Healthcare and Life Sciences

Technology Design and Development

We design, develop, integrate, deploy, and support technology for Healthcare and Life Sciences. The majority of technology we design and develop is integrated with one or more of the following:

  • Artificial Intelligence - AI
  • Machine Learning - ML
  • Deep Learning
  • Computer Vision
  • Machine Vision
  • Natural Language Processing - NLP
  • Natural Language Understanding - NLU
  • Natural Language Generation - NLG
  • Neural Machine Translation - NMT/MT

Important Note:

We adhere to the Regulations and Guidelines established by the United States Food and Drug Administration - FDA.

HealthIT

Health Information Technology - HealthIT

Health Information Technology is Health Technology, particularly Information Technology - IT, applied to Health and Healthcare. It supports Health Information Management across Computerized Systems and the Secure Exchange of Health Information between Consumers, Providers, Payers, and Quality Monitors

HealthTech

Healthcare Technology - HealthTech

Health Technology is defined by the World Health Organization - WHO, as the "application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures, and systems developed to solve a health problem and improve quality of lives."

DigitalHealth

Digital Health Technology - DigitalHealth

The broad scope of digital health includes categories such as:

  • Mobile Health - mHealth
  • Health Information Technology - HealthIT
  • Wearable Health Technology Devices
  • TeleHealth and TeleMedicine
  • Personalized Medicine

From mobile medical apps and software that support the clinical decisions doctors make every day to artificial intelligence and machine learning, digital technology has been driving a revolution in health care. Digital health tools have the vast potential to improve our ability to accurately diagnose and treat disease and to enhance the delivery of health care for the individual.

Digital health technologies use computing platforms, connectivity, software, and sensors for health care and related uses. These technologies span a wide range of uses, from applications in general wellness to applications as a medical device. They include technologies intended for use as a medical product, in a medical product, as companion diagnostics, or as an adjunct to other medical products (Devices, Drugs, and Biologics). They may also be used to develop or study medical products.

MedTech

Medical Technology - MedTech

Medical Technology - MedTech, is every product, service, or solution using medical technology to improve people’s health by preventing, diagnosing, monitoring, and treating disease.

MedTech is quite beneficial for healthcare providers. The prime aim of advancement in MedTech is to improve the overall quality of patient care in a medical setting. These devices aid them by producing accurate results. This allows the clinicians to structure a better and more improvement-oriented treatment plan for the patient. Since the initial results i.e. laboratory results and scans are free of errors, therefore, it is likely for the patient to improve at a much faster pace.

Moreover, MedTech devices and procedures save time for both clinicians and patients. Today, the procedures are made much less complicated. MedTech also creates better, advanced, and less invasive treatment options. MedTech favors reducing the duration of hospital stay as well as the requirements for rehabilitation. The accurate, time-savvy, and less complicated nature of MedTech makes it a discipline of ease and comfort for the healthcare providers.

MedTech is a combination of technology and medical interventions. This is the most significant combination as it has provided numerous significant contributions to improve the overall medical care. Clinicians and patients exclusively use tablets, smartphones, and mobile apps which access the Electronic Health Records (EHR) to bring benefit to both ends.

MedTech holds credit for introducing the very successful concept of TeleHealth and TeleMedicine services. Today patients and healthcare providers have the facility to discuss their disease over a video call instead of traveling to a location hundreds of miles away to another city or the country. This facility nullifies the traveling expenses.

Moreover accessing all kinds of health information by the healthcare providers is only a click away. Healthcare providers carry smartphones and tablets throughout their duty. They can look for drug information, medical history of patient/EHR and even research papers is an effortless job.

mHealth

Mobile Health Technology - mHealth

mHealth (or m-health) is short for mobile health, the practice of medicine and health care over mobile devices, tablets, PDAs, and computers. As an industry, the mHealth field has seen exponential growth in recent years thanks to widespread use in developing nations and increasingly accessible mobile technology. Many people are familiar with eHealth, the branch of healthcare that makes use of computers, emails, satellite communications and monitors. mHealth technology performs similar functions, such as obtaining vital signs, delivering information to doctors and allowing remote exams, on tablets, cell phones and other portable devices.

mHealth focuses on obtaining information immediately to diagnose illnesses, track diseases and provide timely information to the public in undeserved countries. Mobile Health Technology - mHealth is especially important in remote areas where doctors and nurses may not be present to provide treatment. Doctors and nurses working in these remote areas rely on mHealth for timely information on handling diseases, and can also obtain actionable health information to pass on to others near them. This mobile health technology also speeds training and education relative to health issues to medical students and interns working in remote communities.

At the end of 2014, it is estimated that millions of patients around the world were making use of home monitor services, which were all based on mobile connectivity. These devices are not the same as traditional computer connections or cell phones. They have their own cellular communication systems and fixed modem connections dedicated for their use.

As Healthcare Technology changes, so does our Digital Health lexicon. For example, if a person looks up a symptom on the Internet using their computer, it isn’t considered as practicing mHealth. Years ago, however, this was a revolutionary healthcare practice, not just an everyday task. Now, programs and devices dedicated specifically to remote health are further advancing what we consider “everyday” technology. Remote care will eventually be considered as commonplace as in-office visits or research at a computer.

The Difference between mHealth, Telehealth and TeleMedicine

The difference between mHealth, TeleHealth and TeleMedicine, then, is that TeleHealth and TeleMedicine refers to all instances of Healthcare via the use of modern technology, whereas mHealth refers to the concept of mobile self-care — consumer technologies like smartphone and tablet apps that enable consumers to capture their own health data, without a clinician’s assistance or interpretation.

So, unlike TeleHealth and TeleMedicine, which encompasses Clinician-to-Clinician, Clinician-to-Patient, and Patient-to-Patient interaction, and unlike RPM, which involves Clinician-to-Patient and Patient-to-Patient interaction, mHealth is limited to Patient-to-Patient interaction (or Patient Self-Interaction).

Think of mHealth, then, as User-Directed Health Technology that falls into the categories of sports, fitness, and well-being. It may help to think of it as something akin to a Smartphone App, whereas TeleHealth and TeleMedicine are more accurately defined as Clinician-Directed Remote Patient Monitoring Technology.

Biomedical Science

Biomedical Science

Biomedical sciences are a set of sciences applying portions of natural science or formal science, or both, to develop knowledge, interventions, or technology that are of use in Healthcare or Public Health.

Such disciplines as Medical Microbiology, Clinical Virology, Clinical Epidemiology, Genetic Epidemiology, and Biomedical Engineering are Medical sciences. In explaining physiological mechanisms operating in Pathological Processes, however, Pathophysiology can be regarded as Basic Science.

Biomedical Sciences, as defined by the UK Quality Assurance Agency for Higher Education Benchmark Statement in 2015, includes those science disciplines whose primary focus is the Biology of Human health and disease and ranges from the generic study of Biomedical Sciences and human biology to more specialized subject areas such as pharmacology, human physiology and human nutrition. It is underpinned by relevant Basic Sciences including anatomy and Physiology, Cell Biology, Biochemistry, Microbiology, Genetics and Molecular Biology, Immunology, Mathematics and Statistics, and Bioinformatics.

As such the Biomedical Sciences have a much wider range of academic and research activities and economic significance than that defined by Hospital Laboratory Sciences. Biomedical Sciences are the major focus of Bioscience Research and funding in the 21st century.

Biomedical Science staff mostly work in Healthcare Laboratories diagnosing diseases and evaluating the effectiveness of treatment by analyzing fluids and tissue samples from patients. They provide the 'engine room' of Modern Medicine.

Roles within Biomedical Science

A sub-set of Biomedical Sciences is the science of Clinical Laboratory Diagnosis. This is commonly referred to in the UK as 'Biomedical Science' or 'Healthcare Science'. There are at least 45 different specialisms within healthcare science, which are traditionally grouped into three main divisions:

Life Sciences specialties

  • Molecular Toxicology
  • Molecular Pathology
  • Blood Transfusion Science
  • Cervical Sytology
  • Clinical Biochemistry
  • Clinical Embryology
  • Clinical Immunology
  • Electron Microscopy
  • External Quality Assurance
  • Haematology
  • Haemostasis and Thrombosis
  • Histocompatibility and Immunogenetics
  • Histopathology and Cytopathology
  • Molecular Genetics and Cytogenetics
  • Molecular Biology and Cell Biology
  • Microbiology including Mycology
  • Bacteriology
  • Tropical Diseases
  • Phlebotomy
  • Tissue Banking/Transplant
  • Virology

Physiological Science Specialisms

  • Audiology and Hearing Therapy
  • Autonomic Neurovascular Function
  • Cardiac Physiology
  • Clinical Perfusion
  • Critical Care Science
  • Gastrointestinal Physiology
  • Neurophysiology
  • Ophthalmic and Vision Science
  • Respiratory and Sleep Physiology
  • Urology
  • Vascular Science

Physics and Bioengineering Specialisms

  • Biomechanical Engineering
  • Biomedical Engineering
    Clinical Engineering
  • Clinical Measurement
  • Diagnostic Radiology
  • Equipment Management
  • Maxillofacial Prosthetics
  • Medical Electronics
  • Medical Engineering Design
  • Medical Illustration and Clinical Photography
  • Non-Ionising Radiation
  • Nuclear Medicine
  • Radiopharmacy
  • Radiation Protection and Monitoring
  • Radiotherapy Physics
  • Rehabilitation Engineering
  • Renal Technology and Science
  • Ultrasound
Biomedical Research

Biomedical Research / Medical Research

We develop technology for Biomedical Research / Medical Research.

Biomedical Research is the broad area of science that looks for ways to prevent and treat diseases that cause illness and death in people and in animals. This general field of research includes many areas of both the life and physical sciences. Utilizing biotechnology techniques, Biomedical Researchers study Biological Processes and Diseases with the ultimate goal of developing effective treatments and cures.

Biomedical Research is an evolutionary process requiring careful experimentation by many scientists, including Biologists and Chemists. Discovery of new medicines and therapies requires careful scientific experimentation, development, and evaluation.

Medical Research

Medical Research, also known as Experimental Medicine, encompasses a wide array of research, extending from "Basic Research", involving fundamental scientific principles that may apply to a pre-clinical understanding – to Clinical Research, which involves studies of people who may be subjects in clinical trials.

Biomedical Engineering

Biomedical Engineering

Biomechanical Engineering is a Bioengineering sub-discipline, which applies principles of Mechanical Engineering to Biological Systems and Stems from the scientific discipline of Biomechanics. Biomedical Engineering is the application of the principles and problem-solving techniques of engineering to biology and medicine. This is evident throughout Healthcare, from diagnosis and analysis to treatment and recovery, and has entered the public conscience though the proliferation of implantable medical devices, such as pacemakers and artificial hips, to more futuristic technologies such as stem cell engineering and the 3-D printing of biological organs. Biomedical Engineering focuses on the advances that improve human health and health care at all levels.

Topics of interest in the field include Biomedical Engineering and Agricultural Engineering. Biomechanics, specifically, is the study of biological systems such as the human body, combined with the study of mechanics, or mechanical applications. Using the skills learned from biology, engineering, and physics to research and development for Healthcare, such as organs that have been made from artificial materials, or new advances with prosthetic limbs.The creation of Biomaterial, which is a fake material that can be integrated into living tissue or can live in sync with biological material, is one of the biggest advances in medicine to this day.

Biomedical Engineers differ from other engineering disciplines that have an influence on human health in that Biomedical Engineers use and apply an intimate knowledge of modern biological principles in their engineering design process. Aspects of Mechanical Engineering, Electrical Engineering, Chemical Engineering, Materials Science, Chemistry, Mathematics, and Computer Science and Engineering are all integrated with human biology in Biomedical Engineering to improve human health, whether it be an advanced prosthetic limb or a breakthrough in identifying proteins within cells.

There are many sub-disciplines within Biomedical Engineering, including the design and development of active and Passive Medical Devices, Orthopedic Implants, Medical Imaging / Radiology / Radiomics, Biomedical Signal Processing, Tissue and Stem Cell Engineering, and Clinical Engineering, just to name a few.

Biomedical Technology

Biomedical Technology

Biomedical Technology is the application of engineering and technology principles to the domain of living or biological systems, with an emphasis on human health and diseases. Biomedical Engineering and Biotechnology alike are often loosely called Biomedical Technology or Bioengineering.

Biomedical Technology is a broad term that combines engineering and technology to solve biological or medical problems involving humans, especially the design and use of medical equipment used to diagnose and treat various diseases. Biomedical technology can also be broken down into smaller sub-fields, like Biomedical Informatics, Engineering, Science and Research.

Biomedical Technology Sub-Fields

  • Biomedical Informatics

Biomedical Informatics is the branch of Biomedical Technology that deals with the tracking and measuring of Biomedical data by using computers and technology. As a Biomedical Technician, you'd use the information they gather to better understand different issues, such as how diseases spread or how well health systems are performing.

  • Biomedical Engineering

The branch of Biomedical Technology concerned with the application of engineering design and principles to medical and biological issues is called Biomedical Engineering. Biomedical Engineer's work involves developing and growing synthetic organs or creating prosthetic limbs to replace diseased or injured parts of the human body.

  • Biomedical Research

Biomedical Research is the study of various chemicals and substances used to develop and improve medicines that are used to treat disease. The research is often conducted using equipment and methods developed by people working in other branches of biomedical technology.

  • Biomedical Science

Biomedical Science, also known as Health Science, is the application of Chemistry, Biology, Physics, Engineering, and other scientific disciplines to the research and treatment of human health issues.

Biomedical Technology and Biomedical Science overlap in many aspects, but Biomedical Scientist, focuses more on the actual research and treatment of disease, while Biomedical Technician, deal more with researching and developing technologies and methodologies used to treat disease.

Precision Medicine

Precision Medicine

Precision Medicine - PM is a medical model that proposes the customization of Healthcare, with medical decisions, treatments, practices, or products being tailored to a subgroup of patients, instead of a one‐drug‐fits‐all model. In Precision Medicine, diagnostic testing is often employed for selecting appropriate and optimal therapies based on the context of a patient’s genetic content or other molecular or cellular analysis. Tools employed in Precision Medicine can include molecular diagnostics, imaging, and analytics.

Most medical treatments are designed for the "average patient" as a one-size-fits-all-approach, which may be successful for some patients but not for others. Precision medicine, sometimes known as "personalized medicine" is an innovative approach to tailoring disease prevention and treatment that takes into account differences in people's genes, environments, and lifestyles. The goal of precision medicine is to target the right treatments to the right patients at the right time.

Advances in precision medicine have already led to powerful new discoveries and FDA-approved treatments that are tailored to specific characteristics of individuals, such as a person's genetic makeup, or the genetic profile of an individual's tumor. Patients with a variety of cancers routinely undergo molecular testing as part of patient care, enabling physicians to select treatments that improve chances of survival and reduce exposure to adverse effects.

Next Generation Sequencing (NGS) Tests

Precision care will only be as good as the tests that guide diagnosis and treatment. Next Generation Sequencing - NGS tests are capable of rapidly identifying or 'sequencing' large sections of a person's genome and are important advances in the clinical applications of Precision Medicine. Patients, physicians and researchers can use these tests to find genetic variants that help them diagnose, treat, and understand more about human disease.


The FDA's Role in Advancing Precision Medicine

The FDA is working to ensure the accuracy of NGS tests, so that patients and clinicians can receive accurate and clinically meaningful test results. The vast amount of information generated through NGS poses novel regulatory issues for the FDA. While current regulatory approaches are appropriate for conventional diagnostics that detect a single disease or condition (such as blood glucose or cholesterol levels), these new sequencing techniques contain the equivalent of millions of tests in one. Because of this, the FDA has worked with stakeholders in industry, laboratories, academia, and patient and professional societies to develop a flexible regulatory approach to accommodate this rapidly evolving technology that leverages consensus standards, crowd-sourced data, and state-of-the-art Open-Source Computing Technology to support NGS test development. This approach will enable innovation in testing and research, and will speed access to accurate, reliable genetic tests.

SOURCE: The United States Food and Drug Administration - FDA

SOURCE URL: https://www.fda.gov/medical-devices/in-vitro-diagnostics/precision-medicine


Precision Medicine's Relationship to Personalized Medicine

In explaining the distinction from a similar common term of Personalized Medicine, the National Research Council explains:

Precision Medicine refers to the tailoring of medical treatment to the individual characteristics of each patient. It does not literally mean the creation of drugs or medical devices that are unique to a patient, but rather the ability to classify individuals into sub-populations that differ in their susceptibility to a particular disease, in the biology or prognosis of those diseases they may develop, or in their response to a specific treatment. Preventive or therapeutic interventions can then be concentrated on those who will benefit, sparing expense and side effects for those who will not. Although the term 'personalized medicine' is also used to convey this meaning, that term is sometimes misinterpreted as implying that unique treatments can be designed for each individual.

On the other hand, use of the term "Precision Medicine" can extend beyond treatment selection to also cover creating unique medical products for particular individuals—for example, "...patient-specific tissue or organs to tailor treatments for different people." Hence, the term in practice has so much overlap with "Personalized Medicine" that they are often used interchangeably.

Precision Medicine's Scientific Basis

Precision Medicine often involves the application of Panomic Analysis and Systems Biology to analyze the cause of an individual patient's disease at the molecular level and then to utilize targeted treatments (possibly in combination) to address that individual patient's disease process. The patient's response is then tracked as closely as possible, often using surrogate measures such as tumor load (versus true outcomes, such as five-year survival rate), and the treatment finely adapted to the patient's response. The branch of Precision Medicine that addresses Cancer is referred to as "Precision Oncology".

The field of Precision Medicine that is related to Psychiatric Disorders and Mental Health is called "Precision Psychiatry."

Inter-personal difference of Molecular Pathology is diverse, so as inter-personal difference in the exposome, which influence disease processes through the interactome within the tissue microenvironment, different from person to person.

As the theoretical basis of Precision Medicine, the "unique disease principle" emerged to embrace the ubiquitous phenomenon of heterogeneity of disease Etiology and Pathogenesis. The unique disease principle was first described in Neoplastic Diseases as the unique tumor principle. As the exposome is a common concept of Epidemiology, Precision Medicine is intertwined with Molecular Pathological Epidemiology, which is capable of identifying potential Biomarkers for Precision Medicine.

Precision Medicine in Practice

The ability to provide Precision Medicine to patients in routine clinical settings depends on the availability of Molecular Profiling Tests, e.g. individual germline DNA sequencing.

While Precision Medicine currently individualizes treatment mainly on the basis of Genomic Tests (e.g. Oncotype DX), several promising technology modalities are being developed, from techniques combining Spectrometry and Computational Power to Real-Time Imaging of drug effects in the body.

Many different aspects of Precision Medicine are tested in research settings (e.g., Proteome, Microbiome), but in routine practice not all available inputs are used. The ability to practice Precision Medicine is also dependent on the knowledge bases available to assist Clinicians in taking action based on test results.

Early studies applying Omics-based Precision Medicine to cohorts of individuals with undiagnosed disease has yielded a diagnosis rate ~35% with ~1 in 5 of newly diagnosed receiving recommendations regarding changes in therapy.

On the treatment side, Precision Medicine can involve the use of customized medical products such drug cocktails produced by pharmacy compounding or customized devices. Precision Medicine can also prevent harmful drug interactions, increase overall efficiency when prescribing medications, and reduce costs associated with Healthcare.

The question of who benefits from publicly funded Genomics is an important Public Health consideration, and attention is needed to ensure that implementation of Genomic Medicine does not further entrench social‐equity concerns.

Artificial Intelligence - AI in Precision Medicine

Artificial Intelligence - AI is a providing paradigm shift toward precision medicine. Machine Learning - ML algorithms and models are used for Genomic Sequence and to analyze and draw inferences from the vast amounts of data patients and Healthcare institutions recorded in every moment.

Artificial Intelligence - AI techniques are used in Precision Cardiovascular Medicine to understand Genotypes and Phenotypes in existing diseases, improve the quality of patient care, enable cost-effectiveness, and reduce readmission and mortality rates. A 2021 paper reported that Machine Learning - ML was able to predict the outcomes of Phase III clinical trials (for treatment of Prostate Cancer) with 76% accuracy. This suggests that clinical trial data could provide a practical source for Machine Learning-based tools for Precision Medicine.

Precision Medicine may be susceptible to subtle forms of algorithmic bias. For example, the presence of multiple entry fields with values entered by multiple observers can create distortions in the ways data is understood and interpreted.

Precision Medicine Initiative

In his 2015 State of the Union address, U.S. President Barack Obama stated his intention to fund an amount of $215 million to the "Precision Medicine Initiative" of the United States National Institutes of Health. A short-term goal of the Precision Medicine Initiative was to expand Cancer Genomics to develop better prevention and treatment methods. In the long term, the Precision Medicine Initiative aimed to build a comprehensive scientific knowledge base by creating a national network of scientists and embarking on a national cohort study of One Million Americans to expand our understanding of health and disease.

The Mission Statement of the Precision Medicine Initiative read:

"To enable a new era of medicine through research, technology, and policies that empower patients, researchers, and providers to work together toward development of individualized treatments". In 2016 this initiative was renamed "All of Us" and an initial pilot project had enrolled about 10,000 people by January 2018.

Benefits of Precision Medicine

Precision Medicine helps Healthcare Providers better understand the many things—including environment, lifestyle, and heredity—that play a role in a patient's health, disease, or condition. This information lets them more accurately predict which treatments will be most effective and safe, or possibly how to prevent the illness from starting in the first place.

In addition, benefits are to:

  • Shift the emphasis in medicine from reaction to prevention
  • Predict susceptibility to disease
  • Improve disease detection
  • Preempt disease progression
  • Customize disease-prevention strategies
  • Prescribe more effective drugs
  • Avoid prescribing drugs with predictable negative side effects
  • Reduce the time, cost, and failure rate of pharmaceutical clinical trials
  • Eliminate trial-and-error inefficiencies that inflate health care costs and undermine patient care