Questions related to Medical Devices
In the medical device industry the application of TPS principles is primarily seen as a matter for manufacturing process and supply chain only. This is due to the regulatory environment in which they exist.
In Europe, Medical Device Regulation (MDR) & in the USA, Food and Drug Administration (FDA) and Central Drugs Standard Control Organization (CDSCO) in India postulated stringent rules that bio-compatibility is a must for healthcare devices, especially for class-III devices.
Why bio-compatibility is necessary and what are those class-III medical devices?
Im currently working on the thesis project on materiovigilance of ocular medical devices and despite having good theoretical knowledge, the project is not showing any progress. Is there any other approaches for the materiovigilance on ocular medical devices except observing patients for Adverse events using ocular medical devices as Interventions
I am currently looking for a research in PVD coating of medical devices. I am interested on PVD coating of AlTiN for metal cause it has low reflection and is compatible for surgical instrument. I want to doping it with Ag so it has antibacterial effect. But will it make the reflection of material completely change or will it depends on Ag-doping composition?
As per title, I'm interested in knowing whether any commercially available (not research based), medical devices are manufactured (even if partly) through the polymerisation of monomers using photoinitiators such as Irgacure, Eosin-Y, riboflavin etc. Specifically, polymerisation of the material outside of the body. Equivalent to the polymerisation of a polymeric coating on a stent within a manufacturing facility.
I am planning to conduct a clinical investigation as per ISO 14155:2020 for one of our products for which the target population is neonates. Our product is already commercially available on the investigation site and it is a proven medical device, so we have confirmed for conducting an observational study.
From our understanding of ISO 14155:2020, Informed consent can be waived by the Ethical Committee, but there is also a statement that except for consent applying requirements for personal data protection. Our target population is neonates so there is no way we are going to disclose personal details.
My question is do we not need to get Informed consent from parents for this observational clinical study??
Thanks in advance!!
I am trying to sterilized my medical device which is well encapsulated in PDMS. I have tried to use Autoclave sterilization at 121C for 15-20 minutes but autoclave process changes the mechanical properties of the PDMS.
Can someone guide me what type of sterilization technique will be useful here that do not impact the response and also keep the device biocompatible.
The development of a vaccine for COVID-19 has become a battleground for many countries to prove to the world/their own peoples that their technology is superior and better than the competitors at the international stage. it is always a point of concern when science is serving the political establishment. Russia claimed that they have developed 'the first' Covid-19 vaccine. WHO is raising concern about the validity of this claim and urging Russia to provide sufficient data to back this claim.
Is it possible for the same scenario to be repeated in the US? An election is near and COVID-19 vaccine development can influence the result.
The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace.
What is the best way for monitoring heart rate with medical devices for the patient suffering from severe burn? it seems to me that ECG leads cannot attach to the skin for these patients properly. Is there any kind of special contactless leads for this issue?
EU directives on medical devices only include medical devices for human beings. Medical devices for veterinary use are not included in the legislation and therefore there is no requirement that they must be CE-marked as medical devices or meet the essential requirements for the CE marking.
In Italy there are no local regulations for the design, manufacture and marketing of medical devices for veterinary use.
What local regulations are in force in the EU and not-EU countries?
First of all, thank you for your consideration about this question.
I've been working on development of in-vitro diagnostic medical device as research engineer since 2013. Especially, my major is to develop kit using colorimetric method, immunoassay and electrochemistry method.
Btw, I am wondering how could I remove the positive signal at the zero concentration when using colorimetric method. In other words, sometimes I face difficulties because color reaction occurs at zero concentration (There is no substrate I want to analyse).
Please kindly share your advice.
Hi, I did a literature review on innovation diffusion theories (Rogers), and I attempted to test the practicality of these theories when introducing novel medical devices. I did semi-structured interviews with clinicians. So is it correct that I am using a deductive method since I am looking for existing concepts in my data? What method should I use to analyse the interviews? Thematic? Content? Thank you!
What are different coil shapes used in Transcranial Magnetic Stimulation? What are their differences (in induced current)? Do they have different applications?
we are conducting cytotoxicity tests since over an year and aren't able to get a stable test. We are no in the validation phase but there are some effects we can't explain. Here is an overview how we conduct the test in compliance with DIN EN ISO 10993-5:
- Seeding 1 x 10^4 cells in a 96-well plate (except the outer wells) --> incubate for 24 h
- Adding medical device extracts (100%, 50%, 10%, 1%) and controls:
- positive control: 1% Triton X (P)
- negative control: cell media (N)
- blank (B): media that was shaken with cell culture media for 24 h at 37 °C in the same kind of container like the medical device was shaken (in compliance with DIN EN ISO 10993-12)
- Incubation for 24 h
- Discard the media and add 50 µl MTT solution (10 mg/ml) --> incubate for 2 h
- Discard and add 100 µl Isopropanol --> incubate for 30 min
- Read out with microplate reader
See the pictures below...the cells are all the time okay until extracts and controlls are added...So something must happen at this point. Sometimes the negative control dies randomly. Sometimes the blank dies. Sometimes only one extract dilution which makes no sense. Does anyone have an idea?
I am going to combine the antibiotic for coating on medical devices.
Supported by medical teams in France, we were asking to investigate on medical filter alternatives in case of emergency measures. For sure it won't replace normed medical device, but it could be better that tissue/clothe around mouth and nose.
We are currently 3d-printing facial mask (based on tpu shore 95) as alternative to the lack of standard medical filtration masks (out of stock). We are materials physico-chemist and manage the 3d printing of the mask solid support, but not specialists in membrane filtration or medical device. We understood that it required filtration for droplets bigger than 5 microns, but maybe also aerosols droplets (<5microns) in ideal case.
WE NEED YOUR HELP to know which material could be used as filter integrated the whole device (see picture of the 3d printed masks). The filter can be changed easily and the mask support cleaned (detergent, alcohol and temperature).
Candidate materials FOR FILTERS :
It could be already manufactured existing products (cotton wheel for make up, tissue, sponge, vaccum cleaner...) or any product that could be easily manufactured in large volume?
If you have any advice or recommendations, please help us. We need interdisciplinary collaboration.
Here can be download the open sources STL to 3d-printed the mask (NanoHack STL digital Files) here:
I kindly thank you for your help,
Support to all.
Dr Sophie Groult
due to the COVID-19, IEEE ICTS4eHealth 2020 will be held virtually.
Authors of the accepted papers will be invited to upload a 15 minutes presentation of their work, and their video will be available through this website to all interested readers.
Accepted papers will be anyway included in the ISCC 2020 Proceedings, and will be submitted for inclusion to IEEE Xplore. The ISCC Proceedings have been indexed in the past by ISI, dblp, and Scopus.
For each paper accepted at ICTS4eHealth workshop, one of the authors will have to pay a reduced fee just to cover the IEEExplore costs:
• IEEE Author Member Fee: 100 Euros
• IEEE Authors Non-Member Fee: 125 Euros
Authors of selected papers will be invited to submit an extended version in the IEEE Journal of Biomedical and Health Informatics (WoS Impact Factor 4.217, Scopus SJR 1.122) - Special Issue on "Enabling Technologies for Next Generation Telehealthcare".
5th edition of the IEEE International Workshop on ICT Solutions for
in conjunction with the Twenty-Five IEEE Symposium on Computers and Communications
e-Health is one of the major research topics that have been attracting cross-disciplinary research groups. The deployment of new emerging ICT technologies for Health, especially based on Cloud computing, the Internet of Things (IoT), and Computational Intelligence, is attracting the interest of many researchers. The use of Cloud computing, IoT technologies, and methods typical of Soft Computing and Computational Intelligence have been very prominent recently and can be of great help in finding good solutions to many practical healthcare applications.
- Cloud computing applications for eHealth
- Internet of Things (IoT) applications for eHealth
- Assistive Technology (AT).
- Informatization, Management and Organization of BME Environments
- Bioinformatics and Computational Biology and Medicine
- Communication, Networking and Monitoring in Bio-systems
- Monitoring of Vital Functions with Sensor and ICT Systems
- Biosensors and Sensor Networks
- Advanced Bio-signal Processing
- Distributed BME Applications
- Telehealth, Telecare, Telemonitoring, Telediagnostics
- e-Healthcare, m-Healthcare, x-Health
- Assisted Living
- Smartphones in BME Applications
- Social Networking, Computing and Education for Health
- Computer Aided Diagnostics
- Improved Therapeutic and Rehabilitation Methods
- Intelligent Bio-signal Interpretation
- Data and Visual Mining for Diagnostics
- Advanced Medical Visualization Techniques
- Personalized Medical Devices and Approaches
- Modelling and Computer Simulations in BME
- Human Responses in Extreme Environments
- Other Emerging Topics in BME
- Web accessibility
- Hardware & Software personalized assistive technologies
- Assistive systems for users who are blind or visually impaired
- Cloud computing and AT
- Integration between home-based assistive technologies and patient health data
- User-centered design of electronic assistive technologies
- Usability of assistive technologies
- Computer vision in AT
- User interfaces for home-based assistive technologies
- Use of prescription systems and assistive technologies
- Experience from real world assistive environment deployment
- Assistive Technologies for Urban Environments
- Healthcare modeling and simulation
- Knowledge discovery and decision support
- Biomedical data processing
- Wearable devices
- Sensor-based mHealth applications
• Submission deadline: May 09, 2020 (extended - firm deadline!)
• Notification of paper acceptance: May 29, 2020
• Submission of camera-ready papers: June 08, 2020
• Registration: June 08, 2020
Manuscripts should describe original work and should be no more than 7 pages for full papers and 4 pages for short papers in the IEEE double column proceedings format including tables, figures and references. Download manuscript templates for IEEE conference proceedings here.
All papers should be submitted via EasyChair using the following link https://easychair.org/conferences/?conf=ieeeiscc2020 and selecting "ICTS4eHealth Workshop" track.
Authors must use the IEEE conference proceedings format obtainable at: https://www.ieee.org/conferences_events/conferences/publishing/templates.html
IEEE Journal of Biomedical and Health Informatics:
J.BHI Special Issue on “Enabling Technologies for Next Generation Telehealthcare”
BEST PAPER AWARD:
A "Best Paper Award" Certificate will be conferred on the author(s) of a paper presented at the workshop, selected by the Chairs based on scientific significance, originality and outstanding technical quality of the paper, as assessed also by the evaluations of the members of the Program Committee.
Please visit http://icts4ehealth.icar.cnr.it for more information and if you have any questions kindly get back to us by sending an email at email@example.com.
The diversity of medical devices, their increasing complexity, as well as the development of devices for personal use have increased the risk associated with misuse. The use made by "operators", by health professionals as well as patient himself must also be carefully evaluated to reduce the risk of incidents. Finally, the global environment (care structure, nursing home, home etc.) must also be taken into account. The concept of user experience indeed takes on its full meaning by aggregating the factors linked to the end-user, the device and their environment.
The design of clinical studies on the drug focuses on the pharmacological action of the product, trying to eliminate all biases related to the user, the context and the patient through randomization. But is this what should be done for the clinical evaluation of a new medical device, or should we imagine methodologies that, unlike drugs, would take into account users and their environment?
We have a machine which has a chamber that is used to dry small medical samples. The machine, generally speaking, applies multiple cycles of vacuum and dry nitrogen washings in order to get the relative humidity as low as possible. However, the machine recently seems to have inefficiency problems making it unable to lower the relative humidity to less than 10-15%. Currently, we do not have the means to change, fix, or diagnose the machine, so I have to find a solution for this issue by adding some sort of desiccants in order to lower the relative humidity even more. We have some silica gel that we are experimenting with, but the results do not seem so promising. Silica gel, as far as I could understand, does not desiccate efficiently with its full capacity in such conditions where temperature is relatively high (40-60°C) and relative humidity levels are below 50%. According to my research in the scientific literature, molecular sieve or desiccant clays (like Desi Pak® Bentonite Clay) might be a better solution for me, but I not sure and I am not able find something definitive and direct regarding this issue without diving deep in this topic which I do not know very well.
So, can someone please direct me to right choice, or at least help me to get to choose the best solution for my purposes. The conditions are:
- Temperature is between 40 and 60°C
- Relative humidity is generally less than 50%
- Air pressure inside can get as low as 50 mBar.
- No active air circulation inside the chamber.
- Samples are place for about 3-8 hours.
- The volume of the chamber is less than 500 liters.
Thanks in advance.
The failure of physicians who write papers on medical devices to actually mention the NAME of the medical device they used in the research is going to kill a lot of people when those medical devices fall off the market for lack of clinical data.
if a medical device that is already approved in the US should be modified with a drug component, what would be the difference in the FDA approval process, between an approved and an unapproved drug?
If the drug is unapproved, does that mean that approval of the MD is not possible?
Medical devices cover a wide range of products ranging from eyeglasses to active coronary stent, via wheelchairs. Medical devices are also characterized by a short life in the market, small patient populations and a high potential for innovation. Do you think it is necessary to distinguish different clinical study methods for the authorization of new medical devices to be marketed according to their level of risk?
Medical devices cover a wide range of products ranging from crutch to active pace-maker, via hip prothesis. Classification according to risk in Europe (class I, IIa, IIb or III) or in US allows to get as close as possible to the concept of high risk. But the high risk and these classes do not necessarily overlap completely, and some divergences appear on both sides of the Atlantic Ocean. Do you have any useful elements of high risk definition to facilitate the classification of new medical devices entering the market, all of which, in principle, require clinical investigation?
I am aware of a FDA guidance for inter species drug dosage relation. If the dosage is plated on a medical device and is slowly released- Efficacy extrapolation for an antimicrobial medical implant surface against bacteria for instance, how do we approach that scenario?
Whilst we are awaiting evidence of all types, what is the best current evidence for orthopaedic robots?
In the future, there are many possible study designs and outcome measures. Medical device research is confounded by the inability to blind the surgeon and the varied surgical technique. Registry data may give the answer in the long term but is likely to be confounded by experienced surgeons using the robot and fit patients selecting the robot.
Is the best outcome measure 3D CT measured implant position of robotic vs human ?
I have been trying to data and wave capture from Philips IntelliVue Monitor using Matlab for our research studies in real time. Does anyone have some code they are willing to share? The community's help in this important matter?
I really hope you could devote some of your time to the following:
We are now designing a new dental implant (Class III).
During preclinical stage in vitro and in vivo studies were done. We want to verify the implant by designing a clinical trial, but before that all preclinical studies must be done.
What studies must be included in preclinics to measure safety (technical, biocompatibility etc) by ISO standards? As we know ISO-10993(bio) and ISO-14801(tech) are widely used for dental implants.
May be you can suggest a better tactics to check safety of the medical device?
We use natural rubber to show cytotoxic response to our HFC for MEM elution method. However, sometime the natural rubber does not show a positive response and the whole assay is invalidated. I am wandering if there are other options to be used as cytotoxic positive controls. Thanks for help and a reference to literature or ISO guidelines will be helpful.
I am reading studies evaluating the effectiveness of a medical device for improving scars. The studies I have found so far seem to have small sample sizes, ranging from 10 to 25, except one which included 47 patients. None of investigators performed calculations to determine if the studies were adequately powered. However, they reported statistical significance based on p-value of 0.05 or less, but without any indication of variability such as confidence intervals. I am unsure if these studies were sufficiently powered. And, I am wondering how accurate it will be for one to conclude that the studies were adequately powered based on the p-values. I will greatly appreciate any references to peer-reviewed literature on this issue. Thank you.
In medical device development definition phase, as new system features are introduced, are there any general categories which should form the basis for defining requirements for this new feature(s)?
We are conducting acute toxicity studies with our medical device that formulated with LRS. This a required test to demonstrate bio-compatibility of the medical device.Typically they inject an extract of the device .The extract can be oil and saline.The extract from is administered IP
Dear all, I am looking for a safe screw lubricant that could apply on the medical implant and device production unit that work around 160oC to 500oC. I have found some PFPE, synthetic hydrocarbon and Silicone base lubricant for only medical device but not the production unit.
I wonder is there any specific lubricant for the medical implant and device production machine that could use under high temperature. Have anyone study about it?
EEG (Electroencephalogram) is a technique for recording electrical activity of brain. Traditionally Ag/AgCl, Ag, Stainless Steel are used as the electrode material. Can copper be used for dry EEG electrodes ?
I am conducting a study evaluating risk for pressure injuries among critical care patients. I have EHR data pertaining to moisture, nursing skin assessments, body temperature, and also medical devices for surgical critical care patients. I would like to find a way to indirectly assess micro-climate.
I need a reference for the "pre-clinical testing market for vascular implantable devices (including peripheral stents, angioplasty tools, aortic stents, synthetic surgical grafts, chronic total occlusion devices, embolic protection devices and inferior vena cava filters)"
In Dollars or Euros and for U.S.A, Europe, or worldwide.
Which are the prominent companies in India capable of medical device industrial design support?
Looking to outsource ergonomics, user centric, human factor design support works of our medical devices under development.
If anybody there, please mention your capabilities.
Most laws in Great Britain, Canada, Australia, and the United States have been interpreted as including a "patients right not to want to be told the risks of the medical treatment recommended by his or her physician. Should there be an "opt out clause" in research informed consent so that the individual can volunteer for a research trial for a new drug or new medical device without being told of the risks by the researcher, research team, or informed consent? Is this "opt out clause" in clinical care vs. research on human subjects a "good idea" of a "bad idea"? Why? On what grounds?
TACS is a device that imports frequencies to your brain in order to persuade your brain’s neurons oscillate by them.
Is it possible to enhance the skills of people with usual intelligence and make them smart by importing gamma ray to their brain?
Does the mechanism have long lasting effects?
Have you ever read something about it?
Cell Constraint & Cancer SA
Proof of Concept in 2014: Action of mechanical Cues in vivo on the Growth of a subcutaneously grafted Tumor (Published 21 April 2016, PloS One, R Brossel et al).
Next Step: Proof of Efficacy on orthotopic Graft of Human Pancreatic Cancer in Pancreas of Mice
Combination of two medical devices: A generator of gradient of magnetic field and iron nanoparticles.
We are looking for Partners in the academic and industrial world; We are looking for investors.
Cell Constraint & Cancer (CC & C) is a start-up of biotechnology in support of R&D of a new approach in cancer research. The disruptive innovation (Patent PCT/EP 2014 064995), involves the application of mechanical cues (constraint/stress field) in the treatment of cancer. Physical Oncology defined as the study of cancer tissue with the tools of the solid matter physics is trying to subvert our concept of cancerous tumors.
The demonstration of Proof of Efficacy of this process would consider a crossing to humans by the year 2020. Right now we have begun a feasibility study of Proof of Efficacy, biological as well as physical. Proof of Efficacy itself is planed in Q4, 2016.
CC & C is presently “burning cash”, and is a bet on a success realized by a co-development with a company manufacturer of gradient of magnetic field equipment and/or a pharmaceutical company familiar with injectable ferric nanoparticles.
HbA1c estimation using boronate affinity method requires a blue dye conjugated Boronic acid. I would like to procure one or two commercially available molecules. Please suggest me one or more.
We develop medical devices for characterization of thin tissues which should be produced from plastic/polymers (wall thickness <1 mm ~ 0.5 mm). The devices should be suitable for light microscopy, in the ideal case with a refractive index close to water (which is ca. 1.33 @ 500 nm).
Are there any lists, books or publications with transparent polymers where I can also find the refractive index of the material? Polymers suitable for medical use would be best.
I checked refractiveindex.info but there is a limited amount of polymers. I thought about standard mass production polymers such as PMMA, PS, PP, PE, PET, PC... but also any other transparent polymers!!
Thank you very much!
An exciting opportunity has become available to work full time on a 3-year project to design and develop a smart technology for real-time alarm and remote monitoring system implementation on medical devices. This is a partnership between Manchester Metropolitan University and Pure O2 Ltd, funded by Innovate UK.
Apply for the job here at
You should have high level of expertise in analogue/digital circuits design and simulation and skills to develop electronic hardware in general with experience in embedded systems.
For an informal discussion, please contact Dr Rupak Kharel (firstname.lastname@example.org)
Please share this within your network who might be interested on it.
legal framework regulating application of Articial Intelligence Medical Devices differs in Europe and the United States.
Furthermore, the issues of legal accountability the ethical responsibility that AI applications imply all over the world are worthy of discussion on RG. This because the process of medical devices decision-making is largely unpredictable, therefore holding the creators accountable for it clearly raises concerns.
I would like to ask yours opinion about the role of radiologists in the development and application of AI to medical imaging.
Thanks to everybody!
Cyber-physical systems (CPS) link cyberspace with the physical world through a network of interrelated elements, such as sensors and actuators, robotics, and computational engines. These systems are highly automated, intelligent, and collaborative. CPS examples include energy neutral buildings, zero-fatality highways, and personalized medical devices.
Parallel system (PS) methods are further development and natural extension of control systems and computer—based modeling and simulation，resulting from new and recent advances in computing structure， algorithms， and technology．Parallel system methods might provide effective tools for control and management of complex systems that can not be modeled precisely or experimented repeatedly．
The carotid shunt is made up of a tube on the extremities of which the balloons are glued during the manufacturing process. Quality control (functionality test) are carried out in order to ensure that the product is conform. It has to be ensured that the balloons suffer no leaks.
What are the possible quality control test (non-destructive) that can be put in place after the assembly process to ensure conformity of the product ?
What are the problems encountered with carotid shunts that are used in carotid endarterectomy and their possible solutions?
Would you be kind to recommend me some guidance or study which gives an information regarding the resistance of common organisms (found in the environment or normal flora of the skin) to EtO sterilization?
I am asking in terms of medical device application. Thank you in advance.
Drug companies and medical devices industries provide financial support to clinical researchers, to medical meetings and also provide direct and personal support to physicians paying their travell expenses. How do you criticize those financial relations among health care industries and doctors? Are they ethical ? Should they be cancelled? Drug Advertising or Marketing of drugs should be forbidden? Do they influence clinical decisions and research results?
Glue is discharged from a syringe tip at a constant pressure P through a constant time period t.
The original tip is of diameter d1= 0.20 mm. A new tip is used of diameter d2 = 0.25 mm.
Considering only the tip of the syringe i.e. constant length and constant diameter, does the flow rate (be it mass flow rate or volumetric flow rate) decrease with the new tip for P and t ?
Good morning every one,
Can you help me?
I work on medical device failures ratio. I am searching any open source databases (csv, Access base or others) with a web access.
It will very interesting to obtain device classification informations by medical services (radiology, pediatry, ...), failure dates, hospital or clinical name, country, device and maintenance costs,...
Do you know somme website?
Biofilm formation on medical devices is one of the important problems now due to difficulty of its removal and the complicated microbial infections as well as the decreasing of the effective of antibiotics and disinfectants.
Does anyone have this standard:
Biological evaluation of medical devices — Part 12: Sample preparation and reference material
Can you please send a copy?
Thank you very much
Iridology (also known as iridodiagnosis or iridiagnosis) is an alternative medicine technique whose proponents claim that patterns, colors, and other characteristics of the iris can be examined to determine information about a patient's systemic health.
Now I want to know what medical devices can be used for this process so we can save photos and process them?
Nutrition related diseases are nowadays a main threat to human health and pose great challenges to medical care . A crucial step to solve the problems is to monitor a daily food intake of a person precisely and conveniently . Can use a wearable device to monitor and recognize food intakes in daily life ?
Electronic Fetal Heart Monitoring can be done by listening to your baby's heartbeat with a special stethoscope. More often, it is done using two flat devices (sensors). They are held in place with elastic belts on your belly. One sensor uses reflected sound waves (ultrasound) to keep track of your baby's heart rate. The other sensor measures how long your contractions last. The sensors are connected to a machine that records the details . can the phone be used for recording this signal?
Prior to the actual training of movement in rehabilitation with a medical device, it is often necessary to introduce the exercise and the way the device and/or the training software (program) works, and how the feedback and the movement are tied together. But how can you define the threshold for: the patient has understood the task and is now ready to proceed to the actual training (with less or no assistance). What are feasable markers or parameters (e.g., time to achieve a goal, number of successful repetitions, etc.)? And how can you best show and teach the exercise?
Microorganisms that grow on medical devices form biofilms. Normally, biofilms protect the cells from the animicrobial activity of chemical biocides (including surfactants) and antibiotics. The question is how to destroy or prevent biofilm formation on medical devices?
Sometimes the one who's injured may not be be able to talk and score his pain. for several medical actions the intensity of pain and it's position is required. I've been told using fMRI somehow helps, yet I'm wondering how and I would like to know if there's any more accurate device to measure pain intensity.
- Could you please point me out to some successful Medical sciences applications using partial differential equations?
- Preferably, involving heat, reaction-diffusion, Poisson, or Wave equation.
- If possible in fuzzy environment.
I did a test on a set of subjects (n=28) two times with a medical device. I believe it is kind of intra rater measurement (ICC(3,1)). Could you please tell me if I am right? On the other hand I want to use one normally distributed plot for these two groups. Can I use the mean value for each subject (I did the experiment two times on each subject) then plot it?