One that hello everyone. Today, I will accompany you in exploring the key to successful internet of medical things with emphasis on quality and compliance aspects. So I would like to start with this question. Why should we care about safety? Why is it important at all?Just think uh for a minute of your family and beloved ones, I do believe that you would like to be them safe, especially in a vulnerable state. The primary objective for all medical device producers is to give patients extra care with acceptable risks. It means that the device shall meet strict criteria so they are medically acceptable to be used until they are commercially available. So today we will talk about what is actually internet of medical things, a risk based approach. Uh Why bulletin compliance shall be involved?

Also, I would provide key takeaway message for you and also I would be happy to answer any questions you may have. So who am I? And what am I doing here at all? My name is Marina DEA. I am Compliance Assurance Manager at Systems. I held, I held my master's science degree in Analytical Chemistry, so I could understand the nature of medical device. Also, I have expertise in design regulatory compliance as well as by visibility. So I could assess the medical device from the very different aspects. Also, I have experience uh in design development of very simple medical devices as well as complex ones like for instance, 3D printed implant, as well as smart lab. So uh what is uh internet of medical things? Uh simply put uh internet of medical things are things that connect with each other exchange information and generate automatic actions based on the data. Just to mention, for example, a hospital bed that sends that uh uh sends notifications when a patient is trying to get up or connection the information from a blood pressure or heart rate monitor with a remote device that can send notifications in case of emergency. Internet of medical uh things, applications are limitless and it's definitely more much more than zoom call is your doctor. Let's consider a few examples of internet of medical things. Uh One of the group is the internet of biology technology.

Uh They include the devices that collect biometric uh physiological or behavioral data. Then uh that might be sent to different applications for instance, like mobile application for use. And they also can be classified in the a few groups. So the first group is external group.

And the example here may be a variable by a sensor device that was used to monitor the deterioration of hospitalized commitments in patients, the sensors were installed on the chest of the patients in isolation rooms who were expected to have conducted COVID-19 but who didn't need ventilation.

Every meeting the sensor collect and share information such as heart and respiratory rates is the main indication of potential deterioration to to the healthcare personnel. Also, as a group is uh uh internal. And uh the example here may be a smart pace maker that has embedded software that also collects the information about heartbeat, heart rate and some other and uh vicious data. The heart failure may be may be prevented. And third one group here is uh about if used devices like for instance, smart pills or known as digital pills. So actually, uh these small electronic devices are shaped as pharmaceutical capsules and equipped with sensors or maybe even with with the camera. When such a pill is followed, it can be used to track beetles carried back to a dedicated area and provide picture for instance of gastric track for more accurate diagnosis and much more. So uh next big group related to internet medical things is robots and surgical robots. Surge surgeons can use a tiny internet connected robots to perform complicated uh surgery that are difficult to do with their hands. These devices can also help help to reduce the size of incisions needed for the surgery, making the process less invasive and allowing for faster healing times for patients.

These devices shall be small, reliable and able to interpret complex conditions within the body to make decisions about how to proceed with the surgery. So and one more group uh is uh internet of medical things devices that could help to treat chronic disease management. Uh So according to the world health organizations run nearly 422 million diabetic people globally and continuous striking of blood sugar level is critical for them. And even from time to time, it might be a question of life and death. Today's drug glucose monitoring systems that not only make tests during days and nights, but also do it without painful finger piercing in such a system, a water resistance variable with a sensor is commonly placed under the skin every few minutes. It checks fluid and send data to a smart watch or a smartphone via Wi Fi or Bluetooth for instance. So all of these devices that I have just shared with you uh shall meet the strict criteria to be placed on the market and the medical device manufacturers, how have to provide data that uh could serve as evidence that their medical devices are safe and efficient. And uh this data are reviewed by different regulatory bodies like for instance, FT A or American uh market.

Uh ce Mark is a quality sign for CE E region and AC C mark is um is provided by European uh regulatory bodies and also some others like P MC A for Japanese market, health Canada for Canadian and an MP A for Chinese markets. So as you may guess, uh there are slightly different requirements about safety and effectiveness of medical device for different regions. But what is in common uh for these different regions is that all the uh notified bodies are using risk benefit analysis to be able to assess the medical device. Uh So um to be able, let, let's discuss about risk based approach and let's start with uh risk definition according to ISA 4971 a risk is a combination of probability of occurrence of heart and the severity of the car. The concept of risk can is simply captured within uh this equation that risk is equal hazard multiplied by exposure. As you may know, uh hazard describes the potential to cause harm. It means as that risk is not equal to hazard is not equal to harm its exposure. That makes all the difference here and it means it results in uh that uh risk is specific or specific medical device with specific use. Um In, in the example, uh regarding UV, sun races, humans need a certain amount of exposure to sunlight to stay to stay healthy.

However, excess exposure result in a risk which can be minimized with sun protectors, sun shades and sunglasses. Ok. Right now, we know what is risk but where to start actually what to do with this comparing this Bible via in the beginning, both work in medical device area. All start within intended use. And here you may see that intended use uh capture very different aspects. First of all, it's what for this medical device was developed, who is target audience, who should use it? Shall this medical device be used in hospital or at home? So user profile and also the possible details shall be gathered here with an intended use. Also the ra two main sources of risk. The first source uh relates to analysis of uh of uh own experience, for instance, a medical device producer, uh developed medical device. So this experience may be used as a source of risk. And second group relates to their state of the art. What right now is considered as safe and effective. So here in this group, we could have different standards, regulations, uh guidelines, uh clinical experience, uh uh information from the competitors and so on. So, taking into account the intended use as well as uh analysis of both sources of risk. Uh the risk related to clinical biological functionality, efficiency, reliability, usability, cybersecurity, and even more may be derived.

So um to be able to answer what are the harms related to particular medical device, we could look into different information sources that are demonstrated on left hand, on the right hand, you may see the risk management framework that is incorporated into whole medical device life cycle from the very beginning like design and just start the design uh but still post production.

Uh post production alive. Uh Risk management begins with the development of the design input requirements. As the design involves new risks may become evident to systematically identify and when necessary reduces risk, the risk management process is integrated into the design process in this way, unacceptable risk can be identified and managed earlier in the design process when changes are uh easier to implement and less costly.

So uh as example, let's consider a brain computer interface developed one of the companies. So the brain computer interface BC I is a direct communication pathway between the brain electrical activity and external device. Most common a computer, for instance, or robots cline simply put it enables a person to control external device with just a sold BC is uh could aid people with disabilities and improve national defense capabilities among other users. For instance, BC is may also have potential in treating neurological conditions like Alzheimer's and dementia. Generally BC is connect to the brain in two ways like through implanted or variable devices. The case under consideration is implanted cheap. So this chip was developed and uh animal testing was performed to confirm that uh this chip is safe and effective or towards a step across the base like clinical trials. Usually clinical trials mean that um uh the device should be checked on human and the regulatory body is reviewing existing data for design development as well as animal testing results to assess whether this data is enough to say that the chip is safe and effective or not. You know, this is person's brain, this is not a toy. And in our case, the regulatory body was uh empty. And let's see what they found. Actually, they found some deficiency. Uh here is not like all the deficiencies that we found just uh some of them.

And you may see that uh the bound things relate, for instance, for two mi buyers that can induce inflammation and some other adverse effects in the body. Also migration problem can uh evolve the device effectiveness leading to the risk of surgical removal. It's unclear what to do with the battery because in case of uh something fails with batteries, uh the potential damage uh of brain tissue may occur. And also the device could be vulnerable to cyber attacks that expose brain data or interfere with a device function. So um taking into account all these deficiencies, the submissions of the submission to perform clinical trials on human was rejected. It was rejected because all the balance risks were not addressed as the data provided was not enough to say that the device is safe and effective. The risks.

Uh the chip itself is not saved by design or secured by design and surely it shall be uh fixed uh before next step like clinical trial. Uh All in all, I would like to take the following message. Uh It's to you to become uh every internet of medical sync every medical device that is placed on the market is safe and efficient and may be used when needed. It's because of appliance risk based approach during design uh design of the device and development as well as incorporates in quality and compliance in every step. So if you would like to know more about internet of medical things as well as medical device, please join me via linkedin uh network. Also, I would be happy to answer any questions you may have right now as well as via email. Thank you.