Asian Hospital & Healthcare Management - Issue 43

I S S U E 43

2019

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The Science of Healthcare Delivery Asia’s Healthcare Goes Digital

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Foreword Virtual Hospitals The next wave?

Imagine a scenario where the multi-specialty hospitals worry less about patient walk-ins and focus more on offering clinical healthcare from a distance. Here, doctors and patients are not bound by the physical walls, as hospitals make better use of digital technologies for providing virtual healthcare to patients. No, we’re not talking about an imaginary world or living in illusion. Virtual hospitals or virtual care is not a new phenomenon. While telemedicine enables care providers and patients to stay well-connected, virtual hospitals build a telemedicine network to offer wide range of services such as medical checkups, remote monitoring or in-patient health assessment, all from a centralised source.

There are several examples of healthcare institutions in the US leveraging telemedicine to offer virtual care to their patients. Many hospitals in the US run programmes to develop or launch virtual care centres with the primary objective of offering better care to patients beyond the hospital boundaries, and thus bringing down the cost and reducing length of stay at the hospital. A study by Persistence market research indicates virtual care market could probably cross US$13 billion by 2026, at a staggering 26 per cent CAGR from US$2billion in 2018. North America leads this market in terms of adoption, followed by the European countries together contributing to more than 50 per cent of this growth. The Asia-Pacific region is up for a significant expansion in the virtual care market contributing to market growth.

Increasing demand for quicker access to care, massive availability of connected devices,

and hospitals augmenting their investments in modernising healthcare systems based on advanced technologies contribute to the growth of virtual care. Healthcare organisations and hospitals alike are partnering with companies providing the necessary technology solutions to offer virtual care. This partnership model presents healthcare organisation with a strategic advantage, enabling them to streamline their operations and deliver effective and enhanced care in the long-run.

Adoption of virtual care doesn’t mean hospitals may move away from in-person visits. It is about increasing the availability of healthcare specialists and expert systems, thus widening the reach and offering convenience and cost-effective care to patients. The cover story of this issue delves into the trending topic ‘Virtual health’. In this article, the author describes how powerful the combination of experienced medical professionals and modern expert systems is in providing better care to patients. The author believes that virtual hospitals will lead to a significant transformation in the healthcare industry albeit with improved focus on increased reliability in the diagnosis and treatment methodologies and thus offering high-quality care to patients.

Prasanthi Sadhu

Editor

CONTENTS

COVER STORY

HEALTHCARE MANAGEMENT

06 The Science of Healthcare Delivery Gurrit Sethi, Strategic Advisor, Global Health Initiatives, Global Strategic Analysis

10 Improving Care Management R B Smarta, Managing Director, Interlink Marketing Consultancy Pvt. Ltd.

MEDICAL SCIENCES 20 Clinical Breast Examination Daisy Veitch, Managing Director, SHARP Dummies Pty Ltd.

TECHNOLOGY, EQUIPMENT & DEVICES 24 Current Scenario of Regulation and Monitoring of Medical Devices in Global Realms of World United States, Europe, Japan, China and India

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THE COMING AGE OF VIRTUAL HOSPITALS Prasad Kompalli, CEO, mfine

Vivek Dave, Sachdev Yadav, Bhawna Gulati, Nikita Gupta, Rakesh Yadav Department of Pharmacy, Banasthali Vidyapith

FACILITIES & OPERATIONS MANAGEMENT

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36 The Breath of Life Jeff Thompson, CEO Emeritus Pediatrician, Gundersen Health System

INFORMATION TECHNOLOGY 40 Asia’s Healthcare Goes Digital Nalin Amunugama, General Manager, BOGE Kompressoren Asia Pacific

45 Transformation of Healthcare How technology redefines one of the oldest industries in the world Natalia Kukushkina, Marketing Manager, Dashbouquet Development

48 Transforming to Digital Krishnan Rajagopalan, Chief Growth Officer, Navitas Life Sciences TAKE Solutions Enterprises

53 Future of Healthcare Work in Southeast Asia Eric Dadoun, Chief Commercial Officer, Silverstreet

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SPECIAL FEATURES 18 Research Insights 35 Techno Trends 60 Books

Advisory Board

EDITOR Prasanthi Sadhu EDITORIAL TEAM Debi Jones Grace Jones ART DIRECTOR M Abdul Hannan PRODUCT MANAGER Jeff Kenney

Pradeep Chowbey Chairman Minimal Access, Metabolic and Bariatric Surgery Centre Sir Ganga Ram Hospital, India

SENIOR PRODUCT ASSOCIATES Peter Thomas David Nelson Susanne Vincent PRODUCT ASSOCIATES Austin Paul John Milton CIRCULATION TEAM Naveen M Sam Smith

David A Shore Adjunct Professor, Organizational Development Business School, University of Monterrey, Mexico

SUBSCRIPTIONS IN-CHARGE Vijay Kumar Gaddam HEAD-OPERATIONS S V Nageswara Rao

Gabe Rijpma Sr. Director Health & Social Services for Asia Microsoft, New Zealand

Peter Gross Chair, Board of Managers HackensackAlliance ACO, USA

Malcom J Underwood Chief, Division of Cardiothoracic Surgery, Department of Surgery, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong

John E Adler Professor Neurosurgery and Director Radiosurgery and Stereotactic Surgery Stanford University School of Medicine, USA

In Association with

A member of Confederation of Indian Industry

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HEALTHCARE MANAGEMENT

The Science of Healthcare Delivery The Science of Healthcare Delivery can spiral the ecosystem to elevate the health index of citizens, ensuring lower spend on curative. This science has the ability to transcend the challenges through the supplication of basic needs through the layers of the pyramid of the existing systems, also sideways to help better the generic civic amenities available to the community leading to healthy living.

Gurrit Sethi, Strategic Advisor Global Health Initiatives, Global Strategic Analysis

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good start is half-done, but half-done has still a long way to go. And that is the state of our healthcare services today in India, as also in our neighbouring countries from whatever little I know about it through friends working there and other interactions, the condition is the same in well developed countries like the U.S. In some places there is too much healthcare but then there are places that are ignored. As a healthcare worker, I am the competitive image of my institution in the bigger cities, driven by numbers, driving the numbers, every now and then checking what brings more patients to us. If I were to set up business, I would choose the convenience of a bigger city. Most of us have faced the challenges of scarcity of resources in the tier 2 and tier 3 townships and would like to stay away.

On the other hand, as an urban citizen, I am spoilt for choices going

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over opinions and rankings, and when I am travelling to the rural towns and villages, I am left wondering what if I need medical services and how do these people survive without a doctor close by? And then there are common challenges across the globe that one hears of: availability, and quality. Can we deploy the science of healthcare delivery to transcend these challenges and to create a homogeneity in availability and quality of healthcare services?

As a citizen and a healthcare worker, I am focused on the basic civic amenities for upping the public health metrics. Here is where the science of healthcare delivery can be applied and expanded. While hospitals and clinics support the curative side of health problems, this science can also be applied to the more preventive side.

Ensuring clean and sanitised living places reduces the health burden faced by the delivery mechanism. Here are

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some examples: can I drink water from outlets without worrying about its cleanliness? Can I walk around without worrying about the mosquitoes? The list could be endless! So, let’s look at the delivery side of healthcare.

I wonder how seriously this science is taken in our medical ecosystem today. Is there a method to the madness we can follow? We need to answer questions such as how regulations ensure quality, how the spread of services are monitored and initiated,

how we can ensure there is enough skilled manpower and other resources, how the overall ecosystem is tying into the needs of the population, how far do I need to travel for secondary, tertiary and quaternary care facilities, are medicines available for me?

The science of healthcare delivery at the macro level can create the medical ecology required to service the community, support the environment with policy, and regulations. A the micro level it can help institutions

in overcoming various challenges by pulling together required resources, focusing on optimal utility in innovative technology, and methodology.

The macro level focus required to bring newer techniques and better penetration of facilities to the inner etches of the rural areas. And this in turn can fuel the micro level growth, by enabling a healthy incubation of individual institutions offering quality care and self-sustaining public health institutions. Self-sustenance is critical

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to fuel investment for basic provision as well as betterment of the overall quality curative and preventive vehicles of healthcare delivery.

Altogether, Public-Private Partnerships (PPPs) starting at the individual grass root entities and going global can add to the general pool of ideas and practices. In other countries, different health systems have learned concepts that can be cross-pollinated. While the west continues to learn from its own experiences, the developing world stands to gain by evolving good practices that it can connect and contribute for global gains. Especially given that key challenges across the world remain same: increasing chronic lifestylebased diseases like diabetes and cardiac ailments, related kidney diseases, mental health, drug abuse and women and child health, to name a few.

Having operationalised few of these concepts myself, I am examine some factors that I think are critical to the adoption of this science as we create the local ecosystem below.

1. The first is to enable scientific growth of the individual institutions within the local ecosystems with a focus on how these are built and managed to deliver quality care. The policy and regulations are critical to driving and monitoring progress. There is a need for continual evolution of this framework to drive innovation in technique and methodology. The cost vs value will also help in moving in the right direction, which is important for both free medical care provided by governmental institutions as well as private institutions as they drive a large spend from consumers’ pockets.

2. Digital enablement, the second factor, can immensely fuel the science of healthcare delivery in a direction of value and scale from a micro level to the macro. This holds the key to overcoming various challenges, be these geographical outreach where some basic provision of services can be enabled making use of the internet,

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The science of healthcare delivery at the macro level can create the medical ecology required to service the community, support the environment with policy, and regulations.

or enabling an analytical course where the individual experiences can be strung together to create clinical value for better treatment pathways, ease of access and delivery through digitised platforms for availability of goods and services etc.

3. The third would be to look to develop the skills required to run the various delivery organisations. India is perhaps the largest exporter of skilled manpower, especially in the medical arena. The sad truth here is we do not have enough of it for ourselves. There are numerous medical colleges and nursing colleges and other technical training institutes. Can we create more robust training programmes that make the manpower skilling more useful as they step into the real world? The Indian government has done a beautiful job at creating and initiating the Asha healthcare workers across rural India.

But more is required. Can we make it mandatory for all medical and nursing educational institutions to have the passouts work in rural government healthcare centres for 2 years, much like the Singaporean mandate for their youth serving the army.

4. The fourth aspect of this science would be to look at the support system of the healthcare delivery ecosystem

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of how we ensure the supplies such as equipment at a good value, drugs and consumables which are good quality and at an affordable cost, real estate etc.

In short, to say the overall infra is built to help the caregivers thrive. The cost of real estate and critical instruments often drive many care delivery concepts. The better we get at managing these and co-creating healthy partnerships, the better the care. For example, there are many primary care concepts that have failed or seen hampered growth owing to high cost of real estate in many parts of our country.

5. The fifth aspect would be to enable continuous improvement in care delivery. With the ball rolling on the basic delivery aspects, how do we enable research and hunt for better clinical care through the advent of new medications, new techniques etc.

All of the above are from the perspective of the environment to support incubation and sustenance of institutions. At the level of the institution itself, how these varying facets are brought together would defines how well it thrives. Being a manpower- as well as resource-intensive mechanism, it is critical to deploy costefficient techniques of delivery without compromising on the quality. Digital innovations today are changing the face of the healthcare delivery. Improved and upgraded equipment calls for more efficient treatment possibilities so also for pharmaceuticals.

In short, we cannot undermine that the macro initiatives ultimately help drive the micro level developments.

Thus we need to stress on furthering the science of healthcare delivery.

While the government bodies are expected to drive this, nongovernmental institutions can well be the co-drivers in helping shape this through lobbying. In India we do have many such institutions such as FICCI, Niti Aayog, CII etc. There are numerous successful models of PPPs fostered by the Indian state governments. The

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Gujarat government set up PPPs with the pharmaceutical players creating a bionetwork for care and research institutions almost 30 years ago; in the recent past the Orissa government has instituted PPPs in 20 districts for provision of care. And there are many more examples. And of course there is WHO and other such institutions driving the global to local concepts.

The cumulative health direction of the communities— national and international— can well be defined by how the delivery and support institutions come together. After all, while they have been at it for years, there are still miles to go before we sleep.

AUTHOR BIO Gurrit K Sethi, Strategic Advisor for Global Health Services, Global Strategic Analysis, contributes to healthcare by helping providers build and better business efficiencies and concept development, also strives to contribute socially through the Swiss Foundation, Global Challenges Forum, through conception of sustainable health initiatives. She started her career from the shop floor working her way up to lead and set up different healthcare businesses. In her words, her significant achievements have been in bringing to life different SMEs and SBUs signifying a change in the Indian healthcare scenarios, as the opportunity paved the way along the healthcare growth curve in the country.

With over 18 years in healthcare under her belt, across different healthcare verticals, she has carried transformational changes in the projects she has led, four of those being early stage start-ups. Gurrit is an avid traveller and voracious reader of varied genres, attributes which she says, provide her with incisive insights about people and systems and what drives them.

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IMPROVING CARE MANAGEMENT With a clear vision to deliver the qualitative CARE characterised with availability, accessibility, and affordability parameters, now, the industry is looking at How to adapt to the changing needs of patients and remain fiscally stable? The industry is transforming strategically from volume to value based services.

The program centric and physician centric approach is getting shifted to Patient centric approach which will help to create a relation among practitioners, patients, and their families to align decisions with patient wants, needs, and preferences.

To enable on-demand interaction, IT and AI technologies are looking into improving the experience of patients.

R B Smarta, Managing Director, Interlink Marketing Consultancy Pvt. Ltd.

H

ealthcare administrators are responsible for the overall management of a hospital, starting from managing finances and handling the daily operations. Here, the priorities keep on changing constantly.

Improving Care management would help hospitals to improve their financial performance if they strengthen customer loyalty, build reputation and brand, and boost utilisation of hospital services through increased referrals to family and friends. Research has shown that hospitals with excellent Hospital Consumer Assessment of Healthcare

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Providers and Systems (HCAHPS) patient ratings have a net margin of 4.7 per cent, on average, as compared to just 1.8 per cent of hospital with low ratings.

Today, the consumer has to spend out of pocket expenses on healthcare; hence he is seeking value during health purchases. In this context, value is the cost relationship between expense and quality, which most healthcare consumers equate with service and positive experience. Hospitals that respond to this are poised to thrive in this era of healthcare consumerism.

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Quality Metric Parameters in Healthcare System

The most important factors that hospitals need to consider are based on quality metrics. Measuring the factors contributing to quality metrics helps in addressing the gaps in the care system.

Those gaps can directly assist lay systems and processes in order. Taking this into consideration, the quality metrics include: 1. Patient safety 2. Treatment effectiveness 3. Patient centricity 4. Timeliness

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5. Efficiency 6. Equity measures Patient safety intends to elude harmful factors from the care system.

It can be calculated considering the patient mortality rate segmented by type of illness and treatment provided.

Further more, it can also be measured by calculating the percentage of successful and failed surgeries with complications and postoperative infections or by rate of disease recurrence during hospital stay.

Effectiveness can be calculated based on the percentage of patient

referrals the hospital receives for specific health conditions like stroke, pneumonia, organ replacement, or prevention of surgical infection.

Patient centricity can be studied from the patient’s journey starting from admission and the care that they receive from the hospital till they get discharged. Also, the provision of care instruction during discharge can be measured in certain health cases.

Timeline measure is directly the timeliness of care and service that is provided by the staff of the hospitals.

Efficiency measure is dependent on utilisation of hospital services which can be measured by studying hospital discharge rate.

Equity measure is dependent on hospital’s capacity to provide quality of care and the facilities provided.

It depends on certification of the hospital, use of advanced technologies, percentage of physicians, physician to patient ratio, nurse to patient ratio, no. of beds and types of services provided at the hospital.

Access to health services is defined by availability of Healthcare

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Patient safety

Equity measures

Treatment effectiveness

QUALITY METRICS Patient centricity

Efficiency

Timeliness

Future of CARE Management

Figure 1 Parameters of quality metrics

Professionals (HCPs), ease of admission into the hospital and a healthcare provider with whom the patient can communicate comfortably. There are various barriers that impact health services, including high cost of care, inadequate or no insurance coverage, lack of availability of services, lack of culturally competent care. Improving healthcare services includes accessibility to advance healthcare services and use of evidence-based preventive services.

Clinical preventive services promote the effectiveness of a hospital by promoting the prevention of illness with healthy behaviours, creating awareness amongst society, and identifying risk factors, especially for lifestyle diseases before occurrence of illness.

This includes screening for hyperten-

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Health Records (EHR) interoperability is one of the methods to address the care gap that exists among healthcare providers. Recently a report “Closing Gaps in Care through Health Data Exchange” figured out that “HCPs are incapable of efficiently recognising patient needs according to evidence-based guidelines in a timely manner.”

Given the challenges that range from rising malpractice costs to physician turnover, medical practices must maximise resources and remain profitable. Satisfied patients are easier and more rewarding to care for, they also employ less physician and staff time and are more compliant. If we think strategically then reducing the length of patients’ visits and wait time can reduce treatment costs and increase patient volume. In addition, many hospitals are also realising the need of building financially sound operating models to face diminishing margins due to price controls on drugs, consumables, and medical devices.

sion, diabetes, or colorectal cancer. In addition to primary healthcare and preventive services, emergency medical services are also essential. This is the field where Uber is tweeting in.

A noteworthy development has been observed in recent years which has made emergency medical services accessible.

Challenges in Improvising Healthcare Services

Creating an appropriate management team for quality improvement and ensuring that they have the right tools to support them is critical and essential.

Identifying the gaps in care and then implementing strategies to overcome it with proper tracking system is a need of today’s care management. Electronic

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In 1960 airports deployed new traffic control systems that allowed them to changeover from scheduling a few hundred flights to managing thousands in a day, with improved safety and efficiency in the process.

For healthcare, 2018 was the period of transformation because of digitisation across the industry. Medium and large size hospitals are implementing their own NASA-style command centres designed in a way to serve as a central mission control across the hospital’s functions and services. The objective is to address the questions of capacity, safety, quality, and wait-time issues that have afflicted the system.

Digital healthcare innovations play a major role in providing primary healthcare by means of mobile health, wireless health, connected health, etc.

Technology is providing a way forward to tackle the increasing demand of

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qualitative care with better diagnostic tools and customised therapeutics.

Three developments are providing healthcare organisations insights from countless data sources: Cognitive computing: In the era of digitisation and big data, cognitive computing in healthcare is bridging the gap between care providers and patients. It is turning the enormous scattered fragmented healthcare data into insights that convey the need of personalised medicine. In simple terms, cognitive computing, inclusive of machine learning, neural networks, deep learning, etc. is a set of common techniques to deal with plethora of fragmented data.

Cloud-interfaced interoperable EHRs: Interoperable EHRs associated with artificial intelligence (AI) will enable us to improvise processes and efficient decision making that will boost quality.

Medical interoperability: Interoperability is an ornate word for the ability of healthcare technology in the field of IT systems and software applications to enable communication, exchange of data, and use the information to communicate and share data across wide area. The main objective of medical interoperability is to ensure that doctors, surgeons, and other medical providers have the information on fingertips that they need in order to provide appropriate care.

With rising awareness of data management and EHRs, healthcare organisations have different EHR platforms. One can imagine how tedious it would be to connect the data to provide efficient care. It was observed from a research that: • 36 per cent of medical record administrators reported that they have EHR interoperability issues when they exchange patient health records with other providers.

Improving Care management would help hospitals to improve their financial performance if they strengthen customer loyalty, build eputation and brand, and boost utilisation of hospital services through increased referrals to family and friends.

• 25 per cent of charted physicians indicated that they still cannot exploit meaningful patient information received electronically from external sources as shared data is in silos.

Looking ahead, medical interoperability can provide healthcare organisations certain tools or initiatives as they work toward improved interoperability options.

Internet of Things (IoT): Development of the IoT in healthcare, also known as Internet of Medical Things (IoMT), is a boon to remote areas where availability and accessibility is an issue. It has enabled systems

to furnish services that will provide clinical monitoring, chronic disease management, preventive care, and fitness monitoring. It is characterised by cost advantage, improved efficiency, and bridging the gap and focusing on quality patient care.

Two factors can be considered while promoting quality in health systems. In a developing nation like India, optimisation of resources and expanding the services to enable availability, accessibility, and affordability is essential; whereas in developed nations where health systems are already streamlined, maintaining the quality standards of healthcare delivery internally and between healthcare systems is crucial.

Application of lean management systems in healthcare leads to improving efficiency, customer and employee satisfaction. It also helps to analyse the gaps and to assess the suitability of other activities that add customer value in an optimal way.

This leads to the development of efficient and effective practices with patient-centric mindset.

References: https://ehrintelligence.com/news/4-key-areasto-watch-in-healthcare-interoperability https://rockhealth.com/reports/predictiveanalytics/ https://www.who.int/management/quality/ assurance/QualityCare_B.Def.pdf

AUTHOR BIO R B Smarta has designed management agendas for profitable growth, relevant expansion, launching new concepts, ideas and projects for National and Global clients in Pharmaceuticals, Nutraceuticals and Wellness. Being in the industry for more than 4 decades & in consulting as a pioneer for 3 decades, he has a perfect blend of industry and consulting best practices. He has added value and impact on performance of wide variety of clients, inclusive of start-ups to national and multinational corporate. His firm Interlink has created valuable insights and depth of knowledge in its knowledge bank, along with its consultants and associates.

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COVER STORY

THE COMING AGE OF VIRTUAL HOSPITALS Hospitals are on their way to getting transformed. Hospitals will now have new access, and interaction paradigms at the outset and way better quality and reliability in the methods of diagnosis and treatment. It will be a powerful combination of experienced doctors and expert systems. The central piece of visiting a hospital is consultation and counselling with the doctor. Here is where the biggest paradigm shift is happening. Just as the illness doesn't take an appointment, care shouldn't ask for one. The Internet has shown us, in industry after industry, how distance and time boundaries can be completely removed. We can aggregate the availability in a powerful way to make on-demand access to the doctor a reality. We can completely get rid of the entire ordeal of appointments, travelling and waiting. This is just not an urban convenience use case, on-demand is the natural way to deliver care for millions of urban and rural populations.

Prasad Kompalli, CEO, mfine

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ecently, we had the opportunity to listen to a very senior paediatrician in Bangalore, India talk about the kind of technologies which will empower clinicians. It was inspiring to see an expert with such a vast experience talk about technology that's needed to make his diagnosis more objective and to improve patient care.

We were able to discuss and conceive very concrete solutions in the space of respiratory medicine with his inputs and the studies he has done for several years. For example, a combination

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of sound and image processing can decisively make respiratory disease detection, management, and treatment very simple, standard and scalable.

It will avoid millions of unnecessary hospitalisations and save tens of thousands of lives. It takes great humility and a bold vision of the future for as successful a doctor as him to think about how to make medical judgments more objective, data-driven, and scalable. Being continuously in touch with doctors and hospitals as part of our venture, we have been fortunate

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enough to have met not just one but many such doctors in the last two years.

The vision of a new-age healthcare delivery is emerging very clearly in discussions with many such very respectable and accomplished doctors.

We will probably still call that a hospital. However, it will be completely transformed and will have new access, and interaction paradigms at the outset and way better quality and reliability in the methods of diagnosis and treatment.

It will be a powerful combination of experienced doctors and expert systems.

HEALTHCARE MANAGEMENT

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Data (Collecting Vitals, History and Doctor Notes)

A lot of data can now flow from personal devices. There are, of course, often used examples of watches, wristbands etc. But we see a future where the dozen odd sensors in your phone, the camera and the microphone, combined with algorithms that process and learn from those data signals— are just enough to get to a diagnosis with a high degree of accuracy. There it is, the first step of the process that happens in any hospital today, vitals collection, moved and brought into one's own hand, literally. Mobile tech has made computer interaction less esoteric and more humane. Chat/ Video, data tagging, note taking, document sharing is all now made so easy, simple, intuitive both for the doctors and users. You have to show a rash to the doctor? High definition images that you can tag and add notes along, is now possible, without any

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training requirements for the sender or the receiver. Machine learning is applied to auto-tag suspected cause of that rash by the time doctor looks at it and proceeds to confirm.

On-demand (Doctor Appointments)

The central piece of visiting a hospital is consultation and counselling with the doctor. Here is where the biggest paradigm shift is happening. Just as the illness doesn't take an appointment, care shouldn't ask for one. We can aggregate the availability in a powerful way to make on-demand access to the doctor a reality. We can completely get rid of the entire ordeal of appointments, traveling and waiting. This is just not an urban convenience use case, on-demand is the natural way to deliver care for millions of urban and rural populations.

It's quite possible to do this with technology that aggregates doctors' availability and makes their time more efficient and effective. Ironically enough,

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removal of current appointment system can actually bring more predictability into the entire hospital visit process. A real-time triaging can actually determine who needs a physical examination, who needs doctor consultation, whose case is a simple follow-up, whose is a regular check-up etc. Knowing this and routing appropriately makes the entire process seamless, bringing in new levels of consumer experience and doctor efficiency. Thorough triaging (increasingly by machine, as the algorithms are becoming sophisticated) will happen for every case so that time of the patients and the doctors are effectively used. The end result being on-demand healthcare experience for the patient and massive improvement of reach and efficiency of doctors.

Health Information (Files and Bundles of Paper)

There is really no better alternative to carrying your health records in your

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hand. Consumers need to have access and portability from one hospital to another, one doctor to another. Without solving for consumer ownership and portability, EHR solutions cannot give any meaningful impact to people or providers. In the past, the problem was that, consumers never had so much storage capacity and analysis software in their control until the smartphone era. But now, it makes so much more sense that you just keep all your records in your personal storage—on the cloud and on the phone—and never lose it.

You have the ownership and ability to authorise doctors to see the records as required.

Quality (Intuition and Experience)

We asked a hospital owner, who is also a doctor, a few simple questions: • How do we build a high-quality hospital?

The answer came almost instantly, "We just have to build it at the right place and get some good doctors.”

• So, how do you make good doctors come to you beyond monetary incentives?

The answer this time pretty soon shifted to tertiary care. We were told that equipment, latest and great tech in both diagnostics and procedure equipment, etc. will be the deal breaker.

Most such conversations are similar.

Primary and secondary care, which is the first point of contact for the patient with the doctors, is almost never, top of mind.

The future will be different, though.

More and more decision support, thorough data collection and evidencebased medicine are all becoming important aspects of the doctors' job.

A good doctor can become a great one with these decision support systems.

High levels of quality can be achieved in replicable and scalable ways with the combination of Super Doctors and Assistive Intelligence of the machines.

Particularly in primary and secondary care—which are so much about early detection, prevention, management of the health and disease—quality will become objective and measurable.

Things such as usage of antibiotics to prescriptions of diagnostics tests etc., can all be standardised, and the protocols can be codified to make

operations transparent for the user and effective for the doctor.

More than what a Hospital can do Today

Hospitals of the future will be equally present in virtual and physical channels.

Care will be continuous across points of access and more and more tools and data will be handed over to patients to be able to manage their health and connect to doctor wherever and whenever needed.

Hospitals that we talk to are realising that the business model of building a large facility somewhere and waiting for patients to be extremely sick needing tertiary care is less relevant for the future. There is more meaningful opportunity and scalability to managing consumers health rather than sickness.

Big x00 bedded hospitals are needed but they will be much more efficiently managed with no utilisation pressure.

The hospital of the future will shift to offer healthcare as an Over-The-AirService and have a stake in keeping their subscribers healthy rather than just wait for their sickness and react with treatment.

AUTHOR BIO

Prasad Kompalli, CEO at mfine, Best known for his leadership role at Myntra, India's largest e-commerce store for fashion and lifestyle products, Prasad has built and lead large teams from ground-up, in a career spanning more than 20 years. As the Chief Business Officer of Myntra, Prasad led its growth from being a small ecommerce company to become the largest fashion destination in India, with a revenue nearing 1B. mfine is Prasad’s second entrepreneurial venture, prior to which, he was the cofounder of Indus Bionics - an ambitious attempt to build indigenous low-cost cochlear implants.

Prasad is a big believer in tech-lead transformation of societies and strives to create positive impact for consumers, especially in India, with technology.

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Research Insights Predicting survival from colorectal cancer histology slides using deep learning: A retrospective multicenter study AUHTORS: Jakob Nikolas Kather , Johannes Krisam, Pornpimol Charoentong, Tom Luedde, Esther Herpel, Cleo-Aron Weis, Timo Gaiser, Alexander Marx, Nektarios A. Valous, Dyke Ferber, Lina Jansen, Constantino Carlos Reyes-Aldasoro, Inka Zörnig, Dirk Jäger, Hermann Brenner, Jenny Chang-Claude, Michael Hoffmeister, Niels Halama ABSTRACT BACKGROUND For virtually every patient with colorectal cancer (CRC), hematoxylin–eosin (HE)–stained tissue slides are available. These images contain quantitative information, which is not routinely used to objectively extract prognostic biomarkers. In the present study, we investigated whether deep convolutional neural networks (CNNs) can extract prognosticators directly from these widely available images.

METHODS AND FINDINGS We hand-delineated single-tissue regions in 86 CRC tissue slides, yielding more than 100,000 HE image patches, and used these to train a CNN by transfer learning, reaching a nine-class accuracy of >94% in an independent data set of 7,180 images from 25 CRC patients. With this tool, we performed automated tissue decomposition of representative multitissue HE images from 862 HE slides in 500 stage I–IV CRC patients in the The Cancer Genome Atlas (TCGA) cohort, a large international multicenter collection of CRC tissue. Based on the output neuron activations in the CNN, we calculated a “deep stroma score,” which was an independent prognostic factor for overall survival (OS) in a multivariable Cox proportional hazard model (hazard ratio [HR] with 95% confidence interval [CI]: 1.99 [1.27–3.12], p = 0.0028), while in the same cohort, manual quantification of stromal areas and a gene expression signature of cancer-associated fibroblasts (CAFs) were only prognostic in specific tumor stages. We validated these findings in an independent cohort of 409 stage I–IV CRC patients from the “Darmkrebs: Chancen der Verhütung durch Screening” (DACHS) study who were recruited between 2003 and 2007 in multiple institutions in Germany.

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Again, the score was an independent prognostic factor for OS (HR 1.63 [1.14–2.33], p = 0.008), CRC-specific OS (HR 2.29 [1.5–3.48], p = 0.0004), and relapse-free survival (RFS; HR 1.92 [1.34–2.76], p = 0.0004). A prospective validation is required before this biomarker can be implemented in clinical workflows.

CONCLUSIONS In our retrospective study, we show that a CNN can assess the human tumor microenvironment and predict prognosis directly from histopathological images.

Citation: Kather JN, Krisam J, Charoentong P, Luedde T, Herpel E, Weis C-A, et al. (2019) Predicting survival from colorectal cancer histology slides using deep learning: A retrospective multicenter study. PLoS Med 16(1): e1002730. https://doi. org/10.1371/journal.pmed.1002730 Academic Editor: Atul J. Butte, University of California San Francisco, UNITED STATES Received: May 23, 2018; Accepted: December 17, 2018; Published: January 24, 2019 Copyright: © 2019 Kather et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Data Availability: All data and source codes are publicly available under the following URLs: http://dx.doi.org/10.5281/ zenodo.1214456, http://dx.doi.org/10.5281/ zenodo.1420524, http://dx.doi.org/10.5281/ zenodo.1471616 Competing interests: The authors have declared that no competing interests exist.

Deep learning for lung cancer prognostication: A retrospective multi-cohort radiomics study AUHTORS: Ahmed Hosny, Chintan Parmar, Thibaud P. Coroller, Patrick Grossmann, Roman Zeleznik, Avnish Kumar, Johan Bussink, Robert J. Gillies, Raymond H. Mak, Hugo J. W. L. Aerts ABSTRACT

tion towards predictions and highlighted the importance of tumor-surrounding tissue in patient stratification. We also present preliminary findings on the biological basis of the captured phenotypes as being linked to cell cycle and transcriptional processes. Limitations include the retrospective nature of this study as well as the opaque black box nature of deep learning networks.

BACKGROUND Non-small-cell lung cancer (NSCLC) patients often demonstrate varying clinical courses and outcomes, even within the same tumor stage. This study explores deep learning applications in medical imaging allowing for the automated quantification of radiographic characteristics and potentially improving patient stratification.

CONCLUSIONS Our results provide evidence that deep learning networks may be used for mortality risk stratification based on standard-of-care CT images from NSCLC patients. This evidence motivates future research into better deciphering the clinical and biological basis of deep learning networks as well as validation in prospective data.

METHODS AND FINDINGS We performed an integrative analysis on 7 independent datasets across 5 institutions totaling 1,194 NSCLC patients (age median = 68.3 years [range 32.5–93.3], survival median = 1.7 years [range 0.0–11.7]). Using external validation in computed tomography (CT) data, we identified prognostic signatures using a 3D convolutional neural network (CNN) for patients treated with radiotherapy (n = 771, age median = 68.0 years [range 32.5–93.3], survival median = 1.3 years [range 0.0–11.7]).

We then employed a transfer learning approach to achieve the same for surgery patients (n = 391, age median = 69.1 years [range 37.2–88.0], survival median = 3.1 years [range 0.0–8.8]). We found that the CNN predictions were significantly associated with 2-year overall survival from the start of respective treatment for radiotherapy (area under the receiver operating characteristic curve [AUC] = 0.70 [95% CI 0.63–0.78], p < 0.001) and surgery (AUC = 0.71 [95% CI 0.60–0.82], p < 0.001) patients. The CNN was also able to significantly stratify patients into low and high mortality risk groups in both the radiotherapy (p < 0.001) and surgery (p = 0.03) datasets. Additionally, the CNN was found to significantly outperform random forest models built on clinical parameters—including age, sex, and tumor node metastasis stage—as well as demonstrate high robustness against test–retest (intraclass correlation coefficient = 0.91) and inter-reader (Spearman’s rank-order correlation = 0.88) variations. To gain a better understanding of the characteristics captured by the CNN, we identified regions with the most contribu-

Citation: Hosny A, Parmar C, Coroller TP, Grossmann P, Zeleznik R, Kumar A, et al. (2018) Deep learning for lung cancer prognostication: A retrospective multi-cohort radiomics study.

PLoS Med 15(11): e1002711. https://doi.org/10.1371/ journal.pmed.1002711 Academic Editor: Atul J. Butte, University of California San Francisco, UNITED STATES Received: March 29, 2018; Accepted: November 5, 2018; Published: November 30, 2018 Copyright: © 2018 Hosny et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Funding: Authors acknowledge financial support from the National Institute of Health (NIH-USA U24CA194354, and NIH-USA U01CA190234); https://grants.nih.gov/funding/index.htm. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. www.asianhhm.com

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MEDICAL SCIENCES

Clinical Breast Examination Clinical Breast Examination is an important tool in the screening and diagnosis of breast cancer. However, training healthcare providers in the confident use of the technique using patients can be problematic and time-consuming. This article gives insight into the design and development of biofidelic (life-like) simulation models which can be used in training to help detect cancer.

Daisy Veitch, Managing Director, SHARP Dummies Pty Ltd.

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linical breast examination is one part of what’s called the ‘triple test’ for breast cancer.

The triple test involves some form of imaging, such as mammography or MRI; biopsy as another arm; and Clinical Breast Examination (CBE).

CBE is used by health professionals such as general practitioners, breast surgeons and breast-care nurses trained to recognise different types of abnormalities in the breast. It involves a visual examination, taking a medical history from the patient and physical examination. This includes palpation of the breast, that is, determining by touch which breast lumps are normal and which are suspicious.

come up negative on the others. If you are one of the 10-20 per cent of women with breast cancer that have a negative to mammography your cancer won't be detected in the mass mammography screening programs, it’s detected in one of the two other ways.

A Comprehensive Approach to Breast Examination is Important

The triple test is important because each of its pillars detect cancer in a different way. Imagine the different pillars as parts of a Venn diagram, all intersecting with each other. A proportion of cancers are only detected by mammography or imaging; a proportion are only detected by breast examination; and a proportion are only detected by biopsy. In the centre where the three circles overlap you have cancers known as triple positives.

Some cancers are detected using all three methods, but some are only detected with one of the methods and

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Although CBE is considered by some to be a bit old-fashioned now because of the modern preference for tests, it's still very important.

While mammography is extremely important—it is very specific and sensitive—people who live in remote

MEDICAL SCIENCES

areas or underdeveloped countries may not have any access to the kinds of imaging equipment used.

Also, palpation sometimes detects ‘interval cancers’ — those that only become noticeable between imaging appointments — so CBE can act as a way you can quickly and easily check for the cancer between appointments of, for example, two years.

The fact is that any way that you can detect breast cancer is a good way and you shouldn't cut off any avenue when you're trying to do this because early detection saves lives. Breast cancer is still the most prevalent cancer in women, and the second most common cancer diagnosed worldwide.

The Right Training is Vital in CBE

Clinical breast examination can be taught using theory, lectures, videos, computer simulations/models, virtual

reality simulators, and commonly what's known as a ‘standardised patient’ or as an ‘intimate examination associate’, a paid actor who agrees to have intimate examinations performed on them. Sometimes synthetic models of breasts are used.

Students can get allocated to a breast clinic for a rotation, but because there are so many rotations to choose from, some students may not have this experience. This means that some students graduate with nothing more than a training session or two from their pre-clinical years.

Much teaching now happens outside of major teaching hospitals and is different to how it used to be. There are sensitivities involved in having a large number of students examining someone who has just been diagnosed with breast cancer. Also, the gap between being diagnosed with breast cancer and

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MEDICAL SCIENCES

going into surgery can be very brief which means patients with different types of breasts and different types of breast disease may not be on hand for the students to examine. Medical students would once have practised on each other but female medical students are not going to volunteer for that, just as the male students wouldn't volunteer for prostate examinations or digital rectal examinations.

The Type of Breast Model Matters

Breast simulation models are used quite frequently in training but there can be pitfalls with them. Sometimes they have finger marks on them that indicate, without the student even touching the breast model, where the lumps are on the breast. Often the model is small and doesn't represent anyone with large breasts – an increasing proportion of the population. The model may not represent breast adiposity (fatty tissue) and there's often no normal nodularity (fibro-glandular tissue). When you actually do a breast examination, you'll feel these tissues inside the breast, and other normal anatomical structures such as the milk ducts and ribs. Often none of those are incorporated in a simulation model, just smooth silicone with a lump inserted, so the lump is quite easy to detect—there are no background structures to confuse, like ribs.

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The Art of Developing and Refining the Models

Real and Simulated Breasts – A Comparison

There is a range of what is ‘normal’ in breasts. Clinician and scientist William Goodson MD, a recognised leader in breast cancer, has said that in terms of the detection of breast cancer, there are two important elements. One is the softness (or hardness) of the breast, called the durity. The other is the nodularity. They were the two aspects that our research has focused on in terms of variation.

We tested each individual element, like fat and how soft the fat was, the feeling of the skin, different bits of nodularity and different pathologies, such as fibroadenoma and cancer. Although there was a large range of softness and of nodularity we tried to focus on only using cases that Adelaide breast surgeon Dr Melissa Bochner said were important for teaching.

Various construction materials were used, mostly silicone, MRI scans, traditional casting and three-dimensional (3D) printing to build models with a lifelike look and feel, that is, they are biofidelic. The models were realistic in anthropometry (size and shape), feel (durity and nodularity) and appearance (skin feel and colouring). Visual biofidelity enhances the perception of feel. The anatomically correct layering of ribs was incorporated, soft adipose tissue, nodularity and additional signs of breast disease, both benign and pathological.

With the first model developed, the components were tested individually and once we were happy with them I went into surgery with Melissa. The patient, who had breast cancer, was having a mastectomy. The surgeons took the removed breast and gave it to me on a tray so I was able to feel it and poke it and build a comparable breast model right next to it. This model is right in the middle of the distribution for softness and is also one of the most commonly occurring breast softness type. That first model was relatively easy to develop. From there, getting the other variations and understanding what caused these variations was much more difficult.

Eventually six multilayered breasts were developed representing a range of normal human variation for durity, nodularity and adiposity. The models had much variation in them to do with either the thickness of the material or the way that they were layered. These models were given to a series of breast surgeons, who were asked to take them into the clinic and feel the breasts of the patients and feel the range of models and say whether they thought the breasts were similar or not for nodularity and softness. More than 80 per cent of the time the surgeons said that they were similar or that they couldn’t tell the difference. The breast models are broadly representative of people. However, the softest model is not as soft as the softest patient so potentially we could add another model as the very softest patient to improve the similarity at that end of the spectrum.

To our knowledge, these novel biofidelic models are the first models to incorporate normal human variability and be validated with real patients. They provide a standardised way of teaching health professionals normal from abnormal. The models are ready to go.

However, they would need durability

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MEDICAL SCIENCES

testing prior to manufacturing and some sort of manufacturing protocol if they were going to be mass produced.

This would require additional funding.

The Field of Medical Design

The World of Anthropometry

One of the tools of the medical designer is anthropometry. Anthropometry is the science of making systematic

Breast cancer is the most prevalent cancer in women, and the second most common cancer diagnosed worldwide.

measurements of the human body and is used in both fashion and medical design. Anthropo means human and metry is measure. Anthropometric measurements involve the size (e.g. height, weight), structure (e.g. neck circumference, shoulder and hip width, waist-to-hip ratio), and composition (e.g. lean body mass and percentage of body fat) of humans. It has been used historically, controversially, to try to link physical with racial and psychological traits, and is now used practically in industrial and clothing design, including for work, and ergonomics.

My involvement in anthropometry began when I conducted a survey in 2002 of the Australian population to see if we could find who was average.

It turned out that there's no such thing as average, in fact everybody is a combination of small, medium and large. For example, you could be average for weight and short, or you could be the same weight but very tall and slim,

AUTHOR BIO

This work into breast simulation models and medical manikins grew from a background in the fashion industry. I began working at the Flinders Medical Centre in Adelaide in 2008 including on a project that involved scanning and quantifying the size of women's breasts for a breast reduction study.

Professor Harry Owen, an anaesthetist who is the Head of Medical Simulation, requested help in developing a breast examination model for the largebreasted person because examining people who have a larger BMI is quite a different proposition requiring different techniques. There werenâ&#x20AC;&#x2122;t any models that represented larger people with larger breasts. A grant was obtained and the research was published in 2011.

That year it won the Ken Provins award for the best paper at the Human Factors Conference in Sydney (HFESA). The keynote speaker was Professor Richard Goossens, who is now my professor in Delft University of Technological Design, in the Netherlands. The university specialises in the crossover between medicine and design, including a section called Medisign.

A medical designer acts as a central hub to bring experts into the room, drawing relevant information from them and translating that into something that is a useful product fit for the purpose of whatever it needs to do.

We have developed lactating manikins, a model with a pleural tap for students to practise the medical procedure involved in draining the fluid out of lungs, and smaller models such as one used for practising suturing.

and so forth. Some body measurements are related to each other. Your height is obviously going to be related quite strongly to things like your shoulder height and your hip height from the ground because leg length is associated with height. But circumferences which are related to weight are independent.

The World Engineering Anthropometry Resource (WEAR) of which I am a co-founder is a group of interested experts involved in the application of anthropometry data for design purposes. The members and partners are from around the globe.

WEAR is a non-profit organisation registered in Europe.

Towards Improved Training

Regardless of the technique of breast examination used, there is a need for standardised training to be introduced across Australia: there is currently no standardisation of methodology or performance evaluation for trainees to test whether they have the right skills or not. The current regime for testing students in South Australia for example, doesnâ&#x20AC;&#x2122;t actually test them for palpation skills in terms of the comprehension involved, that is, did they find a breast lump and was it normal or not?

Further unpublished research we have conducted is developing a test that could potentially be used for GP accreditation. The test gives very specific feedback and results such as: What lesions did they miss? Why did they miss the lesions? Then you could give remediation for that person on the part of the technique that they are missing.

Daisy Veitch is an experienced anthropometrist and expert in body scanning. She holds adjunct academic status at Flinders University, Adelaide. Daisy is a PhD candidate at TU Delft, Industrial Design Engineering, Netherlands researching the development of life-like manikins to train professionals in Clinical Breast Examination aiding early detection of breast cancer. She is a Founding Member of the World Engineering Anthropometric Resource (WEAR).

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CURRENT SCENARIO OF REGULATION AND MONITORING OF MEDICAL DEVICES IN GLOBAL REALMS OF WORLD United States, Europe, Japan, China and India The article focuses monitoring of medical devices throughout the globeâ&#x20AC;&#x201D;the current scenario of regulation and approval of the devices which involve different countries having their respective regulatory bodies, which look after different sets of procedure for their regulation of devices, which are classified in distinct classes on the basis of level of risk.

Vivek Dave, Sachdev Yadav, Bhawna Gulati, Nikita Gupta, Rakesh Yadav Department of Pharmacy, Banasthali Vidyapith

R

equirements for the regulation of development, propagation and approval of medical devices are of great competitive interest, which assures that it should be of good quality, safety and efficacy, in order to protect, improve and monitor public health.

After the development and before the distribution of medical devices into the market, it is supposed to be licensed by respective regulatory authorities across the globe. Since the 1980s, it has been reported that there was an abrupt change in the worldwide regulation of medical devices, as the manufacturers were forced to fulfil the regulatory requirements, documented standards, norms, guidelines, specifications, testing methods for the design, and manufacturing of devices. As a consequence, the figure has shifted from very few to 60-65 countries for the implementation of the regulation.

The Global Harmonization Task Force (GHTF) came into existence in 1993,

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aiming to systematise the medical device regulation across the sphere. It was replaced by International Medical Device Regulatory Forum(IMDRF) in 2011 which was concerned with the future aspects of ‘Harmonized medical device regulation’ which involves number of regulatory authorities of Australia, Brazil, Canada, China, Europe, Japan, Russia, Singapore, South Korea, and US under the supervision of World Health Organization (WHO), 1948.

Medical Devices

According to the Federal Drugs and Cosmetics Act, ‘a device is an instrument, apparatus, implement, machine, contrivance, implant or an in-vitro reagent’ that should encounter three conditions: 1)It should acknowledge the official National Formulary or the US Pharmacopoeia.

2) It should be deliberately used in the diagnosis, cure, alleviation, treatment, and prevention of disease. 3) Lastly, it is intended to be used to alter the structure and functionality of human body. Hence use of medical devices has a number of important roles including: 1) It plays a crucial role in improving, protecting, supporting or sustaining life 2) It assists in diagnosis, prevention, monitoring, cures and mitigates disease or injury, 3) It is widely used in research, substitution, alteration and even in the support of the anatomy and physiology of the human body, 4) It is also employed for control of conception 5) last but not the least, it provides knowledge related to medical aspects by means of in vitro testing of specimens obtained from human body.

It has been estimated that an average of 3-7 years is spent for the approval of medical devices; drugs, on the other hand, take approximately 12 years.

Need for Medical Device Harmonisation

Medical device harmonisation aims to ‘encourage convergence in regulatory

Regulation for the approval of medical devices across the globe is a vital requirement in order to ensure quality, safety, efficacy and performance so that they can be introduced into the market for protecting, preventing, improving, and sustaining public health.

practices related to ensuring the safety, effectiveness, performance and quality of medical devices, promoting technological innovation and facilitating international trade’.

Harmonising medical device is essential because it decreases the time span in marketing of products, cuts the cost required to market a product, enhances the efficacy of government as it facilitates cooperation among regulators and even in organising activities of regulation, improves trading and extent of marketing and raise up the public health protection.

Hence this leads to the increment of safety and efficacy of device, thus, it lifts up the public health and also gains consumer’s faith and confidence. A comparative study of the five regions in aspect of regulation of medical devices is in Table1.

United States

In the US, medical devices come under the cloud of United States of Federal Drug and Administration(USFDA).

If a device is sanctioned by the FDA, it reflects to be safe and effective for the intended purpose, it can thus be legally introduced into the market. It uses the ‘least burdensome approach’, which means that the manufacturers

are supposed to present the only that data which are essential to show the device’s safety and efficacy. The devices are classified into three categories on the basis of level of risk as follows: i. Class I - low risk devices, e.g., gauze and tooth brushes. ii. Class II - moderate risk devices, e.g., suture and needles. iii. Class III- significant risk devices, e.g., pacemakers, implantable defibrillators.

For acceptance of devices in US three regulatory pathways are followed: 1) Pre-market notification(PMN) pathway: PMN is also known as 510(k) clearance process and it comes under the section of medical device amendments of 1976. This pathway is for the regulation of those devices which are classified under class I and some (25 per cent) under class II. It is a submission shown to the FDA for the demonstration of the device’s safety, efficacy and substantially equivalence to predicate device (device which is already available in the market). According to Code of Federal Regulation (Title 21, Section 807), if a device is to be cleared through this pathway then the manufacturer is supposed to present that the device is substantially equivalent to the predicate device. Hence, it does not require any clinical data, so it is less time consuming and less expensive than Pre-Market Approval(PMA). Due to this reason it is also called as fast track approval process. Substantial equivalence does not refer to the similar identity of a new and a predicate device. In fact it means that a new device’s ‘intended use’ and “technological characteristics” should be same to that of the predicate device. The intended use means the primary function of device which further includes its “indication of use” which explains that the device should diagnose or treat the disease or condition which it is intended to.

And for the estimation of technological characteristics the manufacturer is

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Comparative study of the five regions in aspect of regulation of medical devices

Table 1

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supposed to submit a description of design, material of construction, and other technological features of device.

In July 2011, the Institute of Medicine (IoM) reported that the process is only concerned with the substantial equivalence to an existing device and is least bothered about its safety and efficacy. Due to this drawback they recommended the abolishment of the process, which forced the manufacturers to provide prior clinical data to support the clearance but the data is not parallel to that of PMA.

‘De Novo Devices’. This involves clinical trials that further provide data essential for manufacturing, approval and adoption of devices. It requires sufficient clinical data for the approval, therefore, it is the strictest device marketing application than PMN. The PMA submission must include information related to use, manufacturing, reference, and performance standards or voluntary standards, outcomes of all non-clinical and clinical studies. This pathway involves four different stages which contribute to the regulation of

2) Pre-market Approval (PMA) pathway: For the evaluation of a device’s safety and effectiveness, the PMA pathway is followed. It is responsible for the regulation of most (75 per cent) of the class II and the entire for class III devices. It is only applicable to those devices which are non-identical to predicate devices.

Thus, such devices are termed as

Stage 1 Pro-Investigationl Device Exemption (IDE) / Pie-clinical evaluation Manufacture/sponsor meets FDA’s office of device evaluation for the beginning of the process and for the approval of new medical device.

FDA reviews pre clinical trial testing as well as its data and talks about the plan of clinical trial of the device.

Stage 4 Post market surveillance According to Safe Medical Device Act 1990, post marketing surveillance is done of the devices which are introduced into the market.

It is done in order to establish the benefits and adverse effect aiming to enhance the quality, safety, efficacy and performance of the device.

It aims on improving the probability of IDE(Investigational Device Exemption) application approval.

PMA

The medical device reporting regulation, reports the adverse event caused by the device to FDA. Later healthcare professionals, Stage 3 manufacturer and patient PMA Submission were also motivated to report device related adverse event to FDA PMA application is prepared by sponsor Med Watch program. and submitted to FDA.

Stage 2 IDE/Clinical testing IDE application is filed after the preclinical trial.

The FDA reviews, is the device is initially suitable for clinical trial and also weather sufficient pre clinical data is produced to support PMA process.

IDE application include- intended use of dexice, preclinical data and clinical trial protocol.

The application include IDE clinical trial analysis data, trade name of the device, owner’s registration number, device’s classification, labeling, intended use, direction of use, declaration of disclosure and other requested information as per CPR Title 21, Section 807.78.

Figure 1 Different stages of PMA pathway

The application is reviewed within 12 month and is further supervised by medical device advisory panel which constitute of physician, scientist, patient, industry and representative who suggest on the medical device approval and on the requirement of additional data.

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Comparision between PMN [510(k)], PMA and HDE S No.

PMN [510(k)]

PMA

HDE

1.

It includes regulation of medical devices of classes I and some (25%) of class II

It includes regulation of medical devices of (75%) class II and class III

It includes regulation of HUD (humanitarian use devices) which are also known as orphan devices

2.

Substantially equivalence to predicate devices are required

Safety and effectiveness of new devices are required

Safety and benefit of devices are required.

3.

Comparison to predicate devices are essential hence no need of clinical data

Scientific evidences are essential (clinical and non-clinical data)

Scientific evidences are essential (clinical and non-clinical data)

4.

Its standard fee is $5,228 hence, comparatively cheaper

Its standard fee is $261,288 hence, expensive

No user fee is required

5.

Must be cleared before marketing

Must be approved before marketing

Must be used after IRB approval, for FDA approved indication

6.

Timeline for approval is 90 days

Timeline for approval is 180 days

Timeline for approval is 45 days

Table 2

medical devices, they are: i. Pre–Investigational Device Exemption/Pre-clinical evaluation, ii. Clinical testing, iii.

PMA submission, iv. Post marketing surveillance. These stages are summarised in figure 1.

Development and approval of medical device (Centre for devices and radiological health)

Preclinical development phase

3) Humanitarian Device Exemption (HDE) pathway: Devices that are used to treat or diagnose rare disorders (fewer than 4000 individuals per year) are included in HDE. The Safe Medical Device Act 1990 and its

Preinvestigation /application coordinated effort with FDA

Characterize the product (Classify the device)

(It includes in vivo animal testing, prototype development, redesigning and retesting cycle)

(Presubmission “Presub or Q-sub” Meetings)

Figure 2 Regulatory process for the approval of medical devices in United States

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Product pathway selection

rules were amended by FDA in 1996, which motivated the manufacturers to produce devices used in rare disorders.

It requires to show safety but not the efficacy of the device. The content and form of this application is similar to that of PMA application except in context of effectiveness requirement. The office of orphan product development regulates HDE through FDA. Besides FDA, IRB (Institutional Review Board) supervises Humanitarian Use Devices (HUD) regulation and approval.

The three pathways involved for the approval of medical devices in US are summarised and compared in Table2. Thereby for the approval of devices firstly the classification of device is identify and according the belonging class, the regulatory pathway is followed in order verify whether the device is suitable to place into market and hence the device is approved under USFDA. The sets of procedures are briefly summarised in figure: 2.

Europe

In Europe, medical devices approval follows the path of ‘harmonisation’ along with the guidelines of the European Union (EU). Medical device regulatory procedures rely on Medical Device Directives (MDD), which in turn consist of three core directives, which are amended for safe

Pathways which demand clinical trials

PMA

Pathways for approval in emergency situation HDE

HDE

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regulation and marketing of medical devices. They are: 1) implantable devices are regulated under directive 90/385/EC (European Commission); 2) most of the other devices are regulated under directive 93/42/ EC; 3) in-vitro diagnostic devices are regulated under 98/99/EC. EU 2017/745 is the new regulation which in freshly published; in the coming 3 to 5 years, these three directives will be replaced by this regulation. As per Directive 93/42/EC, a medical device is defined as “any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; investigation, replacement or modification of the anatomy or of a physiological process; control of conception; and which does not achieve its principal intended action in or on the human body by pharmacological, immunological, or metabolic means, but which may be assisted in its function by such means”.

Annex IX of the MDD 93/40/EEC categorises medical devices into four classes on the basis of the level of risk according to the patient condition and requirement. They are as follows: i. Class I: low risk devices, e.g., sterile dressing and gloves. ii. Class IIa: low-medium risk devices, e.g., surgical blades, suction equipment and radiotherapy equipment. iii. Class IIb: medium-high risk devices, e.g., ventilators and some implant. iv. Class III: high risk devices, e.g., drug eluting cardiac stents, pacemakers and implantable defibrillators.

Class I (low risk) devices are ‘self-declared’ or ‘self marked’ which means that the manufacturer itself

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Identify the device classification and to which evaluation procedure it is suitable

Quality management system (18013485) implementation

A file is prepared which presents necessary legal requirement and other appropriate directive compliance

An authorized representative is elected in Europe whose name and address should be mentioned on the device labeling

Europe declaration of conformity is prepared

A notified body is hired, who judicially examine the manufacture’s quality management and technical file or design of dossier

If all is verified then the manufacturer is issued with European CE certificate

Lastly CE is printed on the device hence the device can be legally marketed Figure 3 Approval process for medical devices in Europe

approves the compliance and applies CE (Conformité Européenne) mark and thus can be placed into European market (according to Annex VII Module A, EC Declaration of Conformity). In case of some devices of Class IIb and Class III (device with predicates) there is no requirement of clinical data.

Class IIa, IIb, and III (devices without predicates) require clinical data to ensure safety. Some class III devices (high risk) require clinical trial data to demonstrate the safety and performance of the device. Furthermore, the devices (except class I devices) are approved through a ‘Decentralised approval

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process’. In this process the application can be filed in any member state and is further reviewed by Notified Bodies (NBs). These bodies were set up within the state and were authorised by a competent authority or health agency.

In Europe there are in total 50 NBs, these NBs are private organisations which sign the agreement with the manufacturers and charge a fee for the certification of the devices. The company is free to choose any NB for the review of a particular class of device. The NB inspects carefully the application and makes sure that it fulfils the EC regulation. If the

TECHNOLOGY, EQUIPMENT & DEVICES

regulatory necessities are met by the devices then it issues the CE mark to the devices. Hence, medical devices marked CE can be sold in any country in Europe. This mark clearly indicates that the product is compliant to relevant legislation of safety. This action by the NB is termed as “conformity assessment” in Europe. The marketed device under the sanction of CE mark does not require any further evaluation but, the new regulation of 2010 has made the requirement for approval of devices tighten in aspect of similarity of new device to that of predicate device (device already in the market), and proactive post marketing surveillance.

The Decentralised Approval process is summarised in figure 3.

Japan

Regulation of medical devices in Japan is a combination of the regulatory processes of US and Europe.

Pharmaceutical Medical Device Act (PMDA) is responsible for the review and approval of the process. Medical devices are classified into four classes

based on the level of risk as follows: i. Class I: extremely low risk devices, e.g., in-vitro devices, x-ray films and devices for dental techniques ii. Class II: low risk devices, e.g., electronic endoscopes, catheters for digestive organs and ultrasound devices iii. Class III: medium risk devices, e.g., dialyser and bone prosthesis iv. Class IV: high risk devices, e.g., pacemakers, artificial cardiac valves and stent graft.

Devices belonging to class I are of extremely low risk and requires a submission of marketing called ‘Todokede’ which means certification for approval is not required. On the other hand, class II devices of low risk and some medium risk devices of class III should have compliance directly related to the norms and standards required for the approval certification. ‘Ninsho’ is the application to be submitted for the approval of device which will be evaluated by registered certification, which is further recommended by the Ministry of

Health, Labor and Welfare(MHLW).

Rest of the devices of class II and IV undergo prior review by the PMDA, and further approval is given on the basis of the MHLW proposal. The submission applications for such devices are called ‘Shonin’ which is quite similar to that of a PMA submission in USA. The devices are manufactured under the disciplines of quality systems compliant with their own rules and regulation in MHLW ordinance 169.

If there is no availability of office space for the companies in Japan, then there is need of an in-country representative to be signatory to the submission and a Marketing Authorization Holder (MAH) license.

On 31 July, 2017, the MHLW formulated a new regulatory framework called fast, a break scheme for innovative medical device to accelerate patient access. The scheme is a collection of organised things required for the approval of innovative medical devices in Japan. Hence, the device should accurately progress at the initial stage of development on the basis of

Traditional Approval Process

Collection of clinical data

Collection of clinical data

Submission review

Submission review

Approval of devices

Approval of devices

Use in market

Use in market

Application of partial charge (e.g., expanded indication, etc.)

Long term effectiveness which is theoretically expected has been demonstrated

Fast Break Scheme Process Post market risk management study

Post market risk management measures implementation collection of data for the confirm use results, long term performance

Figure 4 Comparison flow diagram of traditional approval vs. fast break scheme

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clinical evidence and not restricted to intense prospective randomised controlled trials, and should include clinical data which is agreeable for the prediction of clinical advantages and safety, on the basis of finite patient population in a particular clinical setting. The scheme is only applicable to ‘brand new medical devices’ which should fulfil the following requirements: 1) There should not be an already suitable alternative device unless there is a satisfactory probability of greater safety, efficacy and performance than the existing one. 2) The disease for which it is to be used should be a life threatening disease or a serious disability. 3) Some clinical evidence should be present for support. 4) Commitment of postmarketing to a suitable management and rigorous real world evidence collection and estimation. 5) If a new prospective clinical trial is not conducted, a justification should be given. The traditional approval and fast break scheme is compared in figure 2, which clearly indicates that the traditional one requires more clinical data, whereas in the fast break scheme the innovative medical devices should fulfil specified criteria or standards on the basis of existing clinical data.

Thus it needs lesser data collection and ultimately consumes less time than the traditional process. The comparison between Traditional process and fast break scheme is illustrated by figure 4.

China

In China, for a medical device to be sold in the market, it must be registered with the State Food and Drug Administration (SFDA), which is presently known as China Food and Drug Administration(CFDA). There are two important regulations which should be followed in China: ‘Regulations for the Supervision and Administration of Medical Device’ (2000) and ‘Measures for the Administration of the Medical Device Registration’ (2004). The

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registration requirements are alike to that of the US and Europe.

According to classification of devices on the basis of level of risk the medical devices are divided into three classes as follows: i. Class I: low risk devices e.g., scalpels, stitch scissors and ear probes ii. Class II: moderate risk devices e.g., dural dissectors and disposable umbilical cords iii. Class III: high risk devices, e.g., disposable sterilised syringes and rubber plugs, and disposable venous infusion needles.

Class I devices’ safety and effectiveness is assured by routine administration. Class II medical devices require further supervision for the evaluation of their safety and effectiveness. Class III medical devices need to be precisely controlled in terms of safety and effectiveness as they are used as life saving devices that are implanted into the human body. For registration of devices of Class II and Class III it is essential to present clinical trial data. The devices belonging to Class III and other imported devices are directly supervised by the CFDA.

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A legal agent and a sales person is assigned to get approval by SFDA

Identify the class of the device (class I, II or III)

Original registration document interpretation and review

Assemble the legal and technical documents which are to be submitted to SFDA

Make a testing product sample

Perform the clinical trials of class II and III medical devices

CMDE conducts specialized assessment

SFDA does the final assessment and acquire registration certificate Figure 5 Approval process for medical devices in China

TECHNOLOGY, EQUIPMENT & DEVICES

The application in form 44 as per schedule Y is filed (TR6 challan of Rs 50,000)

CDSCO is responsible for reviewing of the clinical data, publication reports, literature, package inserts

According to the suggestion of MDAC permission is granted under the rule of 122A

The manufacturer is issued registration certificate under form 41 and import license under form 10 which valid for 3 years

The DCGI inspects product information and provides in written about the estimation of regulatory status of a medical device i.e. No Objection Certificate letter is issued Which takes 4-12 weeks

MDAC (medical device advisory committee) inspects the information

The issue of registration certificate takes 6-9 months whereas of import license takes 4-5 weeks

Figure 6 Approval process for medical devices in India

Some of the devices also need the China Compulsory Certification (CCC) apart from medical device registration.

The CCC mark is handled by the Administration of Quality, Supervision, Inspection and Quarantine, a Chinese quality and quarantine authority (AQSIQ).

As per the provision of medical device registration, the application for the purpose of registration of devices can only be lifted by a legal authority of China. The manufacturer is supposed to submit a declaration that the devices withstand the Chinese National Standard and Professional/ Sectorial standards without any kind of alteration, and if any, the manufacturer can add the particular requirement to the CFDA on standard directly connected to the device. The legal and technical documents are submitted to CFDA; further the product sample testing is done. Clinical trial data are

collected and presented to the CFDA for Class II and III devices. The Chinese Medical Doctor Association (CMDA) conducts specialised assessment, and the final inspection is done by the CFDA for registration certification.

The summary of the process of approval of medical device in China is expressed in figure 5.

India

The Central Drug Standard Control Organization (CDSCO) under the Directorate General of Health Services in Ministry of Health & Family Welfare (MoHFW), Government of India(GoI), is the National Regulatory Authority (NRA) which is accountable for manufacturing, import, conduct of clinical trials, laying down standards, sale and distribution of medical devices via enforcement of medical device rules, 2017. It reviews all data submitted which are essential for the approval of

the device. The NRA is supposed to ensure the safety of public health. As the NRA, the CDSCO is responsible for conducting Materiovigilance programme of India (MvPI). The Indian Pharmacopoeia Commission acts as the NCC (National Coordination Centre) for MvPI. The MvPI is supposed to furnish the collection of safety data in a systemic manner, therefore regulatory selections and guidelines for secure use of medical devices being used in India might be based totally on the data generated. The programme supervises MDAE (Medical Devices-associated Adverse Events), spread awareness among healthcare professionals regarding the significance of MDAE reporting in India, and also overlooks the advantages and negative outcomes of the medical devices. It is also intended to generate unbiased evidence-based suggestions and to communicate the findings to all key stakeholders.

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The MDAC (Medical Device Advisory Committee) is a body responsible for the overall inspection of the information. If everything is in favourable the MDAC grants permission under the rule of 122A and ultimately the manufacturer is issued with license under form 41 and the import license under form 10 allowing them to introduce the device into the market. The license issued is valid for only 3 years. The devices which are non-notified need not to be registered with the CDSCO and can be imported throughout the country according to the formal custom rules. The sets of procedure of device regulation are summarised in figure 6.

Currently in India regulation on import of medical are imported from Europe and the US because of their better quality and efficiency.

The import and registration of medical devices occurs under Drug and Cosmetics Rules, 1940 which specify that i) In order to file an application for the import and registration of medical devices under the prescribed guidelines, the importer is given a time period of 60 days. ii) Import is not allowed without the approval of an authorised body, in case of those devices that has never imported in the country before the date of notification. iii) The devices are allowed to be sold for a particular period (up to 6 months) during which the application is being evaluated for approval or rejection. Separate committees are made for the assessment of different classes of devices. The distinct medical device classes categorised on the basis of level of risk are: i. Class A- Low risk devices e.g., thermometers, tongue depressor ii. Class B- Lowâ&#x20AC;&#x201C;medium risk devices e.g., hypodermic needles, suction equipment iii. Class C- Mediumâ&#x20AC;&#x201C;high risk devices e.g., lung ventilators, bone fixation plates iv. Class D- High risk devices e.g. heart valves, implantable defibrillators.

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Conclusion

Regulation for the approval of medical devices across the globe is a vital requirement in order to ensure quality, safety, efficacy and performance so that they can be introduced into the market for protecting, preventing, improving, and sustaining public health. This ultimately lifts up the customerâ&#x20AC;&#x2122;s faith and confidence in the device and in the manufacturer. The devices are classified on the basis of the level of risk into various classes, thus the devices in different classes have different

regulatory steps for approval of the devices varying from region to region.

Although different regions are diverse in the regulatory processes, charge different fee for application filing, and have their own time period in order to approve and to issue a license, at the end all are aiming at one goal, that is manufacturing and marketing of a device which is safe, effective, and of good quality in order to provide their best to the public.

References are available at www.asianhhm.com

AUTHOR BIO Vivek Dave is working in the capacity of Assistant Professor at Banasthali Vidyapith, Rajasthan. He has commendable experience skills coupled with sound theoretical background. He is having experience of more than ten years. He has been working in the field of novel drug delivery system, nanotechnology and has already published several articles in the journal of national /international repute.

He has also recorded his expertise in the form of many chapters and books. He has been recipient of several awards in various conference, seminars & conventions.

Sachdev Yadav is working in the capacity of Associate Professor at Banasthali Vidyapith, Rajasthan. He has commendable experience skills coupled with sound theoretical background. He is having experience of more than 15 years. He has been working in the field of toxicology, genotoxicity and has already published several articles in the journal of national /international repute. He has been recipient of several awards in various conference, seminars & conventions.

Bhawna Gulati is student in master of pharmacy at Banasthali Vidyapith, Rajasthan. Her specialization is Pharmaceutics. She has been certified in diploma of Medical Image Processing and pursing certificate course in German language. In addition she has served two years in National Service Scheme (NSS). She has command in gastroretentive drug delivery and is skilled in UV-Visible spectroscopy.

Nikita Gupta is pursuing Master in Pharmacy from Banasthali Vidyapith, Rajasthan. Her specialization is Pharmaceutics. She has been certified in medical image processing and other educational curriculum. Apart from her academic background she has been part of National Service Scheme (NSS) for two years. She has command in ocular drug delivery and expertise in UV-Visible spectroscopy.

Rakesh Yadav obtained his UG & PG degree from GJUS&T, Hisar and completed his PhD degree from UIPS, Panjab University, Chandigarh in Pharmaceutical Sciences. Currently, he is working as Associate Professor, Banasthali Vidyapith, Banasthali, Rajasthan. He has also presented his research work at various international forums viz. Switzerland, Argentina, Italy, Malaysia, Israel etc. He is an active researcher and published research work in journals of repute.

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Techno Trends EXPLORER- World's First Medical Imaging Scanner Captures 3D Picture of Whole Human Body EXPLORER, the world's first medical imaging scanner that can capture a 3D picture of the whole human body at once, has produced its first scans.

EXPLORER is a combined Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) scanner that can image the entire body at the same time.

It can produce an image in as little as 1 second and, over time, produce movies that can track specially tagged drugs as they move around the entire body. It also scans up to 40 times faster than current PET scans and can produce a diagnostic scan of the whole body in as little as 20 to 30 seconds.

Novel NUS Medical Device Harnesses Magnetic Field to Speed up Muscle Recovery Researchers from the National University of Singapore (NUS) have developed a medical device â&#x20AC;&#x2DC;MRegenâ&#x20AC;&#x2122; that is capable of regenerating muscles in a non-invasive and painless manner.

MRegen makes use of a unique magnetic field to activate energy production and trigger muscle regeneration. The energy produced via the magnetic stimulation 'tricks' muscle cells into thinking that they are exercising, hence activating them to adapt and improve at an accelerated speed.

Scientists Develop Single Direct-totumor Drug-delivery Device to Treat Triple-negative Breast Cancer Houston Methodist scientists have developed Single Direct-totumor Drug-delivery device that treats triple-negative breast cancer. This nanodevice delivers immunotherapy without side effects to treat triple-negative breast cancer.

This tiny nanodevice is smaller than a grain of rice and, once inserted a tumor, it can deliver the medication little by little, gradually releasing the drug from its reservoir. Instead of delivering it to the whole body of a patient, it will establish a novel strategy to deliver immunotherapy straight into a tumor.

Scientists Develop 3D-printed Soft, Artificial Heart Using 3D Printing Scientists have developed a 3D-printed soft, artificial heart made of silicone that beats almost like a human heart. ETH

doctoral student Kai von Petersdorff-Campen has developed a method to create products containing magnets using 3D printing.

Using this artificial heart, damaged human hearts can be replaced without the need for a transplant. The silicone heart features left and right ventricles or chambers, just like a human heart, as well as an additional chamber that acts as the heart's engine by driving the external pump.

The silicone heart weights 390 grams (13.8 ounces) having a volume of 679 cubic centimeters (41 cubic inches), it is slightly heavier but the same size as a normal human heart.

Cambridge Researchers Develop New Technique to 'Listen' Patient's Brain During Tumour Operation A research team of the University of Cambridge, UK has developed a new technique that enables surgeons to listen to a patient's brain activity while performing tumour surgery.

This will enable the surgeon to predict more accurately the likely impact of removing a particular area of brain tissue. It is expected that the technique will offer real-time feedback on the patient's brain activity in operation theatre.

The new technique is intended to enhance the accuracy of the procedure and reduce the risk of impairing brain function.

The new technique will guide the surgeon and save time and make surgery more efficient, more accurate.

Purdue Researchers Developing Novel Biomedical Imaging System to Enhance Diagnosis of Life-threatening Diseases Purdue University researchers are developing a novel biomedical imaging system that combines optical and ultrasound technology to enhance diagnosis of life-threatening diseases.

Users can easily plan the fiber optic bundles to tune the depth using a motorised photoacoustic holder. In this, light is focused, improving the light penetration depth and signalto-noise ratio of the images. Photoacoustic tomography is a noninvasive technique that works by converting absorbed optical energy into an acoustic signal.

Photoacoustic tomography provides information about where blood and lipid are located, along with other essential information. It can also be used to detect or monitor a myriad of diseases, including cardiovascular disease, diabetes, and cancer.

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O

ver 5 million die every year, often in our care, of air quality issues. Millions more of water, soil, and food contamination.

What is our role as healthcare providers in addressing these major areas of poor health?

Many in our industry now realise that we need to move more rapidly

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from being leaders in taking care of sick peopleâ&#x20AC;Śto being leaders in keeping them healthy. Environmental issues are a major determinant of our patientâ&#x20AC;&#x2122;s health outside our hospitals and clinics.

In addition to the millions that die, many times that suffer needlessly, struggle in school, lose work opportunities, or have poor birth outcomes because of

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the pollution around them. Not only have we not solved this problem, we often contribute to toxin burden by our energy utilisation, waste management or purchasing choices.

Leading on health is not only a major moral responsibility it is a great opportunity for us to truly live our mission, accomplish multiple

FACILITIES & OPERATIONS MANAGEMENT

Boldly leading on environmental improvement gives Healthcare a great opportunity to improve the health of our communities, distinguish our organisations, save money and inspire the next generation. Clinicians, hospitals, regions and whole countries are making significant progress in energy, supplies, waste management, and food across Asia, the US and Europe.

Jeff Thompson, CEO Emeritus Pediatrician, Gundersen Health System

distinguishing milestones ahead of our competitors, be an inspirational workplace for our current and future employees, and develop a portfolio of credibility to inspire our community partners. Fortunately, we do not have to feel we need to take this on alone.

The Paris accord was signed by 190 countries, one of the greatest

showings of heads of state ever.

It was a clear declaration that weâ&#x20AC;&#x2122;re not doing nearly as well as we could and that all countries need to make a commitment to do better. Most countries have followed up with a subsequent commitment at Katowice Poland with agreement on rules and goals.

National efforts vary greatly by country but one of the most promising is admitting there is a big problem.

The United State, China, and India have some of the largest economies and contribute the most to greenhouse gas emissions. In Beijing last year, a senior health official pointed out that they lose over 1 million Chinese every year to air pollution. In India a public report pointed out that pollution is second only to malnutrition as a public health problem. Great condor on the part of these very populous countries to say there is a problem and we plan to address it.

The approach to these very important issues varies immensely within countries and regions. China has a very strong national approach to decrease their dependency on coal

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by reportedly installing a football field of solar and two major wind turbines every hour for the last two years.

India on the other hand has had an emphasis on a much more local approach where individual clinicians have written prescriptions for clean air and clean water to help develop public support to improve the quality of those vital elements. Kenya has taken it so far as to pass a constitutional amendment declaring all its people have a right to clean air and clean water.

Every one of our local communities have its own set of issues that provide a wonderful opportunity for the health system serve its mission, distinguish itself and prove we can use a broad array of partnerships to improve the well-being of the whole community. Here are a few examples: In Taiwan the Tzu Chin health system is using food as a medicine to improve their patients and the local economy at the same time. Their no meat approach to food service has decreased the greenhouse gas emissions and the sourcing from the region has decreased transportation costs and the effects on the environment1.

In Seoul, the Yonsei University Health System2 under the leadership of Dr DongChun SHIN have made great progress on the goals towards waste reduction , treatment, safer disposal, and support to green and healthy hospital design and construction.

Indonesia Hospital Association is a very important connector for more than 1,234 hospitals, They, like many others, have chosen to partner with the 1 http://greenhospitals.net/wp-content/uploads/2016/01/ Ming-Nan-Lin-Dalin-Tzu-Chi-General-Hospital.pdf.

2 http://www.yuhs.or.kr/en/

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international organisation Healthcare Without Harm and were a founding member of the global Green and Health Hospital initiatives of Asia3.

Even specialty centres can help lead this work. The Philippine Heart Center has made great strides in everything from energy to sewage disposal and they have also often taken on the role of teacher for other healthcare and community organisations4.

There is some old thinking that being more environmentally sound could hurt business, but many places across the globe have found was to improve their finances, decrease pollution and improve the local economy. Even major investor are seeing the opportunity, billionaire Anand Mahindra in September said he felt that addressing sustainability issues

was the greatest economic opportunity of our century5.

World health organisation has made it very critical part of their sustainability goals for building communities in both urban and rural areas across the world6 (big set of block graphic that is widely used), And the world bank and the U.N. development fund have both included sustainability measures into their applications for future funding.

A frequently asked question with all this activity is what is going on in the United States? Despite the current presidentâ&#x20AC;&#x2122;s high profile disagreement with the Paris accord and infatuations with coal, more than 400 mayors of major cities in the US and 17 governors (making up almost half of the total GDP of the country) have publicly pledged to follow Paris Climate

3 https://noharm-asia.org/issues/asia/global-green-andhealthy-hospitals-asia

5 https://qz.com/india/1082930/anand-mahindra-sustainable-development-goals-are-biggest-business-opportunityof-the-decade/

4 https://www.greenhospitals.net/philippines-gghh-membershowcases-best-eco-friendly-practices/

6 https://www.un.org/sustainable development/sustainabledevelopment-goals/

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7 https://practicegreenhealth.org/

This may seem like a daunting task at first but it is quite easy. If you go to the healthcare without harm website9 you will find many examples of organisations connecting to the community and starting to decrease their impact on the environment. As you will see, many get started by purchasing locally, working with local business coalitions or thinking differently about food water and air quality issues.

For longer-term planning, the World Health Organization, the World Bank and the U.N. Development 9 https://noharm.org/

AUTHOR BIO

guidelines. Healthcare organisations have also leaned in on the effort with over 1000 working with Practice Green Health7 to improve health and the environment. The website can show you many examples of successful organisations that also lowered the cost of care and markedly improved the environment. One of its members, the Gundersen Health System8 is an example of improving the local economy, lowering the greenhouse gas emissions over 90 per cent and saving money at the same time. On an international scale, Healthcare Without Harm organisation which is present in over 50 countries around the world representing thousands of hospitals and clinics all committed to improving the health of the environment while sustaining their work as healthcare provider

Fund all have planning strategies to help communities or individual healthcare organisations develop a more sustainable longer plans to thrive as an organisation as well as improve the wellbeing of your region.

The moral imperative to improve the health and wellbeing of our communities can be combined with a financial path forward that also includes less stress on the environment we must live and breathe in. In addition this approach will help you build strong partnerships in the community and recruit and retain the next generation of committed staff and leaders.

Jeffrey E Thompson is Executive Advisor and Chief Executive Officer, Emeritus at Gundersen Health System. Thompson is a trained pediatric intensivist and neonatologist, and served as Gundersenâ&#x20AC;&#x2122;s Chief Executive Officer from 2001 to 2015. After completing his professional training in 1984, Thompson came to Gundersen with a desire to care for patients and to teach. He was asked to serve on Gundersenâ&#x20AC;&#x2122;s boards beginning in 1992 and was chairman of the board from 2001 to 2014.

8 http://www.gundersenenvision.org/envision/

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ASIAâ&#x20AC;&#x2122;S HEALTHCARE GOES DIGITAL

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INFORMATION TECHNOLOGY

Ageing populations, the rise of chronic diseases, and the growing demand for quality standards and services are realities that are shaping the healthcare landscape in cities around the world today. Delivering value to expanded groups has taken on new importance for healthcare providers, amidst cost and resource constraints and evolving expectations of increasingly empowered consumers. These factors are steadily driving the sector’s transformational shift towards digitalisation, placing smart technologies at the core of processes that leverage interoperability and integration.

Nalin Amunugama, General Manager, BOGE Kompressoren Asia Pacific

A

s the global population ages, the healthcare systems of every country face significant challenges to meet the needs of this demographic. By 2025, 300 million of the projected increase of one billion people will be aged 65 and above by 2025, according to the United Nations (UN). In countries like China and India, there are even greater challenges due to the sheer number of older people. Ageing populations are more likely to suffer from chronic illnesses, and along with rising costs and resource constraints, these challenges are placing a huge burden on government healthcare systems.

Over the last few years however, healthcare providers have worked closely with industries to deliver quality customer experience. The industry is right on track as we see a transformational shift from volume to value of care. Without a doubt, the evolution in data, mobile and cloud technologies has disrupted the healthcare industry, and this disruption has forced healthcare and insurance companies to move towards a model that is more customer-centric.

In Asia, smart healthcare is progressing more rapidly, as evidenced by increasing budgets to support these developments. Healthcare IT expenditure in the Philippines is

predicted to reach US$ 60 million by 2019, while the implementation of the Digital India Initiative is expected to contribute US$ 280 billion to the country’s healthcare sector by 2020.

The surge in digitalised networks and data monitoring systems present promising opportunities for the region’s healthcare sector. These advances, which are seamlessly integrated into mobile health apps on smartphones, provide improved, real-time access to information and speedy treatments, empowering patients to take active control of their health data, and choose the type of care that is best-suited to them.

From expediting diagnosis to enabling remote patient monitoring, smart technologies continue to play a key role in improving patient outcomes, lowering costs, and creating efficiencies in today’s healthcare.

Powered by IoT

Cutting-edge technologies such as the Internet of Things (IoT), powered by cloud computing remediate the laborious task of storing and managing massive volumes of data, while also ensuring smoother back-end workflow.

In larger hospitals like the Nagasaki University Hospital in Japan, this solution has led to optimum productivity and immediate access to data on hand.

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Figure 1 RFID tags facilitate easy tracking and mobilising of medical equipment and devices

Relying on near-field communications technology for data transmission, the mobile touch-screen computers in the hospital reads and confirms a patient’s identity through barcodes located on the patients’ tags. The three-point authentication (nurse, administrator and medication) eliminates the manual process of having to scour through patients’ records, keeping prescription errors to a minimum.

Automated tracking via Radio Frequency Identification (RFID) tags have also successfully been deployed in hospitals to address logistical challenges and reduce inefficiencies. At Denmark’s Det Nye Universitets hospital in Aarhus, staff and approximately 20,000 objects (hospital beds, wheelchairs, medical devices) are embedded with RFID tags to help personnel locate these through information screens installed in the premises or mobile apps. Easy tracking means less time wasted on locating and mobilising much-needed assets, allowing staff to focus on core responsibilities, namely, attending to patients.

Improved accountability and traceabil-

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ity, capable of supporting efficiency and patient safety, will be a cornerstone of this initiative.

Simprints, a biometric fingerprint solution provider from England, uses IoT for faster identification of patients in countries affected by climate disasters. The technology works offline and is a boon for places with unpredictable Wi-Fi connection. Simprints taps into existing mobile data collection apps found in smartphones of frontline workers. When a patient biometrically enrols through Simprints, a unique ID is generated from a fingerprint template, and scanned to the phone.

When wi-fi becomes available, it automatically syncs with Google Cloud.

Simprints’ ability to track beneficiaries worldwide and provide mandatory treatment enables patients in countries like South Asia, Africa and Middle East to have access to basic care.

IoT also facilitates the relationship between patients and healthcare providers, and improves productivity.

Singapore start-up, BitCare launched a two-way audio call feature for nurses to

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respond to patients’ calls from anywhere in the ward using a mobile app. Through this feature, nurses can prioritise their time while managing several patients at a time, and provide assurance that patients would be attended to shortly.

Smart, Safe Monitoring

No doubt, the healthcare industry poses one of the most high-risk working environments. Artificial respiration, surgical tools and inspection of medical devices depend heavily on reliable, round-the-clock supply of medical compressed air. This means, any room with internal shortcomings from energy-wasting equipment must be immediately resolved.

A specialist in compressed air systems, BOGE knows only too well, the importance of compressed air that accedes to statutory requirements and safety standards and recognises the hospitals’ priority in remaining energy-efficient. It leverages Industry 4.0 technologies to guarantee that compressed air production can be evaluated and optimised promptly.

INFORMATION TECHNOLOGY

and idle time, maintenance status and more, ensuring that abnormalities are immediately detected, and performance is welloptimised. Such technologies, centred on digitalised management and coordination, assist hospitals by saving on operating and energy costs while ensuring that medical operations relying on compressed air remain uninterrupted.

Bridging the Gap

Figure 2 Conveniently connected compressors are efficiently managed with BOGE’s Airtelligence Provis 2.0

Among its customised solutions are air compressors equipped with smart monitoring systems. BOGE’s Airtelligence Provis 2.0, for example, commands up to 16 air compressors with the assistance of browserbased visualisation that is linked to an existing server structure enabled by an Ethernet interface. Users can log into their computers to review data, including pressure history and free air delivery.

BOGE’s air status allows users to control up to 32 components—from wherever and whenever—through the air status application on a smartphone. The remote diagnostics tool provides ongoing updates on operating

The demand for medical assistance, medicines and accessible clinics are definitely on an upward trend. Patients these days seek quality healthcare services at affordable costs, and at the touch of a button.

More organisations are now committed to overcoming shortages in manpower within the healthcare industry with much-needed solutions.

The multi-tiered mobile technology, mClinica connects pharmacies, patients, drug companies and distributors on a single platform. The smart inventory monitors drug purchases, to whom and at what quantity, giving pharmacies a clear idea of the supply to demand ratio and the ability to replenish depleting stocks quickly.

Comprising more than 5,000 pharmacies and 70 million patients across Southeast Asia, the Singapore-based company previously identified a combination of drugs in densely-populated Indonesia that could have been lethal, and in the process, was able to act as a preventive measure against pharmaceutical errors.

Short-handed medical experts and lack of access to hospitals can result in lives at risk. The maternal mortality rate in Indonesia is among the highest in the region due to lack of access to antenatal care. In 2014, the Philips Mobile Obstetrics Monitoring (MOM) initiative and Bunda Medical Centre capitalised on the significant mobile penetration rate in the country to bring scalable telehealth to expectant mothers in rural West Sumatra.

Figure 3 With the BOGE air status mobile app, all essential data and functions of compressed air systems are right at users’ fingertips

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The pilot programme allowed midwives to build the health profile of pregnant women with data from tests done in nursing clinics and the soonto-be mother’s home. The data was uploaded from the app to the central MOM server, allowing obstetricians and gynaecologists to supervise the entire pregnancy. Upon detection of high-risk pregnancies, immediate care was rendered.

The discovery of high-risk pregnancies increased three-fold with no maternal deaths recorded. From the tremendous positive feedback received, the contributors signed a deal to launch the programme in 2016. The timely referral and management of the MOM now offer women in rural villages the rare opportunity to see their foetuses during pregnancy and receive similar medical privileges as mothers in urban cities.

Integrated Health Ecosystem

Bringing quality healthcare to new heights, BookDoc radically revolutionised the healthcare experience by streamlining the patient’s journey through consultation-booking, navigation and transport before arriving at the clinic. While locals stand to benefit, travellers who are unfamiliar with a host country can also receive medical help with ease.

Patients simply book an appointment on the regional database, with the option to choose from a range of clinics, including 24-hour medical care. The mobile application works in tandem with reputable organisations like Google (Maps), Grab, Airbnb, Agoda and several recommended hotels and restaurants, creating an integrated healthcare ecosystem online, on a singular plane.

So, What’s Next?

Artificial Intelligence (AI) technology continues to advance at a rapid pace.

AI has the potential to improve patient experience by better anticipating their needs, partnering with healthcare

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providers with next-level patient data and providing outcomes at a faster rate. The use of robotics in healthcare is also expanding. Both AI and robotics can take over or perform tasks such as sorting through enormous volumes of data and medical scans much faster than humans, and in the process, be able to clear pathways for better and earlier diagnostics. For researchers, the assimilated data can present new insights. AI is already being used to detect diseases such as cancer more accurately and in early stages.

Robotic-assisted surgery, such as the da Vinci Xi Surgical System, further enhance the capabilities of surgeons to perform minimally invasive surgery, even in the most complex situations. It is not uncommon to see surgeons sitting at a console, viewing 3D images of the surgical site, and controlling the arms of the robotic instruments inside the patient’s body. Because the robotic arms are tiny, they allow surgeons to make

smaller incisions with greater precision.

Additionally, the da Vinci Xi provides more ergonomic support, giving the surgeon stability, dexterity and proper posture and positioning for lengthy procedures. Robots can also help with simple tasks like lifting patients from their beds and moving them to a consultation room or operating theatre.

The dynamic face of presentday healthcare offers vast growth opportunities for technological innovations in the future-ready healthcare sector. IoT networks, smart monitoring devices, innovative mobile technologies, and AI are game changers, offering the ultimate healthcare experience for both health professionals and patients.

Groundbreaking technologies and the industry’s determination to upend existing healthcare practices will, no doubt, prepare Asia to meet the needs of its growing middle class and rapidly ageing population.

AUTHOR BIO Nalin Amunugama is General Manager at BOGE Kompressoren Asia Pacific, a leading supplier of compressed air systems and solutions for the medical, pharmaceutical, plastics, food, beverage and automation manufacturing industries. Based in Singapore, he is responsible for 15 markets, including Australia, India, Bangladesh, Sri Lanka, Indonesia, Malaysia, Thailand, Vietnam, South Korea, Philippines, Taiwan, Japan, Myanmar, and Singapore.

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INFORMATION TECHNOLOGY

Transformation of Healthcare

How technology redefines one of the oldest industries in the world Natalia Kukushkina, Marketing Manager, Dashbouquet Development

S

ince healthcare is one of the few industries that are crucial for all people worldwide, no wonder it sees huge spending and even bigger investment. As Deloitte1 estimated, in 2020 the global annual healthcare spending may reach US$8.7 trillion.

And in the first half of 2018, US$10.6 billion were poured into the healthcare startups by venture capitalists, as per Forbes2.

These numbers are clear indicators that healthcare today is a whole field of opportunities for both savvy startups as well as huge enterprises that are willing to deploy cutting-edge technology.

However, the implementation of technology within the medical sector started a long time ago, back in the early 1960s. Since then, healthcare went through a massive transformation, both in terms of adopted practices and equipment. And today the healthcare industry stands on the verge of change once again due to massive deployment 1 https://www2.deloitte.com/global/en/pages/life-sciencesand-healthcare/articles/global-health-care-sector-outlook. html 2 https://www.forbes.com/sites/arleneweintraub/2018/07/12/healthcare-vc-investing-could-hit-arecord-high-in-2018/#4487c15165d2

of artificial intelligence, RPA, and other technologies.

The Pain Points of the Past and First Implementation of Technology

Some of the biggest pain points for all the industries at all times have been: • The overwhelming amount of paperwork • High possibility of human error • Mundane and routine tasks that consumed too much time One of the pioneers in the field of medicine digitisation was Homer Warner3 – an American cardiologist who was among the first ones to use computers for decision support in the mid-1950s. In the late 1960s, Warner and his colleagues came up with the monitoring systems that became a globally used standard today and were a true breakthrough back then.

In the eighties, the networking technologies for computer connection gained incredible popularity. And in 1991, Electronic Medical Records (EMRs) were examined and adopted as well.

3 https://www.forbes.com/sites/michaelmillenson/2012/12/18/the-man-who-brought-computers-intomedicine/#f9d831d7f80c

Since then, the healthcare has been steadily transforming towards more efficient and accurate processes.

The implementation of computers and other technologies freed medical specialists from hours, spent on routine work, and allowed them to focus on tasks that are more critical. Moreover, computers significantly decreased the possibility of an error and allowed to keep all processes within one place (or network).

Within the past few years the world has witnessed the rise of the Internet Things (IoT), Artificial Intelligence (AI), and Big Data. Without a doubt, these technologies influenced healthcare significantly and took it to the next level.

Healthcare Today: Robotic Assistants and Disease Predictions

Modern healthcare is heavily influenced by the following technologies: the IoT, AI, Machine Learning, and Big Data. Each of them offers unique solutions that eliminate risks, decrease the possibility of an error, increase the efficiency of work processes and contribute to medical research.

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48

Data science

Drug creation

As can be guessed from the name, data science is all about analysing the data and extracting valuable insights from it.

And, since healthcare involves a lot of work with data, data science contributes greatly to the industry development.

Medical image processing In healthcare, image processing plays a vital role in areas such as diagnostics.

The earlier the disease is diagnosed, the higher the chances are that it will be successfully cured. Examples of such image techniques include X-ray,

According to Drugs.com4, it may take about 12 years for a drug to get submitted (think of all the resources and finances invested into the development). But thanks to data science, the time and investment can be reduced significantly.

With the help of special algorithms, data science makes it possible to forecast how the drug will act and what will be the expected success rate. Such

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Medical Resonance Imaging (MRI), computed tomography.

What data science does is that it offers medical specialists an opportunity for more accurate and thorough analysis. Being able to classify the organ texture, find non-obvious disease indicators etc., data science contributes greatly to the detection of severe conditions, like tumour or artery stenosis.

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4 https://www.drugs.com/fda-approval-process.html

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an approach eliminates the necessity to conduct lab experiments by enabling the tests in carefully crafted simulations.

Computer vision This technology offers accurate analysis and inspection and has found its niche in the sphere of image analysis.

We’ve discussed above that data science contributes greatly to image processing. Due to its ability of detecting the slightest anomalies, computer vision is also used for patient’s scan analysis and increases the accuracy of the image analysis.

This, however, is not the only application of the computer vision in the healthcare. The Gauss Surgical5 company, for example, developed a software that is able to detect the patient’s blood loss in real time—all thanks to computer vision. This proves that if a company has an innovative idea and uses the corresponding technology, it can make an impact on the future of healthcare.

Machine learning A subset of AI, machine learning, is capable of learning and recognising certain patterns in the data and building predictive models upon them.

This technology is widely deployed in the financial industry but in healthcare it plays a crucial role as well, helping medical specialists predict and identify the possible disease and prevent its development.

The deployment of machine learning in healthcare plays acrucial role since many illnesses go unnoticed during the first stage. But with the accurate predictive models, doctors will have a bigger chance to fight cancer, for example, rather than treating the already progressing illness.

Trends for 2019

We cannot state that there will be other groundbreaking technologies in healthcare in 2019-2020, but the ones that are used now will continue 5 http://www.gausssurgical.com/

Today the healthcare industry stands on the verge of change once again due to massive deployment of artificial intelligence, RPA, and other technologies.

to develop. They include more advanced chatbots, wider deployment of predictive analytics, etc. However, certain things will change—find below the innovations that are to be launched in the near future.

The Internet of Medical Things (IoMT) The Internet of Things is slowly turning into the IoMT. This term implies a wide adaptation of smart and medical wearables, including ECG monitors. It is expected that the number of deployed IoMT devices will range between 20–30 billion by 2020, according to Allied Market Research. However, IoMT still has several issues to resolve: like the question of security or efficient communication between the devices.

AR and VR Augmented Reality (AR) is great for educating medical students and putting them into the environments that would be maximally close to real-life situations. But that’s not the only way to use this or the Virtual Reality (VR) technology.

In psychology, the usage of VR helps to put patients in a situation that would be unavailable in the current environment, thus helping to unlock certain memories or identify the pain points.

As for AR, it is used to identify the patient’s veins and place a digital map over it, thus making it easier for clinicians to identify a spot for injection.

Big opportunity for tech companies For technological and app development companies today is the perfect time to join the race and come up with an innovative and efficient solution that can be offered to the healthcare industry. As healthcare gets ready to adopt cutting-edge technology, the biggest issue for the development company is to create a solution that indeed will be useful and helpful.

As for the medical institutions and healthcare companies, they need to find a reliable and trustworthy development company with a proven record of developing and completing successful and healthcare-related projects. Because healthcare is aimed at patients’ wellbeing, there is no room for a mistake at all. So the reputation and experience of a development company indeed will play the biggest role when healthcare representatives will be choosing their provider.

Natalia Kukushkina Marketing Manager Dashbouquet Development

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TRANSFORMING TO DIGITAL

As the pharmaceutical and healthcare industry drive towards developing effective medicines and delivering total solutions for patients, they are trying to leverage new business modes and technologies from other industries to meet changing needs across geographies, patients, providers and regulators.

AI supported â&#x20AC;&#x2DC;Digitalâ&#x20AC;&#x2122; technologies can allow innovative, connected, efficient and savvy adopters to surge ahead in their transformational journey.

Krishnan Rajagopalan, Chief Growth Officer, Navitas Life Sciences TAKE Solutions Enterprises

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harmaceutical industry is in the midst of a renaissance in leveraging latest technologies and evolving operating and delivery models to transform itself. Expectations to meet the demands of patients, providers, physicians and rapidly changing regulatory compliance needs globally are driving the industry to adopt some of the technological advances made by other industries, including healthcare that it was hesitant to leverage just a few years back.

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Trends / Challenges

Opportunities

Burden of Chronic diseases is soaring

Deliver globally effective medicines at a LOWER price

HC Policy makers / Payers and Patients mandate & influence what doctors can prescribe

Every $ must work harder – ‘Pay for performance’ will be rewarded

Emerging markets are maturing

Leverage end to end / global capabilities & develop new capabilities through partnerships

Need for Integrated HC will be critical

Develop effective medicines AND deliver total solutions for patients, hospitals, primary care & at home

‘Value-driven’ clinical dev. program design needed to overcome R&D deficit

Commitment to change process, structure / roles and technology to leverage new models such as RBM, Centralized and remote monitoring

Developing and delivering drugs or devices alone is not enough, but the need to demonstrate their value through ‘pay for performance’ and to provide integrated healthcare to patients in a compliant manner will become more critical to remain competitive.

Increasing pressure to complete trials more efficiently with ‘real-time’ decision making possibilities through technology, ‘Speed to launch’ successfully the first time to ensure maximum revenue realization and the potential to proactively recruit, retain, ensure adherence and continue to provide enhanced services to patients throughout their interactions with pharma are driving the Digital transformation across the value chain. Emergence of IT functions to be a collaborative and partner for business to bring-in the latest developments in digital and SMAC (Social, mobile, analytical and cloud) technologies and sharing the ‘art of possible’ is allowing the industry leaders to push forward with the transformation and realize tangible benefits.

Life Sciences industry is undergoing significant transformation and is forced to move rapidly from being ‘reactive’ to a ‘proactive’ approach.

Patient Centered Care (2010-2016)

Consumer Engagement (2014-2020)

Science of Prevention (2018-2025)

From

To

From

To

From

To

Physician-centered

Patient-focused

Uninformed

Informed, shared decisions

Basic health management

Genome-linked life plan

Transactional, isolating

Care team managed

Limited engagement

Highly engaged/ empowered

Symptom treatment

Monitoring and prevention

Sick-care

Health and well-being

Isolated individual

Socially connected

One-size-fits-all

Personalized therapies

Inaccessible

Convenient and 24/7

Limited consequence

Financial rewards/ incentives

Limited biomarkers

100% accurate diagnostics

Patient turnover volume

Patient health value

Bricks, office hours

Virtual, mobile, Anytime

Big pharmaceuticals

Tailored gene/ microbiome therapies

Unwarranted variation

Evidence-based standard

Physician opinion

Informed shared decisions

Medical competencies

Life, social,and ethics ompetencies

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What is ‘Digital health’ – it means so many things to so many people. It really is the collection, analyses and effective action on data for ensuring patient / customer outcomes.

Data Acquisition

Data Maturation

Collection

Organizing and Storing

Finding Insight

• Large volumeconstant feed

• Exploring new connections that did not exist

• Disparate, fragmented • Unable to unify data and look across information multidimensionally • Real-time “constant acquisition” due to volume & velocity

• Real-time, with history and filtered • Format Structured, semi-structured or unstructured • Modelling - From raw to structured depending on source and use

Analysis

• Forward (prediction)rather than historic • Probabilistic rather than definitive

Industry Imperatives

Action Using Insights to change outcomes

• Comprehensive automated data management and integration

• No orchestrated process across R&D value chain

• IT strategy, systems infrastructure, and “best-in-class” process

• Difficulty with outputs

• Security, archiving and audit trial requirements

• Machine automation

• Difficulty with text, language, voice, numerical, image and video analysis

• “Dynamic” data driven decision-making capabilities for all the stakeholders

Process Orchestration Across the R&D Value Chain The need and impact of Digital initiatives across the value chain are rapidly evolving and both business and IT functions are investing in targeted initiatives. Specific touch points within each of the value chain areas are being identified and investments are being prioritised, with each organisation prioritising their focus based on their own strategic imperatives.

• Site Management • Site Visit Scheduling • Site Monitoring • Report Submission (CRF)

• Mobile e-Laboratory Notebooks (ELN’s) • Tracking Inventory & Managing Samples • Workflow / Approvals • Structure Drawing • Bio-Informatics

• Subject Management • Subject Recruitment • Subject Retention • Subject Engagement • Subject Compliance

2. Drug Development (Preclinical) • Animal Ordering & Stock Management • Animal Census Management

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5. Post Marketing Surveillance

3. Clinical Trials

1. Drug Research (Discovery)

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• Patient Engagement & Support • Patient Profile • Medication Adherence • Patient Education • Appointment Assistant • Gamification • Virtual Coach • Survey & Feedback • Adverse Event Reporting

4. Manufacturing & Supply Chain

6. Commercial Operations

• Inventory Management • Warehouse Automation Fleet Scheduling, Route Planning, Dispatch & • Tracking • Field Service Enablement Asset Tracking

• e-Detailing & Marketing Solutions • Digital Asset Management • Mobile CRM Sales Monitoring Tools(Dashboard) • Service Incident Management

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There are several factors driving the digital innovation in the clinical development area.

Demand for Speed • First movers win most of the market opportunities – ‘need for speed’ is becoming a strategic driver • Cost pressures are driving the industry away from decades-old trend of ‘spend’ and pipeline growth Supply possibilities for real time data and analytics • Near real-time data visibility and advanced analytics provided through a combination of AI, automation and other technologies • Cloud based infrastructure and flexibility / scalability allowing strategic collaborations between technology providers and industry Availability of Digital Technologies • Increasingly sophisticated wearables, mobile devices creating the ‘connect patient’ and digital / virtual trials • IoT, digital supply chain etc., allowing the sophisticated detection and delivery Support from Regulators and Government • Regulators are adopting and encouraging digital approaches – e.g.,

RBM, Sentinel, Digital Health Unit establishment within CDRH (Center of Devices and Radiological Health) • Continued commitment to standards, consortia to drive technology adoption, data transparency.

It is critical to overcome some of the key barriers that limit the broader adoption of digital approaches by pharma, some of which are highlighted below.

Unclear Business Benefits Most initial deployments were used to reduce cost and improve efficiencies; defining business value will be key to extending into areas such as new revenue streams & customer experience

Lack of (Business & IT) Leadership Formal responsibility for IoT rarely exists and diffused accountability is limiting traction and scaling, delaying the time to capture the value at stake

Time to Experiment / Innovate The unprecedented pace of change makes it difficult for many organizations to carve out the time to think “out of the box” and create new value generating solutions

Complexity The volume, velocity and variability of data combined with hybrid vendor environments and the convergence of OT & IT solutions can seem overwhelming to organizations

Digital-organization-Maturity-Model

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Digital transformation means a cultural shift within organisations and we have seen it have a sustainable impact if driven by the C-level leadership. Traditional organisation structures and skills within pharma may not alone be able to

design and implement the changes needed to drive digital initiatives.

Several model organisation structures are possible, but organisations need to identify the most optimal structure that will fit their vision, culture, investment / business case plans and

may also move from one structure to another as they become more mature as a digital organisation.

A step by step approach would allow organisations to ‘walk, run and then fly’ in a phased manner.

• Proof of Technology • Reusable components • Test labs • Industry Best Practice

• Mobile/Social Partnerships • Governance Model • Engagement Models

• Digital COE • Factory Model • Enterprise App Store

• Process Excellence • Domain Centric BA team

Competitive

Re-building your existing processes to fit seamlessly into the mobile paradigm

Get Started

Enabling existing needs on a mobile devices

Metamorphosis of business models catalysed by new age mobile innovations (NFC, AR..)

Convergence of SMAC forces to make that digital leap

AUTHOR BIO

• Mobility Products • Rapid Prototyping • Innovative Engagement Models

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Over two decades of experience in Life Sciences – functional domain and technology consulting, advisory services and P&L management.

Instrumental in building Tier 1 LS consulting and functional BPO services for Infosys and Cognizant Life Sciences, USA. PhD in Bioorganic Chemistry from University of Kentucky and Harvard Cancer Research Fellow with over 20 publications and 1 patent.

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Lead the Competition

• Innovation Hub • Digital Experience Center at Offshore

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FUTURE OF HEALTHCARE WORK IN SOUTHEAST ASIA

In this interview, author shares his perspectives on how we have moved from the ‘face-to-face’ age to the information age of healthcare and shares practical advice on how healthcare organisations can use simple and uncomplicated technology solutions to improve patient-care delivery in an increasingly digitalised world.

Eric Dadoun, Chief Commercial Officer, Silverstreet

How has consumer behaviour changed in the last 5 years in terms of engaging and communicating with healthcare organisations?

Communication as a whole is changing. Consumers now expect a frictionless and fast experience regardless of the organisation they might be engaging with. The introduction of mobile phones, especially smartphones, have changed the way people communicate and there is a paradigm shift in service delivery as people are integrating new technologies in communication. In the case of healthcare organisations, this might be something as complex as accessing test results and medical updates via a secure online interface or as simple as checking into the doctor's office or hospital more quickly.

The daily business of health relies on information and communication and increasingly on the technologies that enable it. In the last five years, we have moved from the ‘face to face’ age of healthcare to the ‘information age of healthcare’. Healthcare Information and Communication Technology (ICT) has the potential to modify the way in which people use health services. Consumer expectations has also changed as a result. Now, there are patients who want to determine their own health needs via advice on the internet or other technological interface and increas-

ingly want faster and more person-centred services from healthcare providers. Our desire for ‘more’: be it better and easier communication processesor an overall improved customer engagement experience is only going to increase in the years to come.

Healthcare organisations are beginning to see the value of using automation to reduce administrative burdens and improve patient-care delivery. Given that Silverstreet has expertise in the healthcare sector, could you share with us how automation is able to improve outcomes?

Could you also provide case studies as an example?

The term ‘automation’ tends to be conflated by the technology we see in sci-fi films and TV. However, we don’t need to let our imaginations get too ahead of us. Automation does not need to be unnecessarily complicated and can bring about practical benefits. Take Short Messaging Service (SMS) for instance, it is ubiquitous, customisable, rapid, automated, and relatively low cost. SMS is regarded as relatively nascent but it has become a focus of healthcare researchers and recommended to use by leading healthcare organisations such as the World Health Organisation1.

1 http://apps.who.int/iris/bitstream/handle/10665/75211/9789241548465_eng.pdf%3Bjse ssionid=9830BC589B71C5003D2BCB6EF15BCB22?sequence=1

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By implementing very basic messaging systems to remind patients of pending appointments, we have seen some of us healthcare customers reduce no-shows by up to 30 per cent. This is a massive improvement in time allocation for their in-clinic staff which can be redirected to focus on other parts of the patient-care delivery process. Non-attendance for appointments in healthcare results in wasted resources and disturbs the planned work schedule.

Another prime example of useful implementation of automated messaging systems are automated reminders for older patients to take their medication at set times throughout the day. As more people live longer, levels of multi-morbidity have increased, leading to more complex medication regimes. Non-adherence can have serious consequences, including hospitalisation and death. Forgetting what to take and when is a commonly cited reason 2 for non-adherence. The significance of having these reminder systems as interventions grows bigger given that Asia is dominated by ageing populations. Asia is expected to be home to over 60 per cent of the total population aged 65 years and older worldwide by the 2030s.

A narrative literature review in 2018 3 systematically reviewed the aggregate impact of these automated SMS reminders on health outcomes and it was found that the text messages are an effective reminder mechanism to improve patient appointment and medical compliance.

These aforementioned concepts are very straightforward that can have an immediate impact on hospitals, clinics and patients alike. On a base level, automation with an impact does not need to be complicated or scary.

In our opinion, the next step in patient-facing automation would be the chatbot technology which will open up a world of healthcare solutions such as ongoing health monitoring, assisting healthcare professionals retrieve patient records as well as providing information and support to patients.

On an organisation level, what are your predictions of health IT trends, especially in the field of communications, in 2019?

Healthcare IT trends are largely tied to major shifts in technology, concerns of cost, quality and access, changing needs and preferences of patients or market incentives. A key role of healthcare ICT is through enhancing care delivery and engagement with patients.

The year 2019 will begin to see a blur between healthcare and IT providers as they work hand in hand to ensure accessibility and affordability of care. One particular trend in the field of communications are voice solutions. We already

2 https://www.ncbi.nlm.nih.gov/pubmed/15175485 3 https://www.sciencedirect.com/science/article/pii/S2214782918300022

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witness tech titans such as Amazon and Google developing targeted voice technologies that could be used well in a healthcare setting. Practical voice solutions in the healthcare industry will gain increasing prominence due to aggressive competition in Research & Development (R&D) from these tech giants. Singapore itself is encouraging innovation in targeted voice technologies from chatbot providers so that these chatbots can be customised to understand the Singapore healthcare system.

However, the healthcare industry still has a long way to go in terms of optimising its communication engagement with customers whether it is through some of the previously discussed base level concepts or more high level chatbot and AI type solutions. Weâ&#x20AC;&#x2122;re thrilled as we see a lot of willingness from healthcare professionals to engage with us on these discussions. There also appears to be a deep understanding within the industry about the benefits these solutions can bring both to them and their patients. We expect to see healthcare institutions continue to seek out ways to give their patients a personal, informative, secure and pleasant experience through automated communication platforms.

What are some recommendations for a healthcare organisation to set itself up for mobile success?

Take it step-by-step! Having the right partners on board to be a change agent is key in restructuring health information management systems. Work with these partners to understand where your pain points are and find out what solutions are available to address these pain points. Ask yourselves a series of questions, â&#x20AC;&#x2DC;Is it efficient?, Is it convenient?, How do we connect to it?â&#x20AC;&#x2122; and ground these conversations in the context of the healthcare industry you are in as well as the objectives of the organisation. The best way to move forward

INFORMATION TECHNOLOGY

is to tackle foundational issues first that can be resolved on a base level before discussing more complex topics such as chatbots and digital security. It is best to guard against adopting any new type of technology before knowing the true capacity of your healthcare IT systems now.

Implementing a mobile healthcare system is complex and requires ongoing discussions and multiple levels of review. It is best to tackle it one level at a time.

Over the past few years, the word ‘chatbot’ has become a buzzword in the tech industry and industries that handle large volume of human interaction, such as in healthcare, are primed to see the largest benefits. Could you share more on the adoption of chatbots by hospitals? What were the responses from consumers and healthcare workers alike?

One of the biggest problems with chatbot adoption is that it has become a buzzword, as you said, and with that comes a lot of hype. Chatbots are not here to solve all of our problems yet as that’s simply not how the technology works. Chatbots and Artificial Intelligence (AI) are just like a newborn baby; they need time to absorb information, learn from that information and generally become smarter.

As a retail and enterprise industry, we are at the newborn stage of chatbots and AI in terms of its capabilities. Instead of trying to convince our partners that these platforms can

solve all of their problems, we are focused on initial point of engagement with customers and patients.

Communication flows such as appointment scheduling / rescheduling, general FAQ about the clinic or about a particular condition and other such Q&A type processes can absolutely be accomplished by chatbot technology and this is the initial point of engagement we are encouraging our partners to focus on. It gives customers and patients easy access to important information and flows while allowing the healthcare staff on the other side to better allocate resources to more critical tasks.

As the technology matures, we will be looking at deeper implementations. For now, there is a lot that can be accomplished in terms of reducing friction and improving efficiencies within the various daily contact points for both patients and healthcare staff.

The Singhealth cyber-attack last year where 1.5 million patients had their medical records stolen was a wakeup call for the healthcare industry to not regard cyber security as an afterthought. In your professional opinion, how are health organisations doing so far in terms of managing cyber security?

There is an increasing awareness of the importance on cybersecurity but there needs to be practical steps beyond just awareness.

�e Professional Approach

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INFORMATION TECHNOLOGY

While there is no bulletproof solution for all cyber security issues, there are various strategies that can be implemented and, at the very least, minimise the likelihood of victimisation. This is especially important in the field of healthcare which also follows the adage that ‘prevention is better than cure.’ Two-Factor Authentication (2FA) is an easy to implement solution in various points of the healthcare process that can offer patients and healthcare professionals a greater sense of security while limiting some cybersecurity attacks that the industry is faced with.

As is the case with all technology, 2FA does not need to be expensive or complicated. In fact, I would argue that it is the responsibility of service providers to make it as easy and cost effective as possible so much so that the healthcare industry is able to justify making this part of their larger cybersecurity strategy.

How does an organisation deal with the ever evolving and increased threat of cyber-attacks?

Simply put, there is no silver bullet that will guarantee protection against any and all future hacking attempts. The unfortunate reality is that hackers are working to improve their breaching tactics in spite of the best efforts of service providers and enterprises to secure these systems. This is an on-going fight that is expected to escalate in the years to come as our world becomes increasingly digital.

That said, consistent and frequent reviews of an organisation’s systems are critical in identifying potentially weak areas so that strategies to secure the system can be developed. It is absolutely critical to keep up with the latest news and updates, be it from other successful hacks or industry events, as part of an ongoing learning process.

Eric Dadoun

is the Chief Commercial Officer of Silverstreet and brings a world of knowledge, relationships and experience with him built on 15 years in the startup, tech and business world.

He plays an integral role at investment firm, Impiro, and helps Silverstreet, its portfolio company, drive partner relationship development, strategy and new initiatives.

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Could you share some practical advice for healthcare organisations to shore up their cyber defences to safeguard sensitive information?

I would recommend working with industry professionals to understand where and how 2FA is able to be implemented to improve base level security issues. It is critical to understand that 2FA is simply one layer in what must be a much larger cyber security strategy.

Nevertheless, there are implementation options for this technology so that it can be made as frictionless as possible for patients while eliminating some of the more common hacking and breach issues. There is no ‘one size fits all’ approach so it is best to work with those around you to understand what this technology can do, how it can fit your organisation and implement some of the best strategies to shore up defences.

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Digitalising Healthcare in Asia-Pacific What kind of healthcare trends do you see in the Asia-Pacific region?

In Asia-Pacific, an estimated 1.1 billion people are expected to be above 50 years old by the year 2025. This region is home to more than 50 per cent of the global population and they account for nearly two-thirds of the global disease burden from major chronic respiratory diseases.1 Right now, the demand for healthcare outstrips the supply of skilled medical professionals. Supply is especially low in rural areas.

In India, for example, 65 per cent of the population lives in rural areas, while only 2 per cent of doctors are available in the countryside. 2 This poses major challenges for our healthcare systems. How can we make healthcare accessible to the growing and progressively ageing population?

Digital technologies and big data will play a key role in tackling these challenges.

openness to digital means. India, for example, has the highest proportion of digital talent3 in the world and the government is implementing various national policies to promote entrepreneurship and digital adoption. The digital boom in China has certainly transformed multiple industries, including healthcare. People are very open partly because there isnâ&#x20AC;&#x2122;t much history to destroy before introducing something new: for example, China went straight from cash to digital payments and skipped credit and debit cards for the most part.

At Siemens, we launched our fully integrated Siemens Digitalisation Hub in Singapore last year. It is the first of its kind in the world and the ideal place from which to serve the digital needs of our customers throughout Asia and beyond. The hub will support the digitalisation efforts of companies in Southeast Asia's urban infrastructure, industry, and healthcare sectors.

How does digitalisation contribute to delivering high-value care in Asia-Pacific?

Digitalisation in healthcare holds great promise. It can help to overcome many of today's healthcare challenges, allowing providers to improve outcomes while saving resources and putting patients into better control and management of their own health. For this region in particular, it has the potential to make healthcare more accessible. Tele-consultancy is one example, where cost can be saved and access increased.

Simply put, the patient does not need to be where the doctor is. Connecting digitally saves travel time, cost and burden for the patient who may not be fit to travel in the first place.

A patient may be scanned on a CT scanner in a remote area while a skilled doctor elsewhere could then evaluate the data. Such a concept is meaningful in places where there are remote populations that do not easily have access to care, such as in the Philippines, Vietnam, India, or China to name a few. That means, high-end services and expert knowledge can be centralised and accessed remotely.

Please tell our readers about Siemens Healthineers AI-Powered Solutions, and the capabilities that it brings onboard.

The ultimate goal of Artificial Intelligence (AI) is to assist in providing better care for patients by transforming data into knowledge and actionable insights. We have been involved in the field of Machine Learning since the 1990s. This is reflected by more than 500 patents in the field of machine learning, 75 basic patents in the field of "Deep Learning" and more than 40 AI-powered systems already in clinical routine. Developing solutions for managing this ever-increasing workload is a crucial task for the healthcare sector. Chinese hospitals can be extremely crowded and the workload of the doctors can be dauntingâ&#x20AC;&#x201C;the average daily patient throughput for a CT can be 150 per day and the doctor may easily need to read around 20000 images per day. That is far more than double the amount of some other countries. Diagnostic experts and physicians need a new set of tools that can handle large volumes of medical data quickly and accurately. This would allow for more objective treatment decisions based on quantitative data and tailored to the needs of every patient.

To provide this new toolset, we need to draw on the power of AI. A specific example is our AI-Rad Companion Chest CT,4

How fast will digital means be adopted in Asia? What are your expectations?

I believe Asia will be the place where Digitalisation happens faster than anywhere else in the world. There is a need for affordable and accessible healthcare, coupled with the availability of digital talent, government support, and 1 MedTech Asia McKinsey report Dec2015

4 AI-Rad Companion is pending 510(k) clearance, and not yet commercially available in the United States and other countries

2 The World Bank

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3 NASSCOM - Indian Start-Up Ecosystem Report (2016/2017/2018); NASSCOM Accelerator/Incubator Report (2017); Capgemini - The Digital Talent Gap Report(2017); KOL Interviews

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an intelligent software assistant for radiology, which can identify organs and potentially disease-relevant changes in the chest. AI-Rad Companion Chest CT is a tool that can simultaneously increase productivity and quality in diagnostic radiology.

ELISABETH STAUDINGER

Which new applications are the most exciting in the digitalisation arena?

Personally, I find the concept of a “Digital Twin” very exciting. Siemens Healthineers is pursuing an ambitious vision–that someday there will be digital twins of individual patients’ entire bodies. These digital companions are intended to be more than just sophisticated anatomical models. In addition to a patient’s clinical information, they could also contain cellular, molecular, and genetic information. If a patient’s physical condition is already known ahead of time, physicians could decide whether a specific drug would be likely to help and at what dosage it should be given. For example, computational modelling of heart function using Artificial Intelligence facilitates extensive, interdisciplinary integration of patients’ clinical data into a Digital Twin of their heart.

The latter can then be used for prognosis and even therapy planning. The Digital Twin helps gain a better understanding of a patient’s disease, predict its course, and even test various types of intervention. The vision is of a life-long, smart Digital Twin that will learn continuously and stay up-to-date with each new batch of clinical data.

How will digitalisation change the way providers themselves interact with each other?

We believe that digitalisation and the associated networking of healthcare providers are essential for the transformation to value-based healthcare. With the Siemens Healthineers Digital Ecosystem, we are providing our customers with much deeper insights than previously possible into the key components that create both clinical and operational value. The main goal of our Digital Ecosystem is integrating and interconnecting data, participants, applications, and services. Imagine the sheer amount of available data. All of a sudden, healthcare providers will not only benefit from insights derived from five hundred but millions of cases. This can be efficient for example when it comes to the diagnosis of rare diseases–where it is crucial to amass a lot of data to identify the best way to diagnose and treat the patient.

Finally, Stephen Hawking famously said, “The development of full artificial intelligence could spell the end of the human race.” Is Stephen Hawking right? Could AI lead to the end of humankind?

Artificial Intelligence and digital means play a key role in the future of healthcare. With the support of AI, radiologists will be able to focus more on what matters: the diagnosis and its impact on the treatment of the patient. It will increase productivity, save resources, thereby enabling more access to care as well. In essence, AI has the potential to strengthen humankind, it will take over the tasks that machines can do for us, and enable us to focus on and spend our time on what really matters: the patient.

With a successful track record in international management roles, Elisabeth Staudinger is one of the few senior female leaders in the healthcare industry. She has worked in Asia-Pacific since 2013 and is currently President of Siemens Healthineers in the region. Her source of inspiration is leading a team of over 7000 people who are passionate about shaping the future of healthcare. She and her team share a common goal: to enable healthcare providers to deliver high-value care.

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Books

CURRENT Medical Diagnosis and Treatment 58th Edition

Selection and Recruitment in the Healthcare Professions: Research, Theory and Practice

Health Care in Crisis: Hospitals, Nurses, and the Consequences of Policy Change

Author(s): Fiona Patterson, Lara Zibarras

Author(s): Theresa Morris

No of Pages: 1904 Year of Publishing: 2018

No of Pages: 379

Year of Publishing: 2018

Description:

Year of Publishing: 2018

Description:

Written by clinicians renowned in their respective fields, CMDT offers the most current insight into epidemiology, symptoms, signs, and treatment for more than 1,000 diseases and disorders. For each topic, you’ll find concise, evidence-based answers to questions about hospital and ambulatory medicine. This streamlined clinical companion is the fastest and easiest way to keep abreast of the latest diagnostic advances, prevention strategies, and cost-effective treatments.

Description:

In Health Care in Crisis, Theresa Morris takes an in-depth look at how this unintended consequence of the Affordable Care Act plays out in a non-profit hospital’s obstetrical ward.

Author(s): Maxine A Papadakis, Stephen J McPhee, Michael W Rabow

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The editors of this collection take a comprehensive look at the latest research surrounding recruitment and selection into healthcare roles. Each chapter is authored by leading experts and, using international case material, the practical implications for workforce policy are explored. They review the key stages in designing effective selection systems and discuss how best to evaluate the quality of selection processes. Evidence from role analysis studies as well as the effectiveness of different selection methods including aptitude and situational judgment tests, personality assessment and interviews are examined. Chapters also cover approaches to student selection and recruitment for postgraduate trainees through to senior appointments.

Finally they highlight contemporary issues in recruitment, including the use of technology, selecting for values, candidate perceptions, coaching issues and how best to promote diversity and widening access.

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No of Pages: 250

Based on ethnographic observations of and in-depth interviews with obstetrical nurses and hospital administrators at a community, not-for-profit hospital in New England, Health Care in Crisis examines how nurses’ care of patients changed over the three-year period in which the Affordable Care Act was implemented, state Medicaid funds to hospitals were slashed, and hospitals were being acquired by a for-profit hospital system. Morris explains how the tumultuous political-economic changes have challenged obstetrical nurses, who are at the front lines of providing care for women during labor and birth.

The Strategic Management of Health Care Organizations (8th Edition) Author(s): Peter M Ginter, W Jack Duncan, Linda E Swayne No of Pages: 528 Year of Publishing: 2018 Description: Strategic Management of Health Care Organizations provides essential guidance for leading health care organizations through strategic management. Strategic Management of Health Care Organizations fully explains how strategic managers must become strategic thinkers with the ability to evaluate a changing industry, analyze data, question assumptions, and develop new ideas. The book guides readers through the strategic planning process demonstrating how to incorporate strategic thinking and create and document a clear and coherent plan of action. In addition, the all-important processes of creating and maintaining the strategic momentum of the organization are fully described. Finally, the text demonstrates how strategic managers in carrying out the strategic plan, must evaluate its success, learn more about what works, and incorporate new strategic thinking into operations and subsequent planning.

Operative Techniques and Recent Advances in Acute Care and Emergency Surgery

Evidence-Based Surgery: A Guide to Understanding and Interpreting the Surgical Literature

Author(s): Paolo Aseni, Luciano De Carlis, Alessandro Mazzola, Antonino M Grande No of Pages: 800 Year of Publishing: 2019

Author(s): Achilles Thoma, Sheila Sprague, Sophocles H Voineskos, Charles H Goldsmith

Description: The aim of this book is to identify and shed new light on the main surgical practices involved in acute care and trauma surgery.

Adopting an evidence-based approach, a multidisciplinary team of surgeons and intensivists illustrate basic and advanced operative techniques, accompanied by a comprehensive and updated reference collection. Emerging surgical procedures in Acute Care Surgery are also explored step by step with the help of ample illustrations.

No of Pages: 360 Year of Publishing: 2019 Description: The purpose of this book specifically is to teach surgeons (academic or community), surgical fellows and surgical residents regardless of the surgical specialty, the skills to appraise what they read in the surgical literature. Surgeons need to be able to understand what they read before applying the conclusions of a surgical article to their practice. As most surgeons do not have the extra training in health research methodology, understanding how the research was done, how to interpret the results and finally deciding to apply them to the patient level is indeed a difficult task.

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Books

Emergency Surgical Management of Colorectal Cancer Author(s): Nicola de' Angelis, Salomone Di Saverio, Francesco Brunetti

Author(s): Salman Ben Zayed

Making Healthcare Green: The Role of Cloud, Green IT, and Data Science to Reduce Healthcare Costs and Combat Climate Change

Contributors: Abdullah Bin Gani, Mohd Khalit Bin Othman

Author(s): Nina S Godbole

No of Pages: 399 Year of Publishing: 2019

No of Pages: 88

No of Pages: 292

Description:

Year of Publishing: 2019

Year of Publishing: 2019

This volume provides an overview of the current evidence-based medical and surgical practice in emergency conditions in colorectal cancer patients.

It offers a multidisciplinary perspective, taking into account the specific characteristics of colorectal cancer patients, the necessary pre-operative assessment, the endoscopic and radiological management, and the surgical treatments.

Description:

Description:

This book presents an advanced systematic mapping review (SMR) and state-of-the-art taxonomy of emergency departments (EDs). Focusing on the patients' level of fulfilment and how it can be enhanced, it examines existing problems like waiting periods and overcrowding and how these can be alleviated to provide a better service.

The author examined research papers from 1964 to 2018, and developed six research questions, organising them using mapping studies, the primary objectives of which were firstly, to obtain a common understanding of the problems that need to be highlighted in EDs, and secondly, to re-analyse the methods used.

This book offers examples of how data science, big data, analytics, and cloud technology can be used in healthcare to significantly improve a hospital's IT Energy Efficiency along with information on the best ways to improve energy efficiency for healthcare in a cost effective manner. The book builds on the work done in other sectors (mainly data centers) in effectively measuring and improving IT energy efficiency and includes case studies illustrating power and cooling requirements within Green Healthcare.

This book is intended for residents and emergency surgeons, as well as all practictioners who treat colorectal cancer patients, such as gastroenterologists, oncologists, and radiologists.and cost-effective treatments.

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Contributor: John P Lamb

Making Healthcare Green will appeal to professionals and researchers working in the areas of analytics and energy efficiency within the healthcare fields.

Data Science for Healthcare: Methodologies and Applications

m_Health Current and Future Applications

Author(s): Sergio Consoli, Diego Reforgiato Recupero, Milan Petkovic

Author(s): Giuseppe Andreoni, Paolo Perego, Enrico Frumento

No of Pages: 367

No of Pages: 140

No of Pages: 400

Year of Publishing: 2019

Year of Publishing: 2019

Year of Publishing: 2019

Description:

Description:

Description:

This book seeks to promote the exploitation of data science in healthcare systems. The focus is on advancing the automated analytical methods used to extract new knowledge from data for healthcare applications. To do so, the book draws on several interrelated disciplines, including machine learning, big data analytics, statistics, pattern recognition, computer vision, and Semantic Web technologies, and focuses on their direct application to healthcare.

This book describes current trends in m_Health technology, systems, and applications. The book proposes a multifaceted view on m-Health opportunities and requirements starting from four aspects: patient, technology, design and innovation.

The analysis is completed by a market segmentation overview and by the most recent research experiences to offer a complete benchmark and vision of m_Health for today and tomorrow. The contributions are based on the outcomes of initiatives on the future of healthcare, funded by the EU in the frame of FP7 and Horizon 2020 and their deployment into real clinical practice. Throughout the book, clinicians, technicians, researchers, and end-users debate their experience, needs, risks, opportunities, and available solutions in this fast moving field.

Medicine has become inhuman, to disastrous effect. The doctor-patient relationship--the heart of medicine--is broken: doctors are too distracted and overwhelmed to truly connect with their patients, and medical errors and misdiagnoses abound. In Deep Medicine, leading physician Eric Topol reveals how artificial intelligence can help. AI has the potential to transform everything doctors do, from notetaking and medical scans to diagnosis and treatment, greatly cutting down the cost of medicine and reducing human mortality. By freeing physicians from the tasks that interfere with human connection, AI will create space for the real healing that takes place between a doctor who can listen and a patient who needs to be heard.

This book is primarily intended for data scientists involved in the healthcare or medical sector. By reading this book, they will gain essential insights into the modern data science technologies needed to advance innovation for both healthcare businesses and patients.

A basic grasp of data science is recommended in order to fully benefit from this book.

Deep Medicine: How Artificial Intelligence Can Make Healthcare Human Again Author(s): Eric Topol

Innovative, provocative, and hopeful, Deep Medicine shows us how the awesome power of AI can make medicine better, for all the humans involved.

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PRODUCTS & SERVICES Company............................................... Page No.

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HEALTHCARE MANAGEMENT

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