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/

TECHNOLOGICAL HISTORY | WOMEN WHO CHANGED THE TECH-WORLD

There are for sure many women who changed the technical and technological world, but here is a selection of 10 women- researchers, technicians and engineers which did remarkable investigations which strongly boosted the progress on computers, networking, programming and computing.

These technology inventions provide besides for many other industry domains the base for development of innovative products in the areas of digital Health, medical devices, production in the medicine industry and many other puzzle parts of the current and future HealthTech.

Ada Lovelace: The World’s First Computer Programmer

Ada was the daughter of romantic poet, Lord Byron, and his wife, Anna Isabella-Byron. Her mathematical talent shone through in her early life, and her skills and interest in machines lead to a working relationship with Charles Babbage. Babbage was the inventor of the “Analytical Engine”, a complicated device that was never actually created, but resembled the elements of a modern computer. As a result of her work on the project, Ada is often referred to as the “world’s first computer programmer”. It was Lovelace’s notes on the Analytical Engine that Alan Turing used as a form of inspiration for his work on the first modern computer in the 1940s.

Ada Lovelace

Grace Hopper: The Esteemed Computer Scientist

Undeniably famous in the tech world, Rear Admiral Grace M. Hopper was an esteemed computer scientist and one of the first computer programmers to work on the Harvard Mark I. Her work led to the development of COBOL, an early programming language we is still used to this day. In 1947, she recorded the worlds first ever real computer bug, and it is also said that she coined the phrase: “it is often easier to ask for forgiveness than to ask for permission.”

Grace Hopper

Hedy Lamarr: The Inventor of WiFi

Hedy was a self-taught inventor and film actress, who was awarded a patent in 1942 for her “secret communication system”, designed with the help of the composer George Antheil. This frequency hopping system was intended as a way to set radio-guided torpedos off course during the war, but the idea eventually inspired Wi-Fi, GPS and Bluetooth technology commonly used today.

Hedy Lamarr

Annie Easley: The NASA Rocket Scientist

Annie was a NASA rocket scientist, and a trailblazer for gender and racial diversity in STEM. When hired, she was one of only four black employees at the Lab. 34 years later, she had contributed to numerous programs as a computer scientist, inspired many through her enthusiastic participation in outreach programs, and broken down barriers as equal employment opportunity counsellor. Easley’s vital work on the Centaur rocket project while at NASA laid the foundations for space shuttle launches in the future. 

Annie Easley

Mary Wilkes: The First Home Computer User

Mary is a former computer programmer and logic designer. She is best known for designing the software for the LINC, one of the earliest systems of an interactive personal computer. Her use of the LINC at home in 1965 made her the first ever home computer user, and her work has been recognised at The National Museum of Computing, Bletchley Park. 

Mary Wilkes (at home with the LINC)

Adele Goldberg: The Inspiration For GUI

Adele was instrumental in the development of the programming language Smalltalk-80, which inspired the very first Apple computer. Adele is said to have referred to the decision to show Steve Jobs Smalltalk as a way to “give away the kitchen sink”. She was probably right! The concepts that Adele and her team set in motion became the basis for graphical user interfaces (GUI) we use every day.

Adele Goldberg

Radia Perlman: The Mother Of The Internet

Nicknamed “Mother of the Internet”, Radia’s invention of the algorithm behind the Spanning Tree Protocol (STP), was instrumental in making today’s internet possible. Her work made a huge impact on the way networks self-organize and move data, and put the basic rules of internet traffic in place. Radia has delivered keynote speeches across the world, and is still a computer programmer and engineer for Dell EMC.

Radia Perlman

Katherine Johnson: The NASA Mathematician

Katherine’s trajectory analysis as a mathematician for NASA was crucial to the success of the first ever US space flight. Her complex manual calculations were also critical in fuure space missions, including the first American in orbit, John Glenn. Katherine ran the numbers programmed into the computer at NASA for the flight by hand, at the request of Glenn. Katherine remembers him saying “if she says they’re good… “then I’m ready to go.” At age 97, she was awarded the Presidential Medal of Freedom, America’s highest civilian honour, by President Obama.

Katherine Johnson

Karen Spaerck-Jones: The Pioneer in Information Science

Karen was a pioneer in information science, and her work is some of the most highly cited in her field. Her development of Inverse Document Frequency (IDF), a weighting factor which evaluates how important a word is to a document, is now standard in web search engines and used to rank a document’s relevance to a search query. She received the highly acclaimed Lovelace Medal in 2007!

Karen Spaerck-Jones

Elizabeth Feinler: The Original Search Engine

Between 1972 to 1989, Elizabeth ran the Network Information Center in California, which was a bit like a “pre-historic Google.” The NIC was the first place to publish the resources and directories for the Internet, developing the original “white pages” and “yellow pages” directories. Her group also developed the domain naming scheme of .com, .edu, .gov, .net, and many more that we use so commonly today.

 Elizabeth Feinler

HealthTech Industry Update | Femtech Innovation on Postpartum Depression (PPD) 

What is PPD: Though most new moms recover and begin to adjust to motherhood within a couple of months, up to 1 in 3 will also struggle with postpartum depression.

Giving birth is undoubtedly one of the most natural of all physiological experiences and many moms struggle with postpartum depression and its effects leave many lingering physical and psychological footprints on new mothers’ lives. 

Quite different from the transient “baby blues,” PPD can last for months. PPD has been a recognized and stigmatized, possibility during the so-called “fourth trimester of pregnancy” for generations.

⚕️Now it is being firmly addressed through Femtech innovations⚕️.

About Femtech first 

Women are being heard like never before, and it is absolutely incredible. The #MeToo movement has created a domino effect of sorts, as company policies that address women’s needs and long-shuttered opportunities for women are increasingly flooding into the mainstream. That includes the tech world, where a newfound emphasis and expectation on coding, software development, and entrepreneurship has been placed on aspiring women.

Not only are women being welcomed into the industry, but they’re also suddenly at the forefront of creating technology that serves and benefits them.

Femtech — apps, devices, services, and other products that focus on women’s health and wellness — is becoming a key player in tech discussions. Femtech ideas have received more than $1 billion in funding between 2015 and 2018, and the industry is poised to become a $50 billion market as soon as 2025, according to a 2018 report by Frost & Sullivan.

Investment in Femtech is certainly growing, but it’s at a shockingly slow pace, considering its potential. The U.S. Food and Drug Administration has cleared more and more femtech applications and products over the past few years, so companies are definitely aware of the buying power of women. However, companies and funders need to recognize the growing power and potential of this new growing category, too.

(readwrite.com, Femtech Is Becoming More Influential. But Is the Market Healthy?)

About Postpartum Depression (PPD) which is now being firmly addressed through femtech innovations. 

Postpartum depression (PPD) is a type of depression that happens after someone gives birth.

After childbirth, a dramatic drop in the hormones estrogen and progesterone in your body may contribute to postpartum depression. Other hormones produced by your thyroid gland also may drop sharply, which can leave you feeling tired, sluggish and depressed.

Postpartum depression doesn’t just affect the birthing person. It can affect surrogates and adoptive parents, too. People experience hormonal, physical, emotional, financial and social changes after having a baby.

Here some overview and risks:

🧑‍🍼 PPD affects 1 in 9 women

🧑‍🍼 PPD can last for months

🧑‍🍼 Other medical conditions often reflecting pre-existing illnesses, infection or sepsis.

🧑‍🍼 Excessive bleeding after giving birth (hemorrhage)

🧑‍🍼 A disease of the heart muscle that makes it harder for your heart to pump blood to the rest of your body (cardiomyopathy)

🧑‍🍼PPD with Femtech health solutions improve mothers situations

Femtech Innovation Application Examples :

➡️️ She Matters platform, which makes talk therapy more accessible (and budget-friendly) for Black moms as according to the Centers for Disease Control and Prevention the mortality rate is almost three times the rate for White women.

➡️  Poppy Seed, empowers women, especially marginalised women, diagnosed with (or with suspected) PPD to take charge of mapping their postpartum care plan and feel more in control in a new and important time of their lives. Poppy Seed provides on-demand and chat-based pregnancy, postpartum, and loss support. 

➡️️ LactApp and MyLee focus on the postpartum and lactation needs of new parents. Both are app-based solutions set up to help mothers gain a deeper understanding of how they’re lactating.

Femtech: Birthing breakthroughs for new moms

Healthcare is challenging to navigate under the best of circumstances. But when you have a new crying baby at home and are managing new mental health and physical challenges, it is completely exacerbated. 

With Femtech health solutions, mothers have more avenues to improve their situations during the postpartum period and can hopefully start to recognize that they are not alone!  💪

Here the whole article by MedCity News: https://medcitynews.com/2023/09/how-femtech-is-filling-historical-gaps-in-the-postpartum-space/

Other interesting blogs: https://thaumatec.com/knowledge/

HealthTech Industry Update | Healthcare Technology Trends in 2023

From virtual care to artificial intelligence and robotics, to the Internet of Things, there are emerging technologies that will shape the healthcare industry in 2023 and beyond. Here an overview of the technologies which have the most impact on the global healthcare and medical systems.

Internet of Medical Things (IoMT) will transform Medicine

  • IoMT devices connect patients and physicians
  • real-time condition patient data is available
  • Technology manufacturers and suppliers with health technology providers to provide best treatment
  • IoMT e.g. drives the growth for heart monitoring, Health alerts and fitness
  • In-home patient monitoring
  • smart clothes and wearable devices with new and more accurate sensors
  • IoMT in health care facilities for Patient Monitoring

Artificial Intelligence and Machine Learning supports:

  • Diagnosis & Monitoring
  • track patients health and personalised care
  • Predictions & trends
  • Accuracy of remote diagnosis
  • Medical Image Analysis
  • Accelerate research and drug discovery and drug treatment adjustments
  • The global AI Market reached 11 billion in 2021, till 2030 a growth of 37% is expected.

Cloud usage for medical and healthcare data and documentation

  • Hospitals
  • non-emergency medical transport providers
  • Medical billing services
  • real time tracking
  • Robust encryption and security systems needed and secure data backup.

Data Sharing and Interoperability between Healthcare organisations

  • From own providers database to universal database
  • Comprehensive picture of patients of diagnostics and treatments
  • Secure Access to medical information

Data breach prevention due to IoMT and digitalization

  • Special solutions and measures by governments and technology companies

Facial Recognition

  • Deep Learning facial algorithms 
  • Medical facilities use it for security, control and data access

Smart technology, implants and robotics

  • Regenerations, Implantations, Prosthetics
  • Personalized
  • Cost reduced
  • 3D printed
  • New lightweight materials

Growth in demand of Healthcare Software, connectivity, accessibility and digitalization

  • Devices and Tools
  • Patient portals
  • Telehealth
  • Hospital Management
  • Patient monitoring, 24 hours
  • Medical billing and invoicing
  • Diagnostics
  • Non-emergency transport
  • growth in mobile devices and applications 
  • 5G access, speed and improved  latency

Nano Medicine

  • Biocompatible nanoparticles and nanoelectronic devices
  • Study diseases on cellular level
  • Self-replicable bots

Virtual and Augmented Reality

  • Education of medical students
  • Remote treatment and therapy
  • Patient interaction
  • Digital twin of the body

Healthcare and Medical industry will continue to grow in 2023 and beyond, with research and new technology which will foster digital tools, connected devices and remote consultations and monitoring, patient supply with medicine and fast help in case of emergency and many new features and improvements more.

Have a look at the video from iSi technolgy:

HealtTech Industry Update | Top Medical Innovations 2023

The Medical Futurist Dr. Bertalan Mesko published beginning 2023 the prognosis of Top 7 medical innovations. There a lot of activities around healthcare digitalization and electronical medical devices ongoing, some in the trial state some for piloting.

Now, after almost 9 Month we can say that most of them are globally many steps further.

The 7 innovation and areas are:

  1. Async telemedicine
    • Consutlation which is not taking place live
    • medical data is sent for analysis
    • Reply will be later
  2. Ambient and emotions A.I.
    • does not disrupt your attention but makes you feel comfortable (light, music,..)
    • A.I. conversation makes you feel good (transfers emotions)
  3. Skin patches for measurements of vitals
    • wireless measures
    • vital signs and health parameters
    • blood pressure, glukose, …
  4. Affordable vein scanners
    • hand held devices
    • monitoring veins under skin with UV light
    • chose which veins for blood samples
    • preventions of mistakes
  5. Synthetic medical records (e.g. GAN)
    • data quality improvement
    • GAN Generative Adversarial Records
    • Data used in Clinical Trials anonymized
  6. Blood draw devices in clinical trials
    • Remote blood testing from home
    • Delivering all needed data to the clinical trial organization
    • Easy to use
    • Trials ongoing
  7. smart TVs for remote care
    • Smart TVs used as remote care platforms
    • many pilots around the world

Thanks a lot Dr. Bertalan, great selection! End of the year we will see which ones are already certified, operational and used.

Here the complete video:

HealthTech Industry Update | Telehealth Visits Lead to Fewer Follow-Up Visits Than Office Visits

The Epic Research study found that 16 out of 24 specialties had higher follow-up rates within 90 days of an initial office visit than a telehealth visit.

This concerned the medical areas:

  • mental health
  • physical medicine and rehabilitation
  • pain medicine

with  more than 20% higher follow-up rate after an in-person office appointment than after a telehealth appointment.

For the medical domains:

  • ophthalmology 
  • obstetrics and gynaecology 
  • podiatry
  • ear, nose and throat 
  • dermatology 
  • allergy
  • paediatric
  • internal medicine

had an at least 9% higher in-person follow-up rate after telehealth appointments than office appointments.

In future studies it will be checked as well both the complexity of visits between telehealth and in-person care and the effect that insurance coverage has on telehealth utilization.

Recommendations:

  • The government and policymakers should use them to inform future regulatory and funding efforts that affect the adoption of telehealth services. 
  • For payers, these findings suggest that telehealth can be a sufficient way to provide care, something that should be considered when determining coverage. 
  • Health systems, meanwhile, should continue offering telehealth as it may be patients’ preferred way of receiving care.

Have a look at the article in MedCityNews and the comments of Jackie Gerhart, chief medical officer of Epic Research.

https://medcitynews.com/2023/07/telehealth-healthcare-virtual-mental-primary-care/

HealthTech Knowledge Guide | What you should know about Clinical Trials

In EU for medical devices and Software of Class 2b and Class 3 and Class 3 in USA/FDA have to prove that all criteria of the:

is fulfilled. 

One point in this Regulation is to undergo Clinical Trials (or Clinical Studies or Clinical Investigations).

The safety, function and value-add of the Devices must be  Bench testing, Technical testing, Computer simulations, Animal studies must be checked and documented. Pre-clinical activities do not use human subjects in this case.

There are different pathways for the US and EU.

In the US, medical device manufacturers that want to pursue a clinical trial must obtain an Investigational Device Exemption (IDE).

Here as well a blog post by Thaumatec where you can have a look about the processing: https://thaumatec.com/knowledge/blog-posts/healthtech-industry-update-from-the-idea-to-a-medical-device/

In the EU MDR has 20 articles for clinical investigations of medical devices that are relevant. Within these articles, the regulation lays out three regulatory pathways manufacturers can take

During the premarket and postmarket phases of the device clinical trials may be executed. 

Early Pilot studies 

in the device development when nonclinical testing is unable to provide information on device functionality and clinical safety at this point of time.

Pivotal studies 

are used to gather definitive evidence of the safety and effectiveness of your medical device for a specific intended use. 

post-market surveillance 

includes both confirmatory and observational types of clinical activities. 

Observational clinical activities

Many post-market clinical activities are categorised as “observational” and they use non-interventional methods to collect data.

Some devices may need:

  • clinical data from all of these categories
  • many will not. 
  • low risk devices relying on well-known technology may not require any clinical investigations 

Here a nice video about clinical trials globally…

And here an article “Medical Device Clinical Trials: Regulatory Pathways & Study Types Explained” from  Jon Bergsteinsson in Greenlight Guru:

https://www.greenlight.guru/blog/medical-device-clinical-trials

Copyrights © Thaumatec 2025