|Year : 2021 | Volume
| Issue : 3 | Page : 156-162
A magical journey into knowledge creation in emergency difficult airway access: Reaching out to the masses, changing the world for all time
Professor, Department of Otolaryngology Head and Neck Surgery, St. John's Medical College and Hospital, Bengaluru, Karnataka, India
|Date of Submission||13-Oct-2021|
|Date of Acceptance||24-Oct-2021|
|Date of Web Publication||22-Nov-2021|
Dr. Arumugam Ramesh
Professor, Department of Otolaryngology Head and Neck Surgery, St John's Medical College Hospital, Koramangala, Bengaluru - 560 034, Karnataka
Source of Support: None, Conflict of Interest: None
This article concludes a four-article series intended to ignite the minds of readers and empower them to create new knowledge in the context of 'emergency difficult airway access.' The first three articles described the process of knowledge creation in a clinical context where the anaesthesiologist is faced with a difficult airway in a medically underserved area. The utility of an educational app, the 'Research Genie (RG),' available on Google Play Store and App Store, to define and design a research study (knowledge creation) was explained. This article concludes the series with educating the reader in creating innovations based on the new knowledge. The steps of creating the product, process, position, and paradigm innovations are explained simply and comprehensively. Innovation jargon has been demystified for medical professionals to grasp the basis of intellectual property (IP). Various categories of IP, namely patents, copyrights, trademarks, industrial designs, geographical indications, layout design of integrated circuits and plant variety protection have been described in an easily understandable format. The biodesign process of Stanford University has been adapted to elucidate the technique of designing medical devices. Identify-Invent-Implement is the framework followed in the Stanford model. The method to frame a needs statement in the strategic focus area of difficult airway access is explained for the reader to begin the process of innovation. Biodesign concepts such as decision tree analysis, business models, stakeholder analysis, financial planning, regulatory and reimbursement basics have been described. The reader is introduced to medical device rules (2017) that govern biomedical innovations in India. The 'RG' bids adieu to the readers with an invitation to create swaraj (freedom) for everyone in the world from economic, social and administrative constraints so that healthcare is affordable and accessible for all.
Keywords: Biodesign, copyright, intellectual property, patent, technology readiness levels
|How to cite this article:|
Ramesh A. A magical journey into knowledge creation in emergency difficult airway access: Reaching out to the masses, changing the world for all time. Airway 2021;4:156-62
|How to cite this URL:|
Ramesh A. A magical journey into knowledge creation in emergency difficult airway access: Reaching out to the masses, changing the world for all time. Airway [serial online] 2021 [cited 2022 Jan 22];4:156-62. Available from: https://www.arwy.org/text.asp?2021/4/3/156/330902
| Introduction|| |
This is the concluding article of a four-article series intended to empower medical personnel in creating new knowledge to manage difficult airways in emergency situations. In the first article 'Defining the destination,' the reader was guided to define precise objectives in 9 domains of healthcare. In the second article, 'Planning your journey with Research Genie (RG),' the utility of a free educational app RG to assist in operationalising research was explained. The third article demystified sample size calculation and statistical tests by educating the reader to discover data required for sample size calculation. Identifying the most appropriate test of significance for a given objective was also described. The utility of the RG to discover these two aspects was elucidated. It is recommended that you read the first three articles to get a complete concept of knowledge creation. The real magic is experienced by utilising new knowledge to create products, processes, strategic positioning or paradigms that impact the lives of human beings. An indigenously created simulator to train anaesthetists in managing a difficult airway is product innovation. Process innovation is an intelligent computer programme that assists in predicting a difficult airway. Integrating this product and process creatively into the postgraduate curriculum is a position innovation. Establishing a system where many users can remotely access these training tools is a paradigm innovation. This article will describe the method to design and expand the utility of these categories of innovations. Knowledge creators must take on leadership in creating these innovations and publish their findings for large-scale expansion and utilisation of their inventions and discoveries through healthcare start-ups. In the words of Dr APJ Abdul Kalam, one of the foremost and inspiring innovators, 'Innovation is born out of cultural excellence, when an individual or nation contrives to fulfil the dream with calculated risks.' One's life is well utilised even if we create one innovation that impacts the lives of persons with a difficult airway.
Living a life of magical experience, now and forever ………….
The steps of innovation described here are adapted from the Stanford University model of biodesign. The model consists of three principal components, namely identify, invent and implement. The subcomponents of these are depicted in a pictorial form in [Figure 1]. This process can appear unfamiliar for many medical personnel. Every concept is described in simple and easily understandable language. The references provide resources for further reading. Readers are recommended to read this article as though they are entrepreneurs with a mission to take their inventions and discoveries to the masses and change the world for all time.
|Figure 1: The process of innovation (Adapted from Stanford Biodesign model)|
Click here to view
| Identifying a Strategic Focus Area|| |
A team of innovators needs to define a strategic focus area. Medical personnel involved in the care of people is the first set of team members. Based on the need, individuals from other specialty domains are included in the team. Securing the airway in difficult situations presenting in the emergency room could be a strategic focus area. The most critical criteria to choose the focus area is the quantum of impact an innovation will make in this domain. In the chosen focus area, the innovators must immerse themselves in the clinical scenario. Clinical immersion spans for 5–6 weeks. Structured observations are performed to document the challenges. In innovation terminology, the term for the challenge is 'negative outcome.' In difficult airway, the negative outcome could be irreversible asphyxia or respiratory failure requiring ventilation. Negative outcomes lead to unmet needs.
| Framing a 'Needs Statement'|| |
Based on the unmet needs, a 'needs statement' is framed. The precise format to frame a needs statement is as follows '(Desired change) in (Who)………. and (Where)………. and (Why)……….' This statement will be the guiding compass to define the shift the innovation will cause in difficult airway situations. It is important that we do not preempt possible solutions, as it will limit the various possibilities to overcome a negative outcome. To further illustrate this pitfall, let us take the situation described in the first article of this series. The negative outcome was irreversible brain hypoxia caused by the inability to secure the airway. The desired change is to ensure oxygenation in such situations. We should not get fixed on securing the airway as a means to ensure oxygenation. We should examine all strategies to ensure oxygenation which could be through an affordable and easily available method to bypass the lungs and oxygenate the body organs. The point is to keep all possibilities open to shift the negative outcome. If many needs arise, then a needs filtering mechanism is used to prioritise the needs. Clinical significance of the negative outcome is a vital criterion that assists in prioritising the needs. The frequency of negative outcomes is the next important criterion to prioritise.
| Understanding Disease State Fundamentals|| |
In this step, the team of innovators educates themselves about the anatomy, physiology, pathophysiology, clinical presentations, outcomes, epidemiology and economic impact of the negative outcomes (irreversible brain hypoxia). As the team may consist of professionals from allied sciences, it is critical that they too understand the scientific basis of negative outcomes. This foundation is of value during brainstorming sessions for the entire team to give valuable inputs.
| Stakeholder Analysis|| |
Before embarking on the mission of innovating, the team must perform stakeholder analysis. Stakeholders are identified by examining the flow of care, equipment and money. A possible list of stakeholders could be patients, patient advocacy groups, physicians, professional associations, nurse practitioners, managers of healthcare facilities, private payers, public payers, government officials and legislators. A structured questionnaire may be employed to understand the views of stakeholders regarding the need to create an innovation to overcome the negative outcome and its clinical and economic impact. There should be ongoing interaction with the stakeholders throughout the innovation process to make it relevant for the beneficiaries.
| Market Analysis|| |
Market analysis is about estimating the number of beneficiaries in the community who will accept the innovation. It also examines whether these beneficiaries will pay for the same. The components of market analysis are market segmentation, market size, market dynamics, market needs, willingness to pay and target market. The terms are self-explanatory. The team should seek the guidance of a domain expert in this area as scientists and medical personnel are unfamiliar with this ecosystem. There are various models and methods to evaluate these components. It is important that adequate market analysis is completed before creating an innovation. This exercise will ensure that the innovation will reach the masses.
| Concept Generation (Proof of Concept)|| |
Concept generation through brainstorming to provide a solution for the unmet need is the next step. Approaching this exercise with an open mind without locking on to a solution early on is essential. Sketching, creating mind-maps, Post-it® notes, idea boards and so on are all ways to document and generate ideas. It is important for everyone to have a voice and to work towards building a consensus. A hands-on organic approach has been shown to spark creativity and innovation. You cannot generate ideas and information beyond what you know. Therefore, literature surveys, generating an intellectual property (IP) database and competitor product analysis, combined with sound technical knowledge and cross-collaboration across different fields of expertise helps generate and select sound concepts. Do not dismiss any ideas even if they seem wild! Aim for at least 100 ideas.
At the end of concept generation, there will be different ideas to address the unmet needs. It is necessary to filter out unsuitable ideas and select the top concept/s. This filtering process is done through both qualitative and quantitative methods. Rating concepts are based on how well they address the needs as well as based on their strengths and weaknesses with respect to IP, regulatory (safety-related), reimbursement (economic-related) and technical profiles. Tools such as the Pugh matrix, expert opinion and surveys can aid in further narrowing down ideas. Once the approach and solution concept has been agreed upon, the selected concept/s are fully defined, and we proceed to the product development phase.
At this stage, an introduction to IP is in order. Every innovation is the IP of the inventor. The types of IP are patents, copyrights, trademarks, industrial designs, geographical indications, layout design of integrated circuits and protection of plant varieties and farmers' rights (PPVFR).,
A patent is an exclusive right granted by a country to the owner of an innovation (product or process) to make, use, manufacture and market the innovation, provided the innovation fulfils the following criteria:
- 'Novelty' meaning, it is not known to the public through any source
- 'Inventive step' which involves a technical advance and/or economic significance
- 'Nonobviousness' in that it appears new for a person skilled in the art
- 'Industrial application' meaning that the innovation is capable of being manufactured and used in the medical industry
A patent is valid for 20 years. The Government of India has created a list of processes called 'Traditional knowledge database of India' which cannot be patented. This was done to allow it to be utilised by everyone and avoid any entity taking ownership by patenting these technologies. The process of procuring a patent includes filing the patent application, request for examination, publication, issuance of examination report, response to examination report, issuance of letter patent document and retroactive payment of annuity. Innovators can apply for an Indian patent or International patent. Substantial expenses are involved in procuring patents. Assistance may be sought from philanthropists for social innovations. Venture capitalists fund business innovations. The 'Claims' section of the patent application is the most critical component where the innovators state specifically their inventive steps.
Copyright is a right granted to the owner for creating an original literary (Computer programmes/softwares/books), dramatic (movies), musical (compositions) and artistic (art) work. The rights include reproduction in any form, circulation among public, performance or communication to public, making cinematographic film or sound recording of the work, translation or adaptation of the work to any other form. A copyright is valid till the life of the creator and 60 years after the death of the creator.
Trademark is a distinctive sign which identifies certain goods or services as those produced or provided by a specific person or enterprise. Trademarks may be expressed as words, letters and numerals or their combinations and may also consist of drawings, symbols, two-or three-dimensional signs or colours, used as distinguishing features. Trademark rights may be used to prevent others from using a confusingly similar mark. Trademark rights are forever. Trade secret like a special recipe is a peculiar type of IP. It has protection till it remains a secret.
Industrial design means the features of shape, configuration, pattern, ornament or composition of lines or colours applied to any article by an industrial or manual process or means and which are judged solely by the perception of the eye. The object of design registration is to see that the artisan, creator or originator of the design is not deprived of his bonafide reward by others applying it to their product. The law provides protection of 15 years for this type of IP.
Geographical indications identify certain agricultural or natural or manufactured goods as originating or manufactured in the territory of a country or a region or locality in that territory, where a given quality, reputation or other characteristics of such goods is essentially attributable to its geographical origin. GI prevents unauthorised use of a registered geographical indication by others, helps in boosting exports and promotes economic prosperity of producers of goods produced in a geographical territory.
Layout design of integrated circuit includes a layout of transistors and other circuitry elements and includes lead wires connecting such elements and expressed in any manner in a semiconductor integrated circuit designed to perform an electronic circuitry function.
PPVFR Act is a system for the protection of plant varieties, the rights of farmers and plant breeders and to encourage the development of new varieties of plants. Criteria for the protection of a new plant variety are novelty, distinctiveness, uniformity, stability and appropriate denomination (generic designation). Novelty means the variety is new, that is not sold or disposed for exploitation at the time of application. Distinctiveness means it is distinguishable by at least one characteristic. Uniformity means being sufficiently uniform in its essential characteristics. Stability indicates that its essential characteristics remain unchanged after repeated propagation.
| Prototyping|| |
Creating products and processes from the concept is prototyping. There are 9 technology readiness levels (TRL) which are as follows:
- TRL 1: Basic principles observed and reported
- TRL 2: Technology concept and/or application formulated
- TRL 3: Analytical and experimental critical function and/or characteristic proof of concept
- TRL 4: Validation in laboratory environment
- TRL 5: Validation in real environment
- TRL 6: Prototype demo in laboratory environment
- TRL 7: Prototype demo in real environment
- TRL 8: Final model demo in real environment
- TRL 9: Proven by multiple real-time use
The terms for the 9 levels are self-explanatory. Innovators will need the assistance of incubators located in institutes such as the Indian Institute of Science, Bengaluru for testing the device to achieve regulatory standards which are described in the following section.
| Regulatory Basics|| |
The most well-known regulatory bodies globally are the US Food and Drug Administration (FDA) and the European Union Certification Entity (CE) whose compliance is recognised globally. Most countries (including India) deem those standards as sufficient for sale and use of medical products. Also in India, approval has to be sought from the Central Drug Standard Control Organisation. Canada, China, Japan and Australia also have their own medical device regulatory bodies and standards. In India, regulatory bodies typically work under one guiding principle i.e., the product performance and safety standards are appropriate for what the product claims to achieve. The submitted product is then considered ready for commercial production and clinical use. The FDA and CE both have their own classification system and special rules and exemptions outlined for each class of device. The existence of a similar approved device in the market, small modifications to one's own approved product and a situation where there is a dire need for a product can all affect the regulatory pathway of a product. Regulatory approval is not guaranteed in any situation. However, by using proper protocols, it becomes more likely. The innovating team should consist of domain experts in this area. Consultants may be involved to gain further insights into regulatory requirements.
| Business Model and Reimbursement Basics|| |
After designing a working prototype and patenting it, the innovators have to create a plan for mass production and marketing of their innovation. They can either establish a start-up company or sell the license to market to an established company. Healthcare start-ups are classified as online pharmacy, telemedicine, personal health management, home healthcare, fitness and well being, diagnostics, biotechnology research and development, medical devices, healthcare information technology, biopharma and genomics.
The main components of a business model are revenue stream, price, margin structure, sales investment, customer training requirement, competitive differentiation, IP, other barriers to entry, clinical hurdles, reimbursement, financial requirements, culture and geography. Market research on all these components must be conducted before scaling up the innovation. Predictive tools such as decision tree analysis can run simulations for the innovators to understand the economic viability of their innovation to take important decisions. Decisions about operating plan and financial models to be employed are critical decisions that innovators must make which are described in the next section.
| Financial Model|| |
Operation plan and financial model ensure sustainability of the innovation for healthcare. A major pitfall that innovators get into is ignoring this critical component of the innovation process. Many a brilliant innovation stops at getting an award at a 'hackathon.' There is no impetus to carry it to the next stage. The fruition of knowledge creation occurs only when its benefits reach the community. The six components of the financial model are operating plan, staffing plan, cost projections, market model, cash flow statement and income statement. A marketing specialist is an important team member and makes all the difference in ensuring that the innovation benefits the community.
We conclude the innovation process with the words of Thomas Fogarty-'The path to innovation is very often lonely and frustrating. Be prepared to be criticized, ostracized, called crazy, inappropriate, outlandish, stupid, intolerable and bound to fail.'
| Adieu from the 'Research Genie'|| |
Mahatma Gandhi had given a talisman for humanity. I have taken the liberty to modify it to now read: 'I will give you a talisman. Whenever you are in doubt, or when the self becomes too much with you, apply the following test. Recall the face of the poorest and the weakest person whom you may have seen, and ask yourself, if the step (Read 'Research/Knowledge creation/Innovation' here) you contemplate is going to be of any use to that person? Will that person gain anything by it? Will it restore that person to a control over their own life and destiny? In other words, will it lead to swaraj (freedom) for the hungry and spiritually starving millions? Then you will find your doubts and yourself melt away.' India was created by people who had sacrificed their all for securing a future for its people. A future where everyone can live with dignity. Swaraj is all pervading. On 15th August 1947 we got swaraj from British rule. We all need to strive for swaraj in all domains. Knowledge creation and innovation have the power to give swaraj for the masses who deal with disease and illness. As health-care professionals, the capacity to create knowledge is like 'Ahimsa and Satyagraha' that Gandhiji employed to transform human beings. A befitting tribute we all can pay to the people who laid the foundation for our nation is by devoting our lives to innovate so that healthcare is accessible and affordable for every person in the world. The RG is a step in this direction. I invite all readers to utilise me and be partners in this mission. Jai Hind!
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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