Definition and Scope of Innovation
The Merriam-Webster dictionary defines innovation simply as a “new idea, method, or device,” or alternatively as “the introduction of something new.”[3] Similarly, the well-respected Cambridge dictionary defines the term as “the use of a new idea or method”[4]. The Wikipedia description stresses that innovation is an “original and more effective” product of a novel idea or creative thought.[5] Thus, all three definitions capture the concept of novelty, although the latter emphasize the additional concept of implementing the novel idea to produce something. The Business Dictionary throws additional light on the term as the “deliberate application of information, imagination and initiative in deriving greater or different values from resources.” It emphasizes innovation as the process by which novel ideas are converted into useful products.[6] In India, the colloquial Hindi word “jugaad” partially captures the concept of innovation as a creative solution from an unconventional use of existing resources. The emphasis is to “make things work, or to create new things with minimal resources.”[7]
It is important to understand the distinction between innovation and invention. The latter clearly describes a novel product or solution, whereas innovation is more likely to be a novel implementation of an existing or new invention. Viewed in this context, innovation need not always stem from an invention.
However, the bottom-line is that invention, innovation and imitation must be driven to satisfy a specific need that is not fulfilled by the existing products, techniques, or processes. In that sense, invention, innovation, and imitation are offspring of the same mother, namely, necessity created by the COVID-19 pandemic.
COVID-19 Inspired Innovations in India: Boon or Bane?
The lockdown period provided the most valuable resource to organizations, institutions, individual professionals, and even the lay public–time (in ample quantity). The availability of time and flexibility of working outside the routine systems and schedules created an immense opportunity for innovation. These innovations occurred despite limited access to raw materials, consumables, and traditional supply chains; that too in an environment wherein face-to-face collaboration among colleagues was nearly impossible.
Professionals across disciplines worked together to devise solutions for practical problems. It has also fostered tremendous industry support for initiatives outside the usual mandate of these organizations. This has resulted in mobilization of industry equipment, raw materials, workforce, and even finances, to support the development of products even without a clear business plan. Government agencies have also announced liberal schemes to fund/support innovation, fast-tracking applications for funding new projects, commercialization of prototypes, scaling-up production of existing products, etc. The emphasis on rapid development of products rather than restricting to proof-of-concept or prototypes bodes well for India as a whole (well beyond the COVID-19 situation). All these are laudable effects.
Government Ministries, State Governments and national organizations (notably. the Department of Science & Technology, Department of Biotechnology, Defense Research and Development Organization, Council for Scientific and Industrial Research, etc.) have liberally promoted innovation in recent weeks through competitive calls for proposals to manage the COVID-19 pandemic effectively. Similar efforts have been made by the private sector, including associations such as the Federation of Indian Chambers of Commerce and Industry, private companies, and crowdsourced platforms.
On the other hand, the race for innovation has triggered a wave of unregulated competition, duplication, plagiarism, and often complete disregard for the principles of protecting intellectual property (IP). Many innovators created hype rather than hope with their innovations. Even prestigious Government agencies/institutions are compiling reports and brochures, rather than ensuring that useful products reach the intended end user. Thus, there is more innovation on paper than in reality. Further, the urgency for solutions compressed the timelines for innovation; hence, half-baked solutions are being released without appropriate testing. Worse, none of the products intended for clinical use have undergone clinical validation. Therefore, many of the products being developed are unlikely to be usable in the clinical or public health domains. Most innovators fully realize that their designs are not novel hence there is no scope of filing patent applications. Such innovators immediately publicize their unoriginal innovations/imitations to the lay press “in the national interest.” In contrast, serious innovators are unable to share their innovations until IP is protected. This has created an ironic situation, wherein genuine innovations are unknown to the public, whereas unoriginal ideas and prototypes are widely available for public discussion.
Fruits of COVID-19 Inspired Innovation in India
The following section briefly highlights some innovations that are either inspired by the COVID-19 pandemic or can have application in this situation.
Respiratory Support Devices
The shortage of mechanical ventilators in developed and developing countries (to meet the need posed by COVID-19) spawned an international as well as domestic race to develop solutions.
Mechanization of Manual Ventilation
Manual ventilation by compressing self-inflating bags (SIBs) is common in most busy Indian hospitals, even before the COVID-19 pandemic. Although it is an uncontrolled process, it is life-saving in situations where mechanical ventilators are inaccessible, unavailable, or unaffordable. The inherent problems with manual ventilation are that ventilation rate, volume, and pressure are uncontrolled resulting in hypo- or hyperventilation. There is often dys-synchrony with the patient’s spontaneous respiratory efforts or cough, no control over situations like endotracheal tube block, displacement, disconnection, etc. Finally, manual ventilation entails tremendous physical, emotional and mental fatigue in persons performing ventilation.
The COVID-19 pandemic stimulated the re-exploration of efforts to automate compression of SIBs, which itself is not a new concept.[8]
[9] In recent weeks, several innovators in various countries[10]
[11]
[12]
[13]
[14] including India[15]
[16]
[17]
[18]
[19]
[20]
[21]
[22]
[23]
[24]
[25] devised mechanical solutions for manual ventilation. Most of these mechanize the compression of the SIB at a preset rate using motors controlled by microprocessors. Some of these devices can be operated using smartphone apps.[15]
[16] One institution went a step further and reported capability to compress two bags with one machine.[26]
Although these devices appear to be attractive solutions, they fail to overcome the inherent problems associated with manual ventilation, as there is no control over ventilation pressure, volume and ratio of inspiratory to expiratory time. This creates the same risks of barotrauma and dys-synchrony noted with manual ventilation. These devices could even be harmful if the SIB gets compressed when the patient is breathing out, thereby driving air rich in carbon dioxide back into the lungs. Further, most of the innovators have not considered how the device can be connected to a patient.
However, all these devices share the common features of extremely rapid development, low(er) price, expansive claims of the device capabilities for COVID-19 patients, lack of clarity of which ventilation parameters can be controlled, extensive publicity in the lay press (without technical details), paucity of laboratory testing data for suitability in clinical care, and absence of clinical validation. Ultimately, most of these devices are unsuitable for clinical use.
Artificial Breathing Capability Device
A group of innovators led by the first author successfully invented and tested a novel ‘Artificial Breathing Capability Device’ (ABCD). This device was conceptualized in 2015, well before the COVID-19 pandemic, as a safer and more efficacious alternative to manual ventilation. Design and development phases were completed during 2016–18,[27] and patent application filed in May 2018.[28]
[Fig. 3] shows the device.
Fig. 3 Front view and side view of the Artificial Breathing Capability Device (ABCD).
ABCD comprises an electromechanical system compressing a SIB, with the unique feature of controlling ventilation by permitting users to set peak inspiratory pressure (PIP), respiratory rate (RR), and inspiration:expiration time ratio (I:E ratio). The present version of the device can deliver PIP in the range of 10 to 50 cm H2O, RR in the range 10 to 60 per minute, and I:E ratio in the range 1:1 to 1:4 (with any fraction in between). This covers most clinical situations requiring respiratory support. Another unique feature of the device is that an exhalation valve is placed just distal to the endotracheal tube; hence, there is no risk of rebreathing expired air. Further, a pressure sensor placed at the same location enables the recording and real-time display of the actually delivered pressure, rate and inspiratory time, with each breath. The device has multiple smart features including self-regulatory checks, cough alarm with temporary cessation of ventilation, endotracheal tube disconnection alarm, endotracheal tube blockage alarm, and bag disconnection alarm.
ABCD was extensively tested using 396 combinations of user settings, and nonstop functioning for 60 continuous days in the laboratory.[29] It was also tested on a patient simulator in PGIMER Chandigarh, proving its capabilities. Clinical testing on live patients has been initiated with due approval of the Institutional Ethics Committee ([Fig. 4]).
Fig. 4 Patient being ventilated using ABCD in the emergency ward. ABCD, artificial breathing capability device.
Although the ABCD is safer and more efficacious than manual ventilation, and well ahead of the current wave of devices compressing ambu bags, it requires further refinements to make it suitable for the ventilatory needs of COVID-19 patients. This process is currently underway and ABCD 2.0 is expected to be available for clinical testing in 2 to 3 months.
Ventilator Splitter
This is a simple mechanical device, permitting one ventilator to ventilate more than one patient simultaneously. This is achieved by using a plastic connector (often 3D printed) to “split” the ventilator output to reach multiple patients. The exhaled air is similarly returned from multiple patients. Naturally, the system can work only if all patients require exactly the same ventilatory settings. Such splitters are not entirely novel and were used previously in the 2017 Las Vegas mass shooting, where most of victims were young healthy adults (with normal lungs requiring physiological ventilation parameters).[30] However, their utility in the context of COVID-19 is uncertain, since ventilatory support of various patients may not be similar, and the risk of cross-contamination is significant. Nevertheless, several Indian innovators imitated the design[31]
[32]
[33]
[34]
[35]
[36] with wide media publicity, although none has been clinically validated.
Oxygen Delivery Splitter
In many Indian hospitals, general wards lack sufficient oxygen points/ports to ensure individualized delivery of oxygen to patients. Many such wards have recently been converted to COVID-19 wards, necessitating assured oxygen supply at every bed. For years, the deficiency of oxygen ports was solved by using Y connectors to split the oxygen flow to reach multiple patients. Naturally, such methods require high-flow of oxygen from the source. This innovation may ensure oxygen at every bed in COVID-19 wards, although it is not known whether they can fulfil the high-oxygen demand of some COVID-19 patients.
Innovations in Personal Protective Equipment Products
Face Masks
An institution in Bengaluru developed a face mask comprising a sheet of nylon or silk sandwiched between polypropylene layers.[37] Rubbing the layers against each other creates a negative charge on the outer layer, whereas nylon gets a positive charge. The double electric charge reportedly protects users from inhaling the Coronavirus. The practical utility of masks requiring rubbing is questionable, given that masks used in COVID-19 are not to be touched by hand at all.
A student of class XI from West Bengal successfully developed an “air providing and virus destroying mask” within 7 days.[38] Lay press coverage reported that “dust particles and harmful elements” somehow get “trapped in water particles and the lipid proteins of the virus are destroyed.” A one-way valve then ensures that “clean air can enter the patient’s lungs.” During expiration, “air exits through another one-way valve and enters another reservoir-container in which the lipid protein of the virus is broken down to destroy it.” Despite these vague details, the Ministry of Science and Technology plans to take this innovation forward.
A private company developed a reusable N95 mask, with viral filtration efficiency of 99.7%, claiming it as the world’s first mask having a “nanotech filter[39].” Apparently, the mask serves to trap the “virus particles, dry them out and break them apart.”
A pharmacy training institution in Vadodara developed a triple-layer mask impregnated with “enzymes and chemical reagents that can copy DNA to RNA.” The institution claimed that contact of the mask with “Coronavirus particles” triggers a reaction, causing the mask to change color.[40]
The Times of India newsgroup launched the “Mask India movement” to encourage people to design and use masks.[41] Apparently more than 1 lakh entries were received, and the movement was commended by the Prime Minister of India. However, the website shows only fabric masks in different designs, shapes and colors.[42]
Face Shields and Splash Guards
Various innovators designed and developed face shields or splash guards. Most either repurposed existing helmet visors or simply attached (overhead projector) transparency to plastic or rubber headbands. The attachments range from crude stapling to buttons or studs. Variations include 3D printing of the plastic parts. The Ministry of Health and Family Welfare’s recent specifications for face shields recommended that they be composed of clear plastic, ensure good visibility, have an adjustable headband, snug fit, be preferably fog resistant, and could be reusable.[43] They should also be compliant with two international standards, that is, “EU standard directive 86/686/EEC, EN 166/2002” or “ANSI/SEA Z87.1-2010.” However, these standards include much more stringent specifications. A footnote states that the item should be accompanied with certification of analysis from national/international organizations/laboratories, indicating conformity to standards” and expiry date of 5 years. Clearly, none of the Indian innovations fulfil these criteria.
Intubation Boxes and Aerosol Guards
A variety of acrylic/plastic boxes have been manufactured to protect healthcare workers from aerosol generated during patient care. The general design includes a box with openings to insert the operator’s hands. Depending on the intended usage, the box may be open at one end (if it is to be placed over the patent’s head) or completely closed (if used for laboratory processing of samples). Although these boxes are based on an open-source design shared by a Taiwanese physician,[44] many Indian individuals and institutions have claimed to have “developed” it with or without additional refinements.[45]
[46]
[47]
[48] The first author has encountered 23 variants of the box design in his own institution, and contributed to designing one for laboratory technicians handling biological specimens of suspected COVID-19 patients. Despite being imitations, the numerous variations making them fit-for-purpose is a tribute to the Indian spirit of innovation. These boxes are one of the few innovations that can be successfully deployed in hospitals managing COVID-19 patients, although their safety needs verification.
Innovations in PPE
The overall design of PPE including hazmat suits is not very complex. The challenge with indigenous innovation is mass producing them rapidly, yet with efficacy and safety. The Indian Navy is producing a cheap(er) PPE “developed” by a naval physician, which has been tested and validated by an (undisclosed) Indian Council of Medical Research (ICMR)-approved testing laboratory.[49] It is composed of a “special fabric” with “high breathability.”
IIT Ropar scientists have “created” a machine to clean and sterilize PPE using “ultrasonication, UV-C irradiation and oxidizing treatment.”[50]
A startup company claims to have developed antibacterial clothing for hospital personnel, using nanosilver.[40] It is unclear how an antibacterial coating will work against the Coronavirus.
Sanitization Solutions
Indigenous Hand Sanitizer Solutions
A south Indian University prepared conventional hand sanitizer on its campus and distributed it to the district health department authorities.[51] Similarly, the Defense Research and Development Organization (DRDO) also produced a hand sanitizer in one of its laboratories.[52] An alcohol-free cow urine-based sanitizer prepared from “distilled cow urine obtained from indigenous cows” mixed with “aromatic essential oil and Ganga jal” is also described on various Internet sites.[53]
[54]
Ultraviolet Light Emitters
Many innovators have developed gadgets using ultraviolet light to “kill the COVID-19 virus” since light with 200 to 300 nm (peak 254 nm) wavelength can kill bacteria and viruses. These gadgets include units such as boxes/suitcases to disinfect small objects,[55]
[56] cabinets and trolleys,[57] full-person sanitation boxes,[58] and larger towers to disinfect rooms[40] or even public spaces.[59] The “disinfection time” with these gadgets is variously described as 3 minutes to 30 minutes, but there is no way to test efficacy.
Ozone
A mineral water manufacturing company has developed disinfection chambers, wherein medical-grade ozone is produced and sprayed in a chamber[60] to decontaminate clothes and exposed parts of the body. Placed in front of hospitals in Mumbai, it “sanitizes” personnel entering or leaving this hospital within 30 seconds.
Silver
A startup company developed alcohol-free aqueous-based colloidal silver solution to disinfect hands and surfaces.[61] Other agencies reported similar developments.[62] The principle is that the silver nanoparticles were previously documented to be effective against HIV, Hepatitis B virus, etc. It is expected that colloidal silver may block RNA replication of the Coronavirus and its infectivity by blocking the surface glycoproteins.
AU Sanitizer
Recently, the National Hub for Healthcare Instrumentation Development (NHHID) claimed the development of a unique sanitizer, incorporating a RNA degrading enzyme, that destroys all Coronavirus components, including its genetic material.[63] It seems that this product can work as a standalone disinfectant but can also be mixed with existing alcohol-based solutions. The product is reported to be highly efficacious and very cheap.
Disinfection Tunnels
An innovator in Tamil Nadu popularized the concept of disinfection tunnels in India. Basically, it is a narrow passage embedded with hundreds of nozzles to spray disinfectant (usually 1% hypochlorite) onto people walking through the passage.[64] This “development” triggered a race of copycat innovations using the same or different disinfectant chemicals. One site installed such a tunnel to spray an ayurvedic product called rajat bhasma.[65] However, it soon became apparent that disinfection tunnels could be more harmful than beneficial.[66] Official agencies rapidly discouraged and then banned the use of such tunnels. Various explanations were offered,[67] rather than simply citing absence of efficacy and safety.
Environmental Sanitization Solutions
A Delhi-based company claimed to have developed a machine that discharges highly ionized water droplets which can oxidize the protein of Coronavirus.[68] The technology ostensibly combines electric energy and water atomization to induce a charge on water droplets. This has apparently been designed to rapidly sanitize large public spaces such as hospitals, transportation hubs, marketplaces, etc.
Another private company developed an antimicrobial coating claimed to be efficacious against viruses for as long as 3 months.[69] This chemical is being used to sanitize the fleet of vehicles of the Gurugram Police Department.
The Indian Army has deployed quadcopters (described as drones with four rotors) to spray up to 5 L of disinfectant chemicals from a height of 10 m to sanitize larger areas within a few minutes.[70]
Diagnostic Testing
Rapid Antibody-Based Kits
On May 14, 2020, ICMR listed 10 antibody-based rapid diagnosis test kits manufactured in India which were satisfactorily validated by the National Institute of Virology.[71] The ICMR document included a disclaimer that the test kits were validated under laboratory conditions and there could be performance variability in field conditions. It also advised that the kits were not intended for diagnosis of COVID-19 infection.
Real-Time PCR Diagnostic Kits
The ICMR website hosted a document dated May 16, 2020, reporting that a total of 71 RT-PCR kits were evaluated and 37 were found to be satisfactory.[72] However, news reports indicate that other diagnostic kits are also expected to be available in the immediate future. One of these products include a probe free RT-PCR based kit developed at IIT Delhi.[73]
Loop-Mediated Isothermal Amplification
Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) has developed a diagnostic kit based on reverse tranase loop-mediated amplification of viral nucleic acid technology.[74] The method has high-specificity as it detects two regions of the Coronavirus gene. SCTIMST scientists claim that the test detection time is only 10 minutes, and total time from receiving the sample to delivering the report is under 2 hours. The technology will make testing far cheaper than existing methods. However, ICMR approval is pending. Another private company also developed a diagnostic platform using LAMP technology.[75]
