Medical Domain Expertise
Pro4People’s unique IT services for the MedTech sector include not only excellent technical competencies and compliance with applicable medical device standards (such as IEC 62304, ISO 13485, ISO 14971) but also a thorough understanding of various medical domain areas. Below is a short summary of the knowledge that we have built along the Software as a Medical Device (SaMD) projects that we successfully delivered to our Clients. You may find our expertise relevant to the character of your products or services. This may in effect position Pro4People as a good candidate for your technology partner in regard to medical device software implementation.
Medical diagnosis, which is considered a way to determine which disease or condition brings about a person’s symptoms, plays a crucial part in patient care before administering the treatment. Software technologies can be used in medical domain to facilitate data collection together with the diagnosis process. They can also provide medical imaging capabilities, support decision making and facilitate laboratory analysis. Such solutions are ordinarily intended to be used by Health Care Professionals (HCPs). There are however also solutions dedicated directly to patients/lay users.
Application of medical device software to facilitate patient diagnosis makes the process less expensive. It also increases its efficiency and accuracy. Dedicated diagnostic solutions can in effect enable an early detection of some diseases (e.g. cancers). They can also make the diagnosis methods more available and allow the diagnosis process to take place remotely.
Skin Cancer Diagnostic System
The goal of skin cancer diagnosis is to determine if the skin lesion is likely to become malignant. Usually the initial skin cancer diagnosis is based on a visual examination by a skin specialist using a special microscope or magnifying lens. Subsequently a biopsy, which involves removing a small amount of tissue for examination under a microscope, may be needed. This should then provide a full diagnosis of a skin lesion.
Software as a Medical Device solutions based on Artificial Intelligence (AI) can become a significant extension to the standard diagnostic procedure because trained neural networks are capable of processing images of a skin lesion and assessing the malignancy of the skin tumour. As a result the capacity of the skin cancer treatment increases and its cost decreases. In addition to that, patients can establish the initial diagnosis by themselves. This approach is also aligned with recommended policies of regular self-examinations. The available research shows that AI-based skin cancer diagnostic systems if properly designed and then trained, can outperform skin cancer specialists.
Read the following case study and learn more about an AI-based diagnostic Software as a Medical Device solution, launched on both European and US markets, compliant with medical device regulations (IEC 62304, ISO 13485, ISO 14971, MDR, 21 CFR 820) that Pro4People has come up with https://pro4people.com/case-studies/skin-cancer-diagnosis-with-artificial-intelligence-ai/
Adherence monitoring plays a vital part in the chronic and complex disease treatment as well as during clinical trials. Medical device software solutions can enhance this process by providing dedicated features to monitor and document patients’ conditions. It can also track dosage of prescribed drugs, manage the treatment path, tailor the therapy to an individual patient’s needs and trigger reminders about a need to take a drug at predefined times. Such medical device software solutions can help maximize efficiency of medications as well as minimize adverse effects. The application of the new IT technologies also enables adherence monitoring to be conducted remotely.
Connected Health Solutions
Connected health solutions revolutionize services in the medical domain mainly through leveraging new technologies together with adding digital features to medical device products and services. Connected health products not only comprise hardware medical devices but also other related components. They may include mobile applications, web applications, standalone applications as well as backend components. These types of solutions enable providing patient health services remotely and moreover personalizing them to the individual patient’s needs. Particularly, such solutions facilitate adherence monitoring and tailored treatment pathways. They also help to bridge the gap between patients, physicians and medical device manufacturers.
The success of connected health solutions requires greater reliability, security as well as seamless integration between all components. The solution as a whole must in effect fulfil its healthcare objectives. It is also crucial that the sensitive health information is secure and accessed in a controlled way.
As a result, a patient can benefit from using their health care services in the home environment. For this reason the cost of providing such service is significantly lowered. The connectivity feature enables healthcare professionals to take actions on early symptoms and directly interact with the patient. Such systems also automatically identify the cases needing direct interaction. Consequently, healthcare providers can support larger number of patients.
Clinical Trial Data Collection
The primary goal of clinical trials is to evaluate the efficacy and safe use of a drug, medical device as well as any other medical domain solution or service. This process involves collecting the relevant data alongside the experiments or observations in clinical research. It is crucial that the data collected together with clinical trials is managed properly. There are several areas in medical domain where medical device software solutions can be used. Medical professionals often use clinical trial management systems to help to plan and then manage the operational aspects of clinical trials. Additionally, dedicated software applications allow patients or physicians involved in clinical studies to enrol in the programs. They can enter the data directly by filling in the dedicated diaries and surveys. Finally, software plays key role in the analysis of collected data by dedicated clinical trial analysts.
Covid-19 Clinical Trials
The outbreak of the COVID-19 pandemic triggered intensive research endeavours worldwide. Researchers want to predict the course of the outbreak, develop vaccine and medicines for, and moreover understand the specifics of SARS-COV-2 infection. Software technologies can find various applications to further COVID-19 research activities. For this reason Pro4People developed a mobile application for its client to be used during COVID-19 clinical trials. The goal of the mobile application was to help patients to collect the information about their health conditions, dosage of taken medications as well as observable COVID-19 symptoms. The application subsequently stored the data in a cloud-based database and then appointed analysts processed it for the needs of the clinical research.
Medical device software solutions can be used for insomnia treatment as a way to drive patient’s behaviour and habits in order to improve the quality of sleep. Furthermore, auxiliary software tools such as mobile or web applications can help to track sleep routines, increase drug treatment adherence. It can also facilitate communication between patients and physicians. Healthcare professionals can then manage and use the collected information to monitor treatment performance and increase its efficiency.
Similarly to insomnia treatment, patients suffering from hypertension can also use Software as a Medical Device. Software tools, e.g. mobile applications, can be integrated together with blood pressure monitors to collect the measurements regularly and track blood pressure trends. Furthermore, patients can use dedicated applications to document blood pressure, taken medications, observable side effects and get feedback on drug prescriptions adherence. Moreover, if needed, to adjust the prescriptions and recommendations.Dedicated medical personnel can access the collected data in order to facilitate treatment management. Mobile applications can also trigger notifications reminding patients of a need to take drugs or measure current blood pressure. This way the system can improve adherence to drug prescriptions as well as enable a healthcare professional to adjust the treatment based on current symptoms and data.
Patient telemonitoring solutions are designed to enable patient care outside of typical healthcare facilities. Devices in this part of medical domain gather the patient data at home or remote geographical locations. This, in effect leads to increased access to care and a decreased cost of healthcare services. Such solutions quite often consist of multiple medical devices (collecting patients’ physiological data such as heart rate, blood pressure, oxygen saturation, and weight) as well as software (enabling connectivity, data management and access to the patient health information remotely for healthcare personnel). Patient telemonitoring solutions are commonly used in treatment of chronic diseases. In effect, patients can stay at their homes and improve the quality of their lives. Physicians can then remotely manage the treatment and tailor therapies to individual needs. They can also promptly respond to events and life threats.
Internet of Medical Things (IoMT in Healthcare)
The newly available technologies enable building complex and scalable medical device solutions consisting of hardware devices coupled with software components: mobile and web applications, cloud-based backend components and databases. That type of solution is called Internet of Medical Things and has various applications in the medical domain. Hardware devices can be used for various purposes: disease diagnosis, supporting therapy and rehabilitation, monitoring of health parameters etc. Patients can use such products at homes, which enables better healthcare information exchange as well as lowers the cost of care and make the solutions more available and efficient.
Medical devices located next to patients (e.g. heart monitors, blood pressure monitors, thermometers) securely send data to software components, e.g. mobile applications, and then to a cloud backend. Additionally, Internet of Medical Things solutions can be integrated with 3rd party systems and services, such as diagnostic solutions, Hospital Information Systems (HIS), or Electronic Health Record (EHR) Software. Usually, such a system processes data received from patients automatically, based on verified algorithms, to identify patient populations who need healthcare professional’s reaction or support. Healthcare professionals can then access such a product through dedicated user interfaces, for instance web applications, or directly via EHR systems, for the needs of therapy management.
Read the following case study in order to learn more about a SaaS platform as a model application of IoMT in healthcare that Pro4People has implemented: https://pro4people.com/case-studies/developing-a-medical-software-as-a-service-platform/
Hospital Information System
Hospital Information Systems are software solutions that are mainly used for the purpose of processing patient data at hospitals. This usually includes systems to gather, process, manage and transfer information about a patient’s health history (Electronic Medical Record). Additionally, hospitals can use dedicated systems to manage their operations, including administrative, financial as well as clinical aspects. The cornerstone of Hospital Information Systems is their reliability, information security as well as precise management of access to sensitive health information. Such solutions can decrease the cost of hospital’s operations and moreover, increase the quality of the offered healthcare services.
Software as a Medical Device solutions can be successfully used to improve a patient’s therapy management. Dedicated software features can help the patient and physicians to document and then manage all information pertinent to the patient’s therapy: diagnosis details, treatment assumptions, medications, adverse effects, and hospital procedures. The overall goal of such systems in medical domain is to increase the efficiency of the patient’s therapy and also tailor it to the actual progress of the therapy. The second important benefit of such connected systems is to enable a healthcare professional to take an immediate decision with respect to the patient’s therapy based on the collected data, symptoms as well as the efficiency of a current therapy.
Please contact us if you found our medical domain experience relevant and are interested in learning more about how we could contribute our technical and regulatory expertise and help you with the development of your products and services for the healthcare market.
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