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, and this may position Pro4People as a good candidate for your technology partner in regard to medical device software implementation.
Clinical Trial Data Collection
Medical diagnosis, which is considered as 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 to facilitate data collection along the diagnosis process, provide medical imaging capabilities, support decision making, and facilitate laboratory analysis. Such solutions are often intended to be used by Health Care Professionals (HCPs), but there are also solutions dedicated directly to patients/lay users.
Application of medical device software to facilitate patient diagnosis makes the process less expensive, also increasing its efficiency and accuracy. Dedicated diagnostic solutions can enable an early detection of some diseases (e.g. cancers), 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. Typically the initial skin cancer diagnosis is based on a visual examination by a skin specialist using a special microscope or magnifying lens. Then a biopsy, which involves removing a small amount of tissue for examination under a microscope, may be needed. This should 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. Trained neural networks are capable of processing images of a skin lesion and assessing the malignancy of the skin tumour. This results in an increased capacity and a decreased cost of the skin cancer treatment, and additionally the initial diagnosis can be established by patients themselves, which is aligned with recommended policies of regular self-examinations. The available research shows that AI-based skin cancer diagnostic systems, properly designed and 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, 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 to maximize efficiency of medications and at the same time minimize adverse effects. The application of the new IT technologies enables adherence monitoring to be conducted remotely.
Connected Health Solutions
Connected health solutions revolutionize healthcare services mainly through leveraging new technologies and adding digital features to medical device products and services. Connected health products not only comprise hardware medical devices but also other related components, such as mobile applications, web applications, standalone applications or backend components. This type of solutions enables providing patient health services remotely and personalizing them to the individual patient’s needs. In particular, such solutions facilitate adherence monitoring, tailored treatment pathways, and help to bridge the gap between patients, physicians and medical device manufacturers closer.
The success of connected health solutions requires greater reliability, security as well as seamless integration between all components to make sure that the solution as a whole can fulfill its healthcare objectives. It is 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, significantly lowering the costs of providing such service. The connectivity feature enables healthcare professionals to take actions on early symptoms and directly interact with the patient. Healthcare providers can support larger number of patients as such systems automatically identify the cases needing direct interaction.
Clinical Trial Data Collection
The primary goal of clinical trials is to evaluate the efficacy and safe use of a drug, medical device or any other medical solution or service. This process involves collecting the relevant data along the experiments or observations in clinical research. Thus, it is crucial that the data collected along clinical trials is managed properly and there are several areas where medical device software solutions can be used. Clinical trial management systems are often used to help to plan and manage the operational aspects of clinical trials. Additionally, dedicated software applications can allow patients or physicians involved in clinical studies to enrol in the programs, enter the data directly by filling in the dedicated diaries and surveys. Last but not least, 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 has triggered intensive research endeavours worldwide. Researchers want to predict the course of the outbreak, develop vaccine and medicines for, and understand the specifics of SARS-COV-2 infection. Software technologies can find various applications to facilitate COVID-19 research activities. 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 and observable COVID-19 symptoms. As the data was stored in a cloud-based database, the details were then further processed for the needs of the clinical research by the appointed analysts.
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. Additionally, auxiliary software tools such as mobile or web applications can help to track sleep routines, increase drug treatment adherence and facilitate communication between patients and physicians. The collected information can be managed and used by healthcare professionals to monitor treatment performance and increase its efficiency.
Similarly to insomnia treatment, Software as a Medical Device can be used to help patients suffering from hypertension. Software tools, e.g. mobile applications, can be integrated 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, to get feedback on drug prescriptions adherence, and, if needed, to adjust the prescriptions and recommendations. The collected data can be accessed by dedicated medical personnel for the needs of 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 but also 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. In this case the patient data is gathered at homes or remote geographical locations, which 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) and 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, allowing patients to stay at their homes and improve the quality of their lives. Physicians can remotely manage the treatment, tailor therapies to individual needs, and 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 integrated with software components: mobile and web applications, cloud-based backend components and databases. That type of solutions is called Medical Internet of Things and has various applications in the healthcare domain. Hardware devices can be used for various purposes: disease diagnosis, supporting therapy and rehabilitation, monitoring of health parameters etc. Such products can be used by patients at their homes, enable better healthcare information exchange, lower the cost of care, make the solutions more available and efficient.
Data from the medical devices located next to a patient (e.g. heart monitors, blood pressure monitors, thermometers) can be securely sent 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 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 purposes of processing patient data at hospitals. This mainly includes systems to gather, process, manage and transfer information about a patient’s health history (Electronic Medical Record). Additionally, dedicated systems can be used to manage a hospital’s operations, including administrative, financial and clinical aspects of a hospital. The cornerstone of Hospital Information Systems is their reliability, information security, and precise management of access to sensitive health information. Such solutions can decrease the cost of hospital’s operations and 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 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 is to increase the efficiency of the patient’s therapy and 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 and 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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