CDSCO Archives - InnoHEALTH magazine http://3.6.81.159/tag/cdsco/ India's first magazine on healthcare innovations Wed, 09 May 2018 05:23:22 +0000 en-US hourly 1 https://wordpress.org/?v=6.9.4 https://innohealthmagazine.com/wp-content/uploads/2017/11/innohealthmagazine-favicon.png CDSCO Archives - InnoHEALTH magazine http://3.6.81.159/tag/cdsco/ 32 32 139068796 Software as Medical Device https://innohealthmagazine.com/2018/issues/software-as-medical-device/ https://innohealthmagazine.com/2018/issues/software-as-medical-device/#comments Wed, 09 May 2018 05:23:22 +0000 https://ztt.nrm.mybluehostin.me/innohealthmagazine?p=4007 The tectonic shifts in technology are transforming human life in ways unfathomable just a few years ago. Health-tech and med-tech are touching our lives continuously through a number of ways – from simple wearable devices to complex invasive devices

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The tectonic shifts in technology are transforming human life in ways unfathomable just a few years ago. Health-tech and med-tech are touching our lives continuously through a number of ways – from simple wearable devices to complex invasive devices; simple AI software which can predict and sense to complex AI software which can diagnose; sensors and other hardware devices including the mobile phone with ever-increasing computing power.

Some of these have made human lives so dependable on these devices, gadgets, software. In some cases, these are dumping human intelligence. We witnessed software wherein by looking at a camera on the mobile phone. The software can predict the heart rate and many other vitals. What if human intelligence gave way in believing the reading as true? The software or the camera is not a medical device. Hence outside the purview of regulations usually applicable to medical devices. Can we ignore the risks? If so, should software be treated as a medical device?

Software as Medical Device (SaMD)

A broadly accepted definition of a SaMD is the one issued by the International Medical Devices Regulation Forum (“IMDRF”); Currently, Australia, Brazil, Canada, China, Europe, Japan, Russia, Singapore and the USA are member countries to this Forum. The FDA has adopted this definition in the US. The Medical Device Directive adopted by the EU in 2010, and in major countries such as Australia, Canada and Japan.

The term “Software as a Medical Device” is defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device. It includes an in vitro diagnostic medical device. SaMD must be capable of running on a computer platform that is not of a medical purpose. And should not need a hardware medical device to achieve its purpose. It can be interfaced or used in a combination with other devices. But cannot be used to drive a hardware device.

The definition, Mobile Application Meeting, also consider as SaMDs. The medical purpose‟ that it must intend to serve can be diagnostic, preventive, investigative, life-sustaining, for treatment of disease or injury, disinfection, control of conception or purely informative. In some jurisdictions, aids for persons with disabilities, devices for assisted reproduction and devices incorporating animal and/or human tissues are also recognized.

A SaMD can also be a means to suggest mitigation of a disease or provide aid to diagnosis. There are further guidelines on the definition of changes to SaMDs- they can be adaptive, corrective or preventive in nature. The manufacturer of SaMD would be a natural or legal person who has the intention for the software to be used under his/its name. It would not include a distributor or the manufacturer of an accessory. The final legal responsibility lies with the manufacturer unless it specifically imposes on another party by the country’s regulatory authority.

Putting them to use

SaMDs are now available in abundance in the Indian market. Both foreign manufacturers, as well as Indian manufacturers, are introducing so many forms of SaMDs. This includes the use of artificial intelligence, IoT, general software etc. Interesting, many SaMDs are enjoying high adoption rates not only for early users but continued users. The glaring point is that there is no legislative framework or guidance policy which works as a guiding principle for the SaMD manufacturers or at least as a self-regulating piece of legislation, in India.

The Medical Devices Rules, 2017 which has come into effect from January 1, 2018. Now defined medical devices and has made a clear distinction between drugs and medical devices. But still, this definition does not include SaMDs or software as a medical device. Interestingly, the draft Medical Devices Rules, 2016 on basis of which the Medical Devices Rules, 2017 have been formalized included software in the definition of medical device. AI, IoT, general software, wearable, and wellness and customized medical devices are flooding with the market. Software as a medical device as a whole should consider with equal importance in the sector. Curiously, the definition of medical devices under Foreign Direct Investment policy includes software.

Regulations

The IMDRF has worked extensively in setting guiding principles for governing SaMD and has put in place a regulatory structure for how the SaMDs shall be governed, regulated, clinically evaluated and how the data shall be evaluated and then used by the SaMD. While India has not yet included any software or apps in its regulatory purview. Countries like U.S.A, Singapore, Australia, EU and Japan has issued guidance documents to make the app developers aware of what might subject to regulation.

The common theme that determines the classification is the level of risk that these apps pose to the consumers. For example, let’s take an app which allows a user to take ECG test by putting their fingers on an external device which is connected wirelessly to the smartphone. It checks the electrical activity of the heart. Such apps may be considered as risky and be subject to regulation since the belief is that any incorrect analysis may hamper a user’s treatment. However, the Government authorities need to strike a balance while assessing these risks so that not all apps need to be certified under the law so that innovation is not hampered.

It is indeed a very fine balance. General wellness apps or products such as apps tracking and assisting in maintaining healthy body weight. Products are generally kept out of the purview of law versus apps which tracks and assists in say monitoring blood sugar or other vitals or treats specific health issues or provides guidance for treatment of specific illnesses. The whole purpose to bring these apps under regulation is that there is a certain amount of rigour before the apps are released to the market. And there is onus and responsibility on these makers. It should enable the app developers to be mindful of how is the product advertises, claims as well.

To protect consumers, certain jurisdictions, like Singapore, have mandated the manufacturers/ app developers to put a clarification statement on their product or on their apps. This statement should clearly state that this app or product is not intended to be used in a diagnosis, monitoring, management or treatment of any disease. Keeping all the innovation in health-tech space, India should provide guidance on SaMDs. The regulatory framework in India for medical devices is by the Central Drugs Standards Organization widely known as CDSCO.

The new Medical Devices Rules, 2017 are comprehensive and now extensively covers almost 351 medical devices and about 247 in-vitro medical devices. It still does not cover SaMDs. Given the increased use of mobile technology and awareness, guidelines on SaMDs could contribute to improving the affordability and availability of healthcare, including rural India, which has a huge user base. Gradual rigour in legislation will allow India to meet increased need, according to when resources for monitoring and enforcement become more available. India already follows the IMDRF regulations with respect to clinical trials. And the clinical evaluation of medical devices, with respect to documents, licensing and safety standards.

It is important for the legislation to allow the industry to grow and achieve its potential. Especially in a country like India where there is a need for the better point of care medical solutions. But at the same time provide unambiguous guidance. A good starting point would be a self-regulating mechanism with a set of standards, methods and procedures, clinical evaluation process. Such guidance would help improve innovation as well and guide the nascent Indian SaMD industry.

(Author is a qualified lawyer who has a keen interest in how tectonic shifts in technology is impacting healthcare delivery. The intersection of law, innovation, interaction with man and machine excites him. Manas works with NovoJuris Legal deeply in AI, IOT, health-tech, med-tech, devices and more in the healthcare segment)

A new paradigm for use of machine intelligence in healthcare

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]]> https://innohealthmagazine.com/2018/issues/software-as-medical-device/feed/ 1 4007 SAFETY STANDARDS: MAKING INDIA'S HEALTHCARE SECTOR SAFER AND FUTURE READY! https://innohealthmagazine.com/2017/blog/safety-standards-for-healthcare-sector/ https://innohealthmagazine.com/2017/blog/safety-standards-for-healthcare-sector/#respond Mon, 15 May 2017 10:31:47 +0000 http://innovatiocuris.com/?p=1323 Medical devices are crucially linked

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Safety Standards: Making India’s Healthcare Sector Safer and Future Ready!

Jibu Mathew is Business Head of UL’s Life and Health Business Unit for South Asia and emerging markets. He has varied experience in IT consulting, regulatory advisory and market access strategy in Medical Electronics, Healthcare and High-tech industry for more than a decade. He is also an Industry representative in Bureau of Indian Standards [BIS] Committee on Medical and Hospital Standards.

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Safety is omnipresent and intrinsic to the entire healthcare delivery spectrum and the entire medical fraternity must move towards industry equilibrium. Medical devices are crucially linked to the growing demands of the healthcare chain which need a strong regulatory framework. This also means sourcing the right kind of equipment and devices from the right vendors and checking them for regulatory approval stamps from established certifying bodies.

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Introduction: India’s Beleaguered Healthcare Infrastructure

Historically, healthcare set-ups were always admired for their commitment and expertise to provide their patient with a new lease of life! From a simple fever to complex surgeries and medical miracles, people from different parts of the world have traveled to India to benefit from the quality services and a comparative cost advantage. India may be a global tourism hub, with a growth rate expected to touch an astounding $8 billion by 2020[1]. However, access to safe and quality healthcare eludes a vast majority of the population[2]. Adding further woe is the dismal expenditure for the sector.

Consider this:

• India has one bed for every 1,050 patients as compared to the US, which has one bed for every 350 patients.

• India’s ratio of 0.7 doctors and 1.5 nurses per 1,000 people is much lower than the WHO average of 2.5 doctors and nurses per 1,000 people.

• To combat this poor doctor-patient ratio, India needs to add 1.54 million doctors and 2.4 million nurses to match the global average[3].

Changing Disease Burden In India

Over the past few years, there has been a palpable transition from infectious to non-communicable diseases (NCD) in the country, owing to change in dietary patterns, economic growth and greater life expectancy. While NCDs remove the threat of immediate mortality, they call for an urgent need to ramp up healthcare technology and innovation to prevent adverse outcomes. For instance, WHO’s health profile for India (2014) points out that 53 percent of deaths in the country are on account of non-communicable diseases (NCD), with diabetes and cardiovascular diseases taking the lead[4]. One in four Indians risks dying from an NCD before they reach the age of 70, the report states. Further, diabetes is engulfing the nation at an alarming rate – 65.1 million people are suffering from the disease in the country, compared to 50.8 million in 2010. By 2030, 100 million people are expected to be diabetic[5].

India – The Healthcare Technology Paradox

To combat the paucity of traditional health infrastructure, e-health, m-health and home healthcare services brought about pioneering changes in healthcare delivery for the rural and inaccessible area[6]. With increasing corporatization and FDI inflows in private healthcare, state of the art treatment is becoming increasingly available to metros, tier 1 and tier 2 cities[7].

This brings to the front an important aspect of healthcare delivery – the use of medical devices, ranging from humble objects like gloves and syringes to complex tools like implants, ventilators and scanning technologies. The medical device sector reveals a deep-seated, but interesting paradox in India’s healthcare system – while the country boasts of being the manufacturing capital of the world for pharmaceuticals, 75% of the medical devices are imported from countries like China, with nearly 30% coming from the United States alone[8]. Most of these devices rampantly used are either substandard, un-calibrated and continue to compromise patient safety!

These revelations imply that it takes just one faulty/substandard medical device to play havoc in our lives. When we approach our healthcare provider, we blatantly overlook what goes on behind the scene – have we ever noticed what kind of medical equipment or invasive devices are being used to cure our ailment? Is it safe and hygienic and absolutely necessary for use? Does it have a regulatory stamp of approval? Is it calibrated correctly? The steep costs of importing these devices are ultimately passed on to the consumer, making access to safe and quality healthcare unaffordable.

Medical Devices Market – Current Scenario

Despite its significant growth, the medical devices industry in India is still at a very nascent stage. In terms of market size, the total medical device consumption in the country at present is to the tune of $ 5.8 billion. When corresponded with the 1.2 billion plus population, the penetration of medical devices into healthcare sector is very minimal, especially in comparison to similar economies, such as China, Korea or Japan.

However, the medical devices sector in India is specifically focused on two aspects – penetration and affordability. Keeping this in view, there is a lot of innovation, in pockets, that is contributing to the growth of this sector. This is specifically in non-communicable diseases space, where screening devices for point of care testing are being created for e.g: cardiovascular diseases, diabetes etc. The medical device industry in India is currently dominated by MNCs that manufacture and import products. There are also small and medium businesses, mainly dealing with disposables and implants and medical electronics. The third segment is that of the startup community.

Challenges In The Med Tech Industry: Inadequate And Antiquated Regulations

Despite the promising emergence of multiple startups in the med tech industry that are targeting the domestic segment, India’s regulations for medical devices are largely inadequate and antiquated. What’s more, the entire sector is loosely governed with lack of strong regulations controlling the production, import or distribution of medical equipments and devices, encouraging the inflow of substandard devices entering the Indian market and harming the consumers. While the government’s support through ‘Make in India’ campaign to help India reach the $ 50 billion devices market by 2025 has laid the platform for the growth of the med-tech sector in India, it also puts a thrust on ensuring that they follow global best practices in manufacturing them. From performance testing and usability to non-clinical testing, the devices need to pass standards tests for evaluation before medical professionals can actually use them, which call for the role of third-party testing labs to test devices and products for a minimum quality level.

Currently, the medical devices industry is faced with an ambiguous regulatory framework, wherein medical devices are treated as drugs under the Drugs and Cosmetics Act. As a result, the distinctive identity for medical devices has been absent for long. Earlier this year, a newborn and a three-month-old were severely burned after a short circuit sparked a blaze in a hospital nursery in Meerut[9]. Over the last few years, the country has been marred by such incidents, raising serious concerns about overall safety in hospitals and the safety and quality standards of medical equipments in particular in India. Sample this… Of the 700 device makers in India and more than 2000 devices sold locally, ranging from a pair of humble reading glasses and gloves to critical MRI machines and implants, only a dismal 22 of them are presently under any direct regulatory supervision by the Drug Controller General of India’s office. India has become a dumping ground for many used and refurbished medical devices which are not calibrated to work in Indian conditions[10].

Safety Compliance, Standardisation & Third Party Certification Is The Key!

India is slowly witnessing gradual change over the last 12-18 months, with a regulatory framework currently developed by the Ministry of Health & Family Welfare and CDSCO (Central Drugs Standard Control Organization). While this landmark move is definitely a welcome step to overhaul the regulatory system in the country, experts still feel that there are significant concerns to be addressed in the draft Medical Devices Rules 2016[11].

Experts believe that following the highest safety standards is the only way to achieve accurate and consistent medical care outcomes. Standards fuel innovation rather than acting as a barrier (as commonly thought), by ensuring a framework / boundaries under which devices can operate. “Can you imagine the impact if there were no standards on the performance requirement of a pacemaker”? Even though India is at the cusp of a quality revolution of sorts, we still have some catching up to do in terms of the conformity assessment framework. In a growingly complex, competitive economic landscape, the need to align people, processes and technology is stronger than ever. In order to compete globally, India needs to develop a culture of product safety and standards.

Safety is omnipresent and intrinsic to the entire healthcare delivery spectrum and the entire medical fraternity must move towards industry equilibrium. Medical devices are crucially linked to the growing demands of the healthcare chain which need a strong regulatory framework. This also means sourcing the right kind of equipment and devices from the right vendors and checking them for regulatory approval stamps from established certifying bodies. From safety, performance testing and usability to non- clinical testing, any medical device requires to be compliant to standards tests for evaluation before medical professionals can actually use them, which call for the role of third party conformity assessment bodies, testing labs to test devices and products to ensure safety and quality is maintained. What India needs is a set of gold standards in the medical devices industry while strengthening the basic device testing infrastructure.

Conclusion – Standards Not A Market Barrier, But A Quality Enhancer

For the country to be in the highest pinnacle of world standards, quality cannot be compromised. Whether it is creating a safe environment for us to live, or dream big with Smart Cities and Make in India Campaigns, our country is marching towards ambitious plans of becoming a hub for global arbitration, reviving the manufacturing sector and strengthening services sector, to name a few. For any of these to become a success, the key is the need to adopt national and international standards while creating a framework for regulations and compliance. However, India has historically struggled to develop a holistic system of standards and regulatory framework. With plenty of legislations in place to drive quality, the challenge has always been enforcement and until such time non-compliant devices continues to creep into the Healthcare delivery system, keeping end users guessing when the next patient safety disaster will happen.

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