IndiaMedToday November 2017 by IndiaMedToday

NOVEMBER 2017, VOLUME 1 ISSUE2 `200

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How

Doctors See

DEBUNKING HEALTHTECH INNOVATION MISCONCEPTIONS

Paying for Gene Therapy

Physician burnout

who will foot the million dollar bill?

Sharing experiences key to healthcare staff well-being

Health 2.0 user-generated healthcare

EDIT NOTE www.indiamedtoday.com

NOVEMBER 2017 EDITOR

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Neelam Kachhap editorial@ indiamedtoday.com

Dr Dr Dr Dr Dr

Alexander Thomas Girdhar Gyani Prem Kumar Nair Bhabatosh Biswas Alok Roy

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CONNECTING THE DOTS ON HEALTHTECH INNOVATION INNOVATION IS the wheel of change. The enthusiasm of healthtech start-ups, gives us hope that something new and hopefully better will emerge from the existing scenario. Recently, an elite group of scientist and healthcare professionals met at ISRO, headquarters Bangalore to explore the possibilities of cross-disciplinary collaboration, for health-tech innovation. It is not surprising that a lot of advanced medical technologies have emerged from space research labs around the world. The nonavailability of healthcare providers coupled with extreme living conditions force space scientist to think outside-the-box and come up with fail-safe healthcare delivery devices and technology. Surgical robotics is one such technology that was born at NASA, to provide adequate medical care for its astronauts during extended spaceflights, like the trip to Mars. Today this technology has become the epitome of precision and accuracy during surgery, advancing difficult procedures, improving quality-of-life and saving many lives.

Can Indian healthcare professionals collaborate with space research scientist to find affordable, efficient medical technologies Can Indian healthcare professionals collaborate with space research scientist to find affordable, efficient medical technologies? Judging by the response at the Bangalore meeting, there is significant interest on both sides. However, there is a lot of skepticism among physicians and specialists regarding crossdisciplinary collaboration for healthcare innovation; may be arising out of lack of information and clarity of the process of innovation. We have tried to look at these misconceptions in our cover-story. Besides, our impact piece is a good read on cost of innovation and the price of the product. The article also looks at funding models to pay for the high-cost products. The opinion piece talks about Make-in-India and how this policy has impacted health-tech innovation and manufacturing in India. We also have a special Health 2.0 section that talks about the conference and has interviews with todayâ&#x20AC;&#x2122;s successful healthcare leaders. We received a huge response to our inaugural issue. Thank you for your support. Do send you views and opinions. We are eager to hear from you.

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CONTENTS

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UPFRONT 03 Editorial 05 Letters 06 News roundup 46 Ask the expert 48 Events

OPINION

COVER STORY

MAKE IN INDIA DREAM OR REALITY? With the right intervention of advanced medical technology, which interestingly is manufactured within the country itself, this malady in our system can be effectively addressed.

PAYING FOR GENE THERAPY

Who will foot the million dollar bill?

While we have newer treatments for lifethreatening diseases, these treatments are so expensive that it may well be outside the reach of the patient. Value-based payments could be one way to work through the problem

November 2017

The life cycle of business is reducing, making products, and business models obsolete more quickly. In the face of overwhelming odds, what keeps a leader going? Health 2.0 Conferences special Issue 36 Interview – Abhishek kapoor, Sen-

Indian Doctors have about Innovation

IMPACT

26 11 traits to win Continually

35 Health2.O

6 COMMON MISCONCEPTIONS

Have Indian doctors failed health-tech innovation? Lack of clarity on health-tech innovation could be one of the reasons why doctors and engineers don’t typically work effectively as a team. Debunking these myths becomes necessary.

FEATURES

PULSE

PHYSICIAN BURNOUT

Sharing experiences key to healthcare staff wellbeing.

ior Vice President –Strategy; Promoter – Regency Healthcare 38 Interview- Matthew Holt is the Co-Chairman, Health 2.O and founder, The Healthcare Blog 40 Interview - Sarang Deo, Associate Professor, Operations Management at Indian School of Business 42 Interview - Vrinda Deval, Managing Partner, GLocalMind 44 Interview - Francis Prashanth, Country Manager – India, Health 2.0

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LETTERS

had a quick look at the contents of your inaugural issue of IndiaMed Today- Reimagining Indian Healthcare. The article on ISRO’s role is very informative and could prove to be a step with a vision for the future. I was delighted to read the contents and I am sure the dynamism of Dr Alex Thomas and the good wishes, support and guidance of Dr Devi Shetty, whose pioneering and out of the box thinking on several facets of healthcare is sure to make a major impact on an affordable medical service for our country. Please keep it up!

K. Kasturirangan Former Chairman, ISRO Chairman, National Education Policy Panel

Healthcare is an ignored field in our society and I applaud the efforts that Neelam Kachhap is making with her new venture IndiaMedToday. Any attempt to bring the issues facing our healthcare into sharper focus can only be commended and this effort seems to be a right step in this direction. I just hope that the magazine, like many other media platforms in India, doesn’t end up becoming the mouthpiece of corporate healthcare and their achievements. Instead, raises the real issues and dilemma facing the organisation and delivery of healthcare in India at all levels. At the same time, we, the public have to recognise that ethical, investigative journalisms needs to be sustainable and we need to support it. We will get what we are prepared to spend our money and time on.

I liked the magazine IndiaMedToday. The cover-story makes an interesting read. The other articles were also interesting. Do include write-ups on concerns of Nurses in future issues.

Kamal Mahawar Consultant General and Bariatric Surgeon, Sunderland Royal Hospital, Uk

I saw this magazine at a friend’s clinic. Today practicing doctors face a lot of problems due to medico-legal problems. Nice to read the Q&A on medico-legal issues. We are not taught all this in medical school so it’s important to share such experiences. Dr Mahesh Shah Ahmedabad

Sheila Nair Nursing Superintendent Delhi

The healthcare sector in India remains one of the largest sectors in terms of both employment and revenue generation. There are many areas of healthcare delivery that need improvement. Its good for a journal like yours to highlight such issues and channel a healthy debate for change. Dr Mukul Verma Mumbai

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NEWS ROUNDUP PHILIPS HEALTHWORKS ACCELERATOR PROGRAM TAKES OFF WITH 4 START-UPS

the biggest challenges in healthcare requires dynamic partnerships. Our world-class startup program gives startups unrivaled opportunities to make a profound difference to the lives of billions of people. The program gives

L- R: Ramakant Vampati and Jo Aggarwal – Founder Touchkin, Geetha Manjunath – CEO & CTO NIRAMAI, Neeraj Kumar Gupta – CTO & Co-founder Parentlane, Vijay Anand MV – CEO & Cofounder Parentlane, Srinivas Prasad – CEO Philips Innovation Campus, Alberto Prado – Head Philips Healthworks, Shibichakravarthy Kannan – Founder and CEO Theranosis.

Philips HealthWork, a healthtech accelerator within Philips, introduced four start-ups chosen and mentored by it at Bangalore. The four healthcare start-ups were scouted and selected from an array of 600 start-ups and will form the first Bangalore cohort as Philips validates these innovation. Philips HealthWork has similar cohort in Cambridge, MA, USA; Shanghai and Eindhoven, Hamburg. Philips HealthWorks program is a unique and intensive 12 week tailored program designed to help the start-ups build, test, derisk and scale their idea. Apart from mentoring, the program also provides technical and business expertise, state-of-the-art technology, co-working space and advice from the top experts within the industry. Speaking at the event Alberto Prado, Head of Philips HealthWorks said, “Tackling

November 2017

access to an outstanding network of experts, investors and healthcare partners and also to our three global innovation hubs. We are very excited about our first Bangalore cohort which is showcasing exciting solutions across a vast array of fields in Healthcare, from Data Science, Oncology, Behavioral health to Parenting.” “Philips HealthWorks startup program is unique. It is customized according to the need of each start-up. We are making a dedicated effort to help start-ups in strengthening their value proposition and become successful sustainable business. We are committed towards building a supportive environment for start-ups across the world,” said Srinivas Prasad, CEO, Philips Innovation Campus, Bangalore. The start-ups included in the Bangalore

cohort are Niramai, Parentlane, Theranosis and Touchkin. The solutions presented include non-invasive breast screening solution, an intelligent social platform that tracks a child’s holistic developmental activities, a solution for monitoring cancer treatment efficacy & clinical outcomes and an emotionally intelligent AI platform. The start-ups showcased their solutions to the audience consisting of healthcare professionals, Philips leaders, leading entrepreneurs and venture capitalists. Talking about their journey and experience with Philips HealthWorks, Dr Shibi Kannan, Founder & CEO, Theranosis said, “There is something special about Philips HealthWorks program. Most of the Startup programs are focused on IT sector, very few of them on Healthcare sector and within that very few are focusing on technology – Philips HealthWork addresses it via attention to both the business side and technology side of healthcare solutions.” Neeraj, Co-founder & CTO of Parentlane said, “Philips HealthWorks program helped us understand the big picture, identify our customers, and understand their pain-points. I especially liked the experimental designs which was an effective way to get the responses from the customers.”

CIPLA’S US SUBSIDIARY RECEIVES FINAL APPROVAL FOR GENERIC RENVELA® TABLETS Cipla Ltd, a global pharmaceutical company announced that its subsidiary, InvaGen Pharmaceuticals Inc. (collectively Cipla), has received final approval for its Abbreviated New Drug Application (ANDA) for Sevelamer Carbonate Tablets, 800mg, from the United States Food and Drug Administration (USFDA) to market a generic version of Genzyme’s Renvela® Tablets, 800 mg. Sevelamer Carbonate Tablets,800mg is a AB-rated generic equivalent to the reference

listed drug (RLD), Renvela® Tablets, 800mg of Genzyme Corporation and are indicated for the control of serum phosphorus in adults with chronic kidney disease (CKD) on dialysis. Renvela® Tablets had US sales of approximately $1.85B for the 12 -month period ending August 2017, according to IMS Health.

CANCER IMMUNOTHERAPY WITH DENDRITIC CELLS NOW AVAILABLE IN INDIA One of the most innovating and advanced cancer treatments, Immunotherapy with dendritic cells infuses a new ray of hope for the cancer patients. Dr Frank Gansauge from Germany and LDG India has brought this treatment facility in collaboration with the renowned Germany based laboratory “Dr. Gansuage”. According to the company Dr. Hari Goyal, Oncologist, Artemis Hospital, Gurgaon and other specialists are using this therapy for their patients. “We are proud of the medical advancements and with Immunotherapy cancer patients are surely going to benefit as this treatment has largely proven its effectiveness worldwide” says Tapesh Singhal, Director, LDG INDIA who has taken the baton forward to introduce this medical facility in India and Indian subcontinents (except China).

Dr Suresh Raghavaiah, Senior Consultant HPB and Multi-organ Transplant Surgeon and Director of the Pancreas Transplant Program at BGS Gleneagles Global Hospital said, “Type-1 Diabetes is a very serious condition which leads to a lot of complications. The patients are usually very young and by the time they are in their teens, develop one or the other complication. The most commonly affected organ is the kidney, leading to kidney failure. If these patients are given simultaneous pancreas and kidney transplant it not only cures the diabetes and prevents all of its complications, but also increases the life span of the transplanted kidney. Transplantation of the Pancreas is one of the most complex transplant operations. We are very happy that all five surgeries have been successful and the patients are doing well.” Gleneagles Global Hospitals is known for its transplant program and performs liver, kidney, pancreas and heart transplants. They have been the first hospital to perform a pancreas transplantation procedure in Karnataka, and are the only hospital in the state to have completed 5 successful Pancreas transplants. One of the patients who underwent a successful transplant has been Mr. Praveen, 32

years of age. He was diagnosed with type 1 diabetes 17 years ago, and has been living with it since then. As a complication of diabetes, he developed eye problems. 4 years ago, he was diagnosed with kidney failure and has had to undergo dialysis for the past three years. Finally, he came to BGS Gleneagles Global Hospitals seeking a kidney transplant. After examination and evaluation by the medical team at the hospital, they were of the opinion that the patient would be better served by a simultaneous pancreas kidney transplant. This would not only treat the kidney failure of the patient, but also treat the diabetes as well, preventing the future development of complications of diabetes while also increasing the life of the transplanted kidney. The surgery took 7 hours, but Dr Suresh Raghavaiah is happy to report that the patient withstood the surgery very well, and was able to be taken off insulin and dialysis immediately after surgery. Along with Dr Suresh Raghavaiah, Dr Raghavendra, Dr Sunil and Dr Deepthi were part of the surgical team. Anaesthesia support was provided by the expert team under HOD Dr Kutappa including Dr Nagesh, Dr Aninditha and Dr Arun. Dr Madhu and team provided critical care assistance. Dr

FIVE SUCCESSFUL PANCREAS TRANSPLANTATIONS PERFORMED AT BGS GLENEAGLES GLOBAL HOSPITALS BGS Gleneagles Global Hospital, a part of Parkway Pantai, has lived up to its reputation of being a multi-organ transplant centre by recently achieving the rare feat of completing its fifth successful pancreas transplantation in Karnataka. Pancreas transplants are usually done for patients with Type 1 diabetes whose native pancreases do not produce any insulin.

L- R: Mr Thomas Mathew, COO, Gleneagles Global Hospitals, Bengaluru, Dr Suresh Raghavaiah, Senior Consultant HPB and Multi-organ Transplant Surgeon and Director of the Pancreas Transplant Program, BGS Gleneagles Global Hospital with patients Mr. Praveen and Ms. Sharbani along with Dr Anil Kumar, Senior Consultant, Nephro-Urologyat BGS Gleneagles Global Hospital

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NEWS ROUNDUP Anil Kumar and team managed the patients’ immune suppression post surgery while Dr Satish Babu and Dr Srinath were part of the endocrinology team. Dr Anil Kumar, Senior Consultant, Nephro-Urologyat BGS Gleneagles Global Hospital added “With time, type 1 diabetes can affect the kidneys, leading to kidney failure. Most often these patients undergo a kidney transplant alone. But this does not prevent them from all the other effects of diabetes like damage to the blood vessels, nerves, eyes and the heart. A Pancreas transplant not only arrests the development of these complications, but also has been found to reverse them in the early stages. All five patients had kidney failure due to diabetes and were receiving daily insulin injections as well as undergoing regular dialysis. All patients have received both a pancreas and kidney transplant. We are happy to report that our oldest patient has sustained these organs for more than 18 months now, and he continues to be free of diabetes and off dialysis. The most recent case of transplant occurred six weeks ago, and is doing well. One of the other major benefits is that the patient takes the same medication as he would have if he had a kidney transplant alone”. Another successful transplant patient is Ms. Sharbani, aged 35 years. She had been suffering from diabetes for more than 20 years, and had developed kidney failure due to the diabetes, having to undergo regular dialysis for the same. Due to the severe nature of the disease, she was frequently having low sugar levels, which would lead to her losing consciousness. She came to the hospital seeking a kidney transplant operation, but was advised a simultaneous pancreas kidney transplant by the medical team, as they rightly felt that it would not only treat her kidney failure but her diabetes as well. The patient withstood the surgery well, and was taken off of insulin and dialysis immediately after surgery. After a stay of 10 days in the hospital, she was discharged from the hospital in a stable condition, continuing her treatment and assessment as an out-patient. “Pancreas transplants are relatively new

November 2017

to India”, says Dr Suresh. “While more than 17000 pancreas transplants have already been performed in the USA, in India only around 60 transplants have been performed of which 5 have been in our hospital alone. Since the surgery is very complex and the patient needs a dedicated team of surgeons, physicians, anaesthetists and critical care experts, not many hospitals have attempted to do pancreas transplants and awareness even amongst the medical community is low. We hope that the success of these patients will encourage other patients to explore Pancreas Transplant as a treatment option”. Mr Thomas Mathew, COO, Gleneagles Global Hospitals, Bengaluru adds, “Gleneagles Global Hospitals has an amazing history of successful multi-organ transplants, having performed the maximum number of simultaneous multi-organ transplants in Karnataka. We are proud to be one of the top 3 hospitals in the country and the only hospital in Karnataka to have completed so many successful pancreas transplants. We have a multidisciplinary team of doctors including endocrinologists, nephrologists, anesthetists, critical care specialists and surgeons who deal exclusively with transplant patients. Pancreas transplant is one of the most complex surgeries and having a multi disciplinary team caring for the patient helps improve the outcomes. We aim to work with the clinical experts to build awareness of world class solutions and make them more available and accessible to our nation.”

CARESTREAM HEALTH INDIA A GREAT PLACE TO WORK ®

Carestream Health India Pvt. Ltd has been certified as a Great Place to Work®, based on a rigorous assessment conducted by the global research and consulting firm, Great Place to Work® Institute. The assessment primarily evaluates 2 pa-

rameters, the Trust Index© and the Culture Audit©. The Trust Index© measures the employee perceptions of the workplace environment. The Culture Audit© is an evaluation of various people practices, programs and initiatives within the organization, under 15 practice areas. Together, these parameters reflect the trust the employees have in the organization and its management, the camaraderie, and pride in what the company does and what their contribution is to the big picture. To qualify, the company needs to score, above 70 per cent positive response in the Trust Index© and a rating above 2 on the scale of 1 to 5 for the Culture Audit©. “This is truly a proud moment for all of us at Carestream. I strongly believe that organizations are only as good as its people and our people are undoubtedly our assets. Their faith in us motivates us to be better each day and we will do whatever it takes to develop them to be able to confidently manage challenges” says Mr. Sushant Kinra, MD, Carestream Health India Pvt Ltd. “Carestream India has participated in this assessment for the first time and we are glad to have received this certification in one go. It is an important validation for us. This is a beginning and we will only grow from here,” says Preeti Pillai, Head - Human Resources, Emerging Markets, Carestream Health India Pvt Ltd.

MIDMARK INDIA LAUNCHES A BEST-INCLASS MOTORISED BED AT AFFORDABLE PRICES Midmark (India), a leader in the area of patient positioning equipment, has announced the launch of their new motorised bed ‘Electra’, designed and positioned to capture a new market in India’s tertiary care sector. The new bed by Midmark India aims to revolutionize the traditional hospital bed and transform it into an accelerator in a patient’s recovery process. The new bed has been designed and built to enhance patient comfort and caregiver efficiency. Priced between the range of INR 1,30,000 to INR 1,50,000 and

engineered incorporating the most modern technological configurations, the new bed Electra is advanced but simpler to use at the same time. Manufactured and designed entirely in India, the bed not only matches world class standards from a quality, efficiency and safety point of view, but also is priced competitively for the Indian healthcare industry. Speaking on the launch of ‘Electra’, Sumeet Aggarwal, Managing Director, Midmark(India) said, “Electra compliments the motorized bed portfolio of Midmark India and is positioned at a vital transient point on the portfolio. It is powered by the most experienced and largest customer support network in India which will result in a lower cost of ownership. The company is looking to increase sales of motorised beds by 20% overall. Through the launch of Electra, we look forward to meet the growing demand of quality motorised beds in India and enter competitive global markets like Africa, Latin America and East Europe over the next 2 years.” Advance positions like the Cardiac Chair are achieved swiftly with help of its embedded panels, elevating patient from a down right position to a sedentary position without any complexity. Bravo can also be configured with X-ray Permeable Backrest and X-ray Permeable Cassette holder so that the patient doesn’t have to be repositioned, which makes it more convenient for the staff to handle with precision.

NIGHTINGALES HOME HEALTH PARTNERS WITH AMPLIFON TO PROVIDE HEARING AID SERVICES

Nightingales Home Health Services, an enterprise of Medwell Ventures announced its association with Amplifon, an award winning company for providing the best hearing care solutions and treatments in India. Amplifon provides the latest technology-enabled digital hearing aid devices to deliver a better listening experience. Through this association, Nightingales and Amplifon are providing hearing aid services to anyone in need within the comfort of their homes. This service will be available in Bangalore, Mumbai, Pune and Hyderabad. According to statistics, in India, 6.3% of the population (63 million) suffers from hearing loss. The estimated prevalence of adult onset deafness was found to be 7.6% and childhood onset to be 2%. Four in every thousand children are born with severe to profound hearing loss. It has been noted by the WHO that half the causes of deafness are preventable and about 30%, though not preventable, are treatable or can be managed with assistive devices. Thus, about 80% of all deafness can be said to be avoidable. The severity of the hearing defect can be measured in several ways. While the main procedure involves how well a patient responds to a normal speech or whispers, the tests are segregated into mainly two categories. The first procedure involves tests on how difficult it is for the patient to maintain constant speech intensity and secondly, it is tested whether the patient is particularly impaired at a certain frequency range. Amplifon and Nightingales brings home modern techniques that involve producing sounds of several frequencies and pitches and thus manually detecting the problem and deriving accurate results from the above tests conducted at home. Nightingales’ collaboration with Amplifon also aims at revolutionizing the method of detecting hearing loss by testing at home. This enables the audiologist to test the hearing capacity of a patient in a regular environment with noise and disturbance which they are exposed to on a daily basis. This set up increases accuracy in comparison to a test conducted in a sound proof room.

Speaking on the occasion, Mr Lalit Pai, CEO and Co-founder of Medwell Ventures said, “Nightingales witnessed an overwhelming response to providing hassle free dental services in the comfort of your home. While speaking with our patrons, we felt the need to expand our offerings by adding specialized services such as providing hearing impairment solutions to our varied categories. With more than 60% of people over the age of 60 suffering from some degree of hearing impairment, loss of hearing is becoming a common household problem. Statistics suggest that 1/12th of the whole population suffer from some extent of hearing loss. While not many realize they have a problem, people across age groups have been diagnosed with early hearing impairment issues which could be resolved with timely medical assistance.”

GENEPEEKS EXPANDS DISTRIBUTION TO INDIA WITH EXCLUSIVE AGREEMENT WITH CORE DIAGNOSTICS GenePeeks, Inc., a computational genomics company focused on transforming disease risk analysis announced an exclusive distribution agreement with CORE Diagnostics, a next-generation diagnostics provider committed to bringing best-in-class clinical technology and innovation to India. This new distribution agreement furthers GenePeeks’ goal of expanding access to its breakthrough preconception screen and advanced analytics platform in new markets around the world. CORE will exclusively offer GenePeeks’ preconception screen in their extensive market of twenty-nine states and seven union territories across India, greatly expanding GenePeeks global footprint. Demand for preconception screening and care in India is increasing, particularly as awareness of heritable disease risk grows.

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NEWS ROUNDUP “GenePeeks is delighted to add CORE Diagnostics to our list of outstanding global partners.” said Anne Morriss, Co-founder and Chief Executive Officer of GenePeeks. “We look forward to working with the exceptional CORE team to address the European bias embedded in traditional screening and help Indian families better understand their risk of conceiving a child with a serious genetic disease.” Zoya Brar, Co-Founder and Managing Director of CORE Diagnostics stated, “We are excited to partner with GenePeeks to expand our portfolio of innovative testing services and support the growing interest from Indian families and their healthcare providers in preconception screening. GenePeeks’ technology provides a unique opportunity to identify risk to Indian families that was often uncharacterized historically and hidden from clinical view.”

HOLOGIC INTRODUCES MORE COMFORTABLE MAMMOGRAM WITH SMARTCURVE™ BREAST STABILIZATION SYSTEM

November 2017

Hologic, Inc announced the commercial availability of its new SmartCurve™ breast stabilization system, which has been clinically proven to deliver a more comfortable mammogram without compromising image quality, workflow or dose. The SmartCurve system is available exclusively with Hologic’s Genius™ 3D Mammography™ exam, the only mammogram that detects more invasive cancers, reduces false positives, and is FDA approved as superior to conventional 2D mammography for all women, including those with dense breasts. For years, women have reported avoiding regular mammograms due in large part to the fear of discomfort associated with breast compression. In fact, a recent survey of 10,000 women found that fear of physical discomfort was the top reason cited for avoiding a mammogram by women who never had one.5 With this in mind, Hologic’s research and development team, led by Tracy Accardi, Global Vice President of Research and Development, set out to reduce breast pain without compromising image quality or exam accuracy. “As a woman, I know firsthand that all too often, annual mammograms are considered

a necessary evil. We understand the critical role the exam plays in the early detection of breast cancer, but we know how uncomfortable, and sometimes even painful, the exam can be,” said Accardi. “The associated anxiety causes many women to avoid or delay this potentially life-saving exam, something we set out to change when developing the firstof-its-kind SmartCurve system.” Breast pain experienced during a mammogram is directly related to the time spent under compression and the pressure distribution on the breast, two factors that must be addressed to improve the mammography experience. The SmartCurve system features a proprietary curved surface that mirrors the shape of a woman’s breast to reduce pinching and allow better distribution of force over the entire breast. The system also features proprietary image processing algorithms that ensure the preservation of image quality and accuracy. The SmartCurve system, combined with the fastest 3D™ mammogram available, makes the Genius exam the obvious choice for women wanting a more accurate exam that is also more comfortable. In a recent clinical study comparing the SmartCurve breast stabilization system to traditional flat paddle compression, the SmartCurve system improved comfort in 93 percent of women who reported moderate to severe discomfort with standard compression. In addition, 95 percent of those surveyed would recommend facilities that use the system.1 The system includes options to accommodate a majority of women and breast sizes, and can be used with Hologic’s MammoPad® breast cushion for even greater comfort.6 In addition to providing women with increased comfort and the accuracy they have come to expect from the Genius exam, the SmartCurve system’s image processing algorithm ensures there is no change in positioning or workflow for radiologists and technologists administering the exam. Clinicians can feel confident they are offering patients an improved experience while maintaining efficiency within their facilities.

“Hologic is the world leader in breast cancer screening technology, and with that leadership comes a responsibility to develop products that provide optimal patient satisfaction without sacrificing clinical performance,” said Pete Valenti, Hologic’s Division President, Breast and Skeletal Health Solutions. “We are thrilled to introduce the new SmartCurve system which, when used with the Genius exam, is the first and only 3D mammography system that is clinically proven to deliver a more comfortable and more accurate mammogram, compared to 2D mammography alone. This game-changing product is yet another example of our dedication to innovation designed to meet the needs of our customers and their patients.” Hologic’s Genius exam is the only mammogram clinically proven to detect 20 to 65 percent more invasive breast cancers compared to 2D mammography alone.2 It also reduces unnecessary callbacks and is the only mammogram FDA approved as superior to conventional 2D mammography for women with dense breasts.3-4 Sheryl Crow, Genius exam spokeswoman, said, “I’ve already been telling women that the Genius exam is the best option for their annual screening. Now that it’s also a more comfortable exam thanks to the SmartCurve system, I’m urging women everywhere to stop making excuses and ask their doctors about the Genius exam today.” The SmartCurve system is available standard on Hologic’s new 3Dimensions™ mammography system and as an enhancement option to existing Hologic Selenia® Dimensions® systems.

ENSURING QUALITY STANDARDS IN GENERIC DRUGS A conference on “Ensuring Quality Standards in Generic Drugs” was organized in Bangalore by ASSOCHAM in association with Department of Pharmaceuticals, Government of India in order to make sure that all pharmaceutical stakeholders in India are on the same quality footing.

The Indian pharmaceutical sector generates about 10 percent of the global pharmaceutical output and is expected to expand to $55 billion by 2020. The Indian generics accounts for 20 per cent of global exports, making India the largest provider of generic drugs globally. Generic medicines in India have received a new impetus with Prime Minister Narendra Modi advocating the usage of these medicines. While the government wants to make cheaper non-branded drugs available to consumers advocating the usage of these medicines, the laws have to stipulate that the generic drugs consumers gets from the pharmacist meets certain quality standards. The Conference was addressed by Bhagoji T. Khanapure, Drugs Controller, Drugs Control Department, Government of Karnataka,Sunil Attavar, President, KDPMA and Chairman & Managing Director,Group Pharmaceuticals Ltd., Suresh Sugavanam, Vice President and Managing Director South Asia, UL India Pvt. Ltd. and R Shivakumar, Chairman, ASSOCHAM Karnataka State Chapter among several other key dignitaries. R Shivakumar, Chairman, ASSOCHAM Karnataka State Chapter in his welcome outlined the right to health should be achieved, among others, by making essential medicines of assured quality at an affordable price. He emphasized that drug manufacturers should pay attention to improving quality standards of the pharmaceutical manufacturing and the regulators should support the industry in this process. Bhagoji T Khanapure, State Drugs Controller, Government of Karnataka said that Government is currently focusing on promotion of generic medicines through Jan Aushadhi Kendras. There are currently few such stores in state of Karnataka and there is need to open more. He requested the industry to come forward in supplying all types of generic drugs to these stores. With regard to quality, he informed the audience that the drug control department collected the legal samples of generic drugs from Jan Aushadhi Kendras and found the quality at par with branded drugs. Bhagoji appraised the indus-

try regarding the opening of a Pharmaceutical Park in Karnataka and requested the industry to invest and be a part of growth of state. In his industry address Sunil Attavar, President, KDPMA and Chairman and Managing Director, Group Pharmaceuticals Ltd. emphasized the need for continual improvement in pharmaceutical product manufacturing and requested the companies to engage and empower the employees. He asked the pharmaceutical education institutions to encourage industrial site visits and on site trainings of teachers and students. Suresh Sugavanam, Vice President and Managing Director South Asia, UL India Pvt. Ltd. In his theme address highlighted that companies must strive to develop a Corporate Quality Culture driven by and adhered to from the most senior levels in the organisation right down to the operator on the factory floor. Everyone involved must be actively encouraged to participate in the Quality Culture and fully appreciate their responsibilities A Report “Cultivating Quality Culture in Generic Drugs Manufacturing” developed by UL India Pvt. Ltd., Knowledge Partner to ASSOCHAM was released at the Conference. Vote of Thanks was extended by Anuj Mathur, Deputy Director & Head-ASSOCHAM Healthcare & Pharma Division to all the dignitaries.

CURA HEALTHCARE LAUNCHES WORLD’S FIRST-EVER ROBOTIC, 360 DEGREE BREAST THERMOGRAPHY SYSTEM Chennai based medical device company, CURA Healthcare launched world’s first, robot-assisted digital 360 degree breast thermography device, an early breast cancer warning system for all age groups. CURA’s illumina 3600 can detect breast anomalies several years ahead of prevalent breast cancer screening methods without causing pain due to compression, without

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NEWS ROUNDUP cer epidemic and large scale breast screening programs are non-existent in India. 1 in 28 women get breast cancer and 1 in 2 die due to late detection, making survival one of the lowest in the world. Early detection programs in developed countries have shown that early screening can help reverse the trend. In USA, 90% of the breast cancer patients lead a long, healthy life due to early detection and early intervention. The breast is a highly complex and one of the most difficult to image human organ as it varies in symmetry, density, size and morphology. Breast tissue is unique due to the mechanism of the mammary vessels, fatty tissue and skin temperatures. Substantial changes could occur to this organ during hormonal changes and different stages of life. Measurement and studying of breast skin (skin is the largest organ of the body with maximum blood circulation- about 25%) temperature and its response to hot and cold challenges in a controlled environment plays an important role in early detection of breast anomalies. illumina 3600 can provide

non-ionizing radiation and without human touch. illumina 3600 is designed, developed and manufactured in India with the support of BIRAC, Department of Biotechnology, Government of India. “With illumina 3600, we believe we have removed most of the barriers to early breast screening – pain, discomfort, radiation safety, and breast exposure. illumina 3600 detects disease years earlier than today’s conventional screening modalities and when it is addressable without invasive and painful procedures. We believe, our illumina can be a big game changer in breast healthcare and with it mass breast screening from early ages can be a reality now in India”,” said M Bala, President and CEO of CURA Healthcare. “illumine 3600 is co-created by women, leading healthcare providers and our experienced engineers to disrupt and transform the

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way breast screening and monitoring is done today. It represents CURA’s commitment to “Aarogya Bharath” through friendly, affordable and accessible technology solutions.” He added. “We at BIRAC are here to stimulate, foster and enhance bio-tech innovation that can bridge existing healthcare gaps and improve lives of 1.3 billion Indians. This is a critical mandate of Government of India. We are pleased to announce the birth of one such innovation - CURA’s illumina 3600, to bridge one of the biggest gaps in the country – addressing the biggest killer disease of the country – Breast Cancer. We are proud to have been part of this disruptive innovation” said Dr Renu Swaroop, Managing Director, Bio-technology Industry Research Assistance Council (BIRAC), Department of Bio-Technology, Government of India. Today, India is staring at a breast can-

early insight into breast care through identification of early breast tissue changes. illumina images allow doctors to differentiate between normal and abnormal breast tissues that may develop or be caused by cysts, estrogen dominance, or fibrous tissue and potentially cancerous tissues. Most cancerous tissues require greater degree of metabolic activity and vascular/ blood circulation and hence will emit an increased regional temperature. The advanced ultra-sensitive infrared camera of illumina 3600 aided by an advanced robot can sense these variations through varying temperature patterns and help detect tissue changes over time. The extreme sensitivity and 360 degree coverage together with advanced digital processing can help detect the earliest thermal signs suggesting pre-cancerous stage of breast tissues or the presence of a tumor that is not yet large enough to be detected by physical examinations, and structural imaging tools. A traditional mammography system can detect breast cancer only when it reaches a

cluster of 4 billion cells or the size of a grape or 1 CM size. illumina 3600 produces these early warning signs at over 97% accuracy without compressing the breast, radiation and any discomfort to the patient making it very attractive for women of all age groups. illumina 3600 can be used for unlimited, repeated exams as it does not emit radiation and is safe. Breast thermography is approved by FDA as an adjunct screening method to current standard of mammography. “illumina 3600 ushers in a new age in breast care. illumina 3600 is like a thermometer for the breast health assessment. The high sensitivity camera of illumina 3600 can detect the minutest heat changes in the breast to indicate the presence of anomalies at cellular levels. A mammography or ultrasound imaging can re-confirm its findings and together, it can be a life saver for all women as the detection takes place years in advance and preventive measures can be taken,” said Dr Sandeep Jaipurkar, Radiologist, Vijaya Health Centre and Breast Clinic, Chennai.” Dr Sandeep Jaipurkar was one of the key partners in development of CURA’s illumina 3600 and principal clinical partner for over 5 years with 5000 case studies. “Many of my patients tell me that mammography is painful experience. illumina 3600 can attract all those women who found the pain, radiation risk, touch and breast exposure a major deterrent in opting for the screening exam,” said Prof Kalpana, Radiologist, Madras Medical College and Rajiv Gandhi General Hospital who acted as a key partner in clinical investigations using CURA’s illumina 3600. “It humanizes the mammography experience by increasing comfort and reducing patient anxiety just as in a spa. With illumina’s capability to provide 360 view of early breast tissue changes and intelligent analysis, we believe breast cancer cannot hide any more. The system’s potential to help increase the number of annual screening exams is a critical advancement in women’s healthcare,” said N Kannan, Head, New Product Development at CURA Healthcare.

INDIAN GOVERNMENT NEEDS TO DO MORE TO TACKLE RISING SALE OF UNAPPROVED ANTIBIOTICS In India, the sale of antibiotics requiring the tightest control and regulation is rising the fastest, warn the researchers. The correspondence published in The Lancet Global Health highlights serious hurdles for controlling antimicrobial resistance in the country. In June 2017, the World Health Organization (WHO) adopted a new classification for antibiotics, to combat rising antimicrobial resistance and preserve the effectiveness of antibiotics that are a ‘last resort’. The new model comprised three categories: ‘Key Access’ antibiotics that should be widely available, ‘Watch Group’ that includes critically important antimicrobials which should only be used for certain infections, and ‘Reserve Group’ antibiotics for severe circumstances when all alternatives have failed. Professor Allyson Pollock, Director of the Institute of Health and Society at Newcastle University, said: “In India, rational use of antibiotics is imperative to limit antimicrobial resistance. It is of concern that sales of irrational and unsafe combinations are increasing and many have never been approved by the government. There are many calls from within the country for a new medicines Act and effective implementation of regulation to ensure rational medicine prescribing and use.” Dr. Patricia McGettigan from Queen Mary University of London said: “In India, total sales of antibiotics are increasing, and for the antibiotics that require the most careful control and regulation, their sales are increasing at the fastest rate. The increases are driven by sales of fixed dose formulations, many of them indiscriminately combining two antibiotics together. Even worse, most of these formulations were never approved by India’s national drugs regulator so their sale is illegal. The government has done nothing effective to stop the sales.” India is a major drug producer with some of the highest sales of antibiotics globally

and the highest levels of antimicrobial resistance. Contributing factors include failures of India’s drug regulatory system which have been identified in government reports, the sale of antibiotics without prescription, and the use of fixed-dose combination (FDC) antibiotics - formulations composed of two or more drugs in a single pill. The team analysed antibiotic sales in India between 2007 and 2012, and found that total antibiotic sales increased by 26 per cent, with the increase mainly due to the growth in sales of FDCs, which rose by 38 per cent. By 2011–12, FDCs comprised a third of total sales in India. When taking into account the new WHO categories, sales of FDCs with Key Access antibiotics had risen by 20 per cent in five years, but those with Watch Group or Reserve Group antibiotics had risen more steeply, by 73 per cent and 174 per cent, respectively. Of 118 different formulations of FDCs being sold, only 43 were approved by India’s national regulator, the Central Drugs Standard Control Organization (CDSCO), even though the sale of unapproved new medicines is illegal in India. Only five of the formulations were approved in the UK or US. Looking at single drug formulations (SDFs) which are composed of a single drug on its own, the majority (58 per cent) of the 2011-12 sales were either Watch Group or Reserve Group antibiotics. Over five years, sales of Key Access antibiotics had risen by 13 per cent, Watch Group by 24 per cent, and Reserve Group by 69 per cent. Unlike FDCs, most of the 86 SDFs on the market in India were approved by the national regulator and were also approved in the UK and US. The researchers say that the changes needed to achieve the WHO vision of good use of antibiotics include banning the sale of unapproved FDC antibiotics and enforcing existing regulations to prevent unapproved and illegal drugs reaching the market. Improved access to health care to reduce nonprescription sales is also needed, alongside research to understand why doctors complicate problems by prescribing unapproved antibiotics.

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OPINION

MAKE IN INDIAA DREAM OR REALITY?

Dr G S K Velu Renowned Healthcare Entrepreneur

November 2017

AS PRIME Minister Narendra Modi’s Make in India (MII) Policy turned 2 years old, the Indian manufacturing industry is on the move to set a firm foothold, globally. Elevating India to become a hub of manufacturing, the government of India has strategic plans put in place to pump in hefty investments to the country. Fostering innovation in all sectors, PM’s MII pillars focus on the following aspectsimproving the ease of doing business by de-licensing and de-regulation; enabling infrastructure such as industrial corridors and opening up FDI. However, in order to bring in an adequate amount of investments and solicit robust growth in the manufacturing industry, the business environment in India itself needs to be more conducive. This policy, if implemented rightly, has significant scope for transforming the overall development of the country.

Step in the right direction Post the National workshop titled “Make in India- Sectorial perspectives and initiatives”, which was held in 2014 in Delhi to prepare the plan of action for the first year and the succeeding three years to advance investments in 25 sectors, much progress has been noticed in this policy. With an increase in FDI, improvement in business environment and many companies already on board for this initiative, the prospective of India developing to a manufacturing nation has definitely surged. With many benefits for global investors; this policy has managed to grab international attention, which in itself is a laudable achievement. On the other hand, what we are still lacking is an axillary initiative to position India as a favored manufacturing destination, among the prospective stakeholders and buyers across the globe.

Bleak picture As far as the healthcare sector is concerned, the situation demands immediate deliberation. According to the World Bank, thrust on healthcare and education are considered to be the key to the success of the programme. However, the industry in itself is an ailing story of paradoxes. Even as Indian healthcare system boasts of having “best in class” service, the country is ranked 143rd among 188 nations on the health front. The country is ranked even below Comoros and Ghana. One of the major reasons for this is the near absence of a holistic healthcare

ecosystem to provide accessible and affordable healthcare to more than 60% of Indian population. With very low health insurance coverage, majority of the rural population can only manage to access the most basic healthcare services. In India, for every 1000 people there are only 7 doctors whereas in other countries it goes in the ranges of 300-500. Globally Competent With the right intervention of advanced medical technology, which interestingly is manufactured within the country itself, this malady in

“In India, for every 1000 people there are only 7 doctors whereas in other countries it goes in the ranges of 300-500”

our system can be effectively addressed. Make in India primarily intends to make the labour force and the technology sector of the country become globally competent. But with inverted duty structures prevailing across the industries, most Indian medical technology firms are not able to use their capacities to the fullest. Manufacturing firms are compelled to buy raw materials at higher import duties that eventually force them to put their products in the market at a higher price. In stark contrast, Indian economy attracts corporate MNC players to set-up low cost manufacturing units in India thereby helping them to sell their products at much cheaper prices. India’s medical device industry is immensely import-driven. With 75% of the products imported, Indian manufacturers are compelled to ship their goods to international markets, converting them to traders from assemblers. A paradigm shift is the need of the hour. In order to build a healthy environment for domestic

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OPINION manufacturers, government needs to exercise special tax exemption on raw materials for promoting local production. With a wholesome improvement in India’s business environment, the healthcare services can be made available at lower costs which will hugely benefit people across classes. Also, increased Foreign Direct Investments in medical devices industry increase the supply and encourage innovations to meet more domestic needs. Trivitron is one of the very few organizations which recognized, early on, domestic manufacturing is the best way to improve the healthcare landscape of the country. The Cost Doldrums Even with the setting up of the infrastructure facilities in a hospital, half of the total expenses go for buying and installing advanced medical technology. With most of the technology imported, it becomes imperative on the part of hospital authorities to charge the patients higher fees for their treatments and services. With an effective realization of MII, domestic manufacturers are encouraged to emerge major players in the market, thereby consequently reducing the overall healthcare costs incurred from patients, the eventual end users. Sustainability has to be the key factor for the successful realization of any new initiative. In order to penetrate medical technology into healthcare, we need to see a spur in innovation. Even from an academic perspective, we need to establish a system that urges one to constantly thrive for novelty. Along with supporting manufacturing, there has to be an equivalent focus on research and development, so that a league of new cohorts can come up with innovative ways to deliver affordable and efficient healthcare solutions. Quality essentials Even as the focus shifts to supporting the domestic manufacturers, it is important not to veer away from quality standards. Therefore, sufficient quality standards have to be ensured in order to seize sustained opportunities for the Micro, Small and Medium size enterprises. With sufficient assistance and support from the government, local players need to scale up their plants to conform to the industry qual-

November 2017

“With many benefits for global investors, this policy has managed to grab international attention, which in itself is a laudable achievement”

ity standards. Policies like ‘preferential policies for procurement’ can be tapped to enhance the production and sales of goods produced locally, rather than importing finished goods from countries like China and Taiwan. More than being a factor which touches everyone’s lives, healthcare, is one of the fastest growing industrial sectors. In an era when brands drive consumption patterns, people are on the lookout for go-to brands in medical technology world as well. When the country can boast of brands, that hold high stakes in the industries of fashion, food, technology etc. it is imperative that healthcare also produces quality-driven brands. For that to happen, MII needs to act as a catalyst to fuel domestic manufacturing to an all-new level.

COVER STORY

common

misconceptions

Indian Doctors have about

Have Indian doctors failed health-tech innovation? Lack of clarity on health-tech innovation could be one of the reasons why doctors and engineers donâ&#x20AC;&#x2122;t typically work effectively as a team. Debunking these myths becomes necessary.

Dr Jagdish Chaturvedi, Director, Clinical Innovation, Innaccel and ENT Consultant, Fortis Hospital, Bangalore

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COVER STORY

“WHAT’S NEW about this idea? I saw the same thing at a conference in Germany. They have been using this in Europe for many years. Why do you want to make the same thing again?” Every inventor in India (and probably all over the world) hears this at least once in their lifetime when their technology is being discussed. I have heard remarks like these numerous times, even for ideas that have demonstrated patentability, and for technologies that have later been licensed out successfully to companies. Are doctors not open to new ideas, or they just want to dissuade innovators? Neither. There are misconceptions and myths surrounding health-tech innovations that need to be addressed. As a doctor, I too have had these misconceptions, and realise now that I had misunderstood many things. This lack of clarity could be one of the reasons why doctors and engineers don’t typically work effectively as a team. Therefore, it helps to clear these misconceptions early on, so that there is a realistic

November 2017

understanding of the processes involved and reasonable expectations from outcomes and engagements. This in-fact should be a prerequisite for initiating cross-disciplinary work. I will try and work through some of the misconceptions in this article.

Open sourcing of a technology that has a relatively smaller market can kill the product entirely

Similar Solution Exists Somewhere Else Oh! The most common misconception is that an idea cannot be patented if a similar solution exists somewhere else. The way I see it is if a solution exists in another geographic location but the problem exists around you, then there will have to be an inventive process to bring that solution to the problem in your own geographic location. It becomes imperative to focus on the problem and decipher how it can be solved in the current surrounding with the given constraints.

This helps to define clearly, the requirements for the solution and hence an opportunity to innovate. In all likelihood, given the diversity in our healthcare setting, these inventive changes will be patentable. If it is just the question of awareness that is stopping hospitals/doctors/patients from buying a similar technology, then the inventive process must be directed towards increasing awareness among potential buyers or figuring out ways to procure such technologies. However, if the high cost of the device is preventing hospitals from procuring them one could look at an alternative solution. Other reasons such as skill and training requirements, human resource requirements, sterilization requirements, lack of maintenance/support for spares and repairs, or special infrastructure requirements, could also restrict the use of the device in our healthcare settings. These factors will need to be modified in a revised and new solution. There could be simple modifications to an existing technology, or a whole new solution to achieve the desired outcomes. And the good news is that these new inventive steps can be patented. A patent office looks for three things before granting a patent – novelty (should be something new), non-obviousness (experts from the field of invention should feel the inventive step is not obvious to think of), and industrial applicability (should be possible to make within known scientific boundaries). So if there is a clinical problem large enough, and you can develop a solution to reduce the burden of the problem, it is a valid and needed invention, irrespective of whether a solution for the problem exists elsewhere. Idea is everything “I have given you a great idea. There can’t be a product without this idea. I want 90per cent of all revenue from this innovation for the rest of my life.” Many doctors may think this is a valid point and may even consider it to be reasonable in some cases. However, when it comes to translating an idea into a product, the risks and effort involved outweighs the risks and effort of generation of an idea. One can argue that the talent and skill required is higher in the idea-generation process, or that the idea evolves only during the

actual development of the product. Nevertheless, when it comes to the actual development of a medical device, it is an expensive and daunting process. The debate can go on forever. Universally, it is the risk taken that defines the compensation and risk is typically measured in terms of expenditure of money and time. Fig 1 lists key activities that are required for the development of a new medical device, along with an estimated figure indicating

Idea/concept generation

Few hours

No expense

Proof of concept development

9 months

INR500,000-1,500,000

Patent filing/intellectual Property protection

3 months

INR200,000-400,000

Developing an alpha prototype

6 months

INR1,000,000-1,500,000

Bench top testing of the alpha prototype

3 months

NR200,000-400,000

Developing a beta prototype

3-6 months

NR1,000,000-1,500,000

Clinical testing of the beta prototype

9 months

NR800000-1,000,000

Human factor analysis

3 months

NR400,000-600,000

Design for manufacturing

3 months

NR500,000

Regulatory pathway

6 months

NR1,000,000

Reimbursement pathway

3 months

NR200,000

Manufacturing (ISO 13485)

6 months

NR10,000,000-(approx)

Sterlization, packaging and labeling

2 months

NR200,000-300,000

Marketing

6-9 months

NR4,000,000-500,000

Distribution/Go-to-market strategy

6 months

NR2,000,000-1,500,000

Adoption be end user

Revenue generation begins

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COVER STORY expenditure of time and money. It can take a full-time core team of four to eight members as long as three to five years to execute all these steps (many of these activities overlap). Many of the engineering, designing and prototyping activities may need to be outsourced, which may require three or four outsourcing partners. Two or three consultants/advisers may be necessary for the regulatory, human factor analysis and legal activities. After having completed clinical evaluation and receiving regulatory approval, a manufacturing partner who is ISO 13485 certified will be required for large-scale manufacturing. The entire process may cost anywhere between INR 3-7 Cr (US$ 500,000–1,000,000). It may now be evident that even though idea generation is a crucial aspect of the invention, realising the idea leading to an actual product involves huge monetary risks along with spending significant amount of effort on a full-time basis. For these reasons, if the contribution of a clinician or an inventor has been purely idea generation, then a royalty agreement of up to 3per cent (divided among the entire inventing team) may be considered reasonable and practical. If the clinician’s involvement is on an ongoing basis for clinical validation, concept refinement, clinical testing and validation, then there can be various other ways for engagement, such as:  Co-founder of a start-up company: Entitles shareholding and ownership of IP rights  Clinical adviser or medical director of a start-up company: Can be entitled to a salary or employee stock options  Medical consultant: Contract-based agreement for fixed deliverables (clinical testing and validation) Chances for success are low, very late returns Another common misconception around inventing a new medical device is regarding its failure to succeed. Many clinicians think it is a complete change of field, it is a neverending research, the chances for success are

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low, and that there is no money or there are very late returns in this field. As a doctor, I too thought the same until I made my first medical device. It is understandable to have these jitters, especially when there is no prior training or experience in the field. I have been in the med-tech space for the past six years (since 2010) and have co-invented numerous medical devices. All this while still practicing as an ENT surgeon at a hospital. I can only speak for myself here. I did not have to change my field to invent affordable medical devices, and in many parts of the world it is common for actively practicing clinicians to be involved in the invention and development of new medical devices. There are, however, some doctors who make a conscious decision to form a start-up company and develop new medical devices. In

my opinion, I do not think that it is an absolute requirementâ&#x20AC;&#x201D;the reason being that as doctors, we are already mandated to carry out scientific research in the form of clinical studies and trials. We are mandated to research new evidences for management of different clinical conditions. Doctors often spend 15 to 20per cent of their time in these activities. The same amount of effort and time can be directed towards inventing new medical devices. The limiting factor here is finding the right set of team members who will work full-time, with the aim of forming a start-up company and take the product all the way to market. This structure may not work very well if the team members are students, interns or other professionals who have part-time or fulltime jobs. If you have the right team, and follow the right process, then there is no need to change your field, carry out never-ending research (you can have a product in the market in twenty-four to thirty months), or have low chances for success. There are plenty of grant-funding opportunities available in India from both, the government and private sources and there are medical device companies who provide seed capital, along with the engineering development platform for teams that work internal to the company to develop a particular product, to ensure financial support and revenue generation within three to five years. Over the last three years, the med-tech ecosystem has improved significantly in cities such

as Bangalore, Pune, Hyderabad and New Delhi. It may be a good idea to start in any of these cities. Open-sourcing is good, patent filing is bad I think it is important to have clarity on this topic early on, as it can adversely affect the outcomes of your innovative efforts. In my opinion, whether to open source an invention (disclose the technology to the public, in order to allow anyone to develop the technology), or protect intellectual property by filing a patent (preventing another party from misusing the technology), is a decision derived from the clinical problem and the solution. It is not really up to the inventors or the team to decide this, but what the solution mandates. Open sourcing of an invention is generally recommended when the magnitude of the clinical problem is so large, that it demands an immediate scaling of the solution so that it can reach the masses very quickly. The technology can therefore be released in the public domain (on the internet through an article) so that many manufacturers or companies can start developing the solution and sell it to the end

If the contribution of a clinician or an inventor has been purely idea generation, then a royalty agreement of up to 3 per cent may be considered reasonable and practical

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COVER STORY user in their geographical regions. The market size should be large enough to ensure that those who choose to develop it and sell it can still run a sustainable business. Typically any technology addressing the burden of an epidemic disease is ideal for open sourcing. A novel idea for a face-mask that reduces the spread of H1N1 infection or viral Flu, if open sourced, can allow quick dissemination of the technology to the masses and reduce the spread of a fatal illness. A good example would be vaccines for an endemic disease such as polio. These vaccines need to be provided for all newborns. In India, with 26 million births every year, it is almost impossible for one or two commercial companies to penetrate such a huge market quickly. On the other hand, open sourcing of a technology that has a relatively smaller market can kill the product entirely. Independent manufacturers will not be able to make sustainable businesses if they know they cannot protect their technology, and therefore most companies or manufacturers will not choose to develop them. Also, many investors or funding sources will choose not to invest, if they know that anybody else can make the same technology and steal their market share (which was already small to begin with). Non Government Organizations (NGOâ&#x20AC;&#x2122;s) and trusts can fund these technologies to an extent but the product will last only as long as the charity lasts. Profitability is important for sustainability of a product regardless

November 2017

of the type of IP protection strategy. Now in a situation where there is immediate and huge demand for a technology or solution, like in a viral outbreak, it may be unethical to prevent the development of the technology by competitors through IP filing. It is important to note that even if there is a patent that protects the technology, it is eventually the decision of the parent company to press infringement charges on anyone who copies the technology. The company may choose not to do so and allow other players to make the device if they are comfortable with it. Patent protection becomes important when there is a stakeholder, who is negatively impacted by your technology and wants to stop you from developing the technology by filing a patent on the same technology before you do. If you have a patent filed before the other party, then they cannot stop you from bringing the technology in the market. But if they filed first for a patent, then they can legally stop you from manufacturing and selling your technology. So filing for a patent protects your rights to develop and commercialise your technology.

Limiting factor here is finding the right set of team members who will work full-time, with the aim of forming a start-up company and take the product all the way to market

Making price and selling price is the same “They are selling the product for INR 1000 and I can make the same thing for INR 200. I’ll sell this for INR 200 and bring the cost down by 5 times.” It is important to note that making price is the Bill of Materials cost (BOM Cost), or the amount required to make the device. The selling price, is the price at which the product is sold or the price at which the buyer buys the device. The selling price is usually four or five times the cost of the making price (as a general rule of thumb). The reasons for an inflated selling price are the margins required for distribution, marketing expenses and sustenance of the company that is developing the device. Indirect expenses in the form of salaries to employees, rent, electricity bills and operational costs are amortized into the profits to ensure the product is sustained in the market for a longer duration of time. Distribution margins can start from 25per cent for established companies and can go as high as 45per cent for newer products. All of this has to be accounted for. So if a device is being sold for INR 1000, then it probably took INR 200 to make it. If one were to sell it for INR 250–300 then there will be no distributor ready to sell the device to the end user. Even if they did and the company chose to give them high margins, it would drive them into lossess very soon. Setting up a direct sales team will be far more expensive than selling through a distributor who already has an established network. It is very unlikely that the product will sustain itself in the market for more than a few months. The need will not be addressed and the clinical problem will prevail. Better solutions are needed solutions “The need is to have a better solution.”How many times have we ended our presentations, meetings and discussions with this thought? Just like the misconception surrounding the type of IP protection pathway (open source versus IP filing), here also the type of solution is defined by the problem. A stethoscope for instance, is a device used to hear heart and lung sounds. It is important to hear these sounds so that a diagnosis can be made in case there is an abnormality and appropriate management can be initiated. If there is no stethoscope, then the only way a doctor can hear the heart and lung sounds is by placing their

ears on the patient’s chest. This is not only going to be ineffective but it is also going to be very uncomfortable for both the doctor and the patient. A device such as a stethoscope is therefore needed. There have been a few start-ups who felt that it will be better to make the stethoscope digital and allow recording of heart and lung sounds, incorporate analysis of the sounds, and also allow it to record and play the sounds for teaching purposes. It made the device expensive and bulky but added all these cool features that promised to make the device better. Despite this, the digital stethoscope did not disrupt the market of the conventional stethoscope. Even today, new doctors buy a traditional stethoscope because all they need is an affordable device that they can be used to make a reasonable diagnosis. This was a late realization for me as I too miscalculated while deciding what technology should be used for any device that I was inventing. Today, I understand that the answer comes from understanding the problem. Once the problem is well understood, the potential user and their skills are taken into account and the resources available at the place of use are identified. After this clarity, the problem defines what technology goes into the solution and at what price point. This will in turn determine the materials, components and design of the solution. This is what will make the solution perfect for the need.

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PULSE

SHARING EXPERIENCES KEY TO HEALTHCARE STAFF WELLBEING IMT team

HEALTHCARE PROFESSIONALS deal with different kinds of stress on a daily basis. It could be physical stress long working hours, or mental like missing out on important family events. Work related stress could be dealing with a difficult case or a difficult patient, conflict with peers, seniors or violence at work. All this adds to the emotional turmoil of a healthcare worker, but what can work in their favour is peer-to-peer communication, sharing. Healthcare staff who regularly share the emotional, social or ethical challenges they face in the workplace experience less psychological distress, improved teamwork and increased empathy and compassion for patients and colleagues, a new study commissioned by the National Institute for Health Research reports. In the first in-depth study in the UK, researchers from the University of Surrey, Kings College London, the University of Sheffield and The King’s Fund examined the impact of Schwartz Center Rounds® (Rounds), on both clinical and non-clinical staff. Rounds are monthly forums that offer a safe space for staff to share experiences with colleagues and to discuss the challenges they face in their work and

November 2017

its impact on them. Schwartz Rounds originated in Boston, USA, and were developed by the Schwartz Center for Compassionate Care in Boston in memory of cancer patient Kenneth Schwartz. They are run in over 400 organisational in the USA. The psychological wellbeing of 500 staff members who attended Rounds regularly, irregularly or not all, was measured over an eight-month period, using the clinically validated GHQ-12questionnaire. Researchers found that the wellbeing of staff who attended Rounds regularly significantly improved, with the proportion of those with psychological distress halving- down from 25 per cent to 12 per cent. There was little change in the psychological wellbeing of staff that did not attend Rounds over this period. When asked of the benefits of Rounds, participants noted that attending led to greater understanding, empathy and tolerance towards colleagues and patients and positive changes in practice. Following the publication of the Francis report which highlighted Schwartz Rounds as being a way of fostering good teamwork and

improving morale amongst staff, the implementation of Rounds in the UK rapidly increased. The research found that Rounds were implemented variably and challenges to implementation and sustainability included ward staff attendance, and the workload and resources required for planning and running Rounds. Jill Maben, Professor of Nursing at the University of Surrey and formerly of Kings College London, said: “Delivering care to patients at some of the most challenging times in their lives has an emotional impact on staff, which undoubtedly impacts on their own wellbeing and on their work. “Our study is the first in the UK to demonstrate that those who regularly attend Rounds see significant benefits; their symptoms of anxiety and depression are reduced, they are better able to cope with the issues they face and have more empathy towards patients and colleagues, which undeniably has a positive impact on those in their care.”Given these impacts it is good to see Rounds running in over 160 organisations in the UK, particularly in light of the Francis report, which called for more compassionate patient care. The challenge is for or-

ganisations to continue to invest in Rounds in resource-constrained environments.” Dr Cath Taylor, Reader at the University of Surrey and formerly of King College London, said: “NHS and hospice staff are the unsung heroes of our society, but the physical and emotional demands placed on them often go unnoticed, leading to high rates of burn out and people often leaving the profession. Rounds are a unique organisational wide intervention that we found benefitted many attendees”. Professor Jo Rycroft-Malone, Director of the NIHR’s Health Services and Delivery Research (HS&DR) Programme, said: “The NIHR is proud to have funded an important piece of research which is the first in depth study of its kind to evaluate the impacts of Schwartz Center Rounds. We feel this was an important area to research following the Francis Report highlighting the importance of Rounds. “Hospital and hospice staff work incredibly hard to care for patients and it is crucial that they can ease the physical and emotional demands they face while also helping to boost colleagues’ teamwork and morale and improve care, compassion and empathy for patients.”

“Delivering care to patients at some of the most challenging times in their lives has an emotional impact on staff, which undoubtedly impacts on their own wellbeing and on their work” Professor Jeremy Dawson, Professor of Health Management at the University of Sheffield, said: “Schwartz Center Rounds offer a valuable support system to healthcare staff, that can help to improve wellbeing, and that enable a focus on compassion and empathy towards colleagues and patients that is difficult to achieve in their otherwise hectic working lives.” Jocelyn Cornwell, Chief Executive of The Point of Care Foundation (which holds the licence to promote and support Schwartz Rounds in the UK and Ireland) said: “We are delighted that this research shows that Schwartz Rounds have sig-

nificant positive impacts on the well-being and experience of the staff who take part in them. The Rounds offer a unique space for all staff in organisations to come together as equals, to share experience and listen to one another. “In environments in which staff are under tremendous pressure, the Rounds offer a much-needed space for reflection and renewal. We hope that organisations that are not doing Rounds will pay attention to the research findings, and organisations that are doing them, will re-double their efforts to sustain them.”

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FEATURE

APPROACH

11 TRAITS TO WIN CONTINUALLY The life cycle of business is reducing, making products, and business models obsolete more quickly. In the face of overwhelming odds, what keeps a leader going?

Dr Deepak Malhotra, Author, Hungry People Better Results: Unleash The Fire Within To Win Continually In Life

November 2017

GREAT LEADERS always work towards improvement. They keep working on their ‘hunger’ to be continually successful. The power of these leaders is only to settle for the best. They break shackles, and make impossible into I M POSSIBLE. To be like them, we must look at things around us differently. Lot of people in your life would come and explain you to re-write your own history. Not many would handhold you through this journey. Ignited ‘fire’ in the wrong side, is the differentiator between ‘good’ and ‘great’ leaders. Good news is that most of these traits can be developed over a period of time. The magic is built within us and it is important for us to enable that magical power. This is an aim to challenge the status-quo and the results would enable you to discover the spectrum of traits for a successful leader.

As Swami Vivekananda said, ‘There is no teacher but your own soul. No one can teach you. You have to grow inside out’. There are specific skills that can help you become the leader you want to be and know you can become. Learning how to stay hungry Everyone likes to be at peace, everyone likes to remain in comfort. As a popular saying, ‘struggle begins only after you leave your comfort zone’. We face a lot of opposition, when we want to change anything, be it a process, people, or a product. No matter how much success life throws in your way, are you still hungry? Not only in times when you are successful, but also importantly, at the time of your failure. “To win continually, hard work is a pre-requisite which never goes out of fashion.” Harsh Vardhan Goenka, Chairman RPG Enterprise

Build on fundamental pillars which ignite ‘fire’ within you The base of leadership pyramid is integrity. “No one in the game or in real life was ever indispensable. The cemeteries are full of all those who thought they were indispensable!” Padma Shri Bishen Singh Bedi. It takes consistency of actions, values, methods, measures, and principles to do the right thing. The leader should be unbreakable. Work on self-discipline, patience, dedication, and intensity. Never be afraid of calling a spade a spade. “A leader should always produce more leaders.” Dinesh Shahra, Founder & Managing Director, Ruchi Soya Industries Limited. Strengthening the fundamentals by compassion, inclusion, and diversity management

“Sometimes to win big you have to take calculated risks,” Padma Shri Kiran Mazumdar-Shaw, Chairperson & Managing Director, Biocon Limited” We leaders are automatic experts of compassion and inclusion. To win continually we must have an empathetic outlook, and the compassion is incomplete without a desire to relieve the suffering. Scientists believe that we secrete the bonding hormones oxytocin, and certain regions of our brain light up, which enables us to care for people. “If one is hungry with

passion, the results will follow automatically.” Nirmala Menon, A top 50 Diversity Expert Embracing Complexity and Tur ing it into Simplicity “No one goes to any exciting destination following a beaten track. One has to be one’s own Columbus,” Dr Santrupt Misra, CEO Car-

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FEATURE

APPROACH ship is about the change you want to bring in yourself, rather than changes you want to bring in others.” Dr Malathi Krishnamurthy Holla, Padma Shri Award Winner, has won more than 400 medals for the country. Ability to Challenge the statusquo Leaders search for opportunities to challenge the norm. They look for improved ways to improve the product, process, services, and objectives of the organization. In doing so, the leaders experiment, take risk, learn from mistakes and failures. ‘We cannot solve our problems with the same thinking we used when we created them’ Albert Einstein.

“No one goes to any exciting destination following a beaten track. One has to be one’s own Columbus,” Dr Santrupt Misra, CEO Carbon Black & Dir. HR, Aditya Birla” bon Black & Dir. HR, Aditya Birla. Technology has increased the pace and impact of change. The life cycle of business is reducing, making products, and business models obsolete more quickly. As required rate of innovation rises, the connections can create tremendous vitality in the economy. Leaders are used to asking, how can we win this game? Today we also must ask, how can we extend this game? Leaders must monitor the changes, look at the risky environment, and align their strategies with the threats they face. Managing ‘Quotients’ It is not EQ and IQ which is important for a leader’s continual success. In today’s competitive and one-click world, self-quotient, socialquotient, adversity-quotient, spiritual-quotient, and much more is required for a leader to be successful. We must be active, must work on

November 2017

our bodies too, must use our senses, read a lot, do something which interests and relaxes us, and challenge and track ourselves long-term. “Engagement shows care and participation. Social media will know more and more about us.” Neeraj Jhanji: The Indian Who powered Facebook ‘Check-In’. As Nand Kishore Chaudhury, founder Jaipur Rugs said to me, “the journey is finding yourself by losing yourself.” Hunger is Developed Daily and not in a Day The hunger inside you is developed in a daily basis. It begins with keen observation of people and their behaviour. It nurtures prominent ethos which gives rise to modernization, inquisitiveness, innovation, responsiveness, and unprejudiced thought process. Hunger for me includes self-development on daily basis. I unlearn and relearn every day. “I believe leader-

Leaders transform talent and organization You should be able to break the moulds and begin to challenge the norm and continuous success would follow automatically. “We must learn to bounce forward and not bounce back.” Co-Founders NSHM Knowledge Campus. “Be the master of your own thoughts, be the leader of your life and never give up. Be a tracer Bullet,” Ravi Shastri, Cricketer and Indian Team Head Coach. Navigating Change-Management Communication from the leaders is the key. They need to guide other people through the emotional change, which is part of change. Outlay in the mind-set, skill set, and toolset is effective to manage change over period. Critical investment would always give you long-term results. Listening to the concerns, the team insights, and experience are critical during execution. Results would definitely follow automatically. “You will be successful if you can ensure team members in the Organization bring their soul to work,” Pankajam Sridevi, MD ANZ Bangalore. Dare to Be You just need to be different. I am a strong believer that if you want something badly enough, you will find a way to achieve it. The leaders emphasized their love for every second of their life. The success and dare to be is somewhere hidden

in the small sentence.“If you have the passion in you to start something, do it immediately and don’t wait for tomorrow.” F C Mustafa, co-founder iD Foods, an inspirational journey of a porter son to a founder. I strongly believe, when going gets tough, tough gets going. Acting like a Champion and Breaking the Cliché Conducting yourself with class and dignity is important. It is important not to make excuses even if you lose. If Sachin Tendulkar can have a very bad patch in International Cricket, he went back to the drawing board and practice. You also have to learn from it and believe in yourself. You will definitely not always win; you must accept it, learn and move on. Also, do not rub it in the face of an opponent when you win. Be happy and celebrate but importantly, respect others’ efforts. You never know, you may be the next loser. Always focus on learning. A real leader always looks for ways to improve. How can I win is what everyone

“To win continually, hard work is a prerequisite which never goes out of fashion,” Harsh Vardhan Goenka, Chairman RPG Enterprise ” wants an answer to? The leaders do not cut corners, cheat, but on the other hand, are always inspiring. “Every time I failed or fell down, I have learned from my mistakes.” Padma Shri Arunima Sinha.

It takes immense courage to answer the action aspiration and the bigger possibilities. People are always capable of more than they think they can achieve. It is important that they know their worth and communicate it through actions. It is an important lesson I learned from Margaret Thatcher. While reading about her, I came across the wonderful lines, ‘You can never lead from the crowd’. “Sometimes to win big you have to take calculated risks,” Padma Shri Kiran Mazumdar-Shaw, Chairperson & Managing Director, Biocon Limited To win continually, you cannot let your fear rock your boat. Fear to fail is critical to most failures. This empirical journey is incomplete, unless you unlearn, re-learn, and discover the power of these leaders and their learning. The 25 great and diverse leaders featured in my book Hungry People Better Results share the traits to win continually and ignite the ‘fire’ in you continuously.

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IMPACT

PAYING FOR GENE THERAPY – WHO WILL FOOT THE MILLIONDOLLAR BILL? While we have newer treatments for life-threatening diseases, these treatments are so expensive that it may well be outside the reach of the patient. Value-based payments could be one way to work through the problem

ON OCTOBER 12, 2017, Food and Drug Administration’s (FDA) Cellular, Tissue and Gene Therapies Advisory Committee unanimously recommended approval for the investigational gene therapy product, Luxturna by Spark Therapeutics, for treatment of patients with vision loss due to confirmed biallelic RPE65-mediated inherited retinal disease.1

Dr Rajat Agrawal, Ophthalmologist & Retina Specialist, Los Angeles, CA; President & CEO, Retina Global

November 2017

Price Point With the likelihood of the treatment being approved by the FDA since they do not usually go against the recommendation of the committee, a debate has begun amongst the healthcare and patient community as to the pricing of this one-time gene therapy intervention. Spark Therapeutics hasn’t mentioned anything so far about the likely price, but analysts are expecting the price to range from US$ 600,000 to a million dollars for this one-time treatment. Whatever be the final price, it is likely to be exorbitant from the perspective of the patient, who is unlikely to afford to pay even a part of

such a huge amount. So who will finally bear the cost? That is itself a million dollar question! The Paradox Why do pharmaceutical companies plan to charge such high costs for these newer treatments? The answer is simple – in most cases, patients require repeat and continuous treatment over a period of time, which translates into significant earnings for the pharmaceutical company over that period of time. By keeping the single unit cost low, that cost becomes more palatable for the payers or the patients if they are paying as an out-of-pocket expense. But these newer treatments are more than likely to be one-time intervention, with the pharmaceutical company faced with the possibility of only a single opportunity per patient to get paid.3 Which suggests that the company has to not only recover research & development costs, but also the planned profit margins, from that single treatment intervention. Since these are complex clinical development programs, and take a

long time to reach critical mass, they become expensive propositions to continue to the finish line for approval. Also, the current programs are all focused on extremely rare diseases, so there aren’t many patients to share the cost drug makers require to justify the expense of research, development and commercialization.3 To consider the patient pool for Spark Therapeutics’ Luxturna, analysts estimate that about 106 patients are likely to be treated in 2018, subsequently increasing to 371 in 2019, and 688 in 2020, amounting to sales of $62 million, $158 million and $193 million, respectively.5 All of the above forces the pharmaceutical industry to charge a significant amount. But health care system isn’t set up for, or can sustain, this type of economic model. Ways and Means Obviously, the ‘one-and-done’ single upfront payment model is the most attractive for the pharmaceutical companies, since it offers them a chance to quickly recoup their investment.

Also, it is more predictable and finite for them to highlight their earnings in their balance sheets. But it runs the risk of alienating everyone with sticker shock, and making it impossible for many patients to get the treatment they deserve.2 So apart from someone bearing the brunt of this significant payment, are there any other (creative) ways of making the patient or the payers pay these exorbitant costs? Health policy experts have suggested other ways, including payments being made in long-term installments. Such an annuity-type system could be preferable to the pharmaceutical industry, since it offers a predictable, recurring future revenue stream for them.2 But the installment system has its critics too. The questions usually raised in such a scenario are whether the treatment be contingent on the patient undergoing regular evaluations to verify that the treatment is indeed working as claimed by the pharmaceutical company? How would these assessments be undertaken? Who will be the final arbitrator in the decision

Newer treatments are more than likely to be one-time intervention, with the pharmaceutical company faced with the possibility of only a single opportunity per patient to get paid

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IMPACT

What metrics should be used to evaluate a drug’s performance and patient outcomes about the continued effectiveness of the treatment? And more importantly, what happens if the drug fails? What if the drug fails in three years, while the patient/payer is on a five-year payment plan? Will there be escape clauses, or potential for partial refunds? Or, conversely, should the drug maker continue to get paid for years after an initial contract period if the drug exceeds expectations? 2 Value-based Payment This brings us to the proposed ‘pay-for-performance’ model, also referred to as value-based payments or contracts. Such concepts have been embraced before in the pharmaceutical industry. A recent report from PricewaterhouseCoopers (PwC) concludes after a survey of 101 pharma executives, that about 25per cent of companies have used value-based contracts of some kind. Also, only about 38per cent of those surveyed feel the benefits of such contracts justify the risks. This despite the fact that 71per cent of pharma executives believe such arrangements could be rewarding for compa-

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nies that bring innovative products to market.3 To highlight some of the difficulties involved in this system of payment, Italy tried value-based payment approach to help bring down drug costs more than a decade ago, asking pharmaceutical companies to return money to the national health system if some of their medicines failed to work as expected. The effort largely flopped. Beginning in 2006, the Italian National Health System negotiated deals with drug makers for certain medicines. It required doctors to track whether their patients were meeting certain goals, and if they were not, the pharmaceutical company would reimburse a share of what it was paid. In 2015, researchers studying Italy’s experiment concluded that the amount of money refunded by the companies was “trifling.” He attributed the low savings to the administrative complexity of tracking the results and said drug companies fought efforts to reimburse for bad outcomes.6 But if we learn from these outcomes, we might be able to get a different result.

Roadblocks There are several obstacles that have been quoted that dissuade pharma industry from adopting more value-based contracts. As per the PwC report, the most frequently cited challenge was getting pharma executives and payers to agree on what metrics should be used to evaluate a drug’s performance and patient outcomes. But there are a host of other problems, including technical hurdles associated with sharing patient data, regulatory concerns and a sheer lack of a single model for value-based contracting that everyone agrees is a good one.3 In recent days, after Novartis received FDA’s approval for Kymriah, its gene therapy treatment for some patients with lymphoma, many expected the company to charge a steep amount for this one-time intervention. But Novartis priced Kymriah at $475,000, which was less than many analysts expected, but still enough to draw ire. The company disclosed that it is collaborating with the Centers for Medicare and Medicaid Services (CMS) for an agreement under which the gene therapy will only be reimbursed if patients respond by the end of the first month. Most of the above discussion is in reference to the United States, which has a unique healthcare model. So what do other countries do to tackle prescription costs? Countries other than the US In the UK, the National Institute for Health and Care Excellence (NICE) acts as a drug-price gatekeeper, routinely rejecting products that fail to demonstrate an adequate return on investment. Italy now asks drug companies to provide some of their products for free — at first. Manufacturers are only paid once results are demonstrated.6 Norway’s health system is run by the government, which not only sets price caps, but also demands evidence that new products demonstrate tangible therapeutic value when compared to older, cheaper medicines. So how will India tackle this pricing issue? India has some unique challenges in healthcare, where majority of people do not yet carry health insurance, and tend to pay the costs of

healthcare delivery out of pocket. In a national survey conducted in 2014 by the Ministry of Statistics and Programme Implementation of the Government of India, it was found more than 80per cent of Indians are not covered under any health insurance plan, while only about 18per cent (12per cent being government funded) of the urban population and 14per cent (13per cent government funded) of the rural population was covered under any form of health insurance. Such a scenario creates huge challenges for patients in India. Obviously, there is no way most Indian patients can afford to pay the million-dollar price for these newer treatments. Inducing more of the population to buy insurance is also not going to help, since the payers will not be willing to pay these steep claims. Central or State Governments cannot be expected to foot the prohibitive bill either, though both the Central and State Governments have come up with

innovative health insurance schemes such as Rashtriya Swasthya Bima Yojana (RSBY) by the Centre, and Rajeev Arogyashree Scheme (Andhra Pradesh), Yeshaswini and Vajpayee Arogyashree Schemes (Karnataka). These

type of disease. Considering the number of potential patients are likely to be more than what these companies expect to get treated in the developed economies such as US or Europe, these companies can consider reducing the cost

Health policy experts have suggested including payments being made in long-term installments schemes are meant for the poor to receive basic and reasonable healthcare, and hence cannot be expected to come under pressure due to the steep payments required for the new therapies. One interesting aspect for pharma companies to consider with respect to India is the sheer number of patients for any particular

of the treatment to suit the Indian market, thus allowing for a bigger pool of patients to get the benefit of these newer treatments. Novartis India has attempted to tackle the high cost of RanibizumabÂŠ, which is sold as Accentrixâ&#x201E;˘ in India, while the trade name in most other countries is Lucentisâ&#x201E;˘. Intraocular lens companies,

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IMPACT that manufactured the artificial lens placed in the eye during cataract surgery, reduced the cost of the lenses for the Indian market in the 1990s when the cost was considered prohibitive for most Indian households. Which brings us to the aspect of value-based payment for such type of treatments in India. Considering the unique nature of the Indian healthcare market, it is likely that most patients will not be covered by insurance for the foreseeable future. In which case, who will deal with the pharma companies in setting the value-based contracts? It will either be healthcare policymakers and/or patient representatives, including major hospitals or nonprofit patient support organizations. But even with a setup in place, individual patients may find it difficult to deal with major pharma players in fighting for their personal cause. And hence, unless the valuebased contracts are supported by some regulation by the Government, it is likely to fail, similar to what happened in Italy as referenced above. With such challenges currently facing the country, the most likely possibility will be for patients in India to pay for these expensive treatments in installments. With the new AAD-

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HAR card system becoming a major part of financial dealings in India, it is likely that patients and/or family members will have to share significant personal details before the affected patient will receive these treatments. Another unique system that could be put in place, where Indian banks offer loans to patients/family members for them to repay over time, which will help the pharma companies recoup their costs sooner. Look for win-win In conclusion, it is believed such new forms of treatments will require payment and patient care systems that are as novel as the medications themselves. Apart from payment in installments, others creative ways of payments will include value-based payments, establishing insurer risk pools and financing one-time payments. A successful model must address patients who change insurers or employers, and track their health outcomes over time to ensure payments arenâ&#x20AC;&#x2122;t being made if the treatment stops being effective.4 Value-based contracting can ensure that payers and/or patients arenâ&#x20AC;&#x2122;t on the hook when

a treatment isnâ&#x20AC;&#x2122;t effective. Consultations involving pharma companies and payers can help set appropriate prices. Discussions with policymakers can help set an appropriate regulatory framework.4

REFERENCES: 1.

https://www.technologyreview. com/s/609075/fda-vote-sets-stagefor-gene-therapys-future/ http://www.xconomy.com/national/2014/01/27/gene-therapylurches-ahead-sees-thorny-futurequestions-on-price/ https://www.forbes.com/sites/ arleneweintraub/2017/10/11/ here-come-more-genetherapies-and-more-pricingdebates/#39d69289577e http://lab.express-scripts.com/lab/ insights/drug-options/gene-therapyholds-great-promise-but-big-price https://www.marketwatch.com/ story/spark-therapeutics-promisinggene-therapy-for-vision-loss-couldcost-1-million-2017-10-13 https://www.nytimes. com/2017/07/10/health/prescription-drugs-cost.html

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ED AT ER â&#x20AC;&#x2122; EN E -G AR ER THC â&#x20AC;&#x2DC;US AL HE

INTERVIEW

“WHEN WE STARTED WE TOOK A HUGE RISK BY MAKING A CORPORATE HOSPITAL WHERE THE CONCEPT DID NOT EXIST” Kanpur-based Regency Healthcare Ltd, hogged the limelight in March this year, when the company announced approximately US$ 14 million funding from a consortium of leading global investors. While Industry watchers saw the move as a new era of investment opportunities in tier 2 cities; what most enthusiasts failed to note was 16 years of hard work put in by Dr Atul and Dr Rashmi Kapoor in shaping Regency, the flagship 200 bed Hospital that treats over 270,000 patients every year. Abhishek Kapoor, Senior Vice President –Strategy; Promoter – Regency Healthcare spoke to M Neelam Kachhap about Regency’s journey and the Group’s future projects. Excerpts:

Tell us about the tipping point when Regency hospital became Regency healthcare? Healthcare landscape in Uttar Pradesh is dotted with a lot of small nursing homes and standalone hospitals. Regency Hospital was started by Dr Atul and Dr Rashmi Kapoor in 1992. There was a long gestation period and bouts of financial struggle as the doctor couple were establishing the concept of a corporate hospital for the first time in Uttar Pradesh.

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Regency saw its first profits in 2008, after 16 years of gestation. Between 2008 and 2012 a lot changed within the organization. That was the time when I came back from US and joined the hospital. This was also the time when we started the consolidation process. We decided to get funding and expand our reach. We bought an existing hospital and turned it into our second setup. That was the moment when we became Regency Healthcare – not just a hospital anymore.

Moreover,diabetes is on the rise and we are moving towards becoming the diabetic capital of the world.As you would know diabetes is a risk factor for end stage renal disease. Now can you see the huge need for dialysis? Even though it is s a niche area the demand for dialysis is not going to die down any soon. What is your outlook for the cancer care market in India? Deaths from cancer worldwide are estimated to reach 13.1 million in 2030. India has nearly 3 million cancer patients and a million new cases are reported in India every year. In time to come, non-communicable diseases will become the norm rather than exception. Early detection is the key to treatment of cancer along with constant follow up. While looking for a new technology what points do you consider? While evaluating new technology we essentially look for fitment and modularity, so that it can be implemented across phases for better acceptability by staff/users. We also look for ease of adoption/usability, scalability, security, support/ maintainability and most importantly cost/recurring costs.

What made a midsize hospital in a tire 2 city take the PE plunge? When we started in 1992, we took a huge risk by making a corporate hospital when the concept did not exist in Uttar Pradesh, let alone Kanpur. We wanted to do things differently while still delivering quality healthcare. We are still following the same direction. We are the first hospital to attract PE investment. We are the first to have strategic partnerships with stakeholders and joint ventures with other providers. This speaks highly of our ca-

pabilities and the immense opportunities here. Why did dialysis centers took precedence in your growth strategy? Last couple of years have seen a lot of investment in healthcare. Be it a new business model or an existing healthcare chain a lot can be learned from these success stories. I was working with one of the brilliant dialysis providers in America when I decided to come back to establish dialysis in Kanpur. If you look around youâ&#x20AC;&#x2122;ll find a huge gap in dialysis beds in India.

Pls tell us about the current HealthTech landscape in India? Healthcare has become one of Indiaâ&#x20AC;&#x2122;s largest sectors both in terms of revenue & employment. The industry is growing at a tremendous pace owing to its strengthening coverage, services and increasing expenditure by public as well private players. The outlook for the sector is promising though it is currently experimental and evolving. During 2008-20, the healthcare market in India is expected to record a CAGR of 16.5 per cent. The total industry size is expected to touch USD160 billion by 2017 & USD280 billion by 2020 Pls could you talk about the HealthTech. Which area in Healthtech really ignites your interest? Health-tech is scene is quite exciting currently. I am looking forward to some technologies around patient and clinician engagement platforms. Another area that interests me is the continuum of care management.

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INTERVIEW

“I HOPE INDIA MAKES FASTER USE OF SCALABLE AND CHEAPER SMACK HEALTH TOOLS THAN WE’VE SEEN IN THE US AND EUROPE” Matthew Holt is the Co-Chairman, Health 2.O and founder, The Healthcare Blog. He talks about the new technologies which will impact healthcare in 2018 and SMACK Health. Tell us about SMACK health? SMACK Health is the concept of post enterprise level technology (Social & Sensors, Mobile OS, Analytics, Cloud) applied to health care. We need empathy in health tech, hence the added K for kindness. The term appropriated from Cognizant and widely used in India but not much elsewhere; contrasts with enterprise based electronic medical records, which are essentially a continuation of 1990s style client server technology. The point to realize is that while all computer technology is digital, when people say digital

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health they are talking about SMACK Health. Do you see a higher uptake of health technologies for healthcare delivery in India? India has the good fortune of being a late arrival to the tech party and therefore can skip the enterprise specific phase and go straight to cloudbased tools and applications. So my hope is that India makes faster use of more scalable and cheaper SMACK Health tools than we’ve seen in the US and Europe.

Technology-enabled innovations are driving healthcare delivery around the world. Could you tell us about 5 such innovations that healthcare providers should look out for in 2018. Weâ&#x20AC;&#x2122;re moving beyond SMAC in the real world, outside of health care. The major trends are artificial intelligence - machine learning and automated chatbots - augmented and virtual reality, and physical manifestations of artificial intelligence -- yes that means robots. For health care those tools will be see in 2018 and beyond, but first we are going to fully use remote visits,

sensor based monitoring, asynchronous clinical visits, and online patient education tools. The fifth noticeable technology will be diagnosis tools predominately using the camera and processing capacity of a smart phone. India is already seeing a great deal of this, particularly around eye care. How is Health 2.0 helping health tech communities around the world? Our mission is to showcase the greatest new

technologies and to introduce those companies to a wider audience. We also want to our tech community to interact widely with each other and the local actors in the healthcare system. Since 2007 weâ&#x20AC;&#x2122;ve put on conferences, local chapters in dozens of countries, challenges and supported the community with market research and matchmaking. With our recent merger with HIMSS we are looking to increase the reach of new technologies even further into the health care system.

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INTERVIEW

â&#x20AC;&#x153;IT IS CRITICAL THAT NOVEL HEALTHCARE DELIVERY SOLUTIONS BE DEVELOPED BY CROSSDISCIPLINARY TEAMS INVOLVING DOCTORS, ENGINEERS AND MBASâ&#x20AC;? Sarang Deo, Associate Professor, Operations Management at Indian School of Business. His primary area of interest is health care operations with special emphasis on investigating the impact of operations decisions on population level health outcomes. Here he talks about how healthcare delivery can be improved with patient-centric approach. Tell us about the tipping point when Regency hospital became Regency healthcare? Healthcare landscape in Uttar Pradesh is dotted with a lot of small nursing homes and standalone hospitals. Regency Hospital was started by Dr Atul and Dr Rashmi Kapoor in 1992. There was a long gestation period Healthcare delivery market in India is retail-oriented, but consumer demand for convenience and greater transparency of price and quality information seems to be lost on the providers. Your comments. I agree partly with this comment. Traditionally,

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there has been a lack of focus and emphasis on convenience of patients. However, that is changing fast. Increasingly providers are asking how they can manage the waiting times of patients in the outpatient departments better. They are beginning to see the value of these improvements as better experience in outpatient department can mean improved yield in inpatient departments. The increase in emphasis is also because of infusion of professional management into the hospital chains and growth in empowerment and awareness among patients. However, one has to realize that the core of the problem is not going to go

away because in general convenience is not a big priority in all markets in India. Recall your previous experience at the mall or the supermarket. How convenient was the checkout process? What about security check at the airport or driving on the road? Of course, when it comes to quality and price transparency, the situation is slightly different. We need regulators to take up the role of enforcing these things. However, they have taken an alternate approach of trying to cap prices, which might or might not work.

Could you take us through examples of innovation applied to create novel systems of care in India? A lot of interesting work is happening around management of chronic conditions and wellness. This is still not mainstream but a few small organizations are trying to develop financially sustainable solutions for management of chronic conditions such as diabetes and hypertension at the community level. Note that this is very hard, especially if patients are currently feeling well and their functional health has not yet been severely affected by complications arising out of chronic conditions. So, here is the chicken and egg thing. The other interesting developments are in the space of telemedicine in various forms. These include for-profit models for delivering telemedicine in rural areas (either by outsourcing the remote end of the network by franchising to RMPs and informal providers or by outsourcing the central end of the network by engaging with the qualified providers in cities) or integrated models of delivering care to Tier-2 cities. Also, telemedicine is being used to provide second opinions for complex conditions such as cancer. Do you think strategies for engaging patients as partners will benefit providers in India? I do not see that happening in the short run. I have heard from many clinicians - why would anyone want to focus on outcomes if there is no way of monitoring these and getting rewards for better outcomes. This is tied to the earlier comment about creating transparency on quality through scorecards. In the absence of good clinical data to compare providers and hospitals, patients are going to go by non-clinical measures of quality of service - cleanliness, food, built environment, friendliness and helpfulness of staff. As a result, providers are going to spend time and effort in building their capabilities along these dimensions. Could you tell us about the rise of personalized technology and how it will affect healthcare delivery in India?

Personalized technology is too broad and it can have very different connotations depending on whom you ask. If you think about personalized drugs and medicines, I feel that we are long way from that becoming the mainstay in the Indian healthcare system. It is possible that some level of personalization might start happening on the wellness front - personalized diet and exercise plans are a reality even now. The question is can those be more evidence based, where evidence is both “state-of-art” and “individual response to certain regimens”. I can give you an example from my own research in the field of TB treatment, where adherence to medication is quite important. We are designing a field experiment to investigate the impact of personalized reminders and home visits depending on patients’ past adherence to medication as against the current practice, wherein every patient is supposed to take their medication under the supervision of a DOTS provider.

Pls could you talk about how strategic collaborations and key stakeholder relationships can be integrated to strengthen the health care delivery models? Increasingly, healthcare is moving out of the realms of the medical professionals. This is natural given the advent of new technology, not just information technology but data science as well. However, for these technologies to convert into actual systems of delivery, one will require management skills and systems thinking. It will also have to be combined with the understanding about patient behavior. Hence, it is critical that novel healthcare delivery solutions be developed by cross-disciplinary teams involving doctors, engineers and MBAs. In addition, one would need policy experts to create the conducive regulatory environment so that these innovations are able to diffuse rapidly in the healthcare ecosystem.

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INTERVIEW

“IN THE CHANGING HEALTHCARE LANDSCAPE, KEY OPINION LEADERS(KOL) TAKE ON AN EVEN MORE CRITICAL ROLE IN BOTH AS ADVISORS AND INFLUENCERS” Vrinda Deval, Managing Partner, GLocalMind and is responsible for the global sales, relationship management and marketing at GLocalMind. Here she talks about the company and its reach in India. What does a Healthcare fieldwork company do? We work with medical companies who are looking for market research to enhance their product or launch a new product. We undertake quantitative and qualitative research, survey data collection with healthcare professionals using online or face to face approach. We work with all types of healthcare companies be it a start-up or a multinational company. We connect our clients with physicians through our global technology platform in 56 countries across 80+ specialities for purpose of Research and Marketing

GLocal Mind has grown rapidly establishing a community of physicians and allied healthcare professionals across 57 countries, 86 specialities and 60 medical conditions. With extensive experience conducting fieldwork globally, GLocal Mind designs solutions to suit research objectives delivering impactful insights sourced from physicians, allied healthcare professionals, payers, key opinion leaders, patients and caregivers. Physicians get to share their views and opinions on research objectives influencing on key decisions made by corporates influencing healthcare outcomes.

Pls tell us about your company GLocal Mind? Our company was founded in 2010 and since then

Pls tell us about key opinion leader management services. In the changing healthcare landscape, key opinion

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leaders(KOL) take on an even more critical role in both as advisors and influencers. GLocal Mind follows a proprietary methodology for identifying and profiling international, national, local and emerging KOLs that can be customized as per client objectives and needs. KOLs can be physicians, academia, pricing and policy makers, institutions or advocacy groups. They help in conducting clinical trials, marketing newly developed drugs, guiding policy, market entry strategy etc. Our services our suitable for scientific, commercial, regulatory/ market access and advocacy teams and include:  KOL Identification – Adopting a three step approach. We identify leading KOLs for a given therapeutic area and market. We have the ability to gather secondary information from various sources including medical as-

tions in the survey on request. Panelists that are unresponsive, inattentive and/ or fraudulent are marked in the panel and are not invited to participate in any studies. Fraudulent panelist details are retained to prevent reregistration.

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sociations, events (physicians attended in conferences, symposiums, seminars, and workshops), clinical trial registries and major universities across various therapy and geographical areas. In addition we can take peer nominations by way of primary research surveys to make our process more robust. We then assign scores and rate the KOLs based on a wide range of parameters. KOL Profiling and Data Management – We build detailed medical profiles to provide a well-rounded view of the KOL. Medical profiles will contain general information, professional information, activity and participation information. KOL Influence Mapping and Analysis - We group the KOLs based on common areas of interest and activity and showcase their spheres of influence. Network maps help us with understanding professional networks and connect. Profile Updation – We can update existing lists and databases of KOLs periodically ei-

ther the full profile or any specific parameter as required by our clients. What is the global market for healthcare fieldwork ? There is huge demand for the kind of work we do. We estimate a market size of more than two Billion, globally. The figures for India are not enumerated but there seems to be a sustained interest in our work. Could you throw some light on quality assurance for your services? GLocal Mind is responsible for data quality checks for projects that we host. Our in-house quality managers use a variety of techniques for monitoring and eliminating fraudulent participants through active, on-going cleaning and exclusion of offenders from the panel. The team looks for straight liners, monitor participant’s length of interview and compares them to average survey length and include red herring ques-

Pls tell us about your newer services which are technology based. With time and speed of essence in market research, GLocal Mind aims to make fieldwork quicker and easier with the GLocal self-serve tool enabling researchers to estimate feasibility, costs and launch studies in minutes with the click of a few keys. The tool not only reduces time to insights and enables us to provide unmatched competitive pricing for clients who are willing to self-serve themselves, it also lets you generate the invoice for projects completed. Our clients can license our self-service tool to connect with physicians. We also have a home grown ERP that has automated 90 per cent of our business units. This will be ready for licensing soon. Our clients are now able to meet their immediate requirements round the clock with no dependence on time zones. GLocal self-serve may not be ideal for studies demanding niche, hard to reach, low incidence and specialized custom recruitment services. GLocal Mobile - With the increased usage and adoption of mobile for market research, GLocal Mobile was created with the objective to make interaction quick and convenient for our physicians and also is a platform to create multiple products that are more interactive in nature and is possible to conduct on the go. GLocal Panel is an on-going development and the current platform allows the physicians to register on our panel, update profile, receive push notifications of new surveys on their app, forward suvey links, view participation history on their dashboard, redeem incentives and contact GLocal Support through their mobile application. What are your future plans? We would invest in technology to enhance our software to connect our global suppliers as well with our system to create a platform that becomes like a market place for connecting with physicians.

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INTERVIEW

OUR TAG LINE CONTAINS THE GERM OF A COMPELLING IDEA THAT INDIA AND THE SURROUNDING REGION BRING TO LIFE Francis Prashanth, Country Manager – India, Health 2.0 talks about the event and how it can benefit the Indian Healthcare community.

Pls tell us about Health 2.0? Indu Subaiya and Matthew Holt started Health2.0 in 2007, with the first conference in San Francisco setting the trend for what can be described as an explosion of ideas. Today Health 2.0 has grown into a global movement of over 100,000+ entrepreneurs, developers, and healthcare stakeholders. At its core, it is a digital health media company, and in addition to its signature event in Santa Clara, has run conferences in Europe, Latin America, India, Japan and more. Following the success of our events in the United States and in Europe, it made sense that we engage the unmistakable influence India, China and other Asian countries have had in shaping

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how we think about innovation and how we solve healthcare challenges. Pls tell us about Health 2.0’s journey in India? From our very first conference in San Francisco in 2007, Health 2.0 has explored the worlds of ‘user-generated healthcare’. What became our tag line contains the germ of a compelling idea that India and the surrounding region bring to life. Patients are using new tools to guide their own care. And these tools are starting to integrate with the healthcare systems. Doctors, patients, and healthcare organizations are all starting to use new generation of online and mobile

technologies which are fundamentally changing the way healthcare is delivered. Using the same ingredients that have made our events successes in the US and in Europe - Live demos, provocative keynotes, interactive panels - 4th Annual Health 2.0 India conferences will focus on the specific opportunities in the Indian Market. How is this conference different from others? A large part of Health 2.0’s conference programming consists of panels where speakers demo their technology in 3.5 minute bursts with commentators reflecting on what was shown and how they believe it will fit into the health care land-

scape. In Addition, Health 2.0 India integrates the best of India’s web/mobile based technologies, and compares, contrasts and contextualizes them with leading examples of Health 2.0 from around the world. We’ll be seeing what works in the context of India’s evolving health care systems, and what the “boundary-less” online world means for consumers and physicians working in distinct health care systems - all in our lauded format of “Rapid-Fire” technology demos, provocative keynotes, and interactive discussions. What are the benefits of attending Health2.0 event at Hyderabad? Attendees at Health2.0 event can access exclusive tech and business intelligence discussed and showcased at the event. As I mentioned earlier our conference offers healthcare’s newest entrepreneurs unique and intimate access to scores of decision-makers and thought leaders from across the healthcare ecosystem. Additionally we have some brilliant workshops on digital health technology, organizational growth management, connected health, patient relationships, data and analytics, care delivery innovations, interoperability, the impact of consumerism and much more! We also know that the best networking often occurs between sessions, so we have regularly scheduled coffee and lunch breaks to foster networking among attendees, speakers and exhibitors and don’t forget our nightly after-conference receptions Pls tell us about some exciting talks to look forward to? We have a great line-up of thought-provoking key notes spanning from med-tech to digital health-tech innovation in India. We have Balram Bhargava, Professor, School of International Biodesign, AIIMS; Arvind Sivaramakrishnan, Chief Information Officer, Apollo Hospitals Enterprise Limited; Guruprasad Seetharamaia, Director, Medical Screening Solutions,Bosch Healthcare; and Ruchira Shukla, Regional Lead, Venture Capital and Private Equity, South Asia, International Finance Corporation (IFC). There are many other interesting speakers who will no doubt add value to the event.

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Q&A

ASK THE EXPERT

Running a private medical practice in India comes with the risk of lawsuits and property damage. As a medical professional, you are probably well aware of the devastating effects of legal cases and security threats that await doctors who face the blunt of an angry patient. We encourage you to share your queries and concerns regarding legalities of practicing medicine in India to learn more about legal framework, legal cases and the experience of fellow doctors.

Prof ( Dr ) R K Sharma, President, Indian Association of Medico-Legal Experts , New Delhi will answer questions from our readers. Please send in your queries to editor@indiamedtoday.com

October 2017

Q: I am working in an institute where medicolegal autopsies are being conducted on monthly rotation basis where all MLC autopsies are performed by me during a specified month as per duty roaster. Recently, the HOD has made rules stating that he will audit all cases conducted by me before it is being dispatched to I.O, which includes PM reports as well as photos and other evidence. Since he is not actually involved in performance of the medico-legal autopsy, am I within my rights as primary autopsy surgeon to refuse to subject my PM reports to such audits, as it violates confidentiality of the said reports? Name withheld Ans: Please remember that HOD has right to supervise your work and can see all medicolegal work done by you. Confidentiality clause does not bind him, as he is part of team. If you want that he should not audit your report, start writing on all PM reports that you are being supervised by HOD. He will withdraw immediately as he would not like to go to court for evidence.

Q: I am Professor and Head, Department of Pathology at IIMSR, Jalna. I would like to know if it is necessary to take the consent from the patient when performing FNAC. Dr K S Bhople, ex-Dean GMC Aurangabad and HoD pathology. Ans: Since FNAC is an invasive procedure, mostly done in minor OT or sometimes in regular OT, consent in writing is required from patient or guardian. Oral consent is sufficient to do physical examination, X-ray etc. Q: There are incidences when a court case is filed to defame the doctor in particular or to extract money. Can a doctor file a defamation case against these types of people? How can we prove defamation in such cases? Dr Mohd Iqbal, Orthopedic Surgeon, Director, Kota Trauma Hospital Ans: Please note that everyone has fundamental right to approach court of law if they think there is injustice. This right cannot be taken away even by courts. Litigation by patients has to be taken as business risk by all doctors and instead of getting

frustrated, we should make attempts to not land into it. If case comes, take it as way of life and fight professionally. Defamation is very difficult to prove. Q: As an anesthesiologist working in a corporate hospital is it my duty to know the qualifications of the operating surgeon and his registration with the state medical council before giving anesthesia to patients? If there is a medico-legal case will I be held liable if the surgeon is not qualified or registered with the medical council? Name withheld Ans: Please understand that when a surgeon allegedly makes a mistake and is being sued in court/ medical council, invariably anesthetist is also included in the list of alleged culprits. This is the reality. So, anesthetist while working should take precautions that surgeon is duly qualified. Similarly, surgeons should also see whether anesthetists are duly qualified or not. I know it is difficult to object in corporate hospitals but you should inform management if some matter come to your knowledge. If your issues are not addressed properly, change the corporate hospital.

Q: I am a practicing radiologist and am bound to follow PCPNDT rules and regulations. During a foetal wellbeing scan I saw that the fetus had bilateral Hydrocoele. Now if I write this in the report I am breaking the law by declaring the sex of the foetus and if I donâ&#x20AC;&#x2122;t mention it then it is a deficiency in services on my part. Could you guide me as to what I should do? Name withheld Ans: You are wrong in assuming you cannot write Hydrocoele in the report. You can and you should always report congenital abnormalities if detected during foetal wellbeing scan even if it amounts to disclosure of sex of fetus. You are fully protected under the act itself. Q: What are the legal liabilities of a doctor if a patient commits suicide after consultation? For example, If you give all the list of complications of diabetes like diabetic nephropathy, increased risk of CHD, diabetic Retinopathy, etc, and patient goes into depression and commits suicide. Dr J S Suri ,New Delhi Ans: Please note giving information is your duty

and it is patientsâ&#x20AC;&#x2122; right to information. Be assured, nobody will go in depression and commit suicide. Patients do become a bit sad but they overcome this in 2-3 days and accept the new situation. Even if a patient commits suicide, you cannot be blamed. I have observed doctors fear to tell patients about consequences especially in oncology, burns and other life threatening conditions. It has been documented that even in such conditions patient can tolerate sad news quite easily and they can plan their next step like making a will etc. Infect we harm them when we do not tell them the reality, raising false hopes which is an unethical act. We should know how to tell sad news professionally. This is not taught in any medical college.

Disclaimer: This material has been prepared for informational purposes only, and is not intended to replace, and should not be conveyed or constitute legal advice. You should consult professional lawyer and legal advisors before engaging in any legal matter.

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EVENTS AHPI GLOBAL CONCLAVE 2018 Date: Feb 16-17, 2018 Organiser: AHPI Venue: Le Meridien City: Kochi Click: www.ahpi.in Contact: Shikhar Gupta, Assistant Director Shikhar.ahpi@gmail.com

ealthcare industry will play key role to make the economic growth inclusive all over the globe. On one hand it is key social sector contributing to Human Development Index of nation; on the other hand it provides employment to large segment of population per unit investment. Rightly therefore the healthcare is fast

HEALTH 2.0 INDIA 2017 Date: November 10th, 2017 Organiser: Health 2.0 and ISB City: Hyderabad, India Click: india2017.health2con.com Contact: Francis Prashanth: francis@ health2con.com

ince 2007, the Health 2.0 Conferences has been the leading showcase of cutting-edge innovation transforming the health care system. Not your typical stodgy conference, Health 2.0 brings a fresh approach to the space and is the leader in health care technology today. It brings together the best minds, resources and technology for compelling panels, discussions and product demonstrations. Learn the latest trends from industry experts to strengthen your strategy. Hear from influential thought leaders as they discuss new advancements in the health technology landscape and provide solutions to challenges that impact you. Experience new technological platforms to gain insight to what’s new in the market and develop new partnerships. Watch live product demos and engage directly with companies who are looking for new business opportunities.

November 2017

emerging as ‘election agenda’ in all the developing nations. Governments accordingly are working on plans to provide ‘Universal Health Coverage’. Considering that private sector is playing key role in providing healthcare in general and tertiary care in particular, the mission of ‘Health for All’ can be possible only through joint collaboration between public and private sectors including the allied healthcare industry. Keeping above in view, AHPI has chosen the theme for its 5th Global Conclave as; “Is Quality Healthcare Sustainable? Issues, Concerns & Solutions”. The conclave will also encompass the unique blend of 4th edition of ‘AHPI Awards for Excellence in Healthcare’ which will be presented on the eve of 16th February 2018

ADVANTAGE HEALTHCARE INDIA 2017 Date: Oct 12-14, 2017 Orgaiser: FICCI Venue: BIEC City: Bangalore

he 3rd Edition of Advantage Healthcare India 2017 is an International Summit on Medical Value Travel which is being jointly organized by the Ministry of Commerce & Industry, Government of India, Federation of Indian Chamber of Commerce & Industry (FICCI) and Services Export promotion Council (SEPC) from Oct. 12 – 14, 2017 at Bengaluru International Exhibition Centre, Bengaluru India, with the aim of Promoting Services Exports from India.

HEALTHSCAPE SUMMIT SERIES 2017 Date: 30, Nov 2017 - 01, Dec 2017 Venue: The Lalit Ashok, Bangalore City: Bangalore

ealthscape Summit – India, an initiative by IDE that offers one of a kind solution-

oriented platform to overcome the challenges faced by the healthcare industry. Healthscape Summit facilitates Face-to-Face meetings, strategically modelled networking activities and information exchange amongst the most elite assemblage of Hospital Owners, Healthcare Architects, Design Consultants, industry experts and service providers making it the most sought after business summit by the healthcare fraternity of India.

7TH INTERNATIONAL PATIENT SAFETY CONFERENCE Date: Dec 1-2, 2017 Organiser: Apollo Hospitals Venue: JW Marriot City: Mumbai

th International Patient Safety Conference (IPSC) is being organized by Apollo Hospitals Group at JW Marriott Mumbai Sahar, Mumbai on 1-2 December 2017, on the theme of “Exploring New Dimensions in Patient Safety”. A well-knit program with key note presentations, panel discussions, debates, paper and poster presentations, makes this a vibrant forum for exchanging ideas and knowledge, and an opportunity to think, reflect and learn the best from the best.

INDIA HOSPITAL DESIGN & BUILD SUMMIT 2017 Date: 07, Dec 2017 - 08, Dec 2017 Venue: Hotel Vivanta by Taj City: New Delhi

ndia Hospital Design & Build Summit 2017 is scheduled during December 07-08, 2017 at Hotel Vivanta by TAJ in New Delhi, India. The theme for the summit is “Transforming Hospitals”. The event is being organized in association with AHPI and HIMSS India. The aim of the summit is to Leveraging the latest innovations and best practices in Hospital Build in India to deliver cost-effective projects with effective Project management for timely completion of your hospitals.

EVENT REPORT

HEALTHCARE EXCELLENCE THROUGH ADMINISTRATION AND LEADERSHIP

THE FOURTH edition of HEAL (Healthcare Excellence through Administration and Leadership) was held at Baby Memorial Hospital (BMH), Kozhikode, Kerala on October 6-7, 2017. The event brought together students, healthcare professionals and dignitaries in large numbers to discuss industry best practices, areas that required focus and the future of healthcare. The sessions were stimulating and benefited the enthusiastic audience in an effort to transform healthcare from good to great. Research Foundation of Hospital & Healthcare Administration (RFHHA) was the knowledge partner and Association of Healthcare Providers India (AHPI) was the associate partner for the event. Dr Vineeth Abraham, Director, BMH proposed

the welcome address and Dr Soman Jacob, CEO, BMH gave the presidential address. He highlighted the commitment of BMH and the journey of the institution from a 52 bed hospital to a 800 bed hospital. The event was inaugurated by Dr Shakti Kumar Gupta, Medical Superintendent (Dr RPC), AIIMS, New Delhi. In his address he talked about the commitment, care and the leadership of Dr K G Alexander, Chairman, BMH. Dr Shakti Kumar Gupta also set the program to a roaring start with questions to ponder which were deliberated in the subsequent sessions. Prof Mohammad Masood Ahmed, Director, Indo US Hospital, Hyderabad and Col (Dr) Saroj K Patnaik, DGAFMS, Ministry of Defence, New Delhi were Guests of Honour. Dr C Vinoth Kumar, Conference Director proposed

the vote of thanks. Prof Mohammad Masood Ahmed started the academic session with a talk on “Strategic Management in Healthcare Organizations” in which he discussed the importance and need for strategic management in hospitals and also enthralled the audience with case studies and insightful thoughts. Following that, Dr Vijay Tadia, Senior Resident Administrator, AIIMS, New Delhi talked about “Application of Lean Six Sigma in Healthcare” in which he detailed the application of the principles of lean six sigma in healthcare. He emphasised on the fact that defects in processes as well as variation in processes lead to sub-optimal use of the resources in any healthcare organisation.

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EVENT REPORT In a resource constrained country like India it becomes all the more important to use time tested principles of lean six sigma which have given good dividends in healthcare across the globe. He cited few examples of the application of these principles as well as demonstrated their applicability in healthcare during his speech. Day one ended up with a “Special Comedy Show in Healthcare” by Dr Jagdish Chaturvedi, an innovator and a renowned stand up comedian on “Inventing Medical Devices”. As a doctor who has evolved into an innovator of affordable medical devices designed for our Indian setting, he shared his experiences and learning with the medical community which includes doctors, paramedical and hospital administrators. He said “I believe our healthcare professionals understand our healthcare needs very well and they must drive and lead new innovations to improve healthcare in our country. By giving talks on my journey and sharing lessons from my failures in the form of book – Inventing medical devices: a perspective from India, I hope to help more healthcare professionals to take up this task and improve healthcare in our country.” Day 2,started with a talk by Lt.Col (Retd) Sunny Thomas, CAO, BMH on “Hospitals – A Tryst with Environment” which was an eye-opener for many, providing figures from energy saving initiatives and measures adopted at BMH. This was followed by Dr Shakti Kumar Gupta who talked about innovation and entrepreneurship and intelligent hospitals. He said that healthcare innovation and entrepreneurship is the cornerstone for success of any organisation. He pointed out that healthcare has traditionally lagged behind other industries in the area of innovation and entrepreneurship. He stressed that healthcare organisation that successfully foster the culture of innovation and entrepreneurship along with other management strategies will not only increase their chances of survival in a changing and challenging environment but will also be better equipped to provide cost effective high quality services and products. Healthcare sector is growing at a rapid pace and we need to be geared up to face the challenges of the 21st century through research and advances in the field of healthcare. Dr Sadik Kodakat, Chairman, Starcare Hospitals Group addressed the gathering

November 2017

on “Disruptors in Healthcare : Managers & Entrepreneurs Perspective.” In his energizing talk, he explained in detail the various disruptors in healthcare with thought provoking insights and examples. This was followed by the Col (Dr) Saroj K Patnaik who addressed the gathering on “Role of Level Five Healthcare Leadership in India”. He gave a blueprint for healthcare leadership in organizations, more so in the organizational setting thus enabling high standards and impactful governance. The session in the afternoon started with Sri Harsha Govardhana, Managing Director, Sarvagnya Solutions, Hyderabad who talked about “Medical Leadership: Competencies for Clinicians”. In his address, he said “I have interviewed and observed over 90 plus doctors who have built their practice by following highest standards of care, getting outstanding medical outcomes. I checked the validity and application of these competencies over period of last 17 years. These doctors whom I call super star doctors rigorously demonstrate nine medical competencies that provide excellent clinical outcomes in Indian healthcare setting.” Sri Harsha went to explain the competencies in detail, which are clinical excellence, team building & collaboration, doctor- patient relations, management skills, learning & development, health & well being promotion, professional behaviour, governance & compliance and technology adoption for personalised care using precision medicine. This was followed by talk by Saji Mathew, Chief of IT & HR, BMH on “The Employee Experience is the Future of Workplace”. In his talk, he said “Healthcare is considered the most ‘human’ of all endeavours. The performance of healthcare professionals such as physicians and nurses directly affects the physical and mental well-being of patients. Research has clearly identified links between healthcare work attitudes and patient outcomes. In the digital age, Employee Experience is an important concept worthy of attention to drive positive customer experience.” The last session of the day saw Prof (Dr) Anand Gurumurthy, IIM, Kozhikode talk on the topic can car making methods be applied to hospitals? His talk dealt with how the concepts of Toyota Production System (TPS) can be applied within the

healthcare setting such as hospitals to improve the efficiency of the various processes and thereby reduce the overall cost, which would enable health care services to be more affordable and accessible. He highlighted the similarity in terms of the objectives for TPS and healthcare institution such as hospital. For example, the car maker would consider the safety of the customer using the car as the foremost priority, while in the case of a hospital, the safety of patients matters most. Similarly, for both the car maker and hospital the factors such as quality and cost are also important. Apart from this, he also highlighted about the increasing labor cost and shortage of skilled people in the health care setting, which also warrants the need for car making methods. Then, he explained how there are seven wastes identified by Taiichi Ohno, the chief architect of TPS is also prevalent in healthcare with a funny video and noted that these wastes has to be reduced. To accomplish the same, he also suggested some of the tools and techniques of TPS such as “Value Stream Mapping”, 5S, Sphagetti Diagram, Kaizen, Changeover time reduction, etc., which can be used to reduce these 7 wastes. Lastly, he demonstrated the application of the same using a case of Viriginia Mason Medical Centre, a multi-speciality hospital in USA, which has pioneered the implementation of TPS in healthcare setting. He also advocated the use of these concepts in Indian hospitals and healthcare setting to reap various benefits such as reduced cost, reduced patient stay, increased utilisation of hospital equipments, reduced waiting time, increased customer satisfaction. The vote of thanks was proposed by Rohith G, Joint Organizing Secretary, HEAL 2017. The two day session gave new directions and ideas that can be incorporated in healthcare practice to the healthcare professionals and a ringside view to the students community. The audience participation was appreciable with various queries to the speakers after each session and aptly addressed by the speakers. The thoughtful session made the audience crave for more and has provided the drive and direction for the organizers in making HEAL 2018 even bigger. For now, its a long wait and time to chew on the learnings, interpret and realign healthcare practice for greater good and organizational excellence.