that is done in the US.

Does FDA work in Europe?
Office of Global Operations Also referred to as: OGO

One member of the Europe Office is embedded in the European Medicines Agency in Amsterdam, The Netherlands. Interactions with other locations where FDA does not have a foreign presence are also managed by OGO at FDA Headquarters.

What is the difference between FDA approval and CE approval?

The main difference between a CE and FDA certificate relates to where the product is approved to be sold. FDA approval means the device can be sold in the United States and exported from the US after receiving an export certificate, while the CE mark means the device can be sold in the 33 member states of the EU.

What countries does the FDA cover?
FDA’s responsibilities extend to the 50 United States, the District of Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, and other U.S. territories and possessions.

Is the FDA applicable to UK?

The Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) and the Food and Drug Administration (FDA) of the United States of America (US) are the regulatory authorities (collectively, the regulatory authorities) with responsibility in their respective countries.

Both regulatory authorities consider that from time to time circumstances will arise in which sight and/or knowledge of information held by one authority will assist the other in conducting its regulatory functions in relation to medical devices or of ensuring the safety, quality, and efficacy of medicinal products for human use under clinical investigation, authorised for marketing, or under review for marketing authorisation in both the US and the UK.

What percentage of medical devices get approved?
Results 5574 titles and abstracts were screened, 493 full text articles assessed for eligibility, and 218 clinical studies of new medical devices included. In all, 99/218 (45%) of the devices described in clinical studies ultimately received regulatory clearance or approval.

About drugs: A new study by researchers at the Massachusetts Institute of Technology found that nearly 14% of all drugs in clinical trials eventually win approval from the FDA-an amount that is much higher than previous studies indicate.

How much does it cost to get FDA approval for a medical device?
How Much Does a FDA 510k Approval Cost? The vast majority of our FDA 510K clients generally spend in the range of $20,000-$30,000 to have their product or device prepared and reviewed before the actual FDA 510k submission process.

What is fda 510k demonstration?

A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval.

What are the 5 steps for FDA approval?
FDA approval to sell a new medical device must complete a five-step process:

Step 1: Device Discovery and Concept.
Step 2: Preclinical Research-Prototype.
Step 3: Pathway to Approval.
Step 4: FDA Device Review.
Step 5: FDA Post-Market Device Safety Monitoring.

How many clinical trials are needed for FDA approval?
If the new device is deemed not to be substantially equivalent to a pre-amendments device, it must undergo clinical testing and pre-market approval before it can be marketed unless it is reclassified into a lower regulatory class.

About drugs: The FDA typically requires Phase 1, 2, and 3 trials to be conducted to determine if the drug or device can be approved for further use. If researchers find the intervention to be safe and effective after the first three phases, the FDA approves it for clinical use and continues to monitor its effects.

How do I know if a medical device is FDA approved?
Check for Approved and Cleared Products in the Devices@FDA Database: Devices@FDA is a catalogue of approved and cleared medical device information from the FDA. To search for FDA-approved or FDA-cleared products by device name or company name: Go to the Devices@FDA Database.

https://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm

Here the approvals 2023:

https://www.fda.gov/medical-devices/recently-approved-devices/2023-device-approvals

HealthTech Industry Update | Medical Breakthroughs of 2023

New technology in healthcare improves and the healthcare and regenerative medicine fields continue to witness remarkable innovations that promise to revolutionize patient care including new medical technologies.

From gene editing and personalized clinical trials to non-invasive diagnostics, telemedicine and advanced prosthetics control, these innovations offer hope and progress in various areas of medicine.

mRNA Technology
mRNA technology has lately received attention due to the implementation of this research in the new Covid-19 vaccinations. mRNA vaccines offer an alternative to the standard vaccine strategy due to their remarkable effectiveness, fast development, and potential for low production costs.

Virtual Reality
Virtual reality has been around for a while now and it is currently being utilized to treat and manage various psychiatric disorders and conditions, ranging from stress and anxiety to dementia and autism and it is also employed now for efficient pain management by modifying patients’ attitudes and perceptions about pain.

Neurotechnology
Neurotechnology has the potential to improve many aspects of life significantly. It is already being used in the medical and wellness industries, but it also has many prospective applications in education, workplace management, national security, and sports.

Artificial Intelligence
In 2023, AI will be one of the most intriguing technologies transforming the healthcare environment.AI is proven to be extremely useful when it comes to detecting diseases early and quickly verifying an accurate diagnosis. In breast cancer care, for example, AI allows mammography reviews to be 30 times faster with 99% accuracy, minimizing the need for unnecessary biopsies.

3D Printing
3D printers have swiftly become one of the market’s trendiest technologies. It can use game-changing printers in healthcare to generate implants and joints for surgery. 3D-printed prosthetics are becoming increasingly popular because they are completely customized.

Precision medicine
As medical technology progresses, it becomes more personalized to specific patients. Precision medicine considers each patient’s genetics, environment, and lifestyle.

CRISPR
CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) is the most advanced gene-editing technology. It exploits the inherent mechanisms of invading virus immune systems in bacterial cells, which can ‘rip out’ infected DNA strands.

Telemedicine
Telehealth and telemedicine have grown in popularity since the Covid-19 pandemic began in 2020. Telemedicine relates to remote clinical services, whereas telehealth includes remote non-clinical services. Since the pandemic, more individuals have adopted a new way of working and living. This trend is expected to continue, with the worldwide telemedicine industry expected to expand from $68.36 billion to $218.49 billion by 2026.

Health Wearables
The demand for wearable gadgets has increased in recent years, with the advent of Bluetooth in 2000. People use wearables paired with their phones to track their steps, physical fitness, and heart rate to their sleeping patterns and in addition wearables can help prevent chronic illnesses such as diabetes and cardiovascular disease by assisting patients in monitoring and improving their fitness.

Mental health technology
Depression is expected to be the primary source of illness burden globally by 2030, making the need for novel medicines more critical than ever. Many new technologies have emerged in the previous year that can aid patients with their continuing mental health demands. Some apps can increasingly complete patient intakes and provide an initial diagnosis before a patient sees a therapist. As a result, ai-powered tools are revolutionizing how mental health treatments are given.

Clinical Trials Based on Genetic Profiles
Traditional research models have often overlooked race and ethnicity-based genetic differences in disease susceptibility. However, new genomic-based testing models are emerging in Asia, shedding light on genetic factors contributing to various ailments. These personalized therapies based on race and ethnic backgrounds provide hope for families battling genetic diseases.

Non-Invasive Prenatal DNA Testing (NIPD & NIPT)
Non-invasive prenatal diagnosis (NIPD), and non-invasive prenatal testing (NIPT) are revolutionary methods for prenatal paternity testing. Unlike invasive tests like CVS and amniocentesis, NIPD and NIPT use fetal cells found in maternal blood for analysis. These tests can determine paternity, assess the risk of over 100 X-linked genetic disorders, and determine the baby’s gender and blood type, all without risking miscarriage. They offer greater accuracy than standard blood tests and ultrasound scans.

Neurovascular Stent Retrievers for Stroke Victims
The introduction of neurovascular stent retrievers transforms stroke treatment. These devices are designed to swiftly remove blood clots in the brain, preventing long-term damage or even death. Time is crucial in stroke cases, and these stent retrievers, guided through the bloodstream, have proven to significantly enhance recovery rates when used within hours of the stroke event.

Early Cancer Detection Using Protein Biomarker Analysis
Proximity ligation assays (PLA) are introducing a paradigm shift in early cancer detection. These tests enable clinicians to measure and visualize protein complexes, aiding in the early detection and treatment of cancer. Unlike traditional genetic mutation tests, PLA offers real-time information on cancer presence, greatly improving survival rates.

Neuro Sensor Feedback for Controlling Artificial Limbs
Researchers have developed more efficient methods for controlling prosthetic limbs using neural implants. These implants decode neural signals associated with limb movement, allowing patients with spinal cord injuries and traumatic brain damage to control artificial limbs with their thoughts. Ongoing research aims to make these interfaces safer, cheaper, and more accessible.

Treatment for Female Hypoactive Sexual Desire Disorder (HSDD)
Flibanserin, a medication recently approved by the American Food and Drug Administration, offers hope to women with HSDD. This condition, characterized by a lack of sexual desire, previously lacked effective treatments. Flibanserin stimulates natural stem cells and addresses the loss of sexual desire, relieving premenopausal women diagnosed with HSDD.

Non-Invasive Remote Glucose Monitoring for Diabetics
Diabetes management is poised for transformation by introducing non-invasive remote glucose monitoring. This technology eliminates the need for invasive blood tests and skin penetration by continuously measuring insulin levels. Patients receive real-time results, ensuring better control of their condition. Given the global impact of diabetes, this innovation promises a proactive approach to diabetes management.

In conclusion, 2023 brings forth an array of ground breaking medical advances that hold the potential to reshape healthcare and improve the lives of countless individuals.

Here 2 articles with some more details according Pacific Asia Consulting Expertise and and docquity:

https://pacificasiaconsultingexpertise.com/top-10-new-medical-breakthroughs-of-2023/

https://docquity.com/articles/top-8-medical-breakthroughs-in-2023/

HealthTech Knowledge Guide | Service-oriented Device Connectivity (SDC)

Medical devices and IOT connectivity is expanding the connectivity capabilities of medical technologies and is about to revolutionize healthcare. This new international industry standard harmonizes the communication protocols of medical technologies. The IEEE 11073 service-oriented device connectivity (SDC) family of standards defines a communication protocol for point-of-care (PoC) medical devices.

SDC background

SDC is issued by the I Triple E and the International Organization for Standardization organizations leading in the standardization and application of principles like wireless LAN and Bluetooth worldwide.

SDC sees the first standard dedicated to the advanced requirements of connectivity in high acuity medical environments.
SDC enables secure and dynamic interoperability between medical devices at the point of care to potentially reduce preventable medical errors and workflow inefficiencies.
The data transmission is bi-directional even allowing SDC capable devices from different manufacturers to interact.
Since patient data transmitted via SDC is medical grade it can be used by therapy devices to enhance clinical capabilities and by clinicians to make timely care choices.
Security principles like end-to-end encryption ensure that patients personal data is kept secure.

SDC could open up a whole new world of opportunities for technology developers hospitals and clinical personnel alike.

As DC’s open communication protocol permits the aggregation of data from all connected devices helping with clinical decision support and data analytics.
Its support of bind directional data flow enables remote control of medical device functionality which will help to streamline processes.
The availability of data enables smart assistants and automation which can help to reduce errors and improve patient outcomes.
The SDC standard has the potential to transform healthcare with connected devices and the internet of medical things.
SDC should enhance the ability of providers to do their job safely efficiently and cost-effectively.
Most importantly it should advance the delivery and quality of patient care.

And here the overview od the standards

IEEE 11073 SDC Core Standards

The main purpose is to enable manufacturer-independent medical device-to-device interoperability.
Furthermore, interconnection between medical devices and medical information systems is enabled.
However, IEEE 11073 SDC does not compete with established and emerging standards like HL7 v2 or HL7 FHIR.
IEEE 11073 SDC is part of the established ISO/IEEE 11073 family of standards.

ISO/IEEE 11073-20702

The standard “ISO/IEEE International Standard for Health informatics – Point-of-care medical device communication – Part 20702: Medical devices communication profile for web services” (short Medical DPWS or MDPWS) enables the foundational interoperability between medical devices.

This includes the ability of medical devices to exchange data safely in a distributed system and the ability to discover network participants dynamically. MDPWS is derived from the OASIS standard Devices Profile for Web Services (DPWS). It defines extensions and restrictions to meet safety requirements of medical devices for high acuity environments.

ISO/IEEE 11073-10207

The Standard “ISO/IEEE International Standard – Health informatics–Point-of-care medical device communication – Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication” is derived from the IEEE 11073-10201 Domain Information Model. It is designed to meet the requirements of networked systems of medical devices establishing multipoint-to-multipoint communication.

ISO/IEC/IEEE 11073-20701

The “ISO/IEC/IEEE International Standard for Health informatics – Device interoperability – Part 20701: Point-of-care medical device communication–Service oriented medical device exchange architecture and protocol binding” defines the all-over service-oriented architecture.

IEEE 11073-1070X Participant Key Purpose (PKP) Series

PKPs describe process requirements according to the role of a network participant. While P11073-10700 defines the Base PKP with basic requirements for participating providers and consumers, the three additional PKP standards focus on specific functionalities:

Providing and consuming information in terms of metric data
Providing and consuming alerts
Providing and consuming external control functionalities

PKPs are thus independent from the particular medical devices and their concrete medical use case. However, they mainly restrict the IEEE 11073 SDC Core standards to enable safe and interoperable medical device systems and to facilitate the approval process.

IEEE 11073-1072X Devices Specialisation (DevSpec) Series

In contrast to PKPs, the DevSpecs are standards for particular classes of medical devices. DevSpecs describe the way the devices are modelled in the network representation and define requirements for the interaction of provider and consumer via SDC, if necessary.

Open Source Implementations

There are open source libraries available implementing the IEEE 11073 SDC standards:

openSDC (written in Java)
SDCLib/C (written in C++, formerly known as OSCLib)
SDCLib/J (written in Java, formerly known as SoftICE)
SDCLib/J (fork) (written in Java, fork of the former main author which implements the latest features)
SDCri (SDC Reference Implementation) (written in Java)
SDC11073 (written in Python, formerly known as pySDC)

Here the video to this topic from Dräger Global:

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