Blog posts - Page 3 of 13

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:

HealthTech Knowledge Guide | The Promise of Precision Medicine

Precision medicine is an innovative approach that takes into account individual differences in patients’ genes, environments, and lifestyles.

Millions of people have already been touched by the area of precision medicine that has grown directly from biomedical research.

Precision Oncology

It’s still the case in most medical care systems that cancers are classified mainly by the type of tissue or part of the body in which they arose: lung, brain, breast, colon, pancreas, and so on. But a radical change is underway. Researchers are now identifying the molecular fingerprints of various cancers and using them to divide cancer’s once-broad categories into far more precise types and subtypes.

https://www.nih.gov/about-nih/what-we-do/nih-turning-discovery-into-health/precision-oncology

Cancer Immunotherapy

Color illustration of the KRAS protein
In a study of an immune therapy for colorectal cancer that involved a single patient, a team of researchers at the National Cancer Institute (NCI) identified a method for targeting the cancer-causing protein produced by a mutant form of the KRAS gene. This targeted immunotherapy led to cancer regression in the patient in the study.NCI
Another powerful ally in precision oncology has been there all along – the body’s immune system. Our immune system’s natural ability to detect and destroy abnormal cells prevents many cancers from ever developing, just like it protects us from infections. However, cancer cells can sometimes evade this system of immune surveillance. In the relatively new field of cancer immunotherapy, scientists are beating cancer cells at their own game – enlisting a person’s own immune system to control and, in some cases, even cure their cancer.

https://www.nih.gov/about-nih/what-we-do/nih-turning-discovery-into-health/cancer-immunotherapy

Pharmacogenomics

Variety of Non-Proprietary Medicine Bottles on Reflective Surface and Grey Background.
Feverpitched / iStock / Getty Images Plus
In the 1970s, NIH research gave us genetic engineering and launched what is today the $100 billion biotechnology industry, a major source of high-paying U.S. jobs. Virtually every biomedical research lab and pharmaceutical company uses the power of the genomic revolution every day to demystify diseases and search for new cures. Companies today can read the entire DNA sequence of an individual for less than $1,000, and the cost is dropping quickly. This ability to study massive amounts of DNA has helped the field of pharmacogenomics mature rapidly.

https://www.nih.gov/about-nih/what-we-do/nih-turning-discovery-into-health/pharmacogenomics

Rare Diseases

Rare diseases were once considered medical curiosities with little public-health impact. But though such diseases are individually rare, collectively an estimated 25 to 30 million Americans are affected. NIH’s Undiagnosed Disease Program focuses on the most puzzling medical cases referred to the NIH Clinical Center in Bethesda, Maryland. UDP has received nearly 10,000 inquiries, reviewed more than 3,000 applications, and admitted about 900 patients to the NIH Clinical Center for comprehensive weeklong evaluations. Some of these patients with rare diseases have taught us more about common conditions such as osteoporosis, kidney stones, and viral infections. Building on the early successes of the NIH UDP, NIH has extended the program into a network of sites across the country.

https://www.nih.gov/about-nih/what-we-do/nih-turning-discovery-into-health/rare-diseases

Historically, doctors have had to make most recommendations about disease prevention and treatment based on the expected response of an average patient.

This one-size-fits-all approach works well for some patients and some conditions, but not so much for others.

Therefore precision medicine was established.

Here the full article from National Institutes of Health

https://www.nih.gov/about-nih/what-we-do/nih-turning-discovery-into-health/promise-precision-medicine

Healthtech Knowledge Guide | What are Stem cells and what they do

Stem cells offer great promise for new medical treatments. Learn about stem cell types, current and possible uses, and the state of research and practice. People who might benefit from stem cell therapies include those with Parkinson’s disease, Alzheimer’s disease, spinal cord injuries, type 1 diabetes, amyotrophic lateral sclerosis, heart disease, stroke, burns, cancer and osteoarthritis.

What are stem cells?

Stem cells are the body’s raw materials — cells from which all other cells with specialized functions are generated.
Under the right conditions in the body or a laboratory, stem cells divide to form more cells called daughter cells.
These daughter cells become either new stem cells or specialized cells (differentiation) with a more specific function, such as blood cells, brain cells, heart muscle cells or bone cells.
No other cell in the body has the natural ability to generate new cell types.

What stem cells do?

🔬Increase understanding of how diseases occur.

🔬Generate healthy cells to replace cells affected by disease (regenerative medicine).

🔬Test new drugs for safety and effectiveness.

Where do stem cells come from?

There are several sources of stem cells:

Embryonic stem cells: Embryonic stem cells to be used to regenerate or repair diseased tissue and organs. Guidelines define embryonic stem cells and how they may be used in research, and include recommendations for the donation of embryonic stem cells.
Adult stem cells: These stem cells are found in small numbers in most adult tissues, such as bone marrow, or fat, or urine. Emerging evidence suggests that adult stem cells may be able to create various types of cells.
Adult cells altered to have properties of embryonic stem cells: By altering the genes in the adult cells, researchers can reprogram the cells to act similarly to embryonic stem cells. This new technique may allow use of reprogrammed cells instead of embryonic stem cells and prevent immune system rejection of the new stem cells.
Perinatal stem cells: Researchers have discovered stem cells in amniotic fluid as well as umbilical cord blood. These stem cells have the ability to change into specialized cells.

What are stem cell lines and why do researchers want to use them?

A stem cell line is a group of cells that all descend from a single original stem cell and are grown in a lab. Cells in a stem cell line keep growing but don’t differentiate into specialized cells. Ideally, they remain free of genetic defects and continue to create more stem cells. Clusters of cells can be taken from a stem cell line and frozen for storage or shared with other researchers.

What is stem cell therapy (regenerative medicine)?

Stem cell therapy, also known as regenerative medicine, promotes the repair response of diseased, dysfunctional or injured tissue using stem cells or their derivatives. It is the next chapter in organ transplantation and uses cells instead of donor organs, which are limited in supply.

Have stem cells already been used to treat diseases?

Yes. Doctors have performed stem cell transplants, also known as bone marrow transplants. In stem cell transplants, stem cells replace cells damaged by chemotherapy or disease or serve as a way for the donor’s immune system to fight some types of cancer and blood-related diseases, such as leukaemia, lymphoma, neuroblastoma and multiple myeloma. These transplants use adult stem cells or umbilical cord blood.

What is therapeutic cloning, and what benefits might it offer?

Therapeutic cloning, also called somatic cell nuclear transfer, is a technique to create versatile stem cells independent of fertilized eggs. Researchers haven’t been able to successfully perform therapeutic cloning with humans despite success in a number of other species.

Here the full article by MAYO CLINIC:

https://www.mayoclinic.org/tests-procedures/bone-marrow-transplant/in-depth/stem-cells/art-20048117

Healthtech industry Update | Health Tech World changes in 2024 Investor outlook

At HLTH 2023 conference in Las Vegas, Bessemer investors Sofia Guerra and Steve Kraus detailed four predictions about where they think the digital health world is headed in 2024.

The Bessemer Venture Partners released at the conference a report that analysed the digital health sector’s performance over the past five years and offered words of wisdom for the next cohort of start-ups seeking to build resilient business models that can deliver long-term value.

Here the four predictions about where the digital health world is headed in 2024.

“Services-as-Software” will emerge as a new category of healthcare AI

A new category of AI tools are emerging that deliver a service as the final product rather than providing a workflow tool where the end user completes an action. This new trend flips the SaaS model on its head. It is not a workflow tool that a user is interacting with to enable them to do work on the software, it’s going to be the work itself.

Healthcare payment companies will have to align incentives between providers and payers

There is a massive opportunity for software to connect the administrative processes of payers and providers, giving way to a more efficient healthcare payment system. For start-ups to succeed in building this software, they have to follow the money and align incentives between the two parties.

If you want to sell tech to providers, you may need to rethink your distribution model

Indirect monetization as a new distribution advantage emerging in the digital health world. Some start-ups are providing their software for free, shrinking their sales cycles and allowing them to utilize indirect monetization strategies early on.

The biopharma value chain must become more efficient

Start-ups that sell technology to biopharma research teams enable more efficient target discovery and facilitate faster and more efficient clinical trials.

According to this prediction, some big changes are expected, we will see whether everything will come true in 2024. But one thing is certain: without changes, our current healthcare system will no longer be successful possible for everyone, but there are many good approaches and innovations that promise effective healthcare, which we can develop further and transform our current system in a patient focussed, affordable platform for public health.

Here the detailed article from MedCity News: https://medcitynews.com/2023/10/healthcare-technology-investment/

picture – MedCity News Oct 12, 2023

Healthtech industry Update | What Women want out of Their Health Benefits

Women make up nearly 60% of the workforce, yet they’re often not getting what they need out of their health benefits, a new survey shows.

The top issues affecting their health were fatigue, headaches/migraines, general malaise, infection, mental health, physical pain and stomach issues.

The survey, published Tuesday, was from Parsley Health, a virtual primary care company that serves employers. It included responses from 1,271 women ages 18 to 60. All of the women were employed full-time and had health insurance.

🩺49% of employed women said they want “comprehensive support” from one doctor
🩺40% of women want access to a doctor who diagnoses the “root cause” of their condition
🩺39% want better care management services
🩺71% of working women said they would leave their jobs for better benefits
🩺47% of women said their health issues have impacted their productivity at work in the last 60 days
🩺43% have missed one or more days of work because of health issues in the last 60 days
🩺80% of women said they delayed care until their symptoms worsened
🩺67% of women reported they are struggling to get a clear diagnosis
🩺33% women said they’re confident in their diagnosis

⚕️Symptoms and comorbidities for this population are often interrelated and point to bigger, chronic health issues, but more investigation would be needed to properly identify these problems.

Have a look at the article from MedCity News:

https://medcitynews.com/2023/10/women-health-employee-benefits/

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