+972-4-9895914 info@meddev-design.com

Medical Device Buzzwords 2016
M-Health mHealth_illustration_1-1500x770
M-Health is a term used for the practice of medicine and public health supported by mobile devices. The term is commonly used in reference for using mobile communication devices, such as mobile phones, tablet computers for health services and information, but also affect emotional states. The m-Health field has emerged as a sub-segment of e-Health, the use of information and communication technology (ICT), such as computers, mobile phones, communications satellite, patient monitors, etc., for health services and information.
m-Health applications include the use of mobile devices in collecting community and clinical health data, delivery of healthcare information to practitioners, researchers, and patients, real-time monitoring of patient vital signs, and direct provision of care (via mobile telemedicine).
It is a known fact that medical companies evolve for years until finally creating a cure or a life changing device.
Despite this struggle, according to the m-Health Israel, this market’s growth has created a funding turmoil in Silicon Valley. Investment in US digital healthcare startups doubled between 2009-2011, reaching $1.4 billion in 2012 and surpassing $850 million in the first half of 2013.
The future holds great promise for m-Health companies, with a clear forecast that the market of mobile health applications should reach $26 billion by 2017 (61% CAGR) (by Dr. Ralf Jahns, Founder of Research2Guidance).


Medical Device Buzzwords 2016

Edifecs-Healthcare-Population-Health-3Population Health Management (PHM)

Population Health Management is the aggregation of patient data across multiple health information technology resources, the analysis of that data into a single, actionable patient record, and the actions through which care providers can improve both clinical and financial outcomes.

Population Health Management (PHM) seeks to improve the health outcomes of a group by monitoring and identifying individual patients within that group. Typically, PHM programs use a business intelligence (BI) tool to aggregate data and provide a comprehensive clinical picture of each patient. Using that data, providers ca
n track, and hopefully improve, clinical outcomes while lowering costs.

A best-in-class PHM program brings clinical, financial and operational data together from across the enterprise and provides actionable analytics for providers to improve efficiency and patient care. Delivering on the vision of PHM requires a robust care management and risk stratification infrastructure, a cohesive delivery system, and a well-managed partnership network.


Medical Device Buzzwords 2016

nextgov-mediumHIT- Health IT

Health information technology (HIT) is “the application of information processing involving both computer hardware and software that deals with the storage, retrieval, sharing, and use of health care information, data, and knowledge for communication and decision making” (Brailer, D. (2004), The decade of health information technology. HHS Report, July, 21)

For HIT, technology represents computers and communications attributes that can be networked to build systems for moving health information. Informatics is yet another integral aspect of HIT.

HIT is the area of IT involving the design, development, creation, use and maintenance of information systems for the healthcare industry. Automated and interoperable healthcare information systems are expected to lower costs, improve efficiency and reduce error, while also providing better consumer care and service.


Medical Device Buzzwords 2016

1Cyber Security

Most healthcare organizations are aware and worried regarding information privacy and security risks, but they don’t know where to start to improve their security issues. The medical device development is becoming more digital, while at the same time, the safety and security of patients is becoming more conscious.

The benefits of technology in the medical sector is very significant. But the rapid rise of technology, also causes several challenges.

Cyber security will get an integral part of the developing stage and strategy.

The healthcare industry is faced with a unique set of business, environmental and technical drivers of risk, along with a unique set of regulations for personal information and health data management.

Compliance requirements are exacerbated by the scarcity and high cost of skilled privacy and security resources, complex and risky IT technology, and increasingly dangerous and pervasive cyber threats.

The challenges are centered at:

  • Compliance with privacy, consent and other regulatory requirements
  • Identity and data loss theft
  • Shortage of skilled security professionals
  • Consumerization of healthcare or Bring Your Own Device.
  • Assessing their safeguard effectiveness

“Medical devices, like other computer systems, can be vulnerable to security breaches, potentially impacting the safety and effectiveness of the device. This vulnerability increases as medical devices are increasingly connected to the Internet, hospital networks, and to other medical devices.

All medical devices carry a certain amount of risk. The FDA allows devices to be marketed when there is a reasonable assurance that the benefits to patients outweigh the risks. While the increased use of wireless technology and software in medical devices also increases the risks of potential cybersecurity threats, these same features also improve health care and increase the ability of health care providers to treat patients. Addressing cybersecurity threats, and thus reducing information security risks, is especially challenging. Because cybersecurity threats cannot be completely eliminated, manufacturers, hospitals and facilities must work to manage them.  There is a need to balance protecting patient safety and promoting the development of innovative technologies and improved device performance.

FDA recommendations for mitigating and managing cybersecurity threats include:

  • Medical device manufacturers and health care facilities should take steps to ensure appropriate safeguards. Manufacturers are responsible for remaining vigilant about identifying risks and hazards associated with their medical devices, including risks related to cybersecurity. They are responsible for putting appropriate mitigations in place to address patient safety risks and ensure proper device performance.
  • Hospitals and health care facilities should evaluate their network security and protect their hospital systems.” (FDA)


Medical Device Buzzwords 2016-Machine Learning in Biomed

machine-learning_6-100578649-primary.idgeMachine learning offers a principled approach for developing sophisticated, automatic, and objective algorithms for analysis of high-dimensional and multimodal biomedical data.

These algorithms focus on several advances in the state of the art that have shown promise in improving detection, diagnosis, and therapeutic monitoring of disease. Key in the advancement has been the development of a more in-depth understanding and theoretical analysis of critical issues related to algorithmic construction and learning theory. These include trade-offs for maximizing generalization performance, use of physically realistic constraints, and incorporation of prior knowledge and uncertainty. The recent developments in machine learning focused on supervised and unsupervised linear methods and Bayesian inference, which have made significant impacts in the detection and diagnosis of disease in biomedicine.


Medical Device Buzzwords 2016 – Medical Imaging

mainimageMedical Imaging

Medical imaging is the technique and process of creating visual representations of the interior of a body for clinical analysis and medical intervention, as well as visual representation of the function of some organs or tissues (physiology). Medical imaging is used for revealing internal structures hidden by the skin and bones, as well as to diagnose and treat disease. Medical imaging was also used for establishing a database of normal anatomy and physiology to make it possible to identify abnormalities.

Medical imaging encompasses different imaging modalities and processes to image the human body for diagnostic and treatment purposes and therefore plays an important role in initiatives to improve public health for all population groups. Furthermore, medical imaging is frequently used in the follow-up of a disease already diagnosed and/or treated in order to examine the progress of the treatment.

Medical imaging, especially X-ray based examinations and ultrasonography, is crucial in a variety of medical setting and at all major levels of health care. In public health and preventive medicine as well as in both curative and palliative care, effective decisions depend on correct diagnoses. Though medical/clinical judgment may be sufficient prior to treatment of many conditions, the use of diagnostic imaging services is paramount in confirming, correctly assessing and documenting courses of many diseases as well as in assessing responses to treatment.

With improved health care policy and increasing availability of medical equipment, the number of global imaging-based procedures is increasing considerably. Effective, safe, and high quality imaging is important for many medical decision makers and can reduce unnecessary procedures. For example, some surgical interventions can be avoided altogether if simple diagnostic imaging services such as ultrasound are available.

Medical Device Buzzwords 2016 – Personalized Diagnostics

skuldtech-genomics-bioinformaticsExploiting the growing fields of genomics, proteomics and metabolomics improves understanding of human physiology and, critically, the mutations that signal disease susceptibility.

Through these emerging fields, rational design approaches to diagnosis, drug development and ultimately personalized medicine are possible. Personalized medicine and point-of-care testing techniques must fulfill constraints for real-world applicability. Point-of-care devices must ultimately provide a cost-effective alternative to expensive and time-consuming laboratory tests in order to assist health care personnel with disease diagnosis and treatment decisions.

Sensor technologies are also expanding beyond the more traditional classes of biomarkers – nucleic acids and proteins – to metabolites and direct detection of pathogens, ultimately increasing the palette of available techniques for the use of personalized medicine. The technologies needed to perform such diagnostics have also been rapidly evolving, with each generation being increasingly sensitive and selective while being more resource conscious. Ultimately, the final hurdle for all such technologies is to be able to drive consumer adoption and achieve a meaningful medical outcome for the patient.

Medical Device Buzzwords 2016 – DNA

imagesDetermining the order of DNA building blocks (nucleotides) in an individual’s genetic code, called DNA sequencing, has advanced the study of genetics and is one method used to test for genetic disorders.

No question that 2014 and 2015 have been a years to celebrate for the field of genetics. Stem cell therapy, gene therapy, next-generation sequencing as a reliable clinical.

Technical milestones have been met, technical challenges surmounted – palpably, we stand on the cusp of a new era, where we will have means to treat the untreatable and cure the incurable.

New technologies that allow rapid sequencing of large amounts of DNA are being developed every day, the ability to scan the entire genome for common polymorphisms that associate with disease has led to the identification of numerous new risk genes involved in autoimmune phenotypes. Several themes are emerging. Autoimmune disorders have a complex genetic basis; multiple genes contribute to disease risk, each with generally modest effects independently. In addition, it is now clear that common genes underlie multiple autoimmune disorders. There is also heterogeneity among subphenotypes within a disease and across major racial groups. The current crop of genetic associations are only the start of a complete catalog of genetic factors for autoimmunity, and it remains unclear to what extent common variation versus multiple rare variants contribute to disease susceptibility. The current review focuses on recent discoveries within functionally related groups of genes that provide clues to novel pathways of pathogenesis for human autoimmunity.

Medical Device Buzzwords 2016 – Robotics in Medicine

maxresdefaultFrom radiation treatment to eye surgery, rehabilitation to hair transplantation, and robot therapists to robotic pharmacists, and even a robot phlebotomist, healthcare robots are transforming the fields of medicine across the globe.

Many believe healthcare robotics is reaching a tipping point. Robots are becoming cheaper and more capable. The sensors and software that heighten their capability continue to drop in price. And as a new age dawns for robots designed to work collaboratively with humans, medical applications will only gain momentum. Reports are projecting tremendous growth for healthcare robotics in the next five years.

Recently the “Healthcare Robotics 2015-2020: Trends, Opportunities & Challenges” report was released by the Robotics Business Review, that provided strategic information for the global robotics industry.  The findings in this report are intriguing and help segment the robotic health market. In the search for the value of medical robotics, there are three main areas of robotic health: Direct patient care robots, indirect patient care robots, home healthcare robots.

Medical Device Buzzwords 2016 – Cloud Storage of Medical Records

Female doctor working on transparent monitor.

Cloud allows central storage of Medical Records, Healthcare Services, and Big Data.

The “Cloud” is simply a metaphor, that represents a group of servers that has unlimited storage, remotely from the user. Well, just think of the “Cloud” as a hard drive that is not on your computer, but is in a remote location, but accessible to you.  You have access to it, but do not have to have the storage space on your device, or may not have the storage on you device for memory-eating programs.

Today, there are many services that let you store your files “in the cloud,” and access them from anywhere.

The deployment of cloud computing will inexpensively facilitate the collaborative application of diagnosis of patients across hospitals and expand services from regional to global.  Cloud computing has the benefits of highly efficient computing performance, cost-effectiveness, and sufficient storage for data delivery and management. Cloud computing technology and mobile technology should be combined because mobile technology requires high speed data delivery and a big data center where data can be delivered, stored, retrieved, and managed securely.

However, are medical records safe in the cloud? Despite its popularity, there are hidden risks and costs. When it comes to medical records, nothing is more important than privacy. After all, that stuff is really personal. So the growing trend of storing all kinds of data – including medical records – in the cloud, is troubling.

According to a MobiHealthNews article by Jonah Comstock, “Healthcare providers are turning to cloud-based data storage because of the promise of significant savings.” But the cloud isn’t necessarily as secure as other forms of storage. And because providers know that, they’ve got to spend extra money on security, an expenditure that can offset cost savings.” When It comes to medical records in the cloud, security is not optional, it is obligatory.

Medical Device Buzzwords 2016 – Risk Management


The risk management process is a basic and an ongoing stage through the medical device lifecycle. The risk management procedure is presented in ISO 14971 and includes:

1) Identifying hazards and hazardous conditions associated with a medical device that could place patients or healthcare workers at risk.

2) Estimating the potential occurrence of such risks, and evaluating the extent of the consequences.

3) Developing and implementing active safeguards within the device or the production process to control risks.

4) Regularly reviewing and monitoring the process to assess the effectiveness of risk management controls and the risk management process.

Each aspect of a risk management system is thoroughly documented to provide evidence of the manufacturer’s commitment to control risk throughout the entire life of a given medical device design.

A robust risk management system can also provide important value by supporting the development, production and distribution of all types of new medical devices. Products under development are subject to greater scrutiny early in the design stage. This allows for the identification and implementation of changes and modifications to improve functional safety and usability with minimal impact to the product development schedule. For certain types of medical devices, an effective risk management evaluation will also identify risks associated with device reprocessing and reuse. These and other benefits can result in faster time to market, and greater competitive advantages.

Medical Device Buzzwords 2016 – Big Data

Top 5 Software Testing Traps and How to Overcome Them

The future of healthcare is already here. From automated insulin pumps to diagnostic instruments that can interpret their own results, today’s medical devices are smarter and more sophisticated than ever. What’s driving these innovations? The answer is data.

The role of big data in medicine is one where we can build better health profiles and better predictive models around individual patients so that we can better diagnose and treat disease.

Big data comes into play around aggregating more and more information around multiple scales for what constitutes a disease—from the DNA, proteins, and metabolites to cells, tissues, organs, organisms, and ecosystems. Those are the scales of the biology that we need to be modeling by integrating big data. If we do that, the models will evolve, the models will build, and they will be more predictive for given individuals.

The big-data revolution is in its start, and most of the potential for value creation is still unclaimed, but it has set the industry on a path of rapid change and new discoveries.

The analytical capabilities that will be required to capture big data’s full potential, ranging from reporting and monitoring activities that are already occurring to predictive modeling and simulation techniques that have not yet been used at scale.

Medical Device Buzzwords 2016 – Clinical Wearables

Future in Clinical wearables

In the future “Clinical wearables” are going to have more sophisticated sensing, capture and analytical functionalities, thus making the clinical utility of those devices more actionable.

A wearable medical device is mostly known as a biosensor that monitors physiological data, usually with remote/wireless communication. It could be attached to the body as any standard wearable item. Most current wearable medical devices specialize in measuring activities, exercises, distance traveled, calories burned, heart rate, while other devices encompass a wide range of physiological measurements and, in the future, may incorporate enhanced functionality, including monitoring and/or analysis of clinical data such as blood pressure, continuous glucose, saturation and oxygen level, brain activity, temperature, EKG etc.

The FDA categorizes wearables into three classes:

  1. Class A – Wearables that have no potential risk.
  2. Class B – Wearables that have a minimal risk.
  3. Class C – Wearables that have the strictest guidelines because they pose the greatest risk.

As wearable medical devices become more sophisticated and complex, consumer health and wellness devices may end up in a grey area or beyond and may need to shift to fall under FDA purview.

From a business point of view, the size of the wearable medical device market is huge and fast-growing. Estimates predict that it may reach up to $53 billion worldwide with 25–35 percent annual growth within the next three years.

Medical Device Buzzwords 2016 –  Integration of Health Care

הורדA worldwide trend in health care reforms and new organizational arrangements focusing on more coordinated and integrated forms of care provision.

Integrated care is a concept bringing together inputs, delivery, management and organization of services related to diagnosis, treatment, care, rehabilitation and health promotion. Integration is a means to improve services in relation to access, quality, user satisfaction and efficiency. Integrated care may be seen as a response to the fragmented delivery of health and social services being an acknowledged problem in many health systems.

Integrated health systems are considered part of the solution to the challenge of sustaining healthcare system. Integrating systems to share medical histories, create interdisciplinary medical teams, and update doctors on the latest medical research findings, could trim healthcare costs while improving patient care.

In the full implementation of an online clinical information system, the doctor can not only call up test results—which have much less likelihood of getting lost—but also obtain practice guidelines that explain what should be done for a patient with a certain diagnosis. We need systems to ensure that healthcare providers are delivering the best care at the lowest possible cost.


Medical Device Buzzwords 2016 – HIPAA

hipaa-cloudThe Health Insurance Portability and Accountability Act (HIPPA) was enacted by the United States Congress and signed by President Bill Clinton in 1996. It has been known as the Kennedy–Kassebaum Act or Kassebaum–Kennedy Act after two of its leading sponsors.

Title I of HIPAA protects health insurance coverage for workers and their families when they change or lose their jobs.

Title II of HIPAA, known as the Administrative Simplification (AS) provisions, requires the establishment of national standards for electronic health care transactions and national identifiers for providers, health insurance plans, and employers.

The intent of this Act is to protect clients, reduce fraud, improve quality of health care, and set strict standards for how private information about clients is transmitted (the widespread use of electronic data transmissions made things faster but is considered risky). The purpose of HIPAA is that information must be protected for privacy and security.

In earlier days, patient charts were kept in file cabinets or record rooms. Ideally, only those with a need to see those records were allowed access. Today, thanks to the information revolution, all patient information finds its way into data files. Without high levels of security, confidential patient information could easily find its way into the wrong hands.

With regard to patient confidentiality, the general idea is really simple: Those who do not need to know should not be told. Patients in the waiting room do not need to know anything about another patient.

New medical privacy rules meant to protect our health records.