HEALTHCARE Archives

04/06/2019by EOS Intelligence EOS Intelligence No Comments

Surgical Robots – Marrying Cost-efficiency and Innovation

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Robotic-assisted surgeries, being minimally invasive, have been an excellent alternative for conventional open surgeries for quite some time now. Surgical robots use small incisions with broader 3D visualization of the operating area and precision-guided wrist movements. Players in the industry aim to develop solutions that combine medical device technology with robotic systems to provide patients with rapid post-surgery healing and reduced trauma. As surgeons perform an increasing number of procedures worldwide using these robots, the surgical robots market is growing along with the popularity of minimal-invasive surgeries.

Robotic-assisted surgeries have been rapidly adopted by hospitals in the USA, especially since 2000, when the Food and Drug Administration (FDA) approved the da Vinci Surgery System by Intuitive Surgical for general laparoscopic surgeries.

The system excelled its predecessors, such as PUMA 560 robotic surgical arm, which was used for non-laparoscopic surgeries in the late 1980s, by its 3D magnified high-resolution imaging and one centimeter diameter surgical arms to move freely inside the operating area.

These and other variants of surgical robots started to enter the market, enabling surgeons to operate complex minimally-invasive surgeries with improved precision, superior operative ergonomics, enhanced adroitness, and visualization compared to traditional laparoscopy.

Robotics adoption focused on selected specialties

Even though robotic surgeries have been performed for quite some time, are still in the early stages of adoption in surgeries.

The adoption rate of robotic systems is uneven across various specialties with most robotic surgeries being performed in urology, gynecology, and general specialties. These fields also enjoy the fastest rate of adoption, example of which has been found in a 2017 study, in which researchers at Stanford University School of Medicine (California) analyzed data compiled by 416 hospitals on kidney removal procedures from 2013 to 2015. According to the study, robotic-assisted surgeries accounted for just 1.5% of all kidney removal surgeries in 2013, ration that increased to 27% by 2015.

Competition strengthens, challenges the market leader

In 2017, according to international market research and consulting firm, iData Research, surgical robotic systems market was valued over US$2.4 billion with over 693,000 robotic-assisted procedures performed in the USA alone. US-based Intuitive Surgical has long dominated the robotic surgery market with more than 4,800 da Vinci units installed around the globe, and approximately 877,000 surgical procedures performed with the da Vinci Surgical System in 2017. Intuitives’ da Vinci System is the only surgical robotic system which has been approved by FDA for various surgeries in gynecology, urology, cardiothoracic, thoracoscopic, and general surgeries.

In comparison, Intuitive’s competitor TransEntrix’s Sehnhance Robotic Surgical system received a nod from FDA in 2017 specifically for inguinal hernia and gall bladder removal laparoscopic surgeries, while also in the same year a robotic system for spinal surgeries, Mazor X by Mazor Robotics received FDA clearance.

Though Intuitive Surgical is the market leader, other players are not far from getting their products FDA-approved, a fact that has the potential to affect Intuitives’ leadership position.

Cost remains the main challenge for adoption

One major challenge for the robotic systems manufacturers is to convince hospitals to purchase their systems costing millions. For instance, a single da Vinci Surgical System costs around US$0.5 million to US$2.5 million, with additional disposable instruments whose costs range from US$700 to US$3,500 per procedure. Apart from the initial cost, there are other associated costs such as installation, service, and training fees that a hospital has to bear.

Players in this market started to realize that in order to strengthen their position and competitiveness, cost-effectiveness of their systems is the key requirement. Recently, several companies have increased their focus on developing cost-effective surgical robots, attempting not to compromise system’s performance.

Players in this market started to realize that in order to strengthen their position and competitiveness, cost-effectiveness of their systems is the key requirement

Examples of products competing on cost-effectiveness include Titan Medical’s SPORT surgical robotic system that is designed to perform various surgeries such as gynecology, urology, and general surgeries. At the outset, the system costs approximately US$0.95 million (da Vinci: ~US$1.8 million). Further the company claims the robotic system is cost-effective by driving down annual service and per procedure cost by increasing the number of times its disposable and reusable components can be used for various surgeries.

The market leader, Intuitive, also understands the costs pressures and has already established its presence with its low-cost robotic surgical system, da Vinci X, that costs approximately US$1.42 million, which is around US$780,000 cheaper as compared with Intuitive’s most advanced surgical robotic system da Vinci Xi which comes at a price of around US$2.2 million.

Other players are also entering the space, with Alphabet (Google) partnering with Ethicon (a subsidiary of Johnson and Johnson) to manufacture lower-cost surgical robot, planning to introduce it into the market by 2020.

Hospitals’ limited budgets trigger simpler products development

Considering that cost burden is the key challenge to robotics adoption even in large healthcare institutions, small hospitals are generally completely outside of the potential customer base, due to far lower budgets they have to work with.

At the same time, small hospitals feel the pressure to retain surgical patients, and in that they often want to turn to robot-assisted laparoscopic surgeries. As a result of this need paired with limited budgets, certain low-cost substitutes start to arrive to the market, at times indirectly challenging systems offered by the leading players in this area.

Examples of this include Olympus’ ENDOEYE FLEX 3D camera system and FlexDex, tools used for minimally invasive surgeries that allow for wristed-laparoscopy, giving robot-like dexterity without computers and no annual maintenance services.

According to a case presented at SAGES’ World Congress of Endoscopic Surgery in 2018 by Dr. Kent Bowden from Munson Cadillac Hospital, USA, contribution margin (portion of hospital revenue remaining after the variable cost to pay off hospital salaries, service contract, and other fixed costs) for a ventral hernia using da Vinci was US$ 8 per procedure while when using FlexDex it was US$2,605. For an inguinal hernia the contribution margin using da Vinci ranged from US$596 to US$698 whereas by using FlexDex, hospital contribution margin increased to US$1,601-US$1,115 per procedure.

Another example of such a substitute system is the FreeHand robotic arm produced by UK’s OR Productivity. FreeHand is a system that allows the surgeon to hold and control the laparoscope using his own head movements and a foot pedal. The system was developed to provide a range of benefits (stable image, reduced staff count, high precision) at an affordable installation and running cost. The producer promises a fixed per-procedure cost, whose rough estimation points to around US$197 per procedure (unachievable for procedures conducted with advanced systems).

It is clear that these simpler systems are not able to fully replace the higher-end products. However, these substitutes claim to be dexterous, cost-effective robotic solutions sufficient for certain procedures, thus can be perceived as an alternative (and competition) to expensive robots in some cases.

These substitutes claim to be dexterous, cost-effective robotic solutions sufficient for certain procedures, thus can be perceived as an alternative (and competition) to expensive robots in some cases

Robotic surgeries offer many advantages both for surgeons and patients, however, the equipment comes with certain challenges and limitations, which, apart from cost, include increased operating time in some cases, lack of tactile feeling for the surgeon, large space requirement, and long set-up time required for the robotic system. Having said that, cost-effectiveness is (and will continue to be) the main challenge players face while developing and marketing their systems.

EOS Perspective

Advancements in surgical robots are emerging by adding intelligence into the robotic systems with refined haptic feedback and versatility in robots’ arms. Companies are diving deep in this industry by improving their products and coming up with next-generation surgical robotic systems that could perform different types of minimally invasive surgeries.

Nevertheless, huge investment is needed for development of advanced and multi-skilled robots. Gaining investment for such projects is difficult, hence for the time being, it can be expected that the existing players are likely to consider forming partnerships to improve their products and increase their market share.

Gaining investment for such projects is difficult, hence for the time being, it can be expected that the existing players are likely to consider forming partnerships to improve their products and increase their market share

On the other hand, the market might see arrival of new systems based on existing technologies and solutions. They can be sourced from several of Intuitive’s patents that expired in 2016. These included some basic robotic concepts implemented in the robotic system, such as robotic arms control and imaging functionality. Several other patents developed by the company are expected to expire by 2022 (under the US patent law, a solution is protected for a relatively short period of time, generally 20 years).

Such availability of patent-free solutions will encourage other players in the industry to enter the market with similar products, probably at lower price points. This is likely to intensify the competition, which is already tightening, as Senhance robotic systems by TransEntrix got FDA received approval in 2018 for hernia repair and gallbladder removal, while SPORT by Titan Medical is expecting its approval in 2019, giving competition to da Vinci. Furthermore, a new partnership by Google and Johnson & Johnson is on the horizon, likely to bring some form of cost-effective alternative to the existing, more expensive systems, further adding pressure on the solutions offered by existing players.

Such availability of patent-free solutions will encourage other players in the industry to enter the market with similar products, probably at lower price points

The outlook for the robotic systems looks promising with mergers and partnerships among players that could drive innovation in this industry. Collaborating with hospitals to invest in training and application of robotic systems in growing number of procedures should also remain in the competitors’ focus area, as high number of robot-assisted procedures performed regularly provides opportunities for increasing the cost-efficiency and generating revenues that could be directed towards further R&D.

Players in the market need to focus on such high-volume procedures that will be likely to ultimately increase their sales, and allow them to focus on improving their products to deal with current challenges such as cost-effectiveness, limited portability and complex controls of the robotic systems, improving of which can help producers gain a competitive edge.

However, the players in this industry also need to identify new growth avenues – targeting areas where traditional laparoscopic surgeries are still predominantly performed but where robotic assistance could find its place, such as in colorectal and cholecystectomy procedures. There is still a considerable space in the market with opportunities. They can be tapped by putting emphasis on continuous investment in R&D aiming to innovate and develop new solutions that would find application in under-served therapeutic areas or offer new functionalities in order to cover as many therapeutic subsegments of the market as possible.

25/04/2019by EOS Intelligence EOS Intelligence No Comments

A Ripple Effect of Healthcare Fraud in the USA

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In June 2018, the US Department of Justice held nearly 600 individuals, including doctors, responsible for the largest healthcare fraud in the US history resulting in losses of over US$2 billion. Each year, the American healthcare system loses tens of millions of dollars to fraudulent claims not only overloading the healthcare system but also affecting the security and identity of patients and other citizens. To combat the ill effects of healthcare fraud, the government is laying strict measures to monitor such incidents and is using artificial intelligence (AI) to identify threats before they actually occur.

Out of the country’s total health expenditure, estimated to have to crossed US$3.5 trillion mark in 2018, as much as 10% is lost annually due to healthcare fraud (examples include billing for services not provided, providing services not medically needed, and reporting patients as having a more severe illness in order to obtain higher reimbursement), bleeding not only taxpayers’ money but also billions of dollars from the healthcare system.

Over the past decade, reduction in the number of fraud cases in healthcare programs has emerged as a significant priority for the US government and other federal agencies – US Department of Health & Human Services, Office of Inspector General (HHS OIG), the Centers for Medicare & Medicaid Services (CMS), and the US Department of Justice (DOJ). These agencies make laws, use anti-fraud tools, and also partner with private sector to help protect consumers against healthcare fraud.

Anti-Fraud Laws

The need to curb the exploitation of healthcare system by healthcare providers for illegal gains has led to the formation of laws that fight fraudsters, ensuring better quality and more equal medical care to all. These laws assist physicians, if they comply by them, to easily identify the red flags with regards to their relation with payers, other physicians and healthcare providers, and vendors. These are:

False Claims Act (FCA) – enacted in 1863, this civil law prohibits the submission of false claims to the government
Anti-Kickback Statute (AKS) – this criminal law, enacted in 1972 and enforced in the mid-1980’s, prohibits willfully offering, paying, soliciting, or receiving any remuneration directly or indirectly for referrals of federal healthcare program
Physician Self-Referral Law (Stark Law) – introduced in 1988, this law limits physician referrals in case of a financial relationship with the entity
Criminal Healthcare Fraud Statute – As part of the US Code (18 U.S.C. § 1347), this statute prohibits willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain any money under any healthcare benefit program
Civil Monetary Penalties Law (CMPL) – As part of the US Code (42 USC § 1320a-7a), it prohibits willfully executing of a scheme or use false statements to obtain funds held by a federal healthcare program
Exclusions – legally excludes participation of healthcare providers and suppliers in all healthcare programs if convicted of criminal offenses

Policymakers have established these laws to minimize, or at least reduce, healthcare fraud. The laws have contributed, for instance, to the US government being successful in finding parties responsible for healthcare fraud, mainly due to FCA, especially in the form of information coming from whistleblowers. Under the act, there are financial incentives for whistleblowers, who bring healthcare fraud to the attention of the government, receiving 15% to 30% amount of the total recovery. Incentivizing whistleblowers has been successful – through aid from private individuals and units or individuals serving as whistleblowers, the government has been able to recover more than US$31 billion of taxpayers’ funds over the past thirty years.

Anti-Fraud Partnerships

The government is also focusing on strategic partnerships with other private agencies to fight fraud, which include:

Healthcare Fraud Prevention Partnership (HFPP) – A public/private partnership between the federal government, state agencies, law enforcement, private health insurance providers, employer organizations, and healthcare anti-fraud associations with the purpose of exchanging data, building competence and proficiency to fight fraud. Since its inception in 2012 till the end 2017, the number of public, private, and state partner organizations as participants of the partnership reached 85
Healthcare Fraud Prevention and Enforcement Action Team (HEAT) – established as a conjoint effort between DOJ, OIG, and HHS in 2009. The purpose of this partnership is to invest in new resources and technology to prevent fraud, reduce healthcare costs and improve the quality of care, and highlight best practices by providers and public sector employees
Medicare Fraud Strike Force – launched in 2007, resources from federal, state, and local law enforcement entities come together to prevent and combat healthcare fraud by harnessing data analytics and exploratory intelligence
Centers for Medicare & Medicaid Services (CMS) – a federal agency, established in 1965, administers and oversees medical programs by partnering with individuals, contractors, entities, and law enforcement agencies
Office of Inspector General (OIG) – founded in 1976, its purpose is to protect the integrity of HHS programs as well as the welfare of the beneficiaries of those programs
Center for Program Integrity (CPI) – established in 2006, it promotes the integrity of health programs by monitoring and identifying program vulnerabilities through audits and policy reviews
General Services Administration (GSA) – an independent agency of the US government formed in 1949 that maintains the Excluded Parties List System (EPLS) that includes information on entities suspended, disqualified, and/or excluded from receiving contract, financial assistance, and other benefits

Such partnerships and agencies help prevent healthcare fraud on a national scale, to a certain extent, as they take substantive actions to stop fraudulent payments thus improving the overall process of monitoring fraud.

In efforts to combat fraud committed against all health plans, both public and private, the Healthcare Fraud and Abuse Control (HCFAC) Program was established in 1997, under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The program was designed to coordinate federal, state, and local law enforcement activities with respect to healthcare fraud and abuse. Under the program, each year, funds are allotted to the various offices of HHS and DOJ to support the effective and smooth functioning of the programs and partnerships directed towards identifying and fighting fraud in healthcare sector. In 2017, a little above US$1 billion was allocated and over US$2.4 billion was recovered in healthcare fraud judgments and settlements and around US$2.6 billion (including amount assimilated from preceding years) was returned to the government or paid to private persons. The program yielded an ROI of US$4.2 for every dollar spent for the period 2015-2017.

Senior Medicare Patrols (SMPs)

Senior Medicare Patrols (SMPs) are grant-funded projects of the federal US Department of Health and Human Services (HHS), US Administration for Community Living (ACL), Administration on Aging (AoA) – an agency providing leadership and expertise on programs, advocacy, and initiatives affecting older adults and their caregivers and families. These grants are supported by SMP National Resource Center, created in 1997 as a demonstration project in 12 regions moved on to become a nationwide program in 2003 and now includes 54 SMP programs across all the 50 states, the District of Columbia, Guam, Puerto Rico, and the Virgin Islands.

ACL issues a new request for proposals for the program every three years, and then awards grants to a selected project across all regions (each US state, the District of Columbia, Guam, Puerto Rico, and the Virgin Islands). Since 2016, SMP grants are funded as discretionary projects by HHS operating division, ACL, through the Healthcare Fraud and Abuse Control Program (HCFAC) – a program designed to coordinate federal, state, and local law enforcement activities with respect to healthcare fraud and abuse. The resource center, through these projects, reaches out to approximately two million beneficiaries each year via 5,000 volunteers associated with the SMP program.

These projects, through trained volunteer workforce, provide education and assistance to Medicare beneficiaries, their families, and caregivers to identify, prevent, and report healthcare fraud. These groups also help protect elderly persons’ health records, financials, and medical identity. Moreover, they provide assistance, when issues are identified, about whether or not fraud is suspected by referring to the appropriate authorities for further investigation.

Data Analytic Tools

An effective way to prevent fraud in healthcare system is to identify it before claims are paid, and data examination capabilities such as data analysis, predictive analytics, trend evaluation, and data modeling approaches can be utilized to analyze and examine fraud patterns.

Data analytic tools can identify fraud patterns by developing a certain set of rules. One can set up a ‘rule’ or an ‘alarm’ for identifying fraud related to medical expertise – a healthcare provider claiming for a procedure outside his area of expertise or when the claim crosses a certain amount for a particular test or treatment. These tools use AI, continuously mine data, and identify patterns thus enabling the user to set new rules or alarms.

Up to 30% of total healthcare expenditures in the USA are estimated to be related to fraud, waste, abuse, and errors – a key contributor to soaring healthcare costs in the country. Analytic tools, by tracking fraudulent payments have helped in cutting down costs related to fraud and abuse. In 2014, CMS prevented more than US$210.7 million in healthcare fraud using predictive analytics. In addition, the tool also enables CMS to assign risk scores to specific claims or providers, spot claim irregularities or errors that were earlier hard to detect, and identify inconsistent billing patterns thus eliminating future potential fraud.

Government authorities are not the only entities to use data analysis for monitoring and tracking purposes. Insurance companies are also using similar tools to reap benefits and reduce fraudulent payouts. For instance, United Healthcare, a US-based healthcare and benefits services provider that manages more than one million claims every day, transitioned to a predictive modeling environment based on Hadoop big data platform. The company claims to have spawned a 2,200% return on their investment in big data technology.

EOS Perspective

The healthcare system in the USA is considered unstable with no sufficient policies in place to regulate the healthcare pricing. In addition to exorbitant prices, over the years, increasing cases of fraud have not only overburdened the healthcare system but also consumers, contributing to large number of personal bankruptcies due to healthcare treatments being disproportionately expensive. Moreover, as the spending on healthcare is projected to rise rapidly in the coming years – CMS projected healthcare spending to reach nearly US$5.5 trillion by 2025, the cost of healthcare fraud is likely to follow suit, resulting in weighing down the consumers even more as they bear the costs of fraud, topped with an existing unaffordable exorbitant healthcare, thus worsening the situation altogether.

Healthcare fraud is a grave problem and affects the entire healthcare system including patients, government, and insurance companies. The foremost effect of fraud perpetrated by healthcare providers is experienced by consumers as this drains the taxpayers’ pockets in the form of higher insurance premiums, reduced benefits, and overall coverage.

In the USA, insurance fraud accounts for approximately $30 billion in lost revenue for the insurance industry and fraud related to healthcare is the second most common form of fraud after vehicle theft. While it is almost impossible to determine how much health insurers lose every year to fraud cases, as low as 5%, or even less, of these losses are recovered annually. The downside is that the heightened cost of fraud and errors are borne by the customers as the companies translate this loss into higher premiums. This deters many individuals from purchasing insurance policies, which makes them unprotected in case of serious diseases and injuries due to reduced medical coverage (or complete lack of it).

Healthcare fraud is a financial gutter in the healthcare system that not only strips individuals of health benefits and insurance companies of money but also results in higher taxes and budgetary nuisances for the government.

Besides increasing the economic costs, such fraud cases extensively affect an individual’s medical identity. In 2017, of total identity thefts reported in US, nearly 3% were related to medical theft standing at a number of 134,260 cases; the overall tally, however, is anticipated to be much higher as the count of incidents unaccounted for remains unknown. Cases of medical identity theft result in misuse of an individual’s medical information that can cause dire consequences.

Each individual is issued a Medicare number, a unique identification number, as part of the national health insurance program. As these Medicare numbers are distinctive and cannot be changed, unless issued a new one, once compromised, such fraud cases put the person’s healthcare and future benefits at a huge risk. The victim could end up receiving wrong medical treatment or, in some cases, even die due to altered or misrepresented medical records as a case of identity fraud. In addition, medical identity theft also impacts an individual financial stability related to medical concerns – the fraudster ends up claiming the treatment amount in medical bills from insurance company, when the victim actually approaches the insurance company to file a legitimate claim, he is informed that he has already reaped the benefits, thus orphaning the victim of his right to medical care. As an extreme repercussion, victims may also have to deal with legal authorities over false allegations of procuring and possessing illegal drugs.

Given the impact on individuals, medical system, and economy, it is clear that healthcare fraud is a costly problem and a critical threat to the US economy as it not only increases healthcare costs for everyone but also affects common people leaving them incapacitated and vulnerable. While the government has achieved some triumph, over the last few years, in detecting fraud cases and punishing the wrong-doers, the success rate of detecting such frauds is always questionable.

At this stage, though immense efforts are being bestowed in formulating laws and technological investments being made to identify impostors, it is very difficult to ascertain what the government has accomplished, as fraud related to healthcare cannot only be measured in terms of monetary loss. The measure should also include the extent of safeguarding the interest and identity of the citizens, and the degree to which this has been achieved is debatable. It must be noted, however, that in the current scenario, where the key focus is on reducing the rate of fraud in the healthcare sector, while keeping the overall healthcare costs in check, the task in hand for the American government is of mammoth scale.

12/02/2019by EOS Intelligence EOS Intelligence No Comments

India and China Make Space for Domestic Medical Devices

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Medical device industries in India and China have long been dominated by international players, especially when it comes to high-end devices. High investment requirement, long gestation period on ROI, limited support from the government, and relatively low demand and awareness about medical procedures have resulted in limited domestic investments. However, the industry has been evolving as more and more local players are realizing the scope of this high-potential market that is still in its nascent growth stage in India and China. Moreover, increased government support is further expected to boost indigenous production in the industry.

Similar market structures, a whopping difference in size

While the medical device sector in China is far ahead of that of India (with respect to sales, number of players, and investment), they both have a similar market structure, i.e. being dominated by large multinational players, who have built strong relationships with large hospitals, healthcare organizations, and influencers.

Very few local players have had any significant presence in this industry, and those that did hold some share in the market, limited their focus to the low-investment, low-price product range. However, with healthcare spending in the two countries rising significantly, more and more domestic players are entering and expanding into this space.

India’s healthcare industry is poised to reach US$280 billion by 2020 registering a CAGR of 15% during 2016-2020, while China’s healthcare spending is projected to reach US$1 trillion by 2020, growing at a CAGR of about 12% during the decade.

The rise in healthcare spending in both countries is underpinned by rising disposable income, availability and growing awareness about medical care, expansion of health insurance coverage, rising burden of lifestyle diseases and increased stress levels, as well as ageing population (especially in China).

In addition to this, the governments in both countries are providing instrumental support to companies interested and engaged in medical device manufacturing on domestic soil.

Government takes initiative to promote Indian domestic manufacturing

India’s medtech market, which was valued at close to US$4 billion (INR 260.5 billion) in 2015 is expected to reach about US$8 billion (INR 550.4 billion) by 2020, registering a CAGR of 16.1% during 2015-2020, which is significantly higher than the global industry growth of about 4-6%.

Although about 65-70% of the market value is characterized by imports, the current government’s initiatives in the sector (including the Make in India initiative) are expected to reduce the country’s dependency on imports in the medium-to-long term. Some of the initiatives undertaken by the government include allowing 100% FDI in the sector, setting up medical technology and devices parks across selected states to bring down indigenous manufacturing costs by as much as 30%, developing two testing and quality certification labs aimed at monitoring and improving quality of manufactured devices, and issuing Medical Device Rules 2017, which promote domestic manufacturing.

Before the Medical Device Rules 2017, medical devices were regulated as drugs and this resulted in several regulatory bottlenecks with regards to medtech manufacturing. The new set of rules ease the process of obtaining licenses and undertaking clinical trials, encourage self-compliance, and promote a single-window digital platform for the processing and easy tracking of applications and licenses for import, manufacture, sale/distribution, and clinical investigation of medical devices. In addition, the new medical device rules classify medical devices into four categories based on the risks these devices may pose, in line with global standards for classifying and registering medical devices.

In addition to this, the government also corrected the inverted tax structure faced by the industry in the past (i.e. import of finished goods attracted lower duty compared with import of raw materials for domestic manufacturing). Under the 2016-2017 budget, the government relaxed import duty on components and raw materials required to manufacture medical devices to 2.5% and provided full exemption from additional customs duty (SAD). Further, it increased duty on import of finished medical devices from 5% to 7.5% (in addition to imposing an additional duty of 4% on medical devices by withdrawing exemptions.)

While the move of reducing duty on raw materials has been appreciated by the industry, the rise in duty of imported medical devices has met with mixed reviews. India is highly import-dependent with regards to medical devices and a rise in duty on most categories will make medical care more expensive for the consumer.

Further, in June 2017, the union cabinet announced a US$250 million initiative as a part of the National Biopharma Mission to fund bio-tech start-ups in the field of medical devices, bio-therapeutics, etc. The government is also looking to encourage innovation in this space by setting up R&D incubation centers in association with leading research institutions in this field.

Apart from easing the supply side, the government’s initiatives, such as Free Diagnostics Service Initiative also play a vital role in boosting the demand for medical devices (especially in-vitro devices) in the country. Through this initiative, the government, under the National Health Mission aims at providing a minimum set of diagnostics to the underprivileged population in the country.

In addition to this, the program has worked on devising an integrated approach to combat prevalent non-communicable diseases such as hypertension, diabetes, and cancer by undertaking year-round screening and testing. This will result in large government orders for IVDs and other medical devices.

Another initiative undertaken by the government to both support the domestic industry and ensure a more widespread reach of medical devices has been price capping of coronary stents and orthopedic implants. Observing the huge distributor margins on these medical devices, the government undertook a bold step to cap the prices at which stents and knee implants can be sold in India.

Prior to the price control, the average retail price for a bare metal stent was about US$700, while that for a drug-eluting stent was about US$1,800-2,000. In February 2017, the government fixed a ceiling price of ~US$106 (INR 7,260) for bare metal stents and ~US$431 (INR 29,600) for drug-eluting stents.

In a similar move, the government capped prices for knee implants in August 2017. Knee implants, which ranged from ~US$2,308-US$13,121 (INR 158,300 – 900,000) were limited to ~US$791-1,661 (INR 54,270-113,950). In mid-2017, the government published a list of 19 medical devices (including catheters, heart valves, other orthopedic implants, etc.) that will be monitored for pricing, thus similar price capping may be expected for other devices as well.

Large players may withdraw their latest generation products from India, while Indian players will focus only on cost-effective products instead of innovations.

While the intent for the price capping is noble and will provide a boost to the domestic manufacturers who are better equipped at producing low-priced products, several leading international companies, such as Abbott Vascular and Medtronic, have criticized the decision and submitted applications to increase the ceiling price for the premium quality products or allow them to withdraw the products from the Indian market (as per the government’s rules, no manufacturer can withdraw their products from the market for a period of 12 months from the date of the price ceiling without prior approval from the government). This may be detrimental to the overall industry as large players may withdraw their latest generation products from India in the long run, while Indian players will focus only on cost-effective products instead of innovations.

Indian domestic players might go beyond high-volume low-end products

The Indian medical device market is largely import driven with a very fragmented domestic players landscape. While there are around 800 local medical device manufacturers across the country, only 10% have a turnover of more than ~US$7.3 million (INR 500 million).

The small-scale domestic players focus primarily on the consumables and disposables segment of the medical device industry, which include high-volume low-end products such as syringes, needles, and catheters.

The patient aids segment, including mostly hearing aids and pacemakers, is largely import dependent.

While the equipment and instruments segment and the implants segment are largely dominated by foreign players, they have recently seen an influx of local players that have customized their offerings to the Indian market. Karnataka-based Remidio Innovative Solutions has come up with a retinal imaging system, wherein the fundus of the eye connects to a mobile phone camera to take pictures of the retina to detect diabetic neuropathy. The device can also be used in remote areas and the images and results can be shared in real time on the treating doctor’s phone. Similarly, Karnataka-based Tricog Health Services has developed a cloud-based ECG machine for faster diagnosis. Several other players include Sattva, Cardiotrack, Forus Health, etc.

Understanding the needs and price-sensitivity of the Indian market, several leading global players have also created customized offerings for Indian consumers. For instance, GE Healthcare has come up with a compact CT scanner, which consumes less power, while Skanray Technologies has developed affordable X-ray imaging systems to meet the Indian needs.

We can expect a transition in the domestic sector, which will not only focus on high-volume low-end products but also look at entering the high-end innovative segment offering more affordable and locally customized solutions.

Since the Indian government has fixed the inverted duty structure and provided other instrumental support to the domestic sector, we can expect a huge transition in the industry, which will not only focus on high-volume low-end products but also look at entering the high-end innovative segment offering more affordable and locally customized solutions. This may eventually result in a phase of consolidation, with foreign market leaders absorbing several innovative Indian start-ups and established players.

Chinese government also focuses on aiding local producers

China’s medical device market is the third largest globally, after the USA and Japan, and is expected to surpass Japan to become the second largest by 2020. In 2017, the industry was valued at US$58.6 billion, maintaining a double-digit growth over the previous three years.

Similar to the Indian market, the Chinese medical device sector continues to be dominated by foreign players through imports or their locally manufactured products. However, the market is also characterized by the presence of several local players (though smaller in size), especially in the drug-eluting stents, IVDs, and orthopedics segments.

While the foreign players hold the major chunk of innovative medical devices, the government has been taking several and significant steps to promote local companies. The government requires international players to have local legal entities in China for registration and licensing, thus China cannot serve only as an export market.

Another such major step is the regulatory proceedings under Order 650, which mandate clinical trials in China for all class II and III medical devices, with few exceptions. This prolongs the period for obtaining a license to 3-5 years and adds close to US$1-1.5 million (CNY 7-10 million) in costs. However, it has introduced a shorter channel, called the Green Channel, which provides a fast track review option. While the government introduced this to foster domestic innovation, foreign players can use it too. To be eligible for the Green Channel, the device must have a Chinese patent and it must be an innovative product with design progress and records. Products qualifying for the Green Channel are given priority in the registration review and are exempt from the US$90,000 registration fee.

In 2016, the government introduced a second priority review system for certain breakthrough products. Under this fast track channel, the need for a lengthy pre-qualification application process was further eliminated.

The government’s guidelines in its new healthcare reform called The Healthcare Reform 2020 also aim at reducing the share of imported medical devices and promoting locally produced counterparts. Several state-based medical tenders differentiate between local and imported products, giving preference to the former. Moreover, in some tenders a further distinction is made between domestic and foreign-owned local manufacturers. Thereby foreign companies that buy-out local companies to get an easier access into China are also considered as foreign players.

Under its Made in China 2025 plan, the government has also focused on domestic development and manufacturing of high-end and innovative medical devices. These devices include imaging equipment, medical robots, fully degradable vascular stents, and other high-caliber medical devices. The government aims to boost local production of such innovative and high-value devices by supporting the R&D infrastructure and manufacturing capabilities of local players. The government also provides extension of tax benefits for a period of three years if the investment made is used towards the development of medical devices.

Moreover, under the initiative, the government has aimed at increasing the use of locally produced devices by hospitals to 50% by 2020 and 70% by 2025. To pursue this goal, in September 2017, the Sichuan province mandated the use of locally-made devices in hospitals across 15 categories including respirators, PET, and CT scanners.

Just like India, China is also focusing on combating high distribution costs of medical devices, which in turn will make their prices more affordable for the general population. However, instead of capping prices, the government has introduced a Two Invoice System. The system limits the number of invoices between a supplier and the hospital to only two – the first invoice would be from the manufacturer/trading company to a government-appointed supplier/distributor (GAS) and the second invoice will be from the supplier to the hospital. This will eliminate most links in the non-transparent and fragmented distribution network in the Chinese medical device sector, which encompassed several distributors, sub-distributors, agents, etc. (the sub-distributors were engaged due to their personal and long-standing relationships with a set of hospitals). This new system is expected to reduce the corruption level by reducing the number of intermediaries and in turn improving efficiency and reducing prices for the patients.

Chinese players dominate several narrow industry segments

China’s medical device industry is dominated primarily by international players, especially with regards to high-end and innovative devices. Having said that, there are a lot of upcoming local players, although, most of them are still limited to the high-volume low-technology segments.

However, local Chinese players have managed to dominate several narrow industry segments, such as drug eluting stents, which is dominated by three domestic companies, namely Biosensors International, Lepu Medical, and MicroPort. Similarly, local players have managed to capture a significant share of the digital x-ray market, which was dominated by foreign players a few years back.

The orthopedic sector is also characterized by the presence of several large and small local players while a few dominating local players (Trauson, Kanghui, and Montage) have also been acquired by leading international players (Stryker, Medtronic, and Zimmer, respectively). Mindray and Microport, two of the largest Chinese medtech players (who have also successfully internationalized), have strong hold on the country’s patient monitoring equipment and orthopedic segment, respectively.

Moreover, while foreign companies enter the Chinese market to cater to the grade-3 hospitals and the high-end segment, the local players focus primarily on the grade-2 hospitals’ value segment (i.e. products that may not have as many functionalities but serve the basic need). The products in the value segment are more localized in terms of both need and pricing. Several international companies, such as Siemens, Philips, and GE, have also modified their product offerings and have come up with a lower-end range of devices to capture this market (as per experts, the value segment has the potential of becoming much larger in comparison with the high-end segment over the coming years).

Leading Chinese medical device companies are investing heavily in their R&D to move up the value chain with more innovative and high-segment products. Therefore, in the coming years, one can expect intense competition in the Chinese medical device sector.

Similarly, leading Chinese medical device companies are investing heavily in their R&D to move up the value chain with more innovative and high-segment products. Therefore, in the coming years, one can expect intense competition in the Chinese medical device sector, which may also lead to some consolidation. With growing government support to local companies as well as their ease to localize, it is expected that the domestic players will provide a stiff competition to international players unless the latter take action soon.

EOS Perspective

While the governments in both countries are taking significant and constructive steps to increase the reach of the medtech industry as well as boost domestic manufacturing, it is too far-fetched to believe that this will uproot the leading global players from the market. However, that being said, in case global companies such as GE, Siemens, and Philips do not continue to customize and localize their offerings as per the changing needs of these markets, they will definitely lose market share to domestic players.

If global companies do not continue to customize and localize their offerings, they will definitely lose market share to domestic players.

Moreover, with the upcoming regulatory changes, support to local production, and overall surge in demand (especially from tier-2 and tier-3 cities in India and grade-2 hospitals in China), the sector is likely to undergo a phase of consolidation in both countries.

16/08/2018by EOS Intelligence EOS Intelligence No Comments

Driving Down Healthcare Costs with AR and VR Technology

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Augmented Reality (AR) delivers digital components atop an existing reality in order to make it more meaningful and interactive, while Virtual Reality (VR) enables immersive simulation of real-life setting or environment. AR and VR have wide-reaching applications in healthcare, from treatment and therapy to training and education. Though AR and VR have promising applications in healthcare, are these technologies prime for widespread adoption? This will largely depend on how effective these technologies are in relation to its cost of investment. Some of the AR and VR solutions standout to bring in significant cost savings.

In 2015, based on analysis of 80,000 surgical cases (retrieved from 2010 National Inpatient Sample, USA), Johns Hopkins University School of Medicine estimated that if all US hospitals increased the number of minimally-invasive procedures by 50%, nearly 3,600 complications could be avoided and hospital stays could be cut by 144,863 patient days, resulting in total cost savings of about US$288 million annually.

Augmented reality can offer higher accuracy

Despite such evident advantages, minimally-invasive surgeries are not as common as traditional approaches, because they require high precision and accuracy – and that is exactly where AR can be useful. For instance, Philips, a Dutch medical technology company, developed a real-time imaging solution which allows projection of high-resolution 3D image of the patient’s spine and a fully-automatic AR navigation system which guides the surgeon to plan the optimal device path, and subsequently place pedicle screws. The first pre-clinical study on the technology showed that the use of AR technology resulted in 85% accuracy as compared to 64% accuracy in case of conventional techniques. Using AR technology, doctors can perform minimally-invasive surgical procedures with high level of precision and efficiency, while minimizing mistakes and errors, thus reducing the preventable costs.

The first pre-clinical study on the technology showed that the use of AR technology resulted in 85% accuracy as compared to 64% accuracy in case of conventional techniques.

Remote mentoring and assistance delivered through augmented reality

Tele-mentoring is another practical application of AR which can bring considerable cost savings. In some complex cases, the locally available healthcare professionals are not skilled and experienced enough to carry out the procedure and experts from different cities or countries need to be called in to perform the treatment, and this involves a lot of time and costs. There are certain AR platforms that allow experts from remote locations to virtually join a surgical procedure. Using Google Glass or tablet, a real-time projection of the remotely located expert’s hands could be overlaid onto the local surgeon’s field of sight during the procedure.

In 2016, as a part of ongoing neurosurgical collaboration between Children’s of Alabama Hospital (USA) and Children’s Hospital in Ho Chi Minh City (Vietnam), Virtual Interactive Presence and Augmented Reality (VIPAR) telecommunication system was implemented at both hospitals to provide intraoperative assistance. The cost of setting up the hardware, software, and internet connection (for one year) was around US$2,500. This is far less in comparison to the cost of the American experts’ travel and stay in Vietnam. For instance, the expense of sending a team of three doctors from the USA to Vietnam for 14 days could total to around US$12,500.

Virtual reality could be an alternative to opioids

VR therapy is proving to be effective in providing relief from pain. Several studies have suggested that parts of the brain linked to pain-somatosensory cortex and the insula are less active when patients are distracted by an immersive experience created by VR technology, thereby reducing the pain. A clinical study by AppliedVR, a US-based company building VR platform for use in healthcare, suggested that VR therapy was effective in reducing pain by 52%.

This can prove to be a breakthrough in the field of pain management, and possibly reduce the opioid prescription. High-income countries such as the USA, Canada, UK, and Australia are struggling with the opioid crisis. Although, the cost of opioids is relatively low, the resulting addiction problems and drug overdose deaths lead to high societal and economic costs. For instance, the economic cost of the opioid crisis in the USA in 2015 was estimated at US$504 billion (85% of these costs were associated with fatalities resulting from overdose). This was equivalent to about 2.8% of GDP of the country that year. For countries such as the USA, where opioid epidemic is declared as a public health emergency, there is a high demand for non-addictive, less harmful alternative pain therapy such one delivered through as VR.

The economic cost of the opioid crisis in the USA in 2015 was estimated at US$504 billion, equivalent to 2.8% of GDP of the country. For such countries, there is a high demand for non-addictive, less harmful alternative pain therapy such as one delivered through VR.

Virtual visualization can reduce the cost of training

VR-based medical training through immersive visualizations is proven to be more effective than conventional teaching methods. In 2015, Miami Children’s Health System claimed that the medical professionals could retain as much as 80% of the information from a VR training session, compared to 20% retention level with traditional teaching methods.

VR can also help to significantly reduce medical training costs. For instance, elderly care facilities in the USA spend on average US$3,000 per employee to teach tracheal insertion through traditional methods; however, Next Galaxy, a US-based company, developed a VR software that will bring down the cost of training per employee to US$40. This VR software uses leap motion force feedback technology which enables the medical professionals to sense when the procedure is going wrong. As a result, this tool can create a realistic scenario, and medical professionals can have nearly hands-on experience of performing the procedure in a safe and controlled training environment, without risking the life of a patient, thus saving costs incurred in potential litigations.

EOS Perspective

AR and VR are among the next-generation technologies with the potential to transform healthcare. There is a consensus amongst analysts that a healthy growth of the global AR and VR in healthcare market can be expected over the coming years. For instance, a research company MarketsandMarkets estimated the market size at US$769.2 million in 2017, with forecast growth at a CAGR of 36.6% to reach US$4,997.9 million by 2023. Similarly, another research firm, Key Market Insights, expects the market to reach to US$5.6 billion by 2022. Several clinical studies indicate that innovative techniques powered by AR and VR are more efficient and effective over conventional methods, thus spurring the interest of private companies and in turn, expanding the market space.

Though AR and VR technologies offer significant opportunities for cost savings, the cost of investment in such new and emerging technologies is also an essential point of consideration.

There is high uptake of VR applications that are compatible with consumer-grade VR headsets such as Google Cardboard, Oculus Rift, HTC Vive, etc. These devices have already reached mainstream use. Moreover, as the technology matures, the competition is increasing, further driving down the price of the devices; for instance, in 2017, Oculus Rift (headset with motion sensor controller) was priced at US$399, half of its launch price in 2016. Increasing use of more affordable consumer-grade VR devices for healthcare applications will further bring down the cost of investment, thereby driving adoption of the VR technology in the sector.

Increasing use of more affordable consumer-grade VR devices for healthcare applications will further bring down the cost of investment, thereby driving adoption of the VR technology in the sector.

While AR headsets and smart glasses such as Microsoft HoloLens and Google Glass are still in trial version, some of the AR applications can be experienced on any smartphone/tablet without the need of headset or controllers, thus making it more accessible and affordable; for instance, EyeDecide, developed by OrcaMD, is an AR-based mobile app that simulates patient’s vision to demonstrate their actual medical condition. Such applications, which are priced as low as US$1.99 to US$4.99, can be widely used to enhance patient experience.

Healthcare organizations could leverage AR and VR technology to improve efficiency and quality of service and enhance patient care while cutting costs. Moreover, as these technologies are reaching mainstream, the cost of investment is expected to go down. Thus, AR and VR technologies are proving to deliver more value while reducing overall costs.

28/03/2018by EOS Intelligence EOS Intelligence No Comments

Big Data Analytics: A Revolution for the Healthcare Sector

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Big data analytics is beginning to transform the healthcare sector by forging new pathways that lead to data transparency, reduction in healthcare costs, and improved patient outcome through better quality of healthcare services. Traditionally, physicians used their clinical judgment to make treatment-related decisions but over the last few years, the trend has shifted towards evidence-based decision-making by leveraging big data analytics, which correlates massive amount of data to provide quick analysis. Big data analytics is slowly changing the way data is managed, analyzed, and leveraged. Although the big data revolution is at an initial stage of its implementation in this sector and most of its potential for innovation and value creation is yet to be realized, it has already directed the healthcare industry on a path of rapid change and improvement.

In an era where healthcare data exists across different sources and formats – such as images, videos, texts, numerical data, etc. – such an enormous amount of data is incredibly complex and difficult to sort, organize, decipher, and manage. This is where big data analytics steps in. It aids in analyzing structured and unstructured data across multiple data sources, which helps to improve accuracy of diagnosing patient conditions and matching treatments with outcomes. Applying analytics in healthcare could reduce treatment costs, forecast outbreaks of epidemics, avoid preventable diseases, and most importantly, improve quality of life through better medical services.

Big data analytics has tremendous potential to cut down the spiraling healthcare costs. Analytics could be used to reduce preventable emergency room visits and hospitalizations, eliminate unnecessary lab tests, reduce inefficiencies, and avert security breaches and frauds, among others. Some key applications of analytics in healthcare include electronic health records (EHR), predictive analysis, real-time alerting system.

The EHR marketplace, part of big data analytics for healthcare market, in the USA is dominated by suppliers such as Epic Systems (a USA-based organization that develops software for healthcare sector) which held a market share of 22% in 2015. The EHR supplier landscape is consolidated at the top end, with three leaders (Epic Systems, Cerner, and Meditech) occupying majority share of 55% in the market in 2015.

Another segment of the big data analytics for healthcare, i.e. business intelligence market dealing with business intelligence tools support several major big data functions within hospital such as predictive analysis, clinical decision support, clinical workflow optimization, population health management, and financial performance modeling, is fragmented, unlike EHR. While Epic Systems occupies a sizeable portion of the business intelligence market (25% market share), over ninety vendors accounted for further 25% combined share of suppliers operating in the market in 2015.

EOS Perspective

For the longest time, healthcare has lagged behind other industries, such as banking and retail, in the use of big data. However, healthcare sector is now ripe for big data initiatives, which have the potential to completely transform the quality of healthcare services by offering a wide array of applications for predictive analytics, evidence-based accurate treatment decision-making, potential cure for complex diseases, improving clinical documentation, among many others.

For big data analytics to fully succeed, the healthcare industry must undergo few fundamental changes, so that the stakeholders can take advantage of big data. Some issues in the industry arise from resistance to change, as healthcare providers are accustomed to making treatment decisions independently, rather than relying on automation and analytics. Healthcare professionals need to shift from standard regression-based methods to more future-oriented techniques such as predictive analytics, machine learning, and graph analytics that can improve and quicken decision-making and treatment-related judgement.

Other obstacles are structural in nature – several healthcare professionals have chosen to underinvest in information technology because of unsure returns. Additionally, some hindrances stem from the nature of the healthcare sector itself. With presence of several players in the industry, it is not easy to share data with different providers or facilities due to privacy concerns, which hinders the use of analytics on data sets.

Currently, implementation of big data technology in healthcare is limited and mostly concentrated in the USA, largely due to the high infrastructure costs and hefty initial investment. Furthermore, the human expertise required to leverage healthcare analytics lags behind. Nonetheless, healthcare professionals are beginning to understand the value of leveraging volumes of patient data and efforts are being made to overcome all barriers.

Healthcare professionals are beginning to understand the value of leveraging volumes of patient data and efforts are being made to overcome all barriers.

Big data has the potential to completely revamp the healthcare sector, in the same way it has transformed several other industries. Besides reducing costs, big data initiatives could save many lives and improve patient outcomes. Pharmaceutical industry experts, payers, and providers are slowly starting to analyze big data to obtain insights. Although such efforts are in the preliminary stages, collectively they could help the industry to tackle issues such as variability in quality of healthcare and growing healthcare spend. Healthcare stakeholders who decide to invest in data capabilities and promote data transparency will not only achieve a competitive edge but will also lead the healthcare industry into a new era.

*Brief description of healthcare organizations – refer to the infographic

USA-based healthcare organizations – MemorialCare Hospital, Parkland Hospital, Beaufort Memorial Hospital, Kaiser Permanente, Emory University Hospital, and UnitedHealthcare
Israel-based organization providing technology/analytical solutions for the healthcare sector –Zebra Medical Vision
USA-based companies providing software, hardware, and technology solutions and services for the healthcare sector – Epic Systems, Cerner, and Meditech
USA-based provider of information technology solution, owned by Xerox – Affiliated Computer Services

27/02/2018by EOS Intelligence EOS Intelligence No Comments

Infographic: Understanding the Cost Dynamics of 3D Printed Drugs

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Medical industry needs no introduction to 3D printing technology, which has found usage in applications varying from custom prosthetics to surgical procedures. And with the US Food and Drug Administration (FDA) approving the sale of Spritam (in 2016 across USA), a drug used in preventing seizures, produced by Aprecia Pharmaceuticals using 3D printing, this commercial use of 3D printing technology embodies a momentous development in the field of printing drugs. The deployment of this technology offers certain benefits, but also comes at a cost, and affects the cost dynamics of producing a drug.

Cost savings offered by 3D printing technology are massive. Making drugs using printers will gradually reduce the processing equipment required, allowing the final product to be printed on one versatile machine, saving thousands of dollars. Going a step ahead, pharma companies will provide the base products for printing of the medicines at clinics and pharmacies, which means that the investment in production and storage facilities at the pharma company’s end will decline as the physical making of the drug will be shifted closer to the end-user. The technology will also help save on packaging and labelling costs along with bringing down logistics expenses.

However, as 3D printing capabilities develop further and as the cost of printing drugs falls, increasing easy accessibility to these drugs, it will become imperative to address safety and regulatory concerns associated with this technology.

While making drugs with 3D printing technology could be a game changer for the medical industry, it also comes with a potential threat of counterfeit and illegal drugs. As drugs production will be shifted from centralized location of pharma companies, which are able to ensure more controlled and supervised production processes, drugs will be printed at numerous clinics and pharmacies, and hence strict regulations need to be adopted and methods of production need to be appropriately controlled. Unified safety procedures and quality control measures need to be developed so that patients can be assured of the quality of the products.

The immense potential offered by this technology is increasingly materializing through commercialization in developed markets. However, as massive financial inputs from pharma companies paired with research grants and support by governments are still required, it is fair to believe that this technology is still far out from the reach of the less developed parts of the world, at least in the foreseeable future.

21/07/2017by EOS Intelligence EOS Intelligence No Comments

GCC to Introduce VAT: What It Means for Businesses, Economy, and People

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The Gulf Cooperation Council (GCC) countries are gearing towards rolling out a 5% Value Added Tax (VAT) starting January 1, 2018. Economies of GCC countries are highly dependent on the oil and gas sector revenues, which account for about 80% of the GCC governments’ budgets. The recent volatility in oil prices have battered GCC nations’ revenues, which motivated the governments to initiate a reform in the form of indirect taxation with a goal to diversify income sources. VAT is a measure that will impart more stability and robustness to the governments’ income considering the outlook for crude oil still remains volatile, while diversified revenue sources will cushion the GCC economies in times of financial crisis.

A standard rate of 5% will be applied on most products, except specified food items, domestic public transportation, and healthcare, education, and financial services. The proposed VAT rate is much lower in comparison with rates in most European countries, China, and Australia. Nonetheless, the GCC countries still stand to gain in income with the tax implementation – for instance, the UAE is forecast to generate US$3.27 billion revenue during the first year of VAT introduction.

Industries such as construction and automotive are likely to benefit from VAT implementation, while retailers might feel a pinch due to dwindling margins. The sentiment among the citizens is wary to say the least – for instance, according to a survey conducted by CFA Society Emirates, citizens of the UAE did not seem quite optimistic towards the economic impact of VAT across certain parameters such as price inflation, cost of doing business, and inflow of foreign direct investments (FDI).

EOS Perspective

Introduction of VAT could empower the GCC economies by bolstering revenue generation, aiding infrastructure development, and improving productivity levels. While some may believe that VAT implementation could tarnish GCC countries’, particularly the UAE’s, competitiveness and tax-free haven status, it is important to consider that GCC markets’ attractiveness goes way beyond only the tax benefits. GCC’s appeal also lies in developed infrastructure, competitive labor costs, lower trade barriers, and proximity to the developing Asian and African markets – implementation of a new tax reform will not change this favorable business environment.

There have been some discussions regarding the negative implications of VAT, considering residents and businesses have grown accustomed to high incomes and low deductibles for a long time. Post VAT implementation, businesses are expected to incur certain additional costs related to administrative expenses, upgrading IT systems, and training staff members, among others.

Also, highly competitive industry sectors, or those operating with thin margins are likely to witness cash flow burden, as they will be required to meet the VAT costs on purchases before they can be reclaimed from the government – in certain scenarios, when the businesses end up paying more as VAT to suppliers as compared to the VAT collected from customers, the difference can be reclaimed from public funds. The way businesses operate is likely to fundamentally transform once VAT is applied, however, with adequate preparation businesses should be able to introduce systems and processes to avoid unnecessary cost implications as well as smoothly align themselves with the new tax system.

The way businesses operate is likely to fundamentally transform once VAT is applied, however, with adequate preparation businesses should be able to introduce systems and processes to avoid unnecessary cost implications as well as smoothly align themselves with the new tax system.

VAT is not expected to have much impact on a common man, as vital household expenditure items will be exempted from it – this includes about 100 varieties of staple food items and essential services such as healthcare and education. However, for a section of the population with an appetite for luxury goods, services, and lifestyles, as well as for tourists (along with VAT, they will have to pay duty tax again on some goods in their country of origin) the brunt of new taxation is likely to be felt.

Nonetheless, a modest tax rate of 5% will ensure that certain social-economic distortions often associated with VAT are minimized. Also, the decision to exempt a few vital sectors (basic food items, and healthcare, financial, and education services) will ascertain that they are not affected by the tax reform.

VAT imposition is expected to become an essential part of GCC regions’ economic reforms and the taxation policy will immensely aid in diversification of revenue sources. Further, the pre-implementation period should be used by the GCC countries to develop a modern tax administration system that ensures compliance, so that once VAT is implemented, businesses and residents are able to smoothly adapt themselves to the new taxation policy.

23/03/2017by EOS Intelligence EOS Intelligence No Comments

MedTech in APAC – Harmonizing Hazards and Rewards for Rapid Expansion

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Being the third largest medtech market in the world, Asia-Pacific (APAC) is becoming an investment hub for medical technology companies globally. Owing to the economic growth of the region and increasing income of the local population, healthcare affordability and quality are on the rise. These are the ground reasons that drive medtech companies to focus on APAC for growth and business expansion. But having access to many local markets in this vast and diverse region seems a hard nut to crack for the medical device businesses. Singapore, with its favorable business environment, which vigorously defends intellectual property rights, currently seems to be the geography being eyed by major medtech companies. Though Singapore is well-positioned as a gateway to region’s medtech sector, entering other markets in the region is still challenging. With differences in the regulatory frameworks bundled with lack of clear reimbursement strategies, medtech companies find it strenuous to meet the requirements of the regional markets. In order to witness growth, it is imperative for medtech companies to focus on the growing opportunities for industry-wide collaboration, intending to create strong platforms for growth in APAC.

In 2015, APAC was the third largest medtech market in the world, after the USA and EU, accounting for over 22% of the global revenue which stood at US$398 billion. The region’s medtech industry is expected to be one of the fastest growing globally and is forecast to surpass EU by 2020 to become the second largest market behind the USA.

The high potential of APAC is fueled by the highly populated south-east Asian countries (China and India, the world’s two most populous countries, have a combined population of 2.8 billion), aging population (by 2050, Asia population will constitute 25% of the world’s elderly aged 60+), strong economic growth, increased spending power of the middle class, and reduced costs by manufacturing medical devices in the region rather than importing. The medtech revenue generated in the region was US$88 billion in 2015, expected to reach US$133 billion by 2020, achieving a compound annual growth rate (CAGR) of 8.6% over the period of five years.

Companies want to seize APAC’s potential for rapid development of medical devices by investing in the right geography that would support their expansion plans. One such location that offers the right environment for medical device players to grow is Singapore. In Asia, Singapore is the innovation center for medtech players due to its business-friendly regulations.

Companies want to seize APAC’s potential for rapid development of medical devices by investing in the right geography that would support their expansion plans.

The country brags of presence of leading medtech companies such as Medtronic, Baxter International, AB Sciex, Becton Dickinson, Biotronik, Hoya Surgical Optics, and Life Technologies that set up their manufacturing plants and R&D units here due to strong patent laws and easy policies to set up and manage a business. For instance, in 2011, Medtronic, one of the world’s largest medical devices manufacturers, opened its first pacemaker and leads manufacturing facility in Singapore, which was the company’s first Asian site manufacturing cardiac devices. As the number of heart patients in APAC rapidly increases, Singapore is a perfect base to offer modern medical facilities to patients across emerging Asian markets.

The medtech sector in Singapore is growing mainly due to government schemes that focus on investing in the sector. With initiatives such as Sector Specific Accelerator (SSA) Program that identifies and invests in high-potential medical technology start-ups (an amount of US$70 million has been committed for the formation and growth of such businesses) and EDBI, the corporate investment arm of the Singapore Economic Development Board that invests in innovative healthcare IT, services, devices, and therapeutics companies, the Singapore government supports the growth of medtech innovation in the country.

The medtech sector in Singapore is growing mainly due to government schemes that focus on investing in the sector.

Apart from setting up committed bodies, the Singapore government in 2015 announced that it would invest US$4 billion in biomedical sciences research for the period between 2015 and 2020 to strengthen the county’s position as Asia’s innovation center.

While Singapore is a favorable location for medtech manufacturing and R&D, it is still a young market that is witnessing problems similar to the ones seen in other APAC countries. Many countries in the region are also capable of contributing to the technological health innovation but face challenges in broadening their reach and lack assertiveness to develop innovative ways to reach a broader range of patients.

Medical device regulations are the key challenge faced by device manufacturers in the Asian region. Med tech industry is regulated by strict guidelines through each phase of product or service development. In several Asian markets, there are no clear guidelines for device manufacturers that classify medical devices as simple or complex, or even mention how to handle them. Irregularities in clearly laid guidelines for introducing and using such products often create problems for companies to come up with advanced solutions in new geographies of the APAC region. Each country has different regulations for quality control, product registration, and pricing, and these are frequently unclear and inconsistent. This is a considerable concern for medtech players planning to set up a shop in the APAC region.

Medical device regulations are the key challenge faced by device manufacturers in the Asian region.

Another hiccup that the manufacturers face is the lack of definitive reimbursement structure. With new innovations in the healthcare domain, expenditure on medical technology is expected to grow but lack of transparent compensation schemes is a major hindrance. Medical device firms, across APAC region, face the challenge of limited clarity on payment structure of technological products and services. For instance, for medical products such as pacemakers and heart valves that are readily available, the reimbursement cost is generally available, but for progressing techniques or products like LVAD (left ventricular assist device), no coverage guidelines have been established. With this lack of clarity on the structure and level of reimbursement on such advanced products, medtech companies find it difficult to place their products in the market at a competitive price.

With unclear regulations and reimbursement policy structure, the medtech companies face a hard time in the APAC region. Competition from local players also add concerns for these players to survive in these markets. Partnerships of local medtech companies with funding firms and other players are on the rise. Domestic companies often partner with private equity firms that invest in and support the local players to innovate and expand. For instance, Huami Corporation, a manufacturer of wearable fitness monitoring devices, attracted investment from American venture capital firm Sequoia Capital and Xiaomi, a Chinese smartphone player, to develop a device that monitors health (tracking the number of steps walked, number of sleep hours, calories consumed, etc.) selling at a sober price of US$15 as compared to the average price of more than US$150 of its competitive brands including Apple and Samsung.

With unclear regulations and reimbursement policy structure, the medtech companies face a hard time in the APAC region. Competition from local players also add concerns for these players to survive in these markets.

Challenges for entering such a diverse market will take time to overcome, but companies are on the lookout for growth platforms and seem to be willing to leave no stone unturned to capture new opportunities. One such opportunity that multinationals can use to their advantage is partnering with regional stakeholders to access the APAC market. These collaborations are not limited to medtech companies or players in the healthcare domain, but are extended to a broader range of players including regional governments, regulatory bodies, educational institutions, insurance companies, and other technology companies.

Med tech companies are partnering with pharmaceutical players to access local market and widen their network. For instance, in India, Roche, a Swiss healthcare company dealing with diagnostic devices, got into a marketing partnership with Indian drug manufacturer Mankind Pharma, to extend the availability and market penetration of its blood glucose monitors, Accu-Check Go, in tier 2 and tier 3 towns making use of Mankind’s extensive local distribution network. Partnerships are critical for multinational players to rapidly and efficiently increase their geographic presence in the APAC region.

Another opportunity that medtech companies can seize to grow is the appointment of local staff in the regional management. Local people have a better market understanding and know how the system works. The decision making capabilities, if lie in the hand of local leaders, can work in favor of the companies as these leaders better understand the way the market functions. Balancing the availability of local talent and brand’s global assets, medtech players can be successful in developing products as per market needs. A mix of local resources and international talent in crucial to oversee operations in unstructured and fragmented markets such as APAC.

EOS Perspective

Correct assessment of the market needs is critical for any business to be successful. For medtech companies, APAC has been a challenging landscape due to fragmented market, as well as unstructured and complex regulatory environments. But with the focus being shifted to the dynamic and fast growing economies of APAC, the medtech market is positive to grow as the region offers scope of development and growth mainly due to aging population and growing income of middle class.

With challenges unique to each geography in APAC, medtech companies are focusing on partnering and collaborating with local medtech players and other stakeholders in the region. With strategic partnerships, global medtech players can reduce the intensity of competition faced from local companies. Collaborating with the right partner in different aspects of product development ensures growth, right product placement, and speedy market expansion. Association with regional entities are expected to increase, witnessing strong growth of the players in the medtech space.

The regulatory landscape in the region is highly fragmented and needs restructuring. Independent organization such as Asia Pacific Medical Technology Association (APACMed), formed in 2014, assigns itself to strike a balance between medtech companies wishing to enter the APAC market and other regional agencies aiming to improve the standard of healthcare offered to patients. Efforts such as these may bring coordination in the regulatory landscape, but it will take long to come to general consensus on similar laws of conducting business in this field.

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Robotics adoption focused on selected specialties

Competition strengthens, challenges the market leader

Cost remains the main challenge for adoption

Players in this market started to realize that in order to strengthen their position and competitiveness, cost-effectiveness of their systems is the key requirement

Hospitals’ limited budgets trigger simpler products development

These substitutes claim to be dexterous, cost-effective robotic solutions sufficient for certain procedures, thus can be perceived as an alternative (and competition) to expensive robots in some cases

EOS Perspective

Gaining investment for such projects is difficult, hence for the time being, it can be expected that the existing players are likely to consider forming partnerships to improve their products and increase their market share

Such availability of patent-free solutions will encourage other players in the industry to enter the market with similar products, probably at lower price points

Anti-Fraud Laws

Anti-Fraud Partnerships

Senior Medicare Patrols (SMPs)

Data Analytic Tools

EOS Perspective

Similar market structures, a whopping difference in size

Government takes initiative to promote Indian domestic manufacturing

Large players may withdraw their latest generation products from India, while Indian players will focus only on cost-effective products instead of innovations.

Indian domestic players might go beyond high-volume low-end products

We can expect a transition in the domestic sector, which will not only focus on high-volume low-end products but also look at entering the high-end innovative segment offering more affordable and locally customized solutions.

Chinese government also focuses on aiding local producers

Chinese players dominate several narrow industry segments

Leading Chinese medical device companies are investing heavily in their R&D to move up the value chain with more innovative and high-segment products. Therefore, in the coming years, one can expect intense competition in the Chinese medical device sector.

EOS Perspective

If global companies do not continue to customize and localize their offerings, they will definitely lose market share to domestic players.

Augmented reality can offer higher accuracy

The first pre-clinical study on the technology showed that the use of AR technology resulted in 85% accuracy as compared to 64% accuracy in case of conventional techniques.

Remote mentoring and assistance delivered through augmented reality

Virtual reality could be an alternative to opioids

The economic cost of the opioid crisis in the USA in 2015 was estimated at US$504 billion, equivalent to 2.8% of GDP of the country. For such countries, there is a high demand for non-addictive, less harmful alternative pain therapy such as one delivered through VR.

Virtual visualization can reduce the cost of training

EOS Perspective

Increasing use of more affordable consumer-grade VR devices for healthcare applications will further bring down the cost of investment, thereby driving adoption of the VR technology in the sector.

EOS Perspective

Healthcare professionals are beginning to understand the value of leveraging volumes of patient data and efforts are being made to overcome all barriers.

EOS Perspective

The way businesses operate is likely to fundamentally transform once VAT is applied, however, with adequate preparation businesses should be able to introduce systems and processes to avoid unnecessary cost implications as well as smoothly align themselves with the new tax system.

Companies want to seize APAC’s potential for rapid development of medical devices by investing in the right geography that would support their expansion plans.

The medtech sector in Singapore is growing mainly due to government schemes that focus on investing in the sector.

Medical device regulations are the key challenge faced by device manufacturers in the Asian region.

With unclear regulations and reimbursement policy structure, the medtech companies face a hard time in the APAC region. Competition from local players also add concerns for these players to survive in these markets.

EOS Perspective