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Futuristic Safe Injection System: A Big Leap Towards Affordable Healthcare

Bharati Rathore, a former Defense Research Development Organization Researcher and Cognitive Neuro-Scientist, whom I met on LinkedIn, shared the story of inventing ‘Futuristic Safe Injection System-2020’. Bharati and her family are working diligently to help millions facing serious menace of the burden of unsafe injections in the world and invented ‘Futuristic Safe Injection System-2020’. It is a method and device for sustainable drug delivery system. The mission is to eradicate the threat of the adverse effect of reused syringes on humankind. Here are some excerpts.
About the invention:
This disruptive invention provides the most effective, cheapest, safer, greener and ergonomic drug delivery method and device compatible to WHO’s guidelines. It consists of two variants of reusable injector and 18 variants of safely disposable drug-cartridge. It contains piston and retractable needle along with a fixed dose of medicament, wherein needle retracts automatically within the empty cartridge after the injection process. Neither of the two parts per se are syringe but constitute an efficient, simple and user-friendly auto-retractable safety syringe, when both the parts are coupled together. The disposable drug cartridge, thus, constitutes a smart packaging material to pharmaceutical industry. The injector is provided with an LED indicator, which not only regulates and keeps vigil on the entire injection process but also illuminates the injection site in dark hours to conveniently facilitate the injection procedure. Besides, the injector may also be used to collect the fluids safely, when attached with the specially designed Fluid Collector. 

https://www.youtube.com/watch?v=u24Rc7ZIaXo 
Backgrounder:
Bharati’s family came across a World Health Organization (WHO) report regarding ‘the burden of unsafe injections worldwide’ published in 2004. It revealed that only in 2002, up to 70% injections were being given by reused syringes in developing world, causing 1.3 million deaths, loss of 26 million years of life worldwide and estimated increased medical costs $1 billion alone in USA annually. The exposed deadly contaminated needles of used syringes and the Needle Stick Injuries (NSI) caused by such syringes, were held responsible as a primary source of the most dreadful diseases like HIV/AIDS, Hepatitis B, Hepatitis C, gonorrhea, typhus, herpes, malaria, Rocky Mountain spotted fever, syphilis, and tuberculosis as well as other communicable diseases. It reported a spike in new cases, particularly caused by Needle Stick Injuries (NSI) up to 30% of hepatitis B, 41% of hepatitis C and 9% of HIV/AIDS. Increasing lifestyle diseases like diabetes, hormonal problems etc. have added a steep growth of injections. Each injection needs a new syringe every time, which is ultimately discarded after use along with the empty drug container creating ever-growing piles of hazardous medical-waste posing serious health concerns and increasing the  global disease burden as well as global healthcare burden. 
Motivation behind the invention:
“In 2006, doctor prescribed regular insulin shots to my diabetic mother, Dr. (Mrs.) Neelam Rathore. Buying a new syringe for every single shot of insulin for rest of her life was a quite expensive affair but we had to afford. Once, it occurred as an unexpected incident, my younger brother, Jai Hind Rathore, who was hardly of 7 years and student in 3rd Grade, found syringe as a fascinating toy to play with and started collecting the disposed syringes from garbage without our knowledge. One day, while cleaning his cupboard, our mother found a box full of used syringes, she annoyed and scolded him with a warning not to indulge in such activities. Being a doctor, she knew well about the repercussions and the grave hazards of sharp medical waste particularly, the risks of deadly contaminated needle-stick injuries, which made her furious. Despite, it was not possible for the lad to keep away his fascination for syringes as a toy. He still continued having lot of questions behind her fear.” 
“The same year my elder sister Pratibha, student of class 11 and my father Dr. B. C. Rathore) had just finished a research project relating to the density fingerprinting of alloys to determine the purity of gold jewelry using ‘decoding of density method’ without any destruction of such precious jewelry. Our findings subsequently published in ‘Material Letters’ as “Theoretical optimization of constitution of alloys by decoding their densities” in publication of ELSEVIER Journal, which was highly appreciated by Bhabha Atomic Research Centre (BARC), Defense Research Development Organization (DRDO), National Physical Laboratory (NPL, Delhi), Vikram Sarabhai Space Research Centre (VSSRC) etc. and also the then President of India, His Excellency Dr. APJ Abdul Kalam took cognizance and referred the matter to BARC and BIS for further action.”
“At this point of time, we collectively undertook the WHO’s report as a missionary challenge and consistently worked with a zeal to find out a most suitable solution to effectively curb the menace of unsafe injections. Our studies revealed that only and only the retractable syringes may be the perfect solution of this challenge, but the costly retraction mechanism makes the syringes so costly that they are hardly affordable even to o.1% of the global population.”

Global Recognition of the Technology “The European Patent Office, while examining our International Patent Application (PCT/IB2016/051060)WO/2016/142799  has clearly opined as follows:
“Recently, our invention scored 2nd position in the world among 225 inventions/projects submitted from various countries by securing more than 32000 global populous votes at#youforG20: Project of an Interconnected World, an initiative undertaken by Deutschland on the occasion of G-20 Summit-2017 at Hamburg. It has been featured in ISIPS Newsletter of USA (Issue: 7th July, 2017), which is fully dedicated to ensure complete prevention of Needle Stick Injuries (NSI), the ultimate root-cause of  HIV, Hepatitis B & C as well as other communicable diseases worldwide. It has also been shortlisted among few inventions globally in the first stage of ‘The First Mile Innovation Challenge’by The Consortium for Affordable Medical Technologies (CAMTech) of Massachusetts General Hospital in association with GE Sustainable Healthcare Solutions. The invention has also been awarded with ‘BIRAC-SRISTI Appreciation Award-2017’worth Rs.1Lac by ‘Society for Research and Initiatives for Sustainable Technologies and Institution’ (SRISTI) and ‘Biotechnology Industry Research Assistance Council’ (BIRAC) under Department of Biotechnology (DBT), Government of India.Now, we are at final stage of pitching in ‘Millennium Alliance Award’ conducted by FICCI in August, 2017. The system is fully compliant to guidelines laid down by WHO, FDA and NIOSH.”
What was the role of each of the inventors? Have you named the product?
“Family of five, have put our persistent endeavors and invested our entire knowledge, skill, efforts, time, money, energy as well as all available resources in this pious missionary task of designing our dream invention to save the lives of millions. Pratibha Rathore, [Director of Rescitech Vision Pvt. Ltd., M.Tech. in Medical Nanotechnology] – Technical expertise in inventing new technology, Bharati Rathore, [M.Tech. in Cognitive& Neuroscience]- Technical expertise in inventing new technology, Jai Hind Rathore, [Student]- Technical expertise in inventing new technology, 3D Designing, Animation and Virtual Prototyping of the product, Dr. (Mrs) Neelam Rathore,[Medical Practitioner]- Medical expertise, presently working as Medical Officer in a State Ayurvedic Hospital under the Govt. of U. P, Dr. B. C. Rathore- Expertise in Legal and Intellectual Property Rights, Presently working as a Govt. Servant under the Ministry of Commerce & Industry, Govt. of India. 
Have you registered a company in India or plan to do so for the scaling up in terms of manufacturing and marketing? Are you looking at a tech transfer to the industry or you will be founding a company to do so?
“Rescitech Vision Pvt. Ltd., founded in 2014, is a technology and design company with a focus on sustainable innovations. Its mission is to accelerate the world’s transition towards sustainable and inclusive innovation growth by creating simple technologies with no technological divide. Our innovation start-up envisions the complete prevention of Needle Stick Injuries, re-use needle, counterfeit drugs, drug-abuse etc. and simultaneously to avoid the need of separate syringe for injection procedure in order to reduce the cost of injection procedure. Our invention is expected to decrease the bio-medical waste generated due to disposable syringes globally up to 70-75% and save the same extent of raw material particularly plastic material to be converted into bio-medical waste.” 
“Presently, we are trying hard to raise the requisite funds to secure our IPRs worldwide and commercialize our invention from the money obtained from various awards, grants, seed funding, licensing etc. We are zealously trying to become a part of the most ambitious ‘Make in India’ regime of Government of India. We have seriously planned to adopt Licensing model for commercialization and revenue generation.”
How much funds went into the invention? What has been the funding source? Has that been enough?
“Since 2006, all the financial resources, whatsoever, available at our ends have already been streamlined and exhausted completely in inventing and prosecuting patents of this breakthrough technology. Recently, the invention has been awarded with ‘BIRAC-SRISTI Appreciation Award-2017’ worth Rs.1Lac by ‘Society for Research and Initiatives for Sustainable Technologies and Institution’ (SRISTI) and ‘Biotechnology Industry Research Assistance Council’ (BIRAC) under Department of Biotechnology (DBT), Government of India. Now, we are processing to enter in national phase patent applications filing to protect patent rights in potential PCT jurisdictions. Simultaneously, our sincere efforts are underway to R&D and commercially exploit our invention, so that the real benefits of the technology may reach to the end-users. We are also in need of global network and resources, expertise etc. to commercialize our innovation. For all such purposes, we are in urgent and dire need of money. We are putting all possible efforts to arrange the necessary funds from external sources.”Currently at what stage is the product development? Does it require further refinement?“We have successfully completed technical phase as inventors in developing this breakthrough technology. The virtual prototype has been created to ensure its feasibility. International Patent Application (PCT/IB2016/051060) has already been filled, which has been published by World Intellectual Property Organization, Geneva on 15th September 2016 as WO/2016/142799.Now, the invention is ready for commercialization. The European Patent Office (EPO), a globally acclaimed International Search Authority has recognized our entire claims novel, possessing inventive steps and industrially applicable. It fervently inspires our confidence and provides solid footings to assure about the grant of patent in all potential PCT countries. We are in process of filing our national phase patent applications in various potential PCT jurisdictions i.e. USA, Europe, EAPO, ARIPO, China, Japan, Brazil, Australia, Canada, South Africa etc. to secure patent rights. Simultaneously, our sincere efforts are underway to initiate further R&D and commercially exploit our invention, so that the real benefits of the technology may reach to the end-users.”“Presently, we are facing hard a severe crunch of funds urgently required even for filing and prosecuting our national phase patent applications in potential countries. We urgently need to undertake R&D activities too. In order to effectively address all such urgent requirements, we are in urgent need of a huge amount of money in crores along with the expertise resources, which we are clearly lacking and finding no active platform which may support us in accomplishing our pious and visionary mission.”
What are your expectations both in terms of commercialization and revenue?“The statistics reveals that more than 2.5 billion syringes were used in 2010 worldwide which are forecasted to grow by 10% annually. Potential market of syringes is expected to increase from USD 10.56 billion in 2016 to USD 15.99 billion in 2021 at a growth rate of 8.7%. Several governments across the world have started adopting legislation that restricts the frequency of needle-stick injuries (NSIs).  WHO’s Global Health Initiative for Needle Safety is urging countries to transition by 2020 to the exclusive use of the new “smart” syringes. Increasing adoption of safety syringes, increasing demand for vaccines, high prevalence of chronic diseases and increased awareness as well as the requirements on safety syringes are bound to expand enormously the market of safety syringes worldwide. Despite all market constraints i.e. costs, procurement structure etc. will be negated by our technology to effectively meet the rising global demand.”“The medical devices industry has doubled from Rs 31,900 crore in 2013-14 to over Rs 60,000 crore in 2016, with nearly 80% being imported, according to estimates by Association of Indian Medical Device Industry (AIMED).With this huge influx of imports, domestic companies are reeling under the threat of Chinese manufacturers who are dumping products that are 30-40% cheaper. India imported US$ 29.87 million worth of syringes and the overall imported quantity was 783.14 million units in FY 2014-15. The medical devices market in India is dominated by imported products, including products manufactured using imported material, which comprises approximately 75% of the total sales. This is heavily eroding our Forex reserve. The domestic companies which are largely involved in manufacturing low-end products for local and international consumption can now be upgraded to solely manufacture this cheapest, smartest, greener and safer device for domestic as well as global consumption removing our import dependence. Indian can become the sole exporter of this smart indigenous technology to meet the domestic and international demands firmly.”
“Moreover, India is the tenth largest pharma exporter in the world with domestic pharma industry of $12bnin 2015. The Indian Pharmaceuticals Industry (IPI) earns around 70 per cent of its revenues from sale of generic drugs and generates around 50 per cent of its revenues from exports. But the export of injectable is weak due to prime reasons like increase in competition, regulatory issues faced by Indian pharma companies which may be overcome by utilizing strategic innovation for smart packaging of injectable drugs. Moreover, immense opportunities in domestic market as only half of the country’s rural population is covered by the sector and Indian average income keeps rising and the lifespan increases, the middle and upper classes are spending more on healthcare than ever before that will only keep rising in the future and globally as the governments around the world are beginning to favor generics – the strength of most Indian drug companies – for greater affordability, the smart packaging will exponentially increase the domestic as well as export revenues due to it very high reachability, affordability and safety assurance. The smart packaging of injectable drugs in fixed dosage in our Drug-Cartridges will do value addition of latest technology to the finished products which will strategically enhance the commercial as well as export prospects of the product worldwide enhancing their huge revenue, reputation, and goodwill.”“The smart packaging of injectable drugs in fixed dosage ranging 0.5, 1.0, 2.0, 3.0 ml etc. in our Drug-Cartridges will not only facilitate them an extended technologically advanced, smart, safe, ergonomic and aesthetic packaging to add value to their finished products but will also ensure the prevention of all risks and probabilities of under/over-dosage, contamination, wastage of drug etc. during transfer of drug into syringe and further into patient. Our technology will  increase the efficacy of drug by avoiding all risks of contamination with  no further requirement of 5-15% of ‘overfill quantity’ of drugs amounting huge direct input savings of pharmaceutical industry compensating/negating increase in cost and preventing wastage of drugs; ensuring safe disposal of empty drug-cartridge encapsulating used-needle as safe non-hazardous medical waste. Automation being affordable only to big pharmaceutical industry will strictly prevent prevalence of counterfeit-drugs safeguarding their huge revenue, reputation, and goodwill. Such a value addition of latest technology will strategically enhance the commercial as well as export prospects of the product worldwide. Besides, being a green technology, it will reduce the bio-medical waste by 70-75% and simultaneously will save same extent of raw material, particularly the plastic material, from being converted into hazardous bio-medical waste.”
“Futuristic Safe Injection System-2020 is versatile, sustainable, inclusive and strategic innovative solution to fulfil the aim of ‘Pharma Vision 2020’ to make India the global leader in pharmaceutical markets by becoming sole exporter of this breakthrough technology worldwide popularizing ‘Made in India’ generic injectable drugs worldwide. It will also help in meeting Govt. of India’s commitment to phase out disposable syringes, Sustainable Development Goals and Paris Agreement on Climate-Change and global leadership to India for safety syringes by 2020 conferred by WHO.”
What would the approximate cost of the product once in the market? What are your thoughts on affordability for masses?
“First time in the history of syringes, the expensive retraction mechanism has been made frequently reusable in the form of reusable injector. The frequent use of injector decreases its cost almost to zero with each and every next injection procedure. The smart packaging of fixed dosage of drugs in drug cartridges will, however, increase drug’s packaging cost by 20-25% as compared to conventional packaging but it will also save ‘overfill quantity’ containing 5-15% additional precious drug that goes waste which will result inhuge direct input savings of pharma industry compensating/ negating any increase in cost by smart packaging.”
“In proposed innovation, the end-user only needs to buy medicine packed in the drug-cartridge without any further requirement of separate syringe for each and every dose.  NO NEED TO BUY SYRINGE makes this innovation a cheapest and affordable solution for all resulting in huge saving on the out-of-pocket expenditure of the end-used.  It will decrease overall cost of injection procedure by at least 70-75%.  And also will decrease the global health burden as well as global disease burden to a considerable extent simultaneously.”
What are the future plans and way forward? 
“Futuristic Safe Injection System-2020 will effectively reduce Needle-stick injury almost to zero, to exponentially decrease global disease & healthcare burden; democratize healthcare system making it equally affordable and accessible to all; meeting Sustainable Development Goals (SDGs) by multi-fold benefits to healthcare system and fighting grave challenges of healthcare sector’s contribution to Climate-Change by negating the carbon footprint of entire syringe industry to achieve the highest goal of securing a safe, healthy and dignified ‘Right to Life’ for all.”

By TIS Staffer
the authorBy TIS Staffer

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