As the Medical Device Regulation (MDR) updates, the In-Vitro Diagnostics Regulation (IVDR) was established to update the existing European Union In-Vitro Diagnostic (IVD) Device regulations.
The regulatory update of all market requirements for IVD devices led to the implementation of IVDR in May 2017, with a transition period till 26th of May 2022.
The already tight timeline became even more challenging due to the COVID-19 pandemic. The new IVDs and Class A non-sterile devices had still to comply with the IVDR from May 2022.
If you want to know more about:
➡️️ the new requirements
➡️ the challenge
➡️ the benefits
➡️ ️the transition
then here more details from the Med-Tech Innovation news…
Most medical device inventions start out as a single great idea, but how does that idea become a marketed medical device? Here is a brief overview of how a medical device, which can range from a contact lens to a knee implant to an MRI machine, begins with an idea and ends with its submission to FDA.
➡️ Trial enrollment, FDA regulated study/research, Doctors, Clinical Investigators, Documentation
➡️ Study close out, completeness check, FDA Inspection
➡️ IDE
The video highlights aspects of the Investigational Device Exemption (or IDE) process, and provides general information on medical device clinical trials.
The audience is device manufacturers and health care professionals.
Here again how robotics can help in Healthcare, here something about surgery, pros and cons.
Many of the world’s top surgeons are learning first-hand what they can do with surgical robots and it’s unlocking a new era in health care.
One experienced surgeon says “If you’re sitting in the robot you feel like you have control over all the technology around you”.
The surgeons who use it:
➡️ must be extremely good trained and have practised it a lot
➡️️ can see more and can be more precise and minimise fatigue due sitting position
➡️ follow multi-step pathways and gain more information about the structures
➡️ have the advantage of precise dissection, 3D vision, tremor filtration
The advantage for the patients:
➡️ certain types of surgeries are less invasive and need shorter time
➡️ reduced pain and discomfort after the surgery
➡️ shorter hospitalisation, greater degree of movement
➡️ faster recovery time and return to normal activities
The disadvantages:
➡️ Surgical time is in some areas likely to be slightly longer than traditional surgery e.g. joint replacements, and exposing patients to theoretically greater risk of infection
➡️ Any computerised system is only as good as the information that is inputted into it. This includes e.g. the quality of the initial CT scans
➡️high costs of the surgical equipment
Today’s surgical robots extend surgeon’s capacities, they filter out hand tremors and allow manoeuvres that even the best surgeon couldn’t pull off with laparoscopic surgery’s typical long-handled tools.
The importance of robots in surgery becomes higher, but won’t completely replace doctors.
Roche’s Elecsys Amyloid Plasma Panel granted FDA Breakthrough Device Designation to enable a timely diagnosis of Alzheimer’s disease.
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the Elecsys® Amyloid Plasma Panel, an innovative new solution to enable Alzheimer’s disease to be detected earlier.
The Elecsys Amyloid Plasma Panel test detects and measures Alzheimer’s disease biomarkers in blood plasma to indicate the need for further confirmatory testing for Alzheimer’s disease.
Roche is the first in-vitro diagnostics manufacturer to receive this designation for a blood- based biomarker test for Alzheimer’s:
➡️️ The Elecsys Amyloid Plasma Panel is intended to be used in conjunction with other clinical information in symptomatic patients who are being evaluated for Alzheimer’s disease and other causes of cognitive decline.
➡️ The Elecsys Amyloid Plasma Panel has the potential to ensure better identification of patients that require further confirmatory testing, supporting a more timely and accessible diagnosis.
➡️️ This minimally invasive blood-based biomarker test can help to streamline a patient’s journey, improving access to diagnosis and helping them better plan for the future.
The key to transforming the life of people with Alzheimer’s disease is to diagnose as early as possible and intervene with the right care plans!
In previous Industry Updates we showed a surgeon robot innovation which was presented in 2014, here is something more actual.
The Rise of actually real and useful Nanobots making use of the rapidly advancing miniaturisation of robotics and microchips through companies such as TSMC, Intel and Samsung.
These tiny computers/robots potentially will:
➡️️ enter our bloodstream
➡️️cross the blood brain barrier
➡️healing diseases such as cancer
➡️ read and write similar to how Brain Computer Interfaces such as Neuralink currently work
➡️️ enable things such as full dive virtual reality
➡️ even increasing the longevity up to 200 years
The future of technology is looking really exciting, and every day is a day closer to the Technological Singularity.
Once Robots learned to walk & think, humans flying to Mars and us finally merging with technology itself.
If you would like to see more interesting posts, visit our knowledge database: https://thaumatec.com/knowledge/
In 1959, Richard Feynman made the famous assertion that one day we will be able to swallow the surgeon.
Advancements in nanomedicine are soon making that dream come true. In one of the next updates we will show the actual status in nano-robotics but here the beginning.
Nanoroboticist Metin Sitti showed at the World Science Festival 2014 already impressive tiny kind of robots that can act inside of you:
➡️️ is moving forward through the bowel
➡️ sends life data contactless
➡️️ take pictures and sends for monitoring
➡️ make a biopsy and cut without repercussions
➡️️ delivers medicine direct to the right place
Not exactly nanoscopic, but still amazing and hopefully it becomes once available for all gastroenterologists.
Next week we will show in our weekly HealthTech update how it looks now, 8 years later.
Exoskeletons have the potential to help people with disabilities in the future – using a combination of human and machine control.
“It’s important that we give wheelchair users an opportunity to stand out of their wheelchair and take steps on a regular basis,” says physiotherapist Ronan Langan. “We know it will improve their quality of life and potentially their life expectancy.”
Aspects on Exoskeletons in Healthcare :
➡️ Shared autonomy and health are positive contributions in society
➡️ improves the quality of life of injured persons
➡️️ Combines human and machine control
➡️️ The Exoskeleton robot part has low level autonomy
➡️️ The Skeleton detects humans intentions and steers motion
➡️ For the future the goal is that robot gets the same information as the spine
➡️ with this the speed of walking and moving can be improved
One of the most advanced exoskeletons for people with a spinal cord injury is operated in Dublin City University and tested out by Romina, who has used a wheelchair since she was 4.
Youth mental health is one of the most underfunded and neglected, yet crucial global challenges. Fourteen percent of the world’s young people live with a mental health condition, and one young person dies by suicide every 11 minutes.
The Uplink Youth Mental Health Challenge sought to identify some of the leading innovations around the world working to address these transformational needs, especially those led by young people themselves.
119 submissions were received from around the world and 14 Top Innovators were selected to join the Network.
These innovations are mostly from the areas:
➡️ Learning Applications about mental health and understand
➡️ Connect to help and positive influence and negative prevention Applications and counselling
2022 was strengthen the healthTech industry with breakthrough discoveries and innovations.
As we had articles concerning the medical and health-tech trends here again a collection update of the key technology trends and transformations expected in the world of medicine.
The general focus is on improving quality of processes and procedures, affordability of healthcare services, new and enhanced intelligent medical devices, and predicting and preventing diseases instead of treating them at advanced stages.
Here a collection of trends we see:
➡️ Improving patient service quality and affordability:
New AI Applications
Concerns of the Medical Community
Integration of Healthcare Systems with Big Data
Strong patient-provider relation for Patient’s Benefit
Universal Telehealth
Social recognition of health gain value
Consumerism in the Medical Market
medical supply in rural areas
➡️ new and enhanced intelligent medical devices
Nanomedicine and robots
Surgical robotics and environment digitalisation
Internet of Medical Things (IoMT)
wireless connected devices
Smart Implants
VR, Augmented, and Mixed Reality in Healthcare
more intelligent wearables
➡️ Safer, secure, and connected health-tech systems
Data Breach Prevention
Interoperability and Data Sharing Among Healthcare Entities
Precision Medicine Will Force Out the One-Size-Fits-All Approach
Improved and global synchronised regulation and standards
Digital (pandemy) networks system between doctors, hospitals, pharma and health institutions
➡️ Prevention and prediction
Overcoming Mental Health Challenges with Telepsychiatry
Big Data and Analytics to Support Disease Prevention
Annuity Reimbursement will be Introduced to Support Gene Therapy Projects
The environmental impact on health is getting more attention
Social and mental health connected with physical health is more recognized
➡️ Healthtech Business
More digital health unicorns will exit via IPO
HealthTech profits from the merging of interests of Tech Companies and Healthcare Institutions
These Tech companies which are focusing on product quality, innovation, and processes have been growing and will prosper
So all in all a good progress in these topics and a positive foresight to 2023. Some of these trends we had covered already detailed in former Industry updates, some we will cover in future articles.
Healthcare providers are turning to digital to meet consumer demands, an increasing convergence of healthcare and tech companies to improve people’s health in the broadest sense, from prevention to cure to rehabilitation, this is called HealthTech now.
And the race started in the new HealthTech sector with the drivers:
➡️️ Pressure on cost reduction in the Healthcare sector
➡️️ Aging population
➡️ Global pandemic infections
➡️ Better supply in rural areas needed
➡️️ Potential growth of revenue in HealthTech
And related measures and ongoing activities:
➡️ Growing M&A for Healthcare and Tech companies
➡️ Hype in Ideas, Innovations, start-ups
➡️ Growth in data and information sector
➡️ Increase research and development for medical sensors and devices e.g. wearables
➡️ Regulatory actions for data and security
➡️ Hype in Telemedicine solutions e.g. remote doctor visits
➡️ Pharma company connected with patients
The trend is clear and these companies following HealthTech need to change stand out with quality, innovation and performance.
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