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Indian Medical Device Rules: a Step towards Better Future
by EOS Intelligence EOS Intelligence No Comments

Indian Medical Device Rules: a Step towards a Better Future

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Healthcare sector in India is witnessing a churn as a result of the government’s attempt to make healthcare more affordable and to promote domestic healthcare industry. Recent medical devices-related notification is also part of the government’s vision for a better managed healthcare market, though it has ignited a debate about the future of medical device industry. There is hope as well as an apprehension among the stakeholders, as they wait for the notification to become fully effective in next three years.

The Notification

In the second week of February 2020, India’s Ministry of Health & Family Welfare announced that all medical devices sold in the country would be treated as drugs from April 1, 2020 onward and would be regulated under the Drugs and Cosmetics Act of 1940. To understand the context of this announcement, we will have to turn the clock back by about three years.

In 2017, Indian government announced Medical Device Rules-2017 (MDR-17) – a set of rules, which included:

  • Classification of medical devices into four classes (A, B, C, and D), based on the associated risks, i.e. low, low moderate, moderate high, and high risk devices
  • Procedures, including the required documents, for registration and regulatory approval of devices
  • Details regarding manufacturing, quality audit, import/export, and labelling-related requirements

There was no risk-based classification of medical devices prior to 2017 and it was also difficult to introduce new products, as the approval procedures were undefined. In case of imports, only the products approved by Conformité Européene (CE) and the US Food and Drug Administration were allowed. MDR-17 were expected to unlock the potential of Indian medical device market by introducing a well-defined regulatory regime, while assuring quality products to consumers.

Under the rules, a medical device had to be notified as ‘drug’ under the Drugs and Cosmetics Act to be regulated by Central Drugs Standard Control Organization (CDSCO):

  • Initially, 15 categories of medical devices (syringes, stents, catheters, orthopedic implants, valves, etc.) were notified as drugs
  • In 2019, the government notified (effective April 2020) another eight categories – MRI equipment, PET, bone marrow separators, dialysis machines, CT scan and defibrillators, etc., thereby placing a total of 23 categories of medical devices under drugs

The February 2020 notification, called Medical Devices (Amendment) Rules, 2020, has made the entire range of medical devices available in India (about 5,000 different types) under the ambit of drugs, as opposed to 23 categories before the announcement. The compliance requirements are to be enforced in a phased manner, with 30 months given to low and low moderate risk devices and 42 months for moderate high risk and high risk devices.

Indian Medical Device Rules - A Step Towards Better Future by EOS Intelligence

The Concerns

The February notification has drawn reactions, most of them positive, regarding the future from those associated with the industry. There are some concerns as well, such as:

  • What if the device rules accord unrestrained power to drug inspectors due to medical devices being regulated under the Drugs and Cosmetics Act?
  • Would the cost of quality compliance be substantial for device manufacturers?
  • Would the government resort to price control of medical devices, as it does in case of drugs?

Though the concerns are valid, they are unlikely to cause immediate disruption, as there would be at least 30 months (time given for enforcement of compliance for class A and B devices) after the notification date for the rules to start impacting the industry. An increased cost of compliance is a possibility, however, it would be found across the industry and should not impact only specific companies or a specific product segment.

At present, for price control purpose, four medical devices – cardiac stents, drug-eluting stents, condoms, and intrauterine devices – are in the national list of essential medicines that can be further expanded. However, the expansion cannot be directly linked with the medical device rules, which were primarily framed to ensure a better operating environment for industry players. For instance, from the initial list of 15 categories (i.e. about 350 devices) under MDR-17, only cardiac stents and knee implants were brought under price control (condoms and intrauterine devices were already under the price control regime when MDR-17 were introduced).

Impact on stakeholders

Indian medical device industry is expected to evolve under medical device rules (including the February 2020 notification). Even if the impact of the rules is speculative at present, it is interesting to take a look at their potential effect on key stakeholders in the coming years. While the patients appear to be the greatest beneficiaries due to improvement in quality of treatment, wholesalers and retailers of medical devices may have to prepare for a more demanding operating environment.

Indian Medical Device Rules - A Step Towards Better Future by EOS Intelligence

Read more on the implications for all stakeholders in the medical device industry in India in our article: Indian Medical Device Rules: Prospects among Ordeals for Manufacturers

EOS Perspective

Decision to notify all medical devices as drugs for regulatory purpose was a result of a long consultative process, which involved various stakeholders and experts, including Drugs Technical Advisory Board (DTAB). The industry was expecting such an announcement, as the government had previously shown its intent to do so. Hence, the February 2020 notification was only part of the process that was initiated in 2017 with the introduction of medical device rules. The notification is a show of intent by the government of India towards building a better regulated industry offering more quality products, thereby raising the standards of healthcare in the country. The phased implementation of rules is likely to provide enough time for the industry to adapt according to new regulatory requirement.

Any comment on the future of Indian medical device industry on account of probable price control measures would be purely speculative, as it is difficult to predict the outcome of such steps at present. The case in point is of stents, which were brought under price control regime in 2017. There were fears that the move might kill the sector; however, the stent-related procedures have not witnessed decline despite the multinational companies taking their high end products off the shelf, indicating that the domestic manufacturers have been able to cater to demand.

While the end-users can view the medical device rules as a means to provide better care to them, the device manufacturers can also look for positives, especially when the rules are seen along with the government’s other efforts, such as Make in India initiative, to boost domestic manufacturing. Device classification and the associated regulatory requirements have removed ambiguity for the manufacturers of medical devices in India. This clarity might also fast track investments in the sector, as the potential investors now know what to expect while operating in India. Under Make In India, up to 100% foreign direct investment is permitted in medical devices through automatic route.

by EOS Intelligence EOS Intelligence No Comments

EU New Medical Device Regulations: Cause of Ache for Medical Device Players

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Circling around patient care and improving overall healthcare services, the European Parliament has set new requirements for medical device and in vitro diagnostic manufacturers that distribute products in the EU. However, medical device manufacturers have realized that they are bound to face many challenges in order to make their products market-ready, not to forget the gigantic task of implementing new protocols in a timely manner, which will not be easy.

Need for a comprehensive updated medical device regulatory system

EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) were made official in May 2017, with transition period of three years (fully applicable from May 26, 2020) for the former and five years (fully applicable from May 26, 2022) for the latter. These regulations will replace EU’s previous directives: Medical Device Directive (MDD), Active Implantable Medical Devices Directive (AIMDD), and In Vitro Diagnostic Directive (IVDD).

The need for new regulations of medical devices in EU arose from the growing demand for technologically advanced medical products which necessitated more stringent monitoring of these devices to ensure a high level of efficacy and safety among patients.

Unlike earlier version of the regulations where the main focus revolved around the pre-approval stage of medical device manufacturing, the new regulatory guidelines promote an overall product-life cycle approach, focusing on both device safety and performance.

Enhanced supervision, easy documentation of devices, more stringent clinical evidence requirement, and increased supervision on part of authorities providing medical device certifications are some of the key changes in MDR as compared to the EU’s previous directives.

Bumpy road ahead for medical device manufacturers

Reclassifying existing product line-up

Based on the risk factor, changes have been made to the way medical devices are classified. Under MDR, the number of classification rules has expanded from 18 to 22 intensifying the task of product re-classifications by the manufacturer.

For instance, products using software for monitoring purposes being implanted in the body has been reclassified to higher-risk class (from Class I to Class III) which would now require conformity assessment by a notified body (NB – an organization that assess the conformity of medical devices before they are placed on the market), unlike earlier, when Class I products did not require assessment via a NB. This is going to burden players with increased operational costs; thus, it is imperative that the manufacturers familiarize themselves with the classification changes and study the impact on their product portfolio.

New products are also being added to the list of medical devices that earlier were not part of the medical device regulatory framework. For instance, products manufactured utilizing human tissues or cells and devices incorporating nanomaterial, under new regulations, will be considered medical devices. Manufacturers of such products have work cut out for them – from conducting clinical investigations, preparing technical documentation and evaluation processes, to product certification. Though such products could only form a very small percentage of the company’s product range, the task to make them available in the market is great, especially under current circumstances.

Manufacturers who do not comply with the new regulations will no longer be able to market their products in Europe. Thus, a robust strategy in terms of resource allocation, time management, and budget is an absolute must for manufacturers to make this transition possible.

EU MDR Cause of Ache for Medical Device Players - EOS Intelligence

Distress over notified bodies

Strict parameters are also being applied on NBs. Since all devices will require new certification from a NB, only designated NBs will be able to certify a device. The designation process is a complex procedure as it involves audits and corrective actions (once a NB expresses interest). However, while the medical device manufacturers have been in the process of switching to newer protocols since mid-2017, the first designated NB (BSI United Kingdom, the national standards body of the UK) was announced in January, 2019, almost 18 months after the regulations were announced and 14 months into the formally started designation process.

Such time-consuming process raises concern among medical device companies about the ability to complete the necessary conformity assessments within the allotted time. The huge task of recertifying medical devices with only a handful of designated NBs is a cause of worry for companies, as it could potentially result in significant backlogs as the last date approaches. However, there is only so much companies can do – even though they are proactive to comply with the new regulations much ahead of the deadline, poor process planning and lack of supporting bodies (notified bodies in this case) results in a long halt for these players.

The companies are heavily dependent on NBs for auditing and product certification, and the insufficient number of designated bodies adds to the risk of many devices being non-compliant according to new regulations. As of May 2019, less than 40 NBs have filed application for designation procedure (out of 58 designated NBs under the directives); only two have actually received a designated status – BSI UK and Germany based TÜV SÜD Product Service GmbH Zertifizierstellen (certification received in May 2019). With very little time at hand to reassess and rectify issues (if any), this could jeopardize the product availability in the market, resulting in not only risking the patients’ life (due to non-availability) but also in huge financial losses for the players.

Detailed clinical evaluation of medical devices

Owing to reclassification of product categories, many devices will require changes to their existing clinical evaluation reports, another challenge for medical device manufacturers. Manufacturers that have not previously been required to perform clinical testing will have to do so now. For instance, mechanical heart valve sizers will be moved up from Class I to Class III, and unlike in MDD where clinical evaluation was based on literature analysis, new evaluation of valve sizers will require clinical investigation. This will require a huge deal of additional time, money, and expertise, further burdening the device manufacturers.

Medical devices already in the market that remain untouched by the reclassification criteria will still require reassessment of clinical data. If the data do not meet the new requirements, devices will need to undergo additional testing to be recertified, increasing the expense for manufacturers.

MDR also calls for inclusion of risk management within the clinical evaluation expecting clinical risks to be addressed in clinical investigations and evaluation studies – adding another task to the long list of activities to be accomplished before MDR fully rolls out.

Explore our other Perspectives on medical devices markets

Comprehensive demonstration of equivalence data

Unlike MDD, where device manufacturers were able to use clinical data of an equivalent device for their own product registration, under MDR, equivalence is going to be less accepted, particularly for higher risk devices.

There are two ways out – manufacturers can either conduct their own trials not having to deal with the equivalence commotion or they can demonstrate that they have access to the equivalent device (with respect to technical and clinical properties) data. The latter is highly unlikely to happen considering equivalent device would typically belong to a competitor unwilling to grant such access. Thus, with stern requirements for comparative evaluations, more effort, planning, money, and resources will be needed for device manufacturers to demonstrate product safety and performance.

As new medical devices are developed, multiple small incremental improvements (minor changes in design, addition or subtraction of small hardware parts such as bolts or screws) happen over time. Once the device is already in the market, it is practically impossible to conduct a re-trial to gain approval for such small changes. An expected solution to this would be a provision to accept such minor changes through pre-clinical evidence or prior trial results. However, with equivalence testing being reduced drastically under MDR, unless a solution for such cases is offered, manufacturers will have to conduct re-trial and re-document everything, which would result in significantly increased cost. Another issue that could arise from such situations is the reduction in R&D activities inclined towards product improvement.

Trouble galore for SME’s

While making amendments and prioritizing to comply with new regulations seems to be the top most priority for medical and diagnostic device manufacturers, it seems SMEs will be dramatically more impacted than large players – in Europe, a small-sized company employs less than 50 people and has a turnover of less than or equal to €10 million while a medium-sized company employs less than 250 people and has a turnover of less than or equal to €50 million. Owing to the increase in cost, time, and resources associated with the process, the new regulations may put smaller companies under pressure, possibly resulting in altering (such as merging with or being acquired by larger companies) the European medical device market structure, currently dominated by SMEs – there are nearly 27,000 medical technology companies in EU, 95% of which are SMEs.

SMEs also need to be more vigilant when it comes to being associated with a designated NB as not all currently functioning NBs are expected to get a designated status. With their already dwindling numbers married with an increased demand for their services, once the new regulations roll out, it is quite possible that small manufacturers are orphaned since NBs could be partial towards larger players and prioritize them over other small and medium players.

Smaller players will not only have to hire additional personnel for dealing with regulatory issues but also employ clinical trials specialists (for documenting insights to be presented and approved by the NB) for launching products in the market which means higher costs. Adjusting budgets to keep costs under control would hamper other critical business operations, e.g. reduce R&D activities or cut the number of products being launched in the market.

As a step to overcome these issues, players with limited financial resources should strategically study their product portfolio to determine which products are worth investing in for MDR compliance. For doing this, they should lay out a detailed plan for each product and decide whether to remediate, transition, or divest.

It is also advised that SMEs should devise a clear step-by-step approach plan to ensure compliance. As an alternative to hiring transition specialists, they could engage employees from various functions within the organization to take responsibility for specific processes thus keeping costs in check.

EOS Perspective

The changes and revisions required to be carried out under MDR are company-wide and require significant investment to plan and execute. This will lead to players devising a business strategy based on assessing risk associated with product portfolio (whether some products need to be pulled out from the market and what effect it would have on future revenue) or looking for acquisition partners. Based on these decisions, the medical device market topography in EU is expected to see some major changes in the coming years – small companies looking for partners to get acquired or for new partnership with a service provider (specializing in regulations compliance). This will also result in organizational restructuring, revamping design processes, and systems implementation.

Companies have to make crucial decisions around the product portfolio. For some of the already existing products, if reclassified, the cost of compliance could be much higher than actual market returns. In such cases, manufacturers may be compelled to pull away such products from the market resulting in high healthcare costs and ultimately burdening the patients, who (theoretically) form the center point of the MDR. Though this is unlikely to happen at a large scale, since there are always alternative products available, it cannot be denied that this may be a major loophole in MDR requiring immediate attention.

Since SMEs drive the EU medical device market, as an immediate consequence, MDR is not likely to have any positive effect on these players other than distorting their business operations. However, it can only be anticipated that, with time, MDR may adapt and amend to offer some relaxation in provisions especially for small and medium-sized players. Nonetheless, MDR also brings an opportunity for such players to audit their current offerings and come out with an enhanced product portfolio, which could be an opportunity to be capitalized on in the distant future.

Modifications being made in the functioning of NBs are also likely to have an impact on the device manufacturers. For high risk devices, manufacturers may expect deeper scrutiny of design records and data files leading to providing more credentials, in case any query arises. This, along with long wait time for product review (due to reduction in the number of designated NBs) and limited availability of resources (again on account of NBs), could lead to unknown delays for obtaining product re-certification. Thus, companies need to chalk out their market strategies very effectively and be prepared to address any concern that rises during product reviews.

The aim of implementing new regulations is to bring a transparent and robust regulatory framework for medical devices. However, there is no assurance that the new regulations are completely accurate and will apply seamlessly to live case scenarios. Therefore, once implemented, there is a possibility that MDR may see revisions in the initial months of coming into action.

These changes, though certainly positive from a healthcare point of view, are enormous. Transitioning to meet the new standards within the stipulated time frame is challenging for manufacturers. Not adapting to the changes is not a choice for manufacturers as non-compliance could result in losing license to operate in the EU market. And for players fearing stringent scrutiny in the future, operating in the European healthcare market will not be easy once the new regulations come into force.

Google initiatives
by EOS Intelligence EOS Intelligence No Comments

Infographic: Google’s Tech Initiatives Transforming Industries

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Google, beyond being the leading search engine worldwide, is also one of the largest and most innovative companies. Through its innovations, Google along with other Alphabet companies (parent company of Google and its subsidiaries) is transforming various industries by empowering them with technology. Its solutions have reached diverse industries such as agriculture, manufacturing, healthcare, energy, and fishing, among others.

Innovation has always been at the core of Google’s strategy and it is bringing artificial intelligence (AI), machine learning, augmented reality, robotics, among others to shape various industries. It has introduced surgical robots to medicine, Google glass to manufacturing, AI-enabled programs to energy, among various other solutions that are revolutionizing these industries. We are taking a look at where Google has already left its innovative footprint.

Google’s Tech Initiatives Transforming Industries - EOS Intelligence

Alphabet companies included in the infographic:
Verily – Alphabet’s key research organization dedicated to the study of life sciences
Verb Surgical – A joint venture between Johnson & Johnson and Verily
DeepMind – Alphabet’s artificial intelligence company
Global Fishing Watch – An organization founded by Google in partnership with Oceana and SkyTruth
Surgical Robots – Marrying Cost-efficiency and Innovation
by 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.

Surgical Robots – Marrying Cost-efficiency and Innovation - EOS Intelligence

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.

Healthcare fraud
by 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.

A Ripple Effect of US Healthcare Fraud on Consumers and Healthcare System

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.

Medical Devices
by 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.

Medical Devices – India and China Make Space for Domestic 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.

by 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.

by 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

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