Asian Hospital & Healthcare Management - Issue 38

I s s u e 38

2017

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Regulation vs.

Innovation Are We Getting It Right?

Top Challenges Facing IoT/ IoH How we can overcome them?

The Prospects of Cancer Care in Asia Integrated services

Foreword Innovations and Regulations in Healthcare Bridging the Gap Healthcare systems around the world have been grappling with challenges of meeting the ever-increasing demand for better care.

Innovation and technological advancements have played a key role in improving care.

However, innovation does not necessarily limit to new products or technologies. More often than not innovation can happen around organising or executing things, aided by technology.

While care providers have continued to adopt new technologies in the form of modern medical devices and newer treatment approaches, innovation tends to be bogged down in this highly regulated sector. The gap between regulation and innovation needs to be bridged for innovation to flourish and help businesses thrive. The first step in driving innovation to succeed is clear and consistent communication across the organisation. People or teams responsible for innovation need to be in constant communication with legal and regulatory staff.

If the regulatory and compliance challenges are understood and mitigated at the ideation or early stage of a project, there is a better chance of success. From an organisational perspective, healthcare technology innovators can look at some interesting examples.

Companies like Intermountain Healthcare, Kaiser Permanente and Providence Health & Services etc. are known to have established innovation centres in-house to bring forth

key ideas from the staffs that result in both operational efficiencies and improved clinical care, thus benefiting both service providers and consumers.

In some cases, delays in products reaching the patients could also be affected by the knowledge gap between innovators and regulators. Inorderto avoid such delays, regulatory bodies have to take certain measures. The FDA Center for Devices and Radiological Health (CDRH) has taken steps in this direction by establishing mechanisms to provide additional reviewer training via programmes such as the Experiential Learning Program (FDA, 2016b) and the Network of Experts (FDA, 2016c). It is also evident that these measures are not enough and FDA needs to explore new methods for evaluating and regulating products to make approvable products available to patients without any delays.

In the cover story of this issue titled ‘Regulation vs. Innovation - Are We Getting It Right?’, we look at how the regulatory environment has had a significant impact on the introduction of innovative new healthcare products.

Prasanthi Sadhu

Editor

Contents 38

Cover Story

HEALTHCARE MANAGEMENT 06 Managing and Delivering Healthcare Looking forward to challenges R B Smarta, Managing Director, Interlink Consultancy

12 Recruiting Medical Staff It is the culture not the money

Christopher Milne Associate Professor and Director of Research Center for the Study of Drug Development Tufts University School of Medicine

Jeff Thompson, CEO Emeritus and Executive Advisor, Gundersen Health System Samuel E Thompson, HR- Consultant, Gundersen Health system

18 Reactive, Acute Care to Proactive and Preventive Care By engaging patients Tim Morris, Product & Partnership Director, Europe, Middle East, Asia Pacific, Elsevier

MEDICAL SCIENCES 22 Diabesity (Diabetes & Obesity) Newer surgical options shaping up!

Pradeep Chowbey, Executive Vice Chairman, Max Healthcare

28 The Prospects of Cancer Care in Asia Integrated services Yew Oo TAN, Specialist in Medical Oncology, Farrer Park Medical Clinic

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32 Trends in Indian Cancer Market Suresh Ramu, CEO & Co-Founder, Cytecare Cancer Hospital

FACILITIES & OPERATIONS MANAGEMENT 44 Environmental Safety in Hospitals Neven Saleh, Assistant Professor, Biomedical Engineering Department Egyptian University

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INFORMATION TECHNOLOGY 52 Top Challenges Facing IoT/ IoH How we can overcome them?

Kiersey Simon, Co-founder and COO, Bluedrop Medical

56 Books

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Advisory Board

Editor Prasanthi Sadhu Editorial Team Debi Jones Grace Jones Art Director M Abdul Hannan Product Manager Jeff Kenney Senior Product Associates David Nelson Peter Thomas Sussane Vincent John E Adler Professor Neurosurgery and Director Radiosurgery and Stereotactic Surgery Stanford University School of Medicine, USA

Sandy Lutz Director PricewaterhouseCoopers Health Research Institute, USA

Peter Gross Chair, Board of Managers HackensackAlliance ACO, USA

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

Vivek Desai Managing Director HOSMAC INDIA PVT. LTD., India

Product Associates Ben Johnson Austin Paul Veronica Wilson Circulation Team Naveen M Nash Jones Sam Smith Subscriptions In-charge Vijay Kumar Gaddam Head-Operations S V Nageswara Rao

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Managing and Delivering Healthcare Looking forward to challenges The growing demand for the quality healthcare and the absence of delivery mechanisms pose a great challenge, the key growth inhibitor includes fastest growing population and informal costs. Healthcare industry should be able to carry out planning, monitoring and controlling the delivery system in affordable cost. In response new service models, delivery plans, accountability between provider and citizens is essential for effective delivery system.

R B Smarta, Managing Director, Interlink Consultancy

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he growing demand for the quality healthcare and the absence of delivery mechanisms pose a great challenge, the key growth inhibitor includes fastest growing population and informal costs. Healthcare industry should be able to carry out planning, monitoring and controlling the delivery system in affordable cost. In response new service models, delivery plans, accountability between provider and citizens is essential for effective delivery system.

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Affordability

Accessibility

Challenges

Awareness

Quality of health services Figure 1

A healthcare system is the consortium of people, institutions and resources that deliver healthcare services; the sector involves hospitals, the pharmaceutical industry, the health insurance industry and medical technology industry. According to WHO, health services include all services dealing with the diagnosis and treatment of disease, or the promotion, maintenance and restoration of health. The challenge in the delivery of service depends on the way inputs are organised and managed to improve access, coverage and quality of the services to be provided to the users as well as providers. To have a well delivered health services management, leadership plays a crucial role along with good management for quality service delivery and advanced technology

that will bridge the gap of accessibility and coverage of healthcare services to patients for reaching desired health outcomes.

Looking Forward to Challenges

The challenges are faced at each level of system, starting from data management, treatment, patient follow up, providing services, payment, etc. Inadequate quality standard, unfavourable delays in passing the government bills and various reasons make our market commercially unfavourable for indigenous players. The challenges can be enlisted as, • The rising population and awareness is leading to increase in demand of health services • The rising informal cost of health services needs to be controlled

• Affordability of new technology by the common man should be ensured • Focusing on providing quality service to ensure higher customer experience.

Medical insurance plans should be encouraged and out of pocket expenses should be reduced. New government policies should be up taken that will ensure less cost towards health services. Also, focus should be provided towards providing free medical services to patients suffering from diseases like tuberculosis, whereby a common man can afford and take benefits of health services. In case informal costs are enabled then the poor man doesn’t care about health leading to the transmission of the epidemics. Also policies and plans should be made for elderly age group so as to avoid informal costs.

New technologies like Electronic Health Records (EHRs) help in maintaining patient data securely and, whenever needed, the authorised person can view the details instantly like scanning the patient history, prior treatments, which acts as a reference that will help in diagnosis and prescription of medicines quickly.

Telemedicine would help in bridging the gap between the patients and doctors across the world and provide better service from long distance.

The quality of care can be measured looking based on hospital admission rates, patient feedback forms, length of stay, service provided to patients, hospital disbursements, equipment’s and technologies used, physicians visits, outpatient care and spending, home care service and cost, etc.

Health Services the Countryside:

A clear dissimilarity in health status is observed between developed and developing countries, based on mortality rates, including infant mortality, young and child mortality and maternal mortality. With the help of organised plan and infrastructure,

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illnesses can be treated and deaths can be prevented. The account of expenditure spent on health services and quality provided should be accountable and effective management in delivery of health services should be provided.

The needs of rural population are quite different when compared to urban areas. The reason for this may be the difference in geographic, demographic, socioeconomic, workplace, and personal health factors. As we know the urban areas are polluted leading to breathing illness and lifestyle diseases are prominent among urban population. The rural populations mostly include baby boomers, GenX and children below the age 20, as most of the working population migrates to cities for employment.

The healthcare services are provided by public and private sector. Public sector in the healthcare industry is cost effective and affordable and provides services to urban as well as rural regions. The technologies used are not as advanced as in private sector but as per the need of the patients the government tries to cope up. The private sector is a well supplier of quality medical help, but is restricted to the urban populations’ areas and is expensive. Although the demand from rural areas is more they are more profit oriented and since there is no asurety about profit, these providers don’t see rural areas as a potential investment.

information from healthcare providers and significant reduction in waiting time period. In store & forward telemedicine, by means of emails, fax data is provided to the healthcare providers which they can access later as per their time availability. Due to long distance travel, many of the health services are unable to reach rural areas but telemedicine is one of the best ways to deal with it.

Inadequate quality standard, unfavourable delays in passing the government bills and various reasons make our market commercially unfavourable for indigenous players.

Pathway to Impact Healthcare:

The lack of economic investment leads doctors to work in foreign countries.

There should be a way out and we need to standardise all our procedures and build clinics in the rural areas to improve efficiency. Another problem is lack of effective payment and insurance procedure.

Application of Telemedicine in rural areas: Two primary methods are involved in telemedicine: real-time telemedicine, and store & forward telemedicine. In real-time telemedicine the electronic telecommunication allows healthcare providers and patients to send and receive healthrelated information instantly. The most commonly used method for this is videoconference calls. This leads to rural population seeking more

The process of healthcare delivery can be distributed in two parts: behaviour of professionals, and participation of people. Diagnosis of the illness including diagnostic procedure, diagnostic equipments, and treatment consists of recommendation of treatment, follow up to reassess the health. The participation of people includes promotion, advertising, utilisation of the health services, satisfaction with the provided services, and participation in decision making.

In India majority of home healthcare services are delivered by community healthcare workers. The advantage in India is the services are more cost effective just the need is the workers should be effectively skilled.

Now-a-days the joint family system is vanishing, and job and other priorities are leading minimum care being provided to old people sick at home. A pathway can be designed to support people who have experienced a

Overall Pathway to Impact Health System

Budget

Effective and efficient

Delivery system

Health worker productivity, supply management, pocurement

Figure 2

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Levers for change

Facility, equipments, supplies, on time drug supply distribution, waiting time

Impact

Improved care standards and patient satisfaction

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Assessment for needs of patients care to provide home care

Discharge from hospital impending

Onsite / home provision of informal healthcare

Onsite / home provision of formal healthcare

Onsite / home provision of social healthcare

Remote provision of health & socialcare (telehealth)

Enrolment to home care services

Initial integrated care plan

Discharge from hospital

Coordination / revision of intial integrated care plan

Transition into term care service Documentation of home care provided

Monitoring / reassessment of patients care needs Disenrollment from home care service Readmission to hospital

Figure 3

significant ‘event’ such as stroke, MI, or a fractured neck of femur, and illnesses which impact adversely on the person’s ability to live independently. Pathway can be designed focusing on delivering the time-limited interventions to those needful.

The National Association for Home care & Hospice says that 7.6million population is permanently disabled and chronically or terminally ill in the United States, and they receive home care services. The majority of population receiving home care services is over the age of 65, and they need support from someone to take care of them. As time is a limitation, family members are not able to pay enough attention and at such times home care services becomes useful.Also, it costs less compared to hospital stays, and provides access to

a full range of services for people who need medical services throughout the recovery process.

Pathway to Impact Home Healthcare:

This can be divided into three stages.

First is the entering stage, followed by receiving stage, and last, leaving stage. The entering stage may can be subscripted by service user themselves or a family member. The referral is followed by a needs assessment which targets both health and social care needs. The service user is enrolled into the services and an integrated care plan is designed, that includes a formal document that describes the services to be provided and the appropriate intervals. The receiving stage involves the personalised care delivery package

combining informal, formal care; technologies like telehealth can be applied here. Documentation is a vital part of any process and has to be monitored for needs of patient care.

If a case needs medical supervision, then the patient is readmitted to the hospital. The leaving stage involves discharge from the service or transition into term care service.

Management for Delivery of Health Services:

Hospital organisations and other health care firms have to deal with complex structures and situations in order to develop and impart strategies that will lead to positive change.

The determinants of organisational performance consist of three variables: strategies, implementation

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Strategies

Organisational Performance

Environment

Implementation Capability

Figure 4

capability, and environment. Before implementing strategies, it is important to know the root cause of the problem. Organisation can improve health outcomes by applying strategies at various levels, starting from own system management and at the level of individual health facilities. Reducing the waiting times of patient at health centres will save time of every individual involved in process. The following points can be applied for the same: (1) retraining and skilling the registration and medical records clerks, (2) relocating the cashiers, (3) adding up general practitioner, and (4) establishing a clinician for triaging the most severe cases to the emergency area and retaining the less severe cases in the outpatient department. Applying innovative strategies to improve service delivery such as new community-based organisations and workers, facility autonomy, results-based financing, and new information technologies will help in strengthening the healthcare system.

According to the WHO, health services are people centred and inte-

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grated, and are difficult to achieve.

They support countries in implementing and developing policies, reforming strategies, designing and formulating guidelines. Patient centred services include diagnosis and treatment and other clinical aspects of healthcare services, whereas integrated health services involves management and delivery of safe and quality health services. Designing the pathways for various healthcare services by assessing the needs of healthcare providers and expectations of users, applying them in day-to-day life will make processes smooth and easy to follow. Integration of modern technologies like EHR, telemedicine in health services will save time, and provide excellent service to healthcare users.

References are available at www.asianhhm.com

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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Recruiting Medical Staff It is the culture not the money

It is the Culture not the Money. The competition to recruit, and the great advantage to permanently retain the best medical staff is not accomplished by money or flashy perks. It takes clarity of purpose, lived values, and real communication.

The payoff is efficiency, quality and growth.

Jeff Thompson, CEO Emeritus and Executive Advisor, Gundersen Health System Samuel E Thompson, HR-Consultant, Gundersen Health system

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ngagement starts before the first day of work. The competition to recruit and the great advantage to permanently retain the best clinicians is not accomplished by money or flashy perks. It takes clarity of purpose, lived values, and real communication. The payoff is efficiency, quality and growth.

The shortage of high quality medical staff can be a crushing blow to a strong hospital or health system.

Even in times of plentiful staffing, the highest functioning and most collegial providers may be in short supply. Your ability to compete, grow and serve the mission of improving the health

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and well-being of your communities will be impossible without a highperforming engaged medical staff.

There are many who are seduced into believing that it's all about the money. All I need to do is pay big and out - 'perks’ the competition and then you'll be in the driver seat. The data would imply that money is a week glue. Although you may be able to recruit some high performing staff members their ability to deeply engage in the broader responsibilities of the organisation will be limited if the only hook is their paycheck. Similarly , better benefits are attractive and can get people interested but studies show that not only are pay and benefits just a baseline consideration that ultimately will not keep great staff engaged, it also leaves you vulnerable to a bidding war with other like-minded big pay for your talent strategists.

Researchers would point out you do need adequate pay that is viewed as fair and responsive to both economic pressures and individual accomplishments. The benefits package has to be generally competitive and consistent with a long-term view of being part of a strong organisation.

These are necessary but not sufficient.

The pathway to much stronger recruiting and retention is not complicated it is just very hard It doesn't start in the interview room it starts in the boardroom. Clarity is needed from senior most levels of the organisation. What are the goals and priorities of the organisation? Why does the organisation exist? What is the long-term vision and plan? What will be the priorities for both short and long term? All these are important part of attracting individuals who are more likely to help lead your organisation to greater success.

If your goals are about crushing the local competition, or being 1 per cent better than you were before, or being a little bit better than your mediocre peers, it will not be inspirational for

The competition to recruit, and the great advantage of permanently retaining the best medical staff is not accomplished by money or flashy perks.

anyone. And it certainly will not be inspirational for the brightest, the best or the hardest working. These natural builders that you want to become interested and engage will look deeper at your organisation.

If your purpose is clear and the vision of how far you want to go in accomplishing that purpose is inspirational, the next piece to be consistent about is the environment they will be working in. Notice that

we still haven't talked about how much money they're going to be paid, the call schedule, or the benefits. Of course these will be important and they all need to be discussed but if you're aiming for builders that will help lead the organisation forward, then we need people that are interested in what the values are and the likelihood that those values will be lived every day across the organisation.

You don't need a totally unique set of values. It is not the words… it is the consistency of action. They should be clear, understandable, defined, and most importantly, have a path forward to have them lived by everyone (especially the top most leaders) Insightful candidates will figure out pretty quickly if your values say compassion but the staff don’t treat each other well so it’s unlikely they'll treat the patients well. If the value is respect and no one treats anyone with respect but it’s all rank based behaviour they will figure that out immediately.

If integrity is one of the values listed , and the candidate is told to be careful about the contract because the front office can't be trusted, it is unlikely you'll be able to recruit or engage the

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best. The best performers have options they can go to; in order to really distinguish your organisation you need to be clear about your values and then live them consistently through recruitment, orientation, evaluations and every day practice.

Many organisations have written this down so that it can be implemented, not just talked about.

They developed a document called a physician or medical staff compact.

This is not a contract but it is a clear pathway for those looking to start their career or build their career.

The organisation promises to deliver all those things on the left side and

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expects all of the medical staff to live those things on the right side of this document. This is a promise by the organisation and a clear request and expectation of the staff. It has been argued that these rules will limit interest and creative physicians might not come to an organisation or stay engaged.

That is not true. The highest performing, most creative physicians want to know where the guidelines for behaviour. They are interested not only in how they must behave but how they'll be treated, how their staff will be treated, how their families and patients will be treated.

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So now you have built a pathway for physicians where the organisation sets high outward looking goals that serve a greater purpose, that aim for excellence, and internally, it is known how everyone is going to behave. Staff will be supported by the structure and clear promises from the organisation but they will also have an obligation to serve the mission and behave in a way that is healthy for all.

There is no intention to imply that it is easy to live these values or deliver consistently on the compact.

You may have a high-energy member of the medical staff team who behaves very badly despite great quality

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outcomes, a tremendous work ethic and innovation well ahead of the curve. But they are so disruptive to other medical staff members and the support staff that there is a constant stream of complaints. Often senior leaders in healthcare have looked the other way and put a Band-Aid on the problem that needed major surgery.

Short-term thinking would suggest we can just ignore this and move on, the clinician is too valuable to risk making them unhappy. But a longer-term and deeper look would show, and the data would support the fact that this type of behaviour affects the functioning of other medical staff members, the nursing staff and ultimately leads to dissatisfaction, retention and quality issues in an ever expanding circle. It is not complex‌it is just very hard to keep that promise made by the organisation in the compact. It takes courage to be clear about your values and address them. It takes discipline to stick with your compact and your guidelines even when there are some compelling financial and even shortterm patient care issues that may seem negatively affected. And finally you need durability. When you make these hard decisions for a long-term plan there are always short-term consequences that are going to result in you getting a great deal of push back.

Building up that durability through consistency and connections with like minded leaders will be an important part of your work.

As important as these cultural buildings are, however, they are insufficient without several other factors.

Leaving communication to a chain of command is a very bad idea, it is an antiquated leadership style and has never been effective in business or healthcare. The chain of command is often the weakest link in a communication cascade. You need to strike a balance on what is the responsibility of the organisation

and what is the responsibility of the staff member. What is expected of the organisation is clear communication in a timely fashion placed in multiple areas of access. The responsibility of the staff is to access the information online, in person, or written forms of communication that are offered.

It is a dual responsibility. Of course, the medical staff is busy, of course they are burdened with many tasks and responsibilities, but they have to take part of the responsibility to avail themselves of the communication offered.

Along with responsibility to be clear comes the responsibility to manage change. The compact clearly states that you expect the medical staff member to engage in change management and be a leader in constant improvement.

You lose the staff and their insight if the organisation doesn’t take seriously the responsibility to use those procedures and tools that will help them thrive and not be crushed as the pace of change increases. This is a huge distinguishing feature between great organisations and failing organisations.

It will be a competitive advantage for

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Leaving communication to a chain of command is a very bad idea, it is an antiquated leadership style and has never been effective in business or healthcare.

current state, very similar to a physical and history. It asks to collect data to support your position much like looking at lab and x-ray material. It asks you to describe the future state and reevaluate the changes you make on your way to that future state. It is very consistent with how clinicians, nurses and pharmacist train and makes for an easy transition to a staff building rather than staff crushing improvement projects.

Finally organisations that function very well invite the medical staff to be a part of the leadership. Engaging them rather than battling them results is better outcomes for all. The models may vary: physician CEOs or not, physicians highly represented on the board or not. The key is not who has what title. The key is to build a great

Author BIO

those who can learn how to improve the efficiency of the staff again. Longterm, not short-term, thinking is what is needed. Short-term thinking would say ‘we don't want to take her out of clinic to learn these computer things, I am sure she will do fine learning along the way.’ You save a few dollars but end up with a frustrated, less efficient staff for months or years. Short-term thinking would say ‘no we don't want to add another medical assistant because of course that would add some costs’, but if adding one medical assistant increases the efficiency of the medical staff member by 30 per cent or 40 per cent then the cost differential is insignificant to the benefit in both quality and revenue.

When you look at studies about medical staff burn out and dissatisfaction with the job, they rarely lead with “I’d like my benefits 2 per cent richer”, they talk about the persistent struggle of change and support to help accomplish the levels of quality and efficiency they hope to meet.

One of our key responsibilities is to give staff tools to help manage this rapid change and the constant drive for improvement. Lean management systems have taken a lot of negative press with the weak comparison between building cars and fixing people. To the contrary, around the world, there is a growing number of high performing healthcare organisations proving you can engage staff, lower costs and improve quality at the same time.

(Look at Catalysis https://createvalue. org/) Lean management practices can engage the front line all the way through the medical staff. They are simple to use and many of the tools are based on parallel principles that clinicians learned in medical school.

For example, the A3 improvement tool can be used by anyone with any background but is engaging enough to have the medical staff quickly participate in improvement projects.

The form asks you to describe the

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environment for all staff, including the medical staff. If the medical leaders are willing to do that…then invite them in and the leadership team will be strengthened by their commitment and insight. The rest of the staff will be watching so the governance needs to demonstrate that the organisation is moving to serve the broader purpose, it's accomplishing it's major goals and that it's living by its values.

Several themes emerge from this description on how to build an environment that's more likely to recruit and retain your clinicians.

First a dual responsibility on the part of the organisation and on the clinician to agree to set broad goals focused on something bigger than themselves or their pocketbook.

Next, a set of values that are both clear, concise and consistently lived across everyone in the organisation.

A communication and improvement environment that is effective, efficient and improves (not burns) the life out of the staff member.

Finally , senior leaders chosen by their actions consistent with the purpose, goals and values and less so by their previous background or title.

The competition to recruit, and the great advantage of permanently retaining the best medical staff is not accomplished by money or flashy perks.

It takes clarity of purpose, lived values, and real communication. The payoff is efficiency, quality and growth.

References are available at www.asianhhm.com

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 Gundersen’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 Gundersen’s boards beginning in 1992 and was chairman of the board from 2001 to 2014.

“Lead True, Live your values, Build your people, Inspire your community”

A market intelligence leader delivering research and consultancy for the Global Healthcare Industry

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Reactive, Acute Care to Proactive and Preventive Care By engaging patients

Healthcare systems around the world are recognising the need to move from fee-for-service to value-based healthcare. This requires a focus on raising the quality of care as the driver towards value rather than pure cost reduction, as well as engaging the patient. It requires a shift in understanding that patient engagement is no longer the thing to do after the patient has visited the hospital, but should be implemented from the very beginning, before they visit the hospital, and even taking it further back to managing population health.

Tim Morris, Product & Partnership Director, Europe, Middle East, Asia Pacific, Elsevier

H

ealthcare systems around the world are recognising the shift from reactive, acute care, to proactive and preventive care.

This comes at a time when countries are facing the challenges of an ageing population, which in turn has an impact on the healthcare system with potentially unsustainable rise in healthcare spending. Japan, Korea,

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Australia and Singapore are some of the fastest ageing nations in Asia, and these countries are also experiencing a transformation from fee-for-service to value-based healthcare.

Ensuring that healthcare systems continue to be sustainable, would inevitably require better quality and more cost-efficient healthcare services. As patient expectations rise, accessing and

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coordinating care in an appropriate and timely manner for the best outcome for patients is becoming more complex and difficult every day. This requires a focus on raising the quality of care as the driver towards value rather than pure cost reduction, as well as engaging patients. It also requires a shift in understanding that patient engagement is no longer the thing to do after the

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patient has visited the hospital, but should be implemented from the very beginning, before they visit the hospital, and even taking it further back to managing population health.

Challenges in Today’s Healthcare Landscape

It is not only the cost of healthcare that we must consider – today’s healthcare challenge is also the changing nature of illness, with the disease burden shifting from infectious to chronic diseases. The World Health Organization (WHO) estimates that 50 per cent of the global burden of disease is chronic illness.

Chronic disease is also a significant concern for countries in Asia, such as Singapore. One in nine Singaporeans

have diabetes, and the numbers are expected to grow due to a rising obesity levels, and a lack of physical activity and a healthy diet. For similar reasons, China is experiencing a growing burden of cardiovascular disease, a chronic disease that has been on the rise for the last 20 years and now the leading cause of death in the country.

Chronic diseases require a different approach that factors in the complexity of the illness and frequent requirements for proactive and planned integrated care within a system that patients can navigate. If unmanaged, such chronic conditions frequently lead to poor patient outcomes and hospitalisations that are key drivers of costs to healthcare systems.

Increasingly, patients too are demanding more clarity and information from their healthcare providers regarding medical diagnosis and treatment, as well as or from the Internet of Health Things (IoHT), to allow them greater control on their health and wellbeing.

Another obstacle to delivering value-based care is the overwhelming magnitude of medical information and the ability to process all the knowledge into actionable steps for better patient outcomes. By 2020, medical information is expected to double every 73 days.

If physicians were to read everything of possible biomedical relevance, they would potentially need to read around 6,000 articles a day.

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The burden of information overload and the expectation from providers to rapidly incorporate all relevant evidence into practice is likely to negatively impact the quality of care and result in poor and even catastrophic outcomes for patients.

Damage Caused by Variability in Care Delivery

Standing in the way of high value care is variability. Variability in care delivery means that a subset of patients (often a large subset) experience poorer clinical outcomes while paying the same healthcare expenses. Variability in care delivery also leads to spending with reduced benefit. Variability in healthcare takes many forms, but it can be segregated broadly into knowledge and operational variability.

Knowledge variability poses the greatest threat to the quality and cost efficiency of health and healthcare delivery, and is more challenging to identify and address. With an explosion in the rate of medical information

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growth coupled with the slow adoption of research findings into clinical practice, more often than not physicians don’t know what they don’t know.

Operational variability is when healthcare systems, physicians, nurses and other clinicians deliver care differently and, as a result, experience variations in outcomes. Variability arises, for example, when a physician’s handwriting results in the nurse or pharmacist misreading the prescription and compromising the patient’s safety.

The complexity of today’s healthcare system means that not all operational variability is so easily countered. As healthcare reform drives us from acute, reactive care toward proactive, preventative care, operational variabilityand the clinical and financial risk it generates-is prone to metastasising.

One of the primary reasons is the care itself is rapidly moving out of traditional settings, such as hospitals and physician offices, to large retail pharmacy chains, and patient homes. The roles and

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responsibilities of providers are also expanding, with greater clinical care responsibilities shifting to nurses and to patients themselves. Such a rapidly changing, multiple-provider system creates room for operational variability and subsequent patient risk and cost inefficiency.

Fortunately, today’s technologies represent a great leap forward in accessing high-value care information and guidance at all points of care. Within traditional care settings, integrated Electronic Health Records (EHR) systems can reduce some operational variability. But in reality, EHRs serve only as a vehicle to deliver current, credible, evidence-based information. In order to truly address new challenges appearing as our entire healthcare delivery model evolves, Clinical Decision Support (CDS) is the most impactful answer to the vast and destructive problem of variability in care delivery.

CDS solutions deliver evidencebased and current information specific

HEALT HCARE MANAGEMENT

to the patient’s clinical history to the physician, enabling him or her to make the best decision. One such example is clinical pathways. While definitions and approaches to development are numerous, a commonly shared goal of clinical pathways is the longitudinal reduction of operational variability as patients move from care setting to care setting and from provider to provider.

The World Health Organization (WHO) estimates that 50 per cent of the global burden of disease is chronic illness.

‘Push & Pull’ CDSS

They can be added in a modular fashion – order sets, reference solutions, care plans, drug information, and nursing skills.

The Multiplier Effect

Even with the best physicians, nurses and ‘push’ and ‘pull’ CDS solutions in place, if patients are not engaged and invested in making decisions about the care they receive, then the cost of care is still going to increase. Discharged patients who do not take their medications, do their physiotherapy, will be readmitted. This can have a multiplying effect on costs, hospital beds and mortality.

It is important to transfer that awareness of care consistency to patients as well, standardising their approach and letting them understand the care that they should be given.

There are many ways to educate and engage patients. There are interactive and ‘entertaining’ online tools, which use videos and cartoons to make boring information interesting to read or watch.

One such example is Health Nuts

Author BIO

The majority of today’s CDS are ‘pull’ solutions (clinical reference and diagnostic reference), requiring providers to interrupt their workflow to research answers to their clinical questions.

On the other hand, ‘push’ solutions feed current, credible, evidence-based information specific to the patient’s clinical history and current clinical status directly to the physician at the point of care. Elsevier’s Order Sets for Physicians and Care Plans for Nurses are powerful forms of ‘push’ CDS solutions, designed not only to answer questions that physicians and nurses usually ask, but also to answer critical questions that they don’t know they should be asking. For instance, even when a physician fails to appreciate that a cancer patient should undergo blood testing for a genetic syndrome, an order set can push this evidencebased suggestion to the physician.

Best practices can be pushed to nurses to drive quality and cost efficient care regardless of the nurse’s experience (or lack thereof ). Health screening, medication, and other credible preventative and care maintenance information can be pushed to patients, their family, and even their care taker.

A combination of ‘pull’ and ‘push’ CDS offers the greatest opportunity to empower physicians, nurses and other providers to provide the safest, highest quality, most cost-efficient healthcare.

There are many ‘push’ and ‘pull’ CDS solutions to implement and add based on the specific needs and strategies of individual population health providers.

Media’s1 “Huff & Puff: The Asthma App”, which has improved the paediatric pulmonology patient experience at University of California, Los Angeles (UCLA). Appropriate educational opportunities for patients and their families are now readily available on television, tablets, computers and mobile devices. The videos have also significantly reduced the amount of time that clinicians and nurses spend on patient and caregiver education, including post-visit phone calls.

In order to improve the health of our populations and reduce the costs of care, we must make a 180-degree philosophical and cultural shift away from reactive, acute, inpatient care to proactive, outpatient, preventative and maintenance care. Additionally, when we measure value-based care, we not only need to be measuring the cost of care in our hospitals, we need to be looking at long-term care of patients outside hospital walls and measuring that as well.

Patient engagement, no longer is a nice to have. It is no longer just a clinical follow up after a patient has visited a hospital. Patient engagement should start from pre-hospital visits; it should be educating patients before they arrive and actually taking it even further back to population health. It is about managing health and well-being before people become ill rather than having to worry about patients being discharged from the hospital. Only then will we truly see improved outcomes at a population health level.

1 http://healthnutsmedia.com/

Tim Morris has nearly 30 years of healthcare experience from delivering care within a busy London Emergency Department, as a nurse, through to Product & Partnerships Director at Elsevier a world-leading provider of information solutions. His experience in developing and delivering clinical decision support solutions for healthcare has included both primary and secondary care. Within Elsevier, he works with an international team of expert clinicians and technologists to drive current credible evidence based decision support at the point of care.

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MEDICAL SCIENCES

Diabesity

(Diabetes & Obesity) Newer surgical options shaping up!

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MEDICAL SCIENCES

The need for optimal integration with holistic approach (lifestyle modification + pharmacotherapy + bariatric surgery) is the current road to management of obesity. Bariatric surgery has gained popularity worldwide to treat the diabesity ( obesity + diabetes) twin epidemic. The measure of postoperative outcomes of bariatric surgery are assessment indicators which improve the clinical practice. However, the need to make the society aware about obesity as a metabolic disorder, and to control and improve the co-morbidities associated with the combined approach of medical and surgical intervention is the voice of the medical fraternity.

Pradeep Chowbey, Executive Vice Chairman, Max Healthcare

O

besity is a major global economic problem. It is a complex disorder and a major health risk factor linked to cardiovascular disease, stroke, cancer, hypertension, diabetes, and mortality.

Large scale developmental activities and urbanisation in India have brought significant changes in lifestyle and dietary habits in the growing population. According to WHO survey, worldwide obesity has doubled since 1980. The studies reveal obesity is killing three times as many as malnutrition. Obesity is a global burden on society which has a potential to destroy Nations medically and economically. The prevalence of both type 2 diabetes and obesity has globally increased and attributed to adoption of sedentary lifestyle and dissemination of the western diet.

Diabetes is also complex. No one knows this better than the physician managing this entity of myriad presentations. It is also well known that despite best efforts by the treating doctors, a large segment of this population struggles to bring the disease under control. There are several lines of evidence that inflammation of fat directly causes obesity and diabetes. Inflammation begins in the fat cells themselves. Fat cells are the

first to be affected by the development of obesity. As fat mass expands, inflammation increases. Diabesity causes inflammation. Insulin and leptin resistance impair glucose metabolism.

When fat cells become insensitive to insulin, they can’t store any more glucose and hyperglycemia results.

Dr. Francine Kaufman coined the term diabesity (diabetes + obesity) to describe them. Diabesity can be defined as a metabolic dysfunction that ranges from mild blood sugar imbalance to full-fledged type 2 diabetes. Diabesity is a constellation of signs that includes: • Abdominal obesity • Dyslipidemia (low HDL, high LDL and high triglycerides) • High blood pressure • High blood sugar (fasting above 100 mg/dL, Hb1Ac above 5.5) • Systemic inflammation • Increase formation of blood clots.

The harmful impacts of obesity and diabetes are grave and multiple; extending beyond the physiological to damage also the emotional and psychological health of patients.

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MEDICAL SCIENCES

Genetically, Indians are susceptible to weight accumulation, especially around the waist. An obese individual is much more susceptible to diseases such as diabetes, hypertension, osteoarthritis, snoring, infertility, polycystic ovarian syndrome and increased chances of cancer.

What Goes Wrong?

There is no doubt that there is direct co relation between diabetes and obesity and the more severe the obesity, the more stubborn will be the diabetes management for treating diabetes associated with obesity.

Weight gain appears unavoidable when patients with Type 2 diabetes are commenced on insulin. Body weight increases by 2Kg for each percentage point decrease in HbA1C during the first year. Gain in weight mainly represents an increase in fat mass, which enhances insulin resistance and

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increases the risk of obesity related complications.

Causes of weight gain • Reduced glycosuria • Anabolic action of insulin • Fluid retention • Hypoglycaemia and increased calorie consumption • Excess insulin administration • Combination of obesity and muscle impairment: 'sarcopenic obesity'.

There is enormous scientific evidence that weight loss inevitably helps in resolving this condition. If one needs to lose 10-20 kgs, it can be done by healthy diet and lifestyle changes. However, if one needs to lose more than this, surgical intervention must be considered.

Treatment

Treatment should focus equally on remission of both diabetes and obesity and needs to be widely publicised.

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In the light of the escalating global diabetes crisis, the need of the hour is for the physicians and endocrinologists to include surgical management in their armamentarium against obesity. There are wide modalities of treatment for management of obesity. The pyramid of management of obesity include, lifestyle modifications pharmacotherapy and bariatric surgery. With increasing BMI, the treatment modality changes. A BMI of more than 32.5 is associated with diseases such as diabetes, hypertension, osteoarthritis, obstructive sleep apnea etc. These bariatric surgeries have been promising in ensuring good weight loss and rapid resolution of co-morbidities.

In 1998, National Institute of Health guidelines recommended bariatric surgery in morbidly obese (body mass index [BMI] ≥ 40 kg/m2) or patients with BMI ≥35 kg/m2 with co-morbidities such as diabetes and hypertension. The hindgut hypothesis

MEDICAL SCIENCES

Bariatric surgery is the most effective long term treatment for obesity with the greatest chances for improvement and even resolution of obesity- associated complications.

Surgical management of obesity is an option for those who are classified as morbidly obese. A person with BMI of 37.5 or greater is known as morbidly obese. In addition, a patient with a BMI of 32.5 or greater with one or more obesity related diseases is also classified as morbidly obese.

Obesity (bariatric) surgery is a life saving surgery and must not be confused with a cosmetic procedure like liposuction.

by Cummings etal., suggests that insulinotropic gut hormones including Glucagon Like Peptide-1 (GLP-1) and Peptide Tyrosine Tyrosine (PYY), are produced when nutrients arrive at distal intestine, leading to hyperglycemia reversal. The major mechanism of the decrease in plasma glucose after bariatric surgery is acute negative calorie balance. The father of bariatric surgery, Walter Pories pointed out decades ago that acute negative calorie produced same effect on blood glucose that was produced by gastric bypass itself. Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently (STAMPEDE) Trial, the team has shown that patients experienced positive outcomes at one and three-year randomisation, especially after gastric bypass and sleeve gastrectomy procedures, which they found to be superior to medical therapy alone.

Following weight loss surgery, significant improvement has been observed in obesity related comorbidities. 64-100 per cent of patients with Type II DM show resolution or improvement of this ailment. Similar observations are noted in patients with hypertension, where 25-100 per cent of patients experience resolution or improvement of disease. Dyslipidemia is shown to improve or resolve in 60-100 per cent of patients with this disorder.

Patients of sleep apnea preoperatively also show substantial improvement.

Improvement is also documented in patients with cardiac dysfunction, gastroesophageal reflux, pseudotumor cerebri, polycystic ovarian disease, degenerative joint disease, stress urinary incontinence severe venous stasis, non-alcoholic hepatitic steatosis and overall quality of life.

Benefits of weight loss surgery • Diabetes mellitus 77 per cent show improvement • Hypertension 62 per cent recover completely • High cholesterol 70 per cent showed decreased blood levels Arthritis • Majority improve Sleep apnea • Lowered risk of cancer.

Bariatric surgical procedures are increasingly being performed for overweight diabetics. It is now well known that weight loss surgery leads to resolution of co morbidities, especially diabetes, in a majority of patients. However, it is important to consider that these surgeries are highly specialised needing a multidisciplinary team which includes surgeons with technical expertise, anaesthetists and other paramedic staff and most importantly the treating physician for long term follow up and management of these patients. A Centre of Excellence in metabolic and bariatric surgery is the appropriate choice for undergoing this procedure which not only has the team with surgical expertise but also state of the art infrastructure customised for the morbidly obese and round the clock care and support.

Even the International Diabetes Federation endorsed the surgical intervention in uncontrolled diabetes with obesity (Diabesity) Diabetics undergoing these procedures have show a significant improvement of diabetic status, resulting in normal blood glucose and HbA1c levels with immediate or gradual discontinuation of diabetes related medications or insulin.

There is extensive scientific evidence that illustrates that resolution of diabetes has been seen in patients following a gastric bypass surgery even before significant weight loss occurs. The outcomes are also driven by the duration of diabetes, best results are seen if the duration is less than ten years, however at all stages the results are good and satisfactory.

In the given scenario of increasing morbidity due to Type 2 diabetes, bariatric intervention is emerging as a promising cure. It provides exceptional sustained weight loss and remission of type 2 diabetes in addition to related co morbidities and quality of life improvements.

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criteria to define need for surgery and report results.

The International Diabetes Federation position statement states Bariatric surgery is an appropriate treatment for people with type 2 diabetes and obesity not achieving recommended treatment targets with medical therapies, especially with other major co-morbidities.

Surgery is an accepted option in people who have type 2 diabetes and a BMI of 32.5kg/m2 or more.

Surgery should also be considered as an alternative treatment option in persons with BMI 30 to 35 when diabetes is not controlled by optimal medical regimen, especially with cardiovascular disease risk factors.

The IDF statement also states that in Asians, and some other ethnicities of increased risk, BMI action points may be reduced by 2.5 kg/m2 i.e. 27.5 to 32.5 kg/m2(for Indians in particular)

The future promises good optimal integration with holistic approach (lifestyle modification + pharmacotherapy + bariatric surgery) in management of obesity. The introduction of new implantable neuro regulatory devices will automatically detect the intake of food and help in resolving the obesity.

It involves development of better

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Author BIO

Future Research and Advances in Treatment of Obesity

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Conclusion

The last decade has seen surgical treatment for morbid obesity emerge from being the interest of only a few surgeons and physicians to a wellrecognised surgical specialty. This has been consequent to a rapid increase in the incidence of obesity over the past two decades catching the attention of the medical and media community, as well as emergence of minimal access surgery as a technological advancement in surgical sciences. Non-surgical means of losing weight are effective in achieving 5-15 per cent body weight loss. It may be best to educate the patient to the balance between amount of weight loss and surgical morbidity of various bariatric procedures. In this context, although weight loss following restrictive procedures is less compared to the more complex, bypass procedures, the benefit derived is greater in terms of minimal procedure-related morbidity. To optimise the outcome of the procedure, bariatric surgery should be performed on carefully selected patients, in bariatric centres, specially equipped to care for the obese, within a broadly based, multidisciplinary setting that provides lifelong postoperative care.

“Diabesity is a public health emergency in slow motion, Let us join hands together to eradicate this weed from the society.”

Pradeep Chowbey is Joint Managing Director, Chief – Surgery & Allied Surgical Specialities and Director – Minimal Access, Metabolic and Bariatric Surgery at Max Healthcare Institute Ltd., Saket, New Delhi (India). He is former Chairman of the Minimal Access, Metabolic & Bariatric Surgery Centre, Sir Ganga Ram Hospital, New Delhi, the first of its kind in the Asian subcontinent, established in 1996. He is Founder President of Asia Pacific Hernia Society (APHS). He is President - Asia Pacific Metabolic & Bariatric Surgery Society (APMBSS) and President of Asia Pacific Chapter of International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO). He is Honorary Member of German Hernia Society at Germany, Indonesian Hernia Society at Bali, Indonesia & GCC Hernia Society, Dubai, UAE.

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MEDICAL SCIENCES

The Prospects of Cancer Care in Asia Integrated services

In Asia, the incidence of cancer cases is estimated to increase from 6.1 million in 2008 to 10.6 million in 2030 due to ageing and growing populations, lifestyle and socioeconomic changes. While there has been significant innovations in cancer treatment that help prolong a patient’s life and their quality of life, how can patients be supported at every stage of their journey?

Yew Oo TAN, Specialist in Medical Oncology, Farrer Park Medical Clinic

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A

sia is the world's most diverse and populous continent; 4.5 billion of the world’s 7.6 billion people live there, and the population will increase to 5.2 billion by 2050 – with China and India alone accounting for 37 per cent of the worldwide population.

As a consequence of continuing socioeconomic development and increasing control of communicable

MEDICAL SCIENCES

diseases, life expectancy in all Asian countries has significantly increased.

The proportion of people aged 65 years and above is likely to double from the current 7 per cent by 2030. It is wellknown that cancer risk increases with age. Changing lifestyles, increasing urbanisation, changes in reproductive patterns and diet, obesity, tobacco use, alcohol, chronic infection and increasing lifespans contribute to an ever-increasing cancer burden and changing cancer pattern in Asian countries.

Based on GLOBOCAN estimates, about 14.1 million new cancer cases and 8.2 million deaths occurred in 2012 worldwide. It is estimated that 6.7million new cancer cases—39 per cent of new cases worldwide—were diagnosed among 4.5 billion persons (48 per cent of the world population) living in the fifteen most highly developed countries in South, East, South-Central and Southeast Asia: Japan, Taiwan, Singapore, South Korea, Malaysia, Thailand, China, Philippines, Sri Lanka, Vietnam, Indonesia, Mongolia, Pakistan, Laos, and Cambodia.

The striking variations in ethnicity, social norms, sociocultural practices and traditions, socioeconomic development and habits and dietary customs there are reflected in the patterns and burdens of cancer in different regions of Asia. The pattern and incidence of various cancers in different Asian countries vary significantly.

Likewise, cancer care across many Asian countries has improved. Many new cancer treatment facilities have been built and an increasing number of cancer specialists and paramedical personnel are being trained. There are still many populations where access to good quality cancer services are not possible or affordable.

2. What does it mean to have integrated or holistic cancer care services?

Integrated or holistic cancer services are the key to successful management of many cancers today. With the advent of new surgical techniques, development of sophisticated radiation oncology technology and therapies, as well as new drug treatments, cancer treatments today require multidisciplinary teamwork to achieve the best outcome for patients. The role of other paramedical personnel to improve the quality of life and psychological

support is now an integral component of good quality cancer care.

3. When it comes to cancer care – from diagnosis to treatment to monitoring – how does the standard of care in Asia compare to that in other regions?

There is no Asian ‘standard of care’ since it is such a diverse continent, but in developed economies such as Japan, China, South Korea, Taiwan, Hong Kong and Singapore there are national guidelines or internationally accepted guidelines for many cancer specialists. These are used for managing cancers from diagnosis through to treatment and monitoring.

In fact, in these countries, there are many established centres of excellence where international clinical trials are conducted. The outcome of these trials has changed the treatment practice of many cancers, such as lung, liver and stomach cancers.

1.How has cancer care in Asia evolved over the last decade?

The healthcare systems across Asia are diverse and can vary from very rudimentary to very sophisticated.

Likewise, the quality of cancer care is also highly variable. However, with increasing wealth and a growing economy, across many Asian countries, the quality of healthcare delivery has improved in the past decade.

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MEDICAL SCIENCES

4. How do you see integrated or holistic cancer care services benefiting the entire spectrum of users – from patients to caregivers to healthcare providers to the overall healthcare system?

Many cancers among Asians, especially East Asians, have different incidences, causation and molecular profile. The outcome of treatment has shown distinct differences in responses and it is increasingly important to perform certain diagnostic tests on the tumour to show the differences. The healthcare providers and system must be geared to support these important diagnostic tests, in order to obtain the best outcome for the patients. In line with this, there must be integration of the various healthcare providers in approaching the treatment decision.

We are seeing the changing burden of cancer in Asia, along with appropriate management strategies.

Many Asian countries should plan strategies that promote healthy ageing via living healthy lifestyles, tobacco and alcohol control measures, Hepatitis B Virus (HBV) and Human Papillomavirus (HPV) vaccination, cancer screening services, and vertical investments in strengthening cancer healthcare infrastructure to improve equitable access to services.

5. What about rural areas in Asia?

How can they equally benefit from having access to integrated cancer care services?

With improving economies, many cancer patients living in rural areas of Asia have better access to modern diagnostic and treatment facilities. With better transport and communication, many cancer patients in various Asian countries are expecting more accurate diagnosis and treatment for their cancers. A few patients with economic means are travelling to regional cancer centres across national borders to seek better treatment for their cancers. This trend of medical tourism will continue

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The proportion of people aged 65 years and above is likely to double from the current 7 per cent by 2030.

as long as these centres of excellence provide prompt, accurate, state-of-theart care at affordable prices.

6.What is the future of personalised cancer care?

Today, many cancers such as breast, lung, stomach, colorectal, lymphomas and leukemias require precise histopathological and often molecular or genomic profiling to offer precision medicine. Personalised cancer care should now be called ‘Precision Medicine’ as new drugs are prescribed to stop cancer growth based on certain molecular targets found in the tumour or blood. With the explosion

Author BIO

Yew OoTan has been practising as a specialist medical oncologist at Icon SOC Farrer Park Medical Clinic in Singapore for more than 15 months. Prior to that, he was Professor of Medicine at National University of Singapore and he has been practising medical oncology for more than 40 years.

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in genomic medicine, the future of Precision Medicine looks bright and promising. The well-known side effects of cytotoxic drug therapies such as nausea, vomiting, hair loss and low blood counts that many patients fear, may become a thing of the past 7. What are the main factors in providing successful integrated cancer care services and can the healthcare industry support this?

For any integrated cancer care progrmme to be successful, the main ingredient is the collaboration and cooperation between the patient, healthcare providers and industry. The industry can be the companies that make the instruments or the equipment for the healthcare providers or pharmaceutical companies. A symbiotic relationship between the healthcare providers and industry will ensure better integration and holistic care for the cancer patients.

With rapid advances in technology and better understanding of cancer biology, more sophisticated instruments and equipment, as well as targeted drugs or immunotherapy, are required to increase the survival of many advanced cancers.

The tremendous advances in cancer therapies in the past two decades have been unprecedented and this is in no small measure due to the collaboration between healthcare providers and healthcare industry.

The Heart Club The first systematic prospective evaluation of valvotomy for mitral stenosis 1948-1952.

The Club which my book celebrates was convened by Russell Brock in 1948.

The book includes a complete record of the minutes of meetings of cardiologists, radiologists, the clinical scientists of the Medical Research Council unit, the thoracic surgeons and anaesthetists. They report the earliest consecutive series of intracardiac operations until the end of the Clubs active life in 1956. By then cardiopulmonary bypass.

In this introduction to ‘”The Heart Club” I will deal with their work on mitral stenosis as in intracardiac operation before the open heart era.[1] The surgical history of mitral stenosis is well documented in terms of the ten operations chronicled in Cutler’s “final report” in 1929,[2]the moratorium of the 1930sand early 1940s[3] and then the “firsts” of Bailey, Harken and Brock in 1948.[4] The discovery of the previously unknown minutes of “The Heart Club” prompted me to make a more detailed contextual history and I discovered an admirable account of team working leading to Brock’s first operations for mitral stenosis in 1948. The handwritten minutes, penned by Ian Hill on September 13, 1948 includes a note that the anaesthetist “Dr Rink commented on the optimum position for anaesthetisation of mitral stenotics undergoing operation.” Brock scheduled three patients for operation in the in the ensuing fortnight.

The operations by Cutler in Boston in 1923, and Souttar in London in 1925, were each followed by survival for several years but Cutler’s subsequent six patients died within hours or days of operation. The attitude in the medical texts became progressively more set against surgery and the physicians can’t be blamed for opposing the idea of surgery as the 1920s Boston experience appeared to them to have been an unmitigated disaster. Perhaps if Cutler had freed the commissures rather than blindly cutting the leaflets, things might have gone better but that we can never know.

The leading opinion in cardiology was firmly against any further attempts.

It was Harken’s war time experience that Brock relied on to believe that it was worth trying again. Dwight Harken had done some of his training at the Brompton in 1939 and impressed the London Thoracic surgeons. In 1944, with their support, he was chosen as the surgeon in charge of

the 160th US Army Hospital, set up in huts near North Leach in Gloucestershire, England in preparation for the D-Day landings in June 1944. The following year Harken reported the survival of all 134 soldiers from whom he had removed bullets and shrapnel from in and around the heart. Another chance presented by war provided the evidence that Brock needed to embark on heart surgery. An exchange programme set up between Guy’s and Johns Hopkins brought Alfred Blalock to Guy’s where he operated on ten children with Fallot’s Tetralogy. The systemic to pulmonary artery shunt operation devised by Helen Taussig and Vivien Thomas was adjacent to, but not on the heart itself but with the evidence from Harken and Blalock, heart disease could no longer be ruled to be beyond the help of surgery. With his cardiological colleagues, and their names in alphabetical order, the Club reported their first 100 consecutive patients in 1952. The team are shown in the group photograph taken on the roof of Guy’s Hospital.

Reference List 1 Treasure T: The Heart Club. ed 1st, London/New York, Clink Street, 2017.

2 Cutler EC, Beck CS: Present status of surgical procedures in chronic valvular disease of the heart; final report of all surgical cases. Arch Surg 1929;18:403-416.

3 Swazey JP, Fox RC: The clinical moratorium: a case sudy of mitral valve surgery; in Freund P, (ed): Experimentation with Human Subjects. New York, George Braziller, 1970, pp 315-357.

4 Treasure T, Hollman A: The surgery of mitral stenosis 1898-1948: why did it take 50 years to establish mitral valvotomy? Ann R Coll Surg Engl 1995;77:145-151.

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MEDICAL SCIENCES

Trends in Indian Cancer Market

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MEDICAL SCIENCES

Cancer patients need specialist care that necessitates responsibility and is accountable for the quality of the treatment. The last few decades have seen considerable efforts made in the treatment and prevention of cancer around the world, but it still looms large over our lives, especially in India for a multitude of reasons.

Suresh Ramu, CEO & Co-Founder, Cytecare Cancer Hospital

T

he physiology of each organ in the human body is different. Cancer diagnosis produces varying impact on a cancer patient’s life-emotional, social and financial.

Cancer is not just a disease. It’s a disease that can become resistant to almost anything. India is slated to become the country with the maximum populace of individuals below the age of 40 years by the year 2020! Early diagnosis and regular screening tests could alleviate much of the suffering and death due to cancer.

All cancer patients face the difficulty of making the right decisions regarding their course of care. Cancer patients need specialist care that necessitates responsibility and is accountable for the quality of the treatment. The last few decades have seen considerable efforts made in the treatment and prevention of cancer around the world, but it still looms large over our lives, especially in India for a multitude of reasons. The incidence of cancer has reached mammoth numbers with India being the third country after

China and the USA with the maximum number of cancer cases. Ignorance about the disease, its symptoms and a delay in visiting medical experts for a proper diagnosis has increased the prevalence of this illness which is anticipated to grow by 30 per cent in the next 5 years.

Breast cancer is one of the most common cancers to affect women globally as well as India. Lack of awareness contributes towards the growing numbers every year. A majority of oncologists have suggested cancer literacy and amongst women especially those between 40 and 60 years for them to undergo a regular screening schedule which would help detect cancers in their early stages and assist doctors to treat them effectively.

Cervical cancer caused by the Human Papillomavirus (HPV) is another common cancer among Indian women and accounts for 12 per cent while oral cancer accounts for 7 per cent of new cancer cases every year. The three most common cancers that affect men in India are Prostate,

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Lung and Colorectal. Oral cancer is a major health problem in India as in most cases it gets detected only in the later stages of the illness resulting in lesser cure options and higher expenses. This type of cancer is predominant amongst the lower socio-economic classes of the country, because of their high addiction to tobacco, tobacco products and tobacco substitutes. People residing in rural areas are able to avail of minimal health services and very few medical personnel. This delays the diagnosis of the illness leading to inevitable tragic results. The urban Indian women are affected more by cancers of the uterus, ovaries and lungs while men suffer cancers of the colon, rectum and prostate. The Indian Council of Medical Research (ICMR) data has

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explicitly cited the number of cancer cases to increase at an estimated number of 1.45 million new cases every year.

The fast-paced lifestyles, unhealthy eating habits and addictions like smoking and drinking are some of the key factors attributing to the increasing number of cancer cases.

India’s massive socio-economic inequalities in access to healthcare and other areas have led to a steady increase in the number of cancer cases throughout the country. There is immense regional variation in the occurrence of cancer in India.

The rural areas of India experience large numbers of untreatable cancers primarily because of a dearth of funds, knowledge about the disease and extremely poor treatment facilities.

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As a country, India has a minimal rate of public expenditure (1.5 per cent of its GDP) on healthcare which is the cause of the rising incidence of various incurable illnesses, making it a nation with the poorest amount of expenses on public health care. A severe shortage of trained medical & health personnel and a lack of facilities makes access to good treatment highly challenging. The sedentary lifestyle coupled with unhealthy eating habits, consumption of alcohol and tobacco, engender symptoms of various illnesses and a lot of those leading to cancer.

A considerable amount of ongoing research to provide affordable treatment and mitigate the effects of this disease is being complemented by enhanced technology. Some of

MEDICAL SCIENCES

the most notable new technologies includes the Epigenetics treatment which, like chemotherapy (although less toxic), helps to transform cancer affected cells to healthy cells.

To counter these cancer trends, India has become the epicentre for upcoming cancer speciality hospitals.

There are many leading hospitals in India which are furnished with the most advanced technology to treat cancer patients effectively. There are multiple hospitals founded by individuals who have been veterans in the field of cancer care and treatment, who have made a huge difference with their scientific approach and methodologies. Cutting edge technology such as Cyclotron and PET-CT have been introduced in the Indian subcontinent.

Today, Indian hospitals are more than equipped with the latest technology and are at par with international standards of care to treat a multitude of cancer cases. Nuclear medical oncology and molecular oncology departments are not alien to the top leading Indian hospitals which utilise the most advanced technology in the treatment of cancers. Today, cancer treatment is definitely on par and perhaps, in some cases, even better than the existing treatments in some countries across the globe.

Indian Council of Medical Research (ICMR) has predicted that by the year 2020, India will witness more than 17.3 lakhs new cases of cancer and more than 8.8 lakh Indians would die because of it. Unfortunately, a majority of the patients visit hospitals for diagnosis or treatment in the advanced stages of the illness. The need of the hour is therefore heavy investments in prevention techniques, vaccinations, cancer awareness and screening, along with a focus on clinical data research and studies for developing better cancer fighting techniques.

Today, medical researchers and experts are more focused on health literacy as a vast number of the rural

population is totally ignorant of the onslaught of such diseases. Efforts by government are being taken to slash the prices of cancer drugs to make them more accessible to the lower socio-economic sections of society.

Pharmaceutical and biotechnology companies are consistently working on new research in the areas of molecular treatment for varied cancer pathologies.

Many R & D institutes are involved in educational and screening efforts to ensure prevention of disease at early stage. Regenerative medicine such as gene therapy and tissue engineering

Cervical cancer caused by the Human Papillomavirus (HPV) is another common cancer among Indian women and accounts for 12 per cent while oral cancer accounts for 7 per cent of new cancer cases every year.

have shown encouraging results with wide range of cancers including lung cancer, pancreatic cancer, protate cancer, and malignant melanomas. At least 12 companies across India are in the process of developing liquid biopsies to identify cancer cells and tumours. Nanotechnology is being actively resorted to by researchers to selectively treat cancer cells and enhance the efficacy of certain treatments.

Some leading hospitals resort to artificial intelligence based novel breast cancer screening solutions.

Clinicians are now resorting to machine learning which they believe will enable them to develop patientspecific cancer treatments by analysing individual biology. Organ-specific cancer treatment is another insightful procedure which is gaining much success in India. Next Generation Photodynamic Cancer therapy (NGPDT) is a new technology which treats almost every type of cancer.

It uses the therapeutic properties of light to kill the growth of cancerous cells and is regarded as, perhaps the

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MEDICAL SCIENCES

most innovative treatment of this century. This technology is being used in China for the treatment of all except blood cancer. Medical experts are still researching the after effects of the treatment and if proven consistently positive, it may prove to be the best ever treatment for cancer.

Digitisation in cancer care and treatment is a positive step which has been initialised by some of the leading cancer hospitals of India. A digital centre is being set up to connect all 108 hospitals that are a part of India’s National Cancer Grid. This will enable a cancer patient to make a call from

her mobile to a specific number where she will be assisted by specialist doctors and, trained personnel who will discuss, understand and suggest an oncologist at a cancer centre in close proximity to the patient’s residence. This grid will also help in fixing appointments for the patients, update the patient for her next visit and any tests which she may have to undergo. The medical file of each patient will be digitised which will be a boon to the patient especially in the case of second opinions. This grid will also serve in the case of other infectious diseases and specialist treatment for the same. Doctors will be able to document treatment plans in real-time and patients will be able to avail of specific treatment prescribed to them in their city of residence.

Health camps to educate the masses and making them aware of the disease and its repercussions are imperative, especially in the rural regions of a country like India. Health literacy will prove to be one of the most effective measures towards containing this dreaded illness. The commendable amount of R & D in the treatment and cure of cancer has made this disease less of an ominous illness. Efforts are being made to reduce the number of tragedies. A choice of the right hospital and the right treatment facility which entails not only the requisite treatments for illnesses like cancer, but employs a humane approach to serve them throughout their treatment is the need of the hour.

Author BIO Suresh Ramu is the Co-founder, CEO and a member of the Board of Directors of Cytecare Hospitals. Ramu is also a Co-founder & Director of Cytespace Research and Co-founder of Medwell Ventures. Prior to establishing Cytespace in 2011, Ramu spent 10+ years with Quintiles Transnational. As Vice President and Head – India, for Clinical Development Services, he managed all aspects of clinical trials conduct in the country. Holding diverse senior leadership positions, he was instrumental in creating two valuable assets for the organisation – the world’s largest multi-shift data management operations to process clinical trial data, and Asia’s largest cardiac safety lab.

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Technology, Equipment & Devices

Cover Story

Regulation vs.

Innovation ARE WE GETTING IT RIGHT?

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Technology, Equipment & Devices

There is nothing new about the decades-old conflict between regulation and innovation. By definition, innovation is new and uncertain, and therefore risky, while regulation implies control, as in control of the risk from new, untried products. Nonetheless, have we now reached the point where controlling technology has become more risky than allowing promising innovations into the medical marketplace where they can be field-tested while providing access to patients willing to accept the risk. This has been the dilemma that regulatory agencies have struggled to address by ratcheting up their expedited review and approval programs, efforts that will remain half-measures without rapid retooling of the evidence base utilised for regulatory decision-making.

Christopher Milne, Associate Professor and Director of Research Center for the Study of Drug Development, Tufts University School of Medicine

A

lthough prescription drugs comprise a relatively small percentage of overall healthcare expenditures, they nonetheless represent the primary point-of-contact between the majority of the population and the healthcare system. While 62 per cent of Americans fill a prescription in any given year, only 8 per cent typically experience a hospital stay. Worldwide the percentage of healthcare expenditures on medicines ranges from 5-10 per cent in most developed countries to as much as 60 per cent in many developing countries. Thus, in an era when healthcare systems worldwide are confronting the dual challenge of cost-containment and the critical need for breakthrough treatments a primary concern for decision-makers is how well our system is meeting the medical needs of the population, and the role played by prescription drugs. These challenges are increasing in scope and complexity as the world confronts what the World Health Organization (WHO) refers to as the double burden of disease – the current crisis with epidemics, even pandemics, of emerging and re-emerging infectious diseases, along with the growing contribution to mortality and morbidity from Non-Communicable Disease (NCD). A 2015 McKinsey report notes that in Southeast Asia alone, they will experience a 29 per cent increase in the contribution of NCDs to all-cause mortality by 2030 compared to 2005. At the same time, current expenditures on public health are approximately 4-5 per cent of GDP in China and India, compared to twice that in most western European countries. A related trend adding to these challenges evident when

looking at the worldwide output of New Active Substances (NASs are the first approvals of novel drugs anywhere in the world) over the last four years (2013-2016), is that just two therapeutic areas have dominated the last few years (see Figure 1 below).

Oncology has become dominant over the last decade with cardiovascular and CNS disease approvals falling far behind, while infectious disease/vaccines has reached parity with oncology just in the last few years. There are two over arching reasons to be concerned about this trend.

The first is that the trend is not in sync with public healthcare needs. While cancer is certainly a major health problem, it is not the world’s number one health concern in terms of mortality and morbidity, while cardiovascular disease is the #1 killer in the US in terms of overall mortality with the potential to cause a substantial increase in premature deaths in many developed and emerging market countries in the near term. Nor is cancer the most urgent need in terms of innovation, as half of new cancer drugs are among the most novel of genomicallytargeted precision medicines and cancer therapy is benefitting significantly from new advances in immunotherapy as well. The second reason for concern is that the trend runs counter to the mission of national regulatory authorities (NRAs).

NRAs should be addressing unmet medical needs with time and effort proportionate to the public health impacts of the causative diseases within the limits of their resources. If this is not being done, then agency decision-making on priorities and resource allocations should be examined, and recalibrated if necessary. www.asianhhm.com

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Technology, Equipment & Devices

The NAS approval trend is, however, both troubling and perplexing in another context. While NRAs control how many and how fast products reach the marketplace, it is the pharmaceutical industry that controls what drug candidates enter the development pipeline. The two therapeutic areas that have remained static in recent decades – CNS and CVD – represent areas with substantial market potential. Mental health was tied with cancer as one of the four most costly conditions in the US during the decade of the 2000s, and the American Heart Association estimates that over 1/3 of Americans currently suffer some form of CVD. Worldwide CVD is considered the fastest growing NCD health threat as obesity becomes epidemic in developing countries with a growing penchant for adopting western diets that pre-dispose its adherents to metabolic syndrome and its disease sequelae. Meanwhile, WHO projects that by 2020, depression will be the second leading cause of disability worldwide. Despite the enormous market opportunity, however, the number of NAS approvals in these therapeutic areas have been static or declining, with both therapeutic areas together equaling less than half the number of oncology approvals

from 2013 to 2016. At a time when there is increasing availability of prognostic and diagnostic technology for CNS disorders, and promising new approaches for CVD from regenerative medicine and drug-device combination therapy, the continued dominance of oncology/immunology, at 20 per cent of novel drug approvals and 47 per cent of the pipeline (according to a 2017 Pharma projects report) is both economically and medically out of balance. This “bunching up” of the pipeline with oncology products appears to some observers to be a waste of resources as there is now a surplus of competition in some relatively narrow cancer indications. Moreover, a SCRIP Pharma Intelligence analysis in mid-2016 demonstrated that immunooncology is one of the least successful therapeutic areas in terms of Phase III projects moving on to a regulatory filing at only 40 per cent success (compared to 58 per cent for all ~1500 products analysed). While it is true that the recent NAS dominance by oncology approvals is largely a US phenomenon (80 per cent of oncology approvals among global NASs were US) the fact that 50 per cent of NASs worldwide originate in the US and that nearly 50 per cent of the global pipeline

Number of NAS from 2013 to 2016 by Therapeutic Area

Figure 1

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is focused on oncology makes it a global challenge going forward, i.e., the non-US output of NASs appears to have a somewhat better balance of therapeutic areas (see Figure 2), but it is only half the story for the reasons just discussed.

The Up and Down Side of FRPs

Economic dictates of supply and demand, and what the market will bear, explain some of industry’s high level of interest in oncology drugs. Over the last 10 years, the average price for oncology treatments has risen sharply. While high prices act as a ‘pull’ incentive for oncology research and development (R&D) (i.e., they increase the likelihood of sufficient return on investment and thereby act as an R&D incentive), regulatory initiatives aimed at speeding development and review times serve as an equally powerful ‘push’ incentive (i.e., they lower the financial and logistical barriers, and reduce the risk of entering the field of research). Another reason for industry’s focus on oncology is that the enormous investment in basic research by the US National Institutes of Health has led to greater understanding of the pathophysiology and genetic mechanisms of many cancers, which provides exciting new and fertile areas for commercial product development.

Also, the field of cancer research, over the years, has benefitted from a very effective patient advocacy movement.

The American Cancer Society, for one, has been described as “the single most effective disease-based lobby in American pharmaceutical regulation.”

Advocacy is by no means a negative factor but it is a discriminating factor in how resources are prioritised in both the public and private sector. For example, the US FDA employs a full panoply of what the Center for Innovation in Regulatory Science (CIRS) calls Facilitated Regulatory Pathways (FRPs): priority reviews (receive a six month review time, compared to a 10-month standard review); accelerated

Technology, Equipment & Devices

approvals (conditional approval based on surrogate, or indirect measures of benefit); fast track designations (increased access to scientific interaction with the FDA and rolling reviews of portions of product application as they become ready); and breakthrough therapy designation – BTD (includes fast track incentives and ‘all hands on deck’ collaborative, cross-disciplinary engagement by FDA). In the 2000s, oncology drugs received 45 per cent of all FRPs awarded by the FDA. The relationship between regulatory initiatives designed to speed access to important new medicines, and industry’s focus on oncology is supported by the fact that if you look at the number of oncology approvals during the ten-year period before FRPs were implemented (1984 -1993), oncology was not even in the top five therapeutic areas for US approvals. Another example of the dramatic impact of advocacy and in turn the dramatic incentivisation effect of FRPs can be appreciated by the efforts of a stakeholder group of 50 healthcare and labour organisations who petitioned the US Congress to pay attention to the needs in the area of antibiotic resistance. The outcome was the Generating Antibiotic Incentives Now (GAIN) Act, allowing expedited review and approval as well as 5 years market exclusivity, which a USG report in early 2017 stated was already responsible for 101 designations and 6 approvals less than 5 years into the programme.

While it’s not surprising that at a time when the out-of-pocket costs to develop a new medicine exceeds US$1 billion, many companies would be drawn to areas that receive favourable regulatory treatment. An analysis of drugs discontinued during development from 2001 to 2011 showed that financial and strategic factors were responsible for 56 per cent of the discontinuations. Regrettably, however, not every disease area can have its own GAIN Act. Political will

NAS Therapeutic Area Breakdown by Country of First Launch, Excluding the US, 2013 to 2016

Figure 2

and public advocacy are often lacking, and resources at regulatory agencies are finite. It is a zero sum game. The US FDA itself has pointed out such an imbalance can result in performance deficits in one area of responsibility to the detriment of another. This consequence has also been supported by the 2017 Pharmaprojects report highlighting that the expansion of the share of the pipeline by oncology was resulting in other therapeutic areas ‘being squeezed out.’

Emerging Sponsors are the Future

The new drug research and development paradigm is shifting rapidly from traditional big pharma to venture capital–backed small companies. An emerging sponsor is defined by the US FDA as the sponsor listed on the FDA approval letter who, at the time of approval, was not a holder of an approved application in the Orange Book or the regulatory management system for the biologics license application. Of new molecular entity/ new biologics approvals in 2011-12, approximately 40 per cent were from emerging sponsors. Emerging sponsors share many of the same characteristics as companies referred

to as start-ups, or small companies with little or no experience getting products into the marketplace. In early 2017, Pharmaproject reports that of approximately 4,000 pharma firms with active pipelines, 56 per cent have just one or two products in the pipeline, tacitly qualifying them as emerging sponsors. It also noted that Asian firms account for nearly 20 per cent of these firms worldwide, up from 16 per cent last year, and resulting not just from expansion in China but region-wide.

These emerging sponsors are critical to the future of innovation, particularly in challenging areas of R&D. For example, smaller companies have emerged to fill the void in R&D for CNS therapies. Similarly, they are often the seedbeds of innovative products and platforms in such critical areas of unmet medical need as orphan drugs. But, much of their pipeline is at an early stage of development and emerging sponsors come and go quickly. The dramatic demise of orphan drug sponsors has been chronicled in the literature on the ‘valley of death’ (i.e., surviving from late discovery through early clinical phase) but just how dramatic an impact was suggested by a Tufts CSDD study analysing the

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Technology, Equipment & Devices

change in the number of orphan drug sponsors worldwide from 2007 to 2011, with the cohort losing ~150 companies that existed in 2007, but gaining ~200 new companies by 2011. The greatest change occurred among companies characterised as small pharma or small biotech, who experienced a considerably lower likelihood of remaining ‘in the game‘ throughout the period from 2007 to 2011, and yet these small companies comprised the lion's share of companies new to the orphan research and development enterprise by 2011.

Worldwide the percentage of healthcare expenditures on medicines ranges from 5-10 per cent in most developed countries

Asia-Pacific Markets: Reaching Outward, Looking Inward

A McKinsey report in 2015 notes that Asia (arguably excluding Japan) has been one of the greatest beneficiaries of globalsation and is expected to have a CAGR of nearly 9 per cent from 2015-2020 in the global pharma market. Although manufacturing will remain an important contributor to growth in Asia, export-led economic models are now under pressure in most of the region. In China, exports as a percentage of GDP have declined from 37 per cent in 2006 to less than 20 per cent . In Indonesia, exports have dropped from 31 per cent of GDP to

19 per cent . One reason for the decline is that trade, whose contribution to global GDP grew from around 25 per cent in the 1960s to more than 60 per cent in 2008, has since stalled. Another is that Asia’s previously enormous manufacturing cost advantages have shrunk as wage growth has outpaced productivity. In the case of many goods produced in China for North American markets, for example, the cost advantage over manufacturing in the US has declined dramatically over the past decade. The spectre of rising

Number of NAS from 2013 to 2016 by Country of First Launch

protectionism, too, compels Asian policymakers and companies to ensure that they do not rely excessively on export manufacturing.

Nonetheless, the rising affluence of Asian households suggests that the region will continue to be the world’s biggest growth market for health care.

China’s middle class is projected to expand by 36 million households and to represent 40 per cent of the country’s population by 2020, while another 20 per cent will be living in uppermiddle-class and affluent households.

Vietnam is projected to add 5 million upper-middle-class households by 2020, India 11 million, and Indonesia 29 million, according to BCG’s Center for Customer Insight. The region accounts for 40 per cent of world trade—and trade within the region is growing faster than anywhere else in the world. The Asia-Pacific region’s 4.5 billion people account for nearly 60 per cent of the world’s population, and includes many of the world’s fastest-growing economies, according to the 2017 BCG report How Asia Can Win in the new Global Era. The AsiaPacific region seems poised to become a growth market for pharmaceutical as well, as seen in Figure 3, Japan by itself is equal to the NAS output of the EU, while together with the rest of the A-P region it is almost equal to half that of the US. Taking What’s Best from East and West

What can the Asia-Pacific region due to improve its drug development output as well as to ensure that it is meeting its domestic medical needs while taking advantage of the dearth of needed medicines in other lucrative markets internationally.

Prioritisation – This must happen regionally. A national or regional commission of medical priorities should be convened and comprised of experts from government, academia, industry, patient advocates, and the medical Figure 3

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Technology, Equipment & Devices

on joint pain, urinary incontinence, sleep apnea, and mobility.

New Technology – US FDA’s November 2015 report on its mission to keep up with advances in science states that among its main goals is the need to advance Regulatory Science (i.e., developing new tools, standards, and approaches to assess safety, efficacy, quality, and performance) in order to promote the lifecycle approach to regulation for both approvals and postmarket evaluation of risk-benefit profile of drugs, devices and biologics during their entire time on the market. The new FDA Commissioner has stated: “We need to close the evidence gap between the information we use to make FDA’s decisions and the evidence increasingly used by the medical community, payers, and by others charged with making healthcare decisions.” At the same time, the former FDA Commissioner said that he believes FDA needs to be proactive in breaking the logjam on the use of Real World Evidence (RWE) and digging more into “what patients care about,” while current CDER Director Janet Woodcock told the audience at a workshop on RWE that the current clinical trials system is broken and there needs to be new ways to collect and utilise patient data.

FRPs and Emerging Sponsors – There is a growing awareness that the regulatory environment has had a substantial impact on the introduction of innovative new medicines in certain therapeutic areas. It is likely that the use of FRPs is one reason why the US and Japan are more productive in terms of NAS output as CIRS reported in mid-2016 that approximately half of

Author BIO

establishment. Its responsibility would be to assess the country’s immediate and long-term health needs, and review the innovation landscape to determine whether current public and private R&D efforts are appropriately focused and funded. Another step would be to create an FRP Office within each NRA that would triage new drug applications guided by the commission recommendations. To help subsidise these activities, sponsors of candidate drugs would pay an application fee to the NRA. If the new Office determines that a drug candidate is eligible for one or more special regulatory programs, the sponsor would be exempt from paying any additional fees beyond normal user fees.

Patient Focused Drug Development (PFDD) – According to the US FDA, PFDD describes efforts to ensure that the review process benefits from a systematic approach to obtaining patient perspectives on disease severity and unmet medical need. As an example, in the field of CNS, the FDA has proposed a new approach for Alzheimer’s Disease that allows treatments of pre-symptomatic patients to slow the accumulation of substances in the body believed to be biomarkers of clinical disease, or to treat patients with early disease before functional impairment is apparent through an accelerated approval pathway on the basis of assessment of cognitive outcome alone.

Although risky, there is precedent from AIDS activism in the 1990s, during which the FDA and industry handled the risks through patient involvement in a meaningful process of informed consent. Another example of a patientfocused approach was a George Washington University Stakeholder Panel publication of a report suggesting that obesity should be viewed as three conditions: obese but well, obese with risk factors, and obese and sick. Secondary end points for drug efficacy should be added on the benefits side of the scale, such as effects

NASs approved in the US and Japan benefited from FRPs, but only 13 per cent of those approved by the EMA in 2014. We know that small companies are more likely to have multicycle review and less likely to garner approvals, with a 50 per cent approval rate as compared with 80 per cent for medium/large companies, according to an FDA study. It has also been shown in studies by the Tufts CSDD and others that FRP awards are important to investors, because they believe it is a harbinger of likely priority review status and flexibility on risk–benefit decisions

by FDA. Conclusion

There is nothing new about the decadesold conflict between regulation and innovation. By definition, innovation is new and uncertain, and therefore risky, while regulation implies control, as in control of the risk from new, untried products. Nonetheless, we have now reached the point where controlling technology has become more risky than allowing promising innovations into the medical marketplace where they can be field-tested while providing access to patients willing to accept the risk. This has been the dilemma that regulatory agencies have struggled to address by implementing facilitated regulatory pathways. These efforts, however, will remain half-measures without rapid retooling of the evidence base utilised for regulatory decision-making and proper attention to prioritising their application.

Acknowledgement: The author thanks Zachary Smith, research analyst at Tufts CSDD, for his contribution to the graphics and research on NASs.

Christopher-Paul Milne, DVM, MPH, JD joined the Center for the Study of Drug Development, Tufts University School of Medicine (TUSM) in 1998, and is currently a TUSM Associate Professor and Director of Research at the Center. He has published over 100 book chapters and papers on biopharmaceutical regulatory and policy issues worldwide, while serving as an Innogen Center Associate (University of Edinburgh), and recently as Visiting Professor at Kyushu University in Japan.

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Facilities & Operations Management

Environmental Safety in Hospitals The environment within the hospital is critical for life support.

Environmental concerns affect the hospital internally and externally. Indeed, the hospital requires a safe internal environment. Externally the hospital is a contributor to the environmental load of the community. Some internal factors that impact upon hospital environment safety are presented.

Neven Saleh, Assistant Professor, Biomedical Engineering Department, Egyptian University

H

ospitals are representative of complex environment in which different aspects including patients, staff, equipment, services, and information are interfaced. Maintaining a safe environment reflects a level of competent healthcare that must be fulfilled for patient safety. In this context, the clinical engineer plays an important role in providing safe environment within hospital. In general, many factors affect hospital environment internally and externally.

Many internal factors have a significant impact on hospital environment such as waste management, noise, and infection control; and external factors such as sources and treatment of water, sewage treatment and disposal. In this article, some of internal factors are discussed:

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1. Waste management 2. Noise 3. Infection control 4. Radiation safety 5. General building safety 6. Water quality 7. Heating, Ventilation, Conditioning

and

Air

1. Waste Management

Waste management is crucial to promote high quality of healthcare and safe environment within hospitals.

Medical waste is any waste occurring as a result of medical services and scientific research in medicine. In general, the amount of waste generated by healthcare activities is 80 per cent general waste and the remaining 20 per cent is hazardous material.

World Health Organization (WHO)

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divides medical waste into seven basic categories based on their properties and risk level: • Infectious waste • Pathological waste • Sharps • Chemicals • Pharmaceuticals • Genotoxic waste • Radioactive waste The most important factors that should be considered in waste management systems are • Collection system in the generation site (i.e. segregation system, type of containers/bags) • Time and temperature of temporary storage (generation side) • Transport requirements • Central storage conditions • Approved disposal method

Facilities & Operations Management

Every factor should be taken into consideration for a proper waste management system. For example, in collection system medical staff that is responsible of segregation stage must follow the guidelines approved by Ministry of Health (MOH) of their county. For central storage area it should not be located near the general waste central storage. Further more, waste disposal process must be carried out according to approved method such as incineration which is required for disposal of pathological specimens.

The summary of approved disposal methods based on the class is presented in Figure. 1 2. Noise

Noise is defined as unwanted sound.

Several studies have been conducted

Hospitals must comply with the life safety code NFPA 101 of the National Fire Protection Association.

for hospital noise that linked hospital noise to a variety of negative physiological outcomes. The WHO has recommended that noise level should not exceed 35 dB in rooms where patients are treated or observed

and 30 dB in wards rooms. In 1974, the US Environmental Protection Agency (EPA) suggested that the peak noise level in a hospital should not exceed 45dB during the day and 35 dB at night. In fact, the noise level is hospitals usually more than the recommended levels.

Hospitals have various sources of noise such as alarms, paging systems, telephones, computer printers, televisions, delivery carts, staff conversation, equipment, housekeeping activities, air conditioning systems, doors opening and closing, and sounding systems. Of course, one physical effect of the noise is human stress which should be avoided in hospital environment. Topf and Dillon (1988) have described human effects due to noise-induced stress as decrease

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Facilities & Operations Management

in sustained attention, rapid detection, multiple single tasks, and incidental memory.

To overcome the problem of noise within hospitals, some preventive procedures should be carried out.

One form is to measure the noise level periodically to reduce patient exposures to such noises. Another approach is to perform a regular check and maintenance to all systems that are considered as sources of noise including

equipment. Also some practices could reduce noise level, these include: handling different alarms, obligation of instructions in critical areas such as intensive care units, making clear circulation paths for patients and staff,

Classification of hospital waste and methods of treatment

Figure 1

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Source: Pruss A, Giroult E and Rushbrook P, eds. Safe Management of Wastes from Health-care Activities, Geneva, World Health Organization, 1999, page 168. Electronic access: http://whqlibdoc.who.int/publiations/9241545259.pdf

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Facilities & Operations Management

and well training for services providers such as housekeeping.

3. Infection Control

Infection control provides a framework for identification of a hazard and development of an action plan to eliminate the hazard or minimise its effect through control measures.

Control has been achieved by recognising the means of growth, reproduction and transmission of pathogenic microorganisms. The main components of an effective infection control program are illustrated in Figure 2 and listed as following: • Education and training • Surveillance of infection • Policies, procedures, and guidelines • Audit processes • Documented arrangements • Monitoring of hospital hygiene The WHO has classified infection control practices into two main categories: standard precautions and additional (transmission-based) precautions. These category items are

Standard precautions include the following items • Hand washing and antisepsis (hand hygiene) • Use of personnel protective equipment when handling blood, body substances, and secretions • Appropriate handling of patient care equipment and soiled linen • Prevention of needlestick / sharp injuries • Environmental cleaning and spillsmanagement • Appropriate handling of waste Additional (transmission-based) precautions while ensuring standard precautions include • Airborne precautions • Droplet precautions • Contact precautions For infection control management, existence of a clear written policy within the facility to closely monitor and implement infection control processes with feedback measurement as well as compliance with infection control practices is essential. Moreover,

routine practices such as aseptic techniques, single-devices, reprocessing of instruments and equipment, antibiotic usage, handling and use blood and blood products as well as environmental management practices is fundamental for this issue.

4. Radiation Safety

The last two decades have witnessed a technological revolution in diagnostic and therapeutic medical imaging.

However, minimising the risk of radiation exposure is still a challenge.

According to a 2010 US Food & Drug Administration (FDA) white paper, per capita exposure to ionising radiation (from all sources) increased from 3.6 mSv (milli Sievert) in 1980 to 6.25 mSv in 2006. During this time, the contribution that was attributable to medical imaging increased from 15 per cent in 1980 to 48 per cent in 2006, and over two- thirds of all medical imaging in 2010 involved ionising radiation.

Radiation protection is a public health issue for a number of reasons.

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Facilities & Operations Management

The main components of an effective infection control program

Education and Training

Production and dissemination of written policies, procedures, and guidelines

Surveillance of infection

Audit processes

Documented arrangements for dealing with infections

Monitoring of hospital hygiene

Risk-adjusted rates for comparisons

Standardized methodology

Appropriately trained investigators Targeted surveillance (site-, unit-, priorityoriented) Active surveillance (prevalence and incidence studies) Figure 2

First, health effects of radiation are not unique. Second, individuals have only a limited ability to structure or control their own environment. Although radiation exposure awareness has increased among the general public, there is still very little monitoring of cumulative radiation exposure over a patient's lifetime. Successful radiation safety progrmmes must balance engineered safety and personnel training considering technical, scientific, economic, human, and ethical aspects of radiation use. The medical safety progrmme must adequately

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protect patients, care givers, visitors, and the general public. To minimise external radiation exposure hazards in ionising radiation, fundamental principles in radiation protection should be identified as follow: 1.Existence of radiation safety program that cover and support the following activities • Regulatory activities related to radioactive material license • Multilevel relation safety training • Monitoring of occupational radiation doses of personnel • Control of radioactive materials

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• Active participation in planning of new or remodeled facilities • Response and investigation of incidents/accidents • Quality management program.

2.Time, distance, and shielding are other crucial elements in radiation safety that should be regarded.

• Time: The simplest method for protection from ionising radiation is to spend as little as possible in the vicinity of radiation source, in addition, reducing the exposure time by one half reduces the dose received by one half

Facilities & Operations Management

• Distance: Doubling the distance between the person and the source helps to reduce the exposure to a quarter of its original value • Shielding: Shielding is considered as the most significant line of defense.

The more mass that is placed between a source and a person, the less radiation the person will receive.

Gamma ray can be attenuated by using lead shields or concrete.

Nonionising radiation is a significant health hazard in all hospitals.

This type includes ultraviolet, microwave, and laser radiation. Ultraviolet (UV)radiation is frequently used in sterilisation procedures. In fact, UV exposures are best controlled by limiting exposures as function of energy. In application, Microwave radiation is commonly used in hospital diathermy treatment and in microwave ovens. Microwave radiation is controlled by limiting exposure and sources should be periodically surveyed with measurement equipment. On the other side, Lasers have an increasing role in medical treatment. Eyewear is the most common method of protection.

5. General Building Safety

Safety of building is the practice of designing, constructing, operating, maintaining, and removing buildings in ways that gives no one deteriorated health, injuries or death due to the use of building. The vast investment in health infrastructure-hospitals can absorb up to 70 per cent of ministry of health budgets-can be lost when poorly constructed hospitals are destroyed or damaged. Hospitals can be made more resilient and functional through action to improve the sustainability of health infrastructure, including measures to increase the reliability of power and water supply systems.

The physical structure of the hospital may pose hazards to the patients and workers alike. The most common causes of compensable work

injuries are manual material handling, falls, and getting struck by falling or moving objects. Accidents and injuries due to falls and collision can be minimised through: • Establishing a traffic flow pattern • Ensuring clean, dry, unobstructed, and slip-resistant surfaces • Maintaining railings and stair surfaces in good condition • Supervising patients to minimise unnecessary trave.

Fire and smoke alarm system is considered a means to ensure life safety

Topf and Dillon (1988) have described human effects due to noise-induced stress as decrease in sustained attention, rapid detection, multiple single tasks, and incidental memory.

as well as building safety. Hospitals must comply with the life safety code NFPA 101 of the National Fire Protection Association, published in 1997. This standard provides detailed specifications for design, construction, and operation of building to protect occupants from fire.

Gases cylinders and distribution systems are usually considered an integral part of the hospital structure.

Medical gases are vital elements in patient treatment as well as laboratory procedures. Most hospitals have a permanently installed gas distribution system. In this system gas cylinders may be stored in a centralised location separate and apart from other hospital functions. Any gas cylinder should be accorded the following elements of care: • Identify cylinders by written name and colour coding • Secure cylinders to wall or within enclosures • Cap all cylinders not in immediate use • Protect cylinders from temperature extremes • Never use oil or grease on oxygen or nitrous oxide equipment • Never permit smoking or use flames near oxygen or nitrous oxide equipment

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Facilities & Operations Management

6. Water Quality

Water is a strategic energy resource that should be used and managed properly.

In hospitals, water is a necessary utility which is obtained from outside sources.

This utility may serve as a medium for the spread of infections from outside sources to the hospital. A complete chemical analysis of water is required to establish quality levels. This analysis may be performed by local public health agencies or by hospital staff. If the hospital has storage water tanks, they should be cleaned regularly and the quality of water should be sampled periodically to check for bacterial contamination.

In healthcare facilities, the demand of water by different services and users depends on many issues but must always consider potential risks and negative impacts of water use by people (e.g., infection) and equipment (e.g., fast deterioration and damage); the collection and treatment prior to its final disposal and discharge into the sewer system, and the possible environment impact upon the water use cycle (e.g., contamination).

Once the water is delivered to the hospital, it requires further treatment and conditioning to meet specific needs.

The typical treatment of the hospital water supply includes deionisation, distillation, and sterilisation. Most healthcare facilities have six major areas of water consumption: sanitation, Heating, Ventilation, and Air Conditioning (HVAC), clinical and medical procedures, laundry, food services, and miscellaneous uses.

Sanitation and HVAC consume approximately 60 percent of the water in most facilities.

Waste water collected from different services within hospital carries a variety of chemicals and biological pollutants,

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several of which are hazardous.

Wastewater should be included in a hospital's water management and it should be closely monitored and pretreated prior to discharge into the public sewer system.

7. HVAC

The purpose of HVAC system is to provide and maintain environmental conditions, including proper airflow, heating, and cooling within a certain area or the entire hospital.

Installation of HVAC is one of the most important factors by which the architect can combat bacterial infection, and at

Author BIO

• Check gas regulators and do not use a regulator for oxygen or nitrous oxide after it has been used with any other gas.

the same time create environmental comfort.

HVAC system is designed to meet specific values of temperature, relative humidity, and air changes frequency within different areas in hospital based on standards of design. For example, high risk areas such as operating rooms and intensive care units require special ventilation systems through filtration systems (e.g., HEPA filters) and pressure relationship to adjacent areas. In general, clean atmosphere reduces the risk of airborne infection, and dangerous of gases explosion.

References are available at www.asianhhm.com

Neven Saleh is an assistant professor at biomedical engineering department in El-Shorouk Higher Institute of Engineering, Egypt.

She comes with over sixteen years of experience in practicing healthcare technology management. She took place in medical equipment management researches in Italian and Turkish hospitals.

Also, she has an experience in healthcare quality assurance.

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Information Technology

Top Challenges Facing IoT/ IoH

How we can overcome them?

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Information Technology

The field of the Internet of Things (IoT), Internet of Health (IoH), or Connected Health, offer great promise for addressing issues faced by healthcare systems. Without a well-developed process at each point in the system there will be barriers to the roll out and widespread adoption of any new solution.

Kiersey Simon, Co-founder and COO, Bluedrop Medical

T

here are significant issues faced by healthcare systems around the world, including ageing populations, chronic disease, spiralling costs, and a desire to shift care from tertiary to primary settings. The field of the Internet of Things (IoT), Internet of Health (IoH), or Connected Health, offer great promise for addressing these issues.

The basic principle of connected health is quite straightforward. Sensors gather vital data from the patient in the comfort of their home, which can be reviewed remotely. This allows problems to be identified earlier and reduces the number of unnecessary trips for check-ups, which in turn leads to improved outcomes, increased efficiency, and reduced costs.

However, the reality has not been as straightforward. The promise of connected health has been apparent since the early days of widespread access to internet, and yet the rates of

adoption have thus far failed to match the expectations. There are also fewer examples of IoH that can be hailed as major successes at this point than would have been predicted by market analysts 10-15 years ago.

There are many challenges faced by connected health which include unrealistic expectations, reimbursement, integration challenges, and data security to name a few.

This article seeks to explore some of these issues and identify routes to overcoming them.

Matching Expectations

Unrealistic expectations are one of the big issues faced by connected health.

The Gartner Hype Cycle is a curve which is used to graphically display how the level of expectation associated with an emerging technology evolves over time. There are 5 stages to the curve; technology trigger, peak of expectations, trough of disillusionment, slope of enlightenment, and the plateau of productivity.

It describes how expectations ramp up as we initially overestimate the potential of a new technology, which is followed by a period of disillusionment when the realisation occurs that solutions are more difficult to develop and deploy than initially expected.

Some technologies never make it past this point. Others slowly start to make headway as useful applications of the technology identified and exploited.

With sufficient time the market matures, and continued growth comes more in the form of increased efficiency rather than innovation.

Connected health has been in the trough of disillusionment on the Gartner Hype Cycle for the past 8 years. The level of expectation with the field was very high, which is not particularly surprising given that connected health appears to be a panacea for many of the problems faced by healthcare systems. What is unexpected is the length of time it is taking for connected health solutions to demonstrate success and gain widespread adoption.

Focus

One of the issues encountered by connected health has been the muted success to date of solutions which are quite broad, but not very deep. The broad solution seeks to address multiple morbidities and be suitable for a large cohort of patients. Often the broad solution consists of a suite of off-theshelf products that can gather data from the patient, and a subset of these products are given to the patient based on their needs.

A deep solution is one that is purpose built to address a distinct issue for a defined patient population. The monitoring and intervention protocols are developed specifically for the target cohort.

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Information Technology

When these approaches are compared by ‘market size’ or ‘target population’, the broad solution has the advantage. It can be used to address more patients therefore should be more successful for the company producing it, and should be of more use to the healthcare system using it.

However, the needs of different cohorts within a disease state can vary significantly based on patient demographics or the disease stage.

Solutions which target a broad base may not be tailored to maximise the benefit to specific issues.

It is difficult to accurately assess the ‘efficacy’ or ‘cost benefit’ of a broad solution, as it is very challenging to isolate its impact on a specific issue and patient cohort. In such a case the evidence for a deep solution can be gathered in a shorter timeframe, at a lower cost, and because the study is more focused the evidence may be substantially stronger.

Implementing change is always difficult, and without clear evidence of there being a significant benefit associated with the change, it becomes even more difficult. Instead of focusing on broad solutions which may give an incremental benefit over the current standard of care, the emphasis should be on identifying the connected health solution that delivers outstanding benefits. With strong data demonstrating the efficacy and cost benefit, the support to make the transition to the new standard of care will follow.

Drowning in Data

Drowning in data is another issue which has impeded the growth of connected health. The amount of data being collected has increased exponentially, but value of this data has yet to match its volume. The ability to collect and send data does not by itself lead to improved outcomes. Digital snakeoil is term which has been used to concisely label this issue.

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Every healthcare professional has a busy schedule, and imposing a requirement to carve out time to spend reviewing data, which may not be of value to the patient or clinician, is not the best use of anyone’s time. The real value in the data is to provide the healthcare professional with actionable insights.

Ideally the connected health system identifies the occurrence of a problem, and provides both the alert and the recommendation as to what course of action should be taken for that issue. The physician can then focus on administering the appropriate intervention, rather than spending time determining what the appropriate care pathway is. For this to occur, solutions, data review protocols,

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triage, and interventions all need to be developed in collaboration with clinical stakeholders.

By focusing on specific issues that have clear definitions, the connected health monitoring protocols can be developed sufficiently to provide a discrete response and remove the need for clinical interpretation. In such cases the review may be performed by a trainer inspector, or AI, rather than a medical professional.

Reimbursement

The traditional fee-for-service payment model is a significant challenge which must be overcome to enable widespread adoption of connected health solutions.

As most connected health solutions are preventative, and most payment

Information Technology

Data Security

This is an area of increasing concern for all organisations, which has also slowed the deployment of connected health solution as organisation find it difficult to accurately assess the cyber security risk associated with the new connected health solution.

There have been multiple cases of data breeches and ransomware in 2017. It is a requirement not only for getting approval for selling a device, but will also be heavily scrutinised by potential partner organisation such as a hospital group, public health service, or private health insurance

User Design

The level of expectation with the field was very high, which is not particularly surprising given that connected health appears to be a panacea for many of the problems faced by healthcare systems.

company. In each instance all parties need to be comfortable all necessary steps have been taken to minimise the cyber security risks.

The General Data Protection Regulation was recently enacted in the EU. It is currently in a grace period but will come into full effect in May 2018. This will drive multiple requirement for organisations such as increased contractual agreements between partner organisation, and the appointment of a Data Protection Office. Data Protection Commissioners have also been empowered to hand down fines of up to â‚Ź20m or 4 per cent turnover of a particular undertaking following a significant data breech.

Author BIO

models are fee-for-service, there is a gap that must be bridged. Typically, a connected health solution is not an iterative improvement on the current standard of care, it’s something entirely new that hasn’t been paid for before.

As a result, the ability to clearly demonstrate the efficacy and economic benefit become increasingly important to make a strong case for reimbursement. Pilot studies with partner organisations, with a focus on a specific cohort are required to demonstrate the real-world effectiveness of a connected health solution. Traditional clinical trials are potentially of less value than for a therapeutic product. This is because one of the main concerns about connected health solutions is adherence in the real world, which is a challenge to answer with an RCT. Therefore, the solution should have a defined target population and specific measurable clinical and economic outcomes which can be monitored during a study. Data which has been developed in collaboration with an organisation may be more powerful in driving adoption compared to the results of a study carried out elsewhere.

The FDA have recently updated their guidance in relation to human factors and usability engineering for medical devices. The primary focus of this guidance is to minimise risk to the patient. However, the methodologies recommended can be applied to other aspects of the product lifecycle to improve its design for all stakeholders.

Most user design has been focused on how the patient uses the device, but good design is required at each step where there is interaction with the product; the prescription and payment process, training and set up, the actual use of the device by the patient, the review process, and the intervention process.

Without a well-developed process at each point in the system there will be barriers to the roll out and widespread adoption of any new solution.

Closing Thoughts

Connected health offers huge potential for improving outcomes and reducing costs. However, the transition to a new model of care is a challenge that will require support of all stakeholders. For this reason, the midterm focus should be on identifying and implementing solutions which consider all elements of the lifecycle, and which have outstanding data supporting their efficacy and cost benefit. Successfully addressing specific issues will pave the road to more widespread adoption of connected health.

Kiersey Simon is the co-founder and COO of Bluedrop Medical - a connected health startup developing an IoT foot-scanner which utilises computer vision and AI to remotely monitor and prevent diabetic foot ulcers. Simon previously worked at Medtronic in R&D, where he developed implantable devices and was a member of the TAVI BioInnovate Team. Simon holds a Masters in Biomedical Engineering and a Bachelors in Mechanical Engineering, both from University College Dublin.

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Books

Demystifying Big Data and Machine Learning for Healthcare Author(s): Prashant Natarajan, John C Frenzel, Detlev H Smaltz No of Pages: 191 Year of Publishing: 2017 Description: Demystifying Big Data and Machine Learning for Healthcare investigates how healthcare organizations can leverage this tapestry of big data to discover new business value, use cases, and knowledge as well as how big data can be woven into pre-existing business intelligence and analytics efforts. This book focuses on teaching you how to: • Develop skills needed to identify and demolish big-data myths • Become an expert in separating hype from reality • Understand the V’s that matter in healthcare and why • Harmonize the 4 C’s across little and big data • Choose data fi delity over data quality • Learn how to apply the NRF Framework • Master applied machine learning for healthcare • Conduct a guided tour of learning algorithms.

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Realizing the Promise of Precision Medicine: The Role of Patient Data, Mobile Technology, and Consumer Engagement Author(s): Paul Cerrato, John Halamka No of Pages: 218 Year of Publishing: 2017 Description: Realizing the Promise of Precision Medicine: The Role of Patient Data, Mobile Technology, and Consumer Engagement explains the potential of personalized medicine and the value of those approaches in making that potential a reality. The book helps transform one-size-fits-all healthcare into a system that focuses on individual needs and the unique needs of each family member, discussing topics such as U.S. sponsored precision medicine initiative, genomics, the role of electronic health records and mobile medicine, patient engagement and empowerment, health information exchange and patient data protection.

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Managing the Myths of Health Care: Bridging the Separations between Care, Cure, Control, and Community Author(s): Mintzberg No of Pages: 240 Year of Publishing: 2017 Description: In this sure-to-be-controversial book, leading management thinker Henry Mintzberg turns his attention to reframing the management and organization of health care.

The problem is not management per se but a form of remote-control management detached from the operations yet determined to control them. It reorganizes relentlessly, measures like mad, promotes a heroic form of leadership, favors competition where the need is for cooperation, and pretends that the calling of healthcare should be managed like a business.

“Management in healthcare should be about dedicated and continuous care more than interventionist and episodic cures.”

Volume to Value: Proven Methods for Achieving High Quality in Healthcare Author(s): David Kashmer No of Pages: 236 Year of Publishing: 2016 Description: In Volume to Value, the author maintains that the identification and adoption of advanced quality tools in healthcare is ethical, necessary, and, in the long run, cost effective. Through illuminating stories that illustrate specific systemic challenges, Dr. Kashmer offers a far-reaching program based on the Six Sigma principles for using data-driven approaches and methodologies to eliminate defects in processes. His plan will empower health-care professionals to define, measure, analyze, improve, and control procedures while eliminating preventable errors system-wide.

The pursuit of improvement is a never-ending process. But profound, measurable results are possible at every level of the health-care system—from admitting to the ER to the operating room—by adopting the systematic approach to excellence that Dr. Kashmer has shared.

Mapping Clinical Value Streams Author(s): Thomas L. Jackson No of Pages: 123 Year of Publishing: 2016 Description: The value stream mapping methods described in Mapping Clinical Value Streams will help you achieve more efficient healthcare processes and will pave the way to an improved medical system with significantly reduced medical errors and other costly waste.

Part of the Lean Tools in Healthcare series, this user-friendly book will help you understand how to use value stream mapping to provide quality, patient-centered care. Value stream mapping is a powerful tool for observing and depicting processes as they truly are—and for envisioning and reconfiguring the same processes to eliminate errors and other waste. With this book, you’ll learn how to: • Map current-state processes • Create a future-state map with processes streamlined through "flow" and "pull" • Manage the rollout of your future state with "A3" project plans.

Cases for Developing Healthcare Leaders

Author(s): Jeanette Harrison No of Pages: 111 Year of Publishing: 2017 Description: Cases for Developing Healthcare Leaders is a casebook written by Jeanette R. Harrison, MPH. The purpose of the text is to provide sample cases to assist in the development of both early and experienced healthcare leaders. Each section contains a unique case. The cases are followed by case questions designed to enhance discussions on the topics.

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Books

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Continuous Flow for Healthcare

Not Quite a Cancer Vaccine: Selling HPV and Cervical Cancer

Author(s): Thomas L Jackson C Frenzel, Detlev H Smaltz No of Pages: 120 Year of Publishing: 2018 Description: Continuous flow (or cellular manufacturing) is an aspect of Lean production that can boost efficiencies by eliminating waste from a process. By arranging people and equipment into an efficient, process-based cell, this process creates a smooth flow that shortens lead times for delivery to customers.

Part of the Lean Tools in Healthcare series, this user-friendly book will help to improve readers’ understanding of this tool. Through the use of margin assists, the book highlights key terms and points, healthcare examples, and how-to-steps.

Author(s): Samantha D Gottlieb No of Pages: 224 Year of Publishing: 2018 Description: In Not Quite a Cancer Vaccine, medical anthropologist S.D. Gottlieb explores how the vaccine Gardasil— developed against the most common sexually-transmitted infection, human papillomavirus (HPV)—was marketed primarily as a cervical cancer vaccine.

Gardasil quickly became implicated in two pre-existing debates—about adolescent sexuality and pediatric vaccinations more generally.

This book demonstrates why in the ten years since Gardasil’s U.S. launch its low rates of public acceptance have their origins in the early days of the vaccine dissemination. Not Quite a Cancer Vaccine addresses the on-going expansion in U.S. healthcare of patients-as-consumers and the ubiquitous, and sometimes insidious, health marketing of large pharma.

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Statistical, Mapping and Digital Approaches in Healthcare Author(s): Gilles Maignant, Pascal Staccini No of Pages: 230 Year of Publishing: 2018 Description: Statistical, Mapping and Digital Approaches in Healthcare addresses all health territories, starting from the analysis of geographical data (health data, population data, health data systems and environmental data) to new health areas (Health 3.0), i.e. digital health territories. Specific tools are used to question environmental changes, such as health statistics, mapping, mathematical models, optimization models and serious games.

• Uniquely combines the approaches of mathematicians, geographers and physician to the analysis of health territories • Presents views that are based on an interdisciplinary framework, proposing a new look on health • Ideal for both clinicians and policymakers.

Usability and Health Care Technology

Digital Health: Scaling Healthcare to the World (Health Informatics)

Mastering Healthcare Terminology

Author(s): Andre Kushniruk, Elizabeth Borycki No of Pages: 320 Year of Publishing: 2018 Description: Usability and Health Care Technology details and describes how methods from usability engineering can be effectively applied to improve the usability of healthcare information systems and technologies. The book shows how these methods can be used to design, implement, and test health information systems and applications that will lead to more effective, efficient, and safe systems that better support healthcare work.

Readers will gain an understanding of how usability engineering can be applied in healthcare informatics, as the book details a proven, practical, and effective methodological framework for applying these methods to improve the design, implementation, and optimization of healthcare information systems, technologies, and applications.

Author(s): Homero Rivas, Katarzyna Wac No of Pages: 370 Year of Publishing: 2017 Description: Digital Health: Scaling Healthcare to the World addresses the emerging trends and enabling technologies contributing to technological advances in healthcare practice in the 21st Century. These areas include generic topics such as mobile health and telemedicine, as well as specific concepts such as social media for health, wearables and quantifiedself trends. Also covered are the psychological models leveraged in design of solutions to persuade us to follow some recommended actions, then the design and educational facets of the proposed innovations, as well as ethics, privacy, security, and liability aspects influencing its acceptance.

Furthermore, sections on economic aspects of the proposed innovations are included, analyzing the potential business models and entrepreneurship opportunities in the domain.

Author(s): Betsy J Shiland No of Pages: 736 Year of Publishing: 2018 Description: Learn how to communicate clearly and confidently with other members of the healthcare team! Mastering Healthcare Terminology, 6th Edition covers medical terms and definitions in small chunks of easy-to-follow learning segments that are followed immediately by exercises and review questions to reinforce your understanding. Organized by body systems, this work text includes over 100 case studies and medical records with review questions. Also included are mobile-optimized quizzes and flash cards that make it easy to study terms anytime, anywhere. This popular introduction to medical language is perfect as a career refresher or college-level learning.

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Products & Services Company............................................... Page No.

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HEALTHCARE MANAGEMENT

GlobalData............................................................................... 17

Algeria Health Ad..................................................................... 11

Lessa......................................................................................IBC

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Cantel....................................................................................OBC Device Informed...................................................................... IFC GlobalData............................................................................... 17

INFORMATION TECHNOLOGY Device Informed...................................................................... IFC GlobalData............................................................................... 17

TECHNOLOGY, EQUIPMENT & DEVICES Cantel....................................................................................OBC Device Informed...................................................................... IFC

Suppliers Guide Company............................................... Page No.

Company............................................... Page No.

Algeria Health Ad..................................................................... 11

IMMEXLS................................................................................. 50

www.algeriahealthexhibition.com

www.immexls.com

Cantel....................................................................................OBC

Lessa......................................................................................IBC

www.medivators.com

www.lessap.com

Device Informed...................................................................... IFC

Medtech Forum........................................................................ 03

www.deviceinformed.com

www.apacmed.org

GlobalData............................................................................... 17

Quest Conferences................................................................... 05

www.globaldata.com

To receive more information on products & services advertised in this issue, please fill up the "Info Request Form" provided with the magazine and fax it, or fill it online at www.asianhhm.com by clicking "Request Client Info" link. 1.IFC: Inside Front Cover 2.IBC: Inside Back Cover 3.OBC: Outside Back Cover

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