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A structured process for unmet clinical need analysis for medical device innovation in India: early experiences
  1. Jagdish Chaturvedi1,
  2. Andrew Logan2,
  3. Girish Narayan3,
  4. Shakuntala Kuttappa3
  1. 1Department of Otolaryngology, Apollo Hospitals, Bangalore, Karnataka, India
  2. 2Department of Human Biology, Stanford University, Palo Alto, California, USA
  3. 3Department of Emergency Medicine, St John's Medical College & Hospital, Bangalore, Karnataka, India
  1. Correspondence to Dr Jagdish Chaturvedi, Department of Otolaryngology, Apollo Hospitals, NO 15, Type 5, NIMHANS Quarters, Dairy Circle, BRC Campus, Bangalore 560029, Karnataka, India; dr.jagdishc{at}ymail.com

Abstract

It is estimated that approximately 75% of medical devices and diagnostics come to India from imports. A WHO report on medical devices highlighted that most devices present in developing countries have been designed for use in developed countries. Consequently, when these medical devices are implemented in India, they are either unaffordable or are maladapted to fit the complex healthcare ecosystem. A strong need exists to develop technologies that are intentionally designed to suit the Indian healthcare system. To address these issues, we have applied a modified version of the biodesign process, originally developed by Stanford University, to identify unmet clinical needs in the field of emergency medicine at a tertiary referral hospital in southern India. Since the biodesign process was originally created to identify unmet needs in a more mature Medtech ecosystem, we have altered its implementation to make it more suitable to the evolving Medtech ecosystem that prevails in India. At the completion of 2 months of clinical immersion by a multidisciplinary team, 100 unmet needs with significant negative outcomes were identified. The team then took all the need statements collected during the period of the clinical immersion and applied four rounds of precalibrated filters to arrive at the top 10 most compelling clinically validated needs that would be selected for the phase of invention. In this article, we present our reasons for making modifications to the biodesign process, our results and our experiences while implementing this process in an Indian healthcare system.

  • Affordable
  • Inventions
  • Frugal
  • Global Health
  • Trauma
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Introduction

75% of medical devices and diagnostics used in India are imported.1 A WHO report on medical devices highlighted that most devices present in developing countries have been designed for use in developed countries.2 Consequently, when these devices are implemented, they are either unaffordable or are maladapted to fit the complex healthcare ecosystem that exists in many developing nations.3 In western countries, medical technologies are evaluated using a structured health technology assessment (HTA), which is defined as the “systematic evaluation of the properties and effects of a health technology, addressing the direct and intended effects of this technology, as well as its indirect and unintended consequences, and aimed mainly at informing decision making regarding health technologies”. This assessment helps ensure that all stakeholders are considered in the implementation of medical devices.4 Because its medical technology ecosystem is still in its infancy, India does not yet have a formalised process to carry out such evaluations.5 One must also consider that 60–80% of healthcare in India is delivered in the private sectors, with close to 80% of the population paying for healthcare out of pocket.6 This limits the impact of insurance coverage decisions on devices and makes the implementation of expensive medical procedures difficult.7–9 These factors have contributed to a lack of implementation and development of medical devices tailored for the Indian healthcare system.

As a result of these conditions, medical practitioners often need to create makeshift solutions by repurposing available medical equipment. A common example of this is the usage of an intravenous drip set and cannula to evacuate fluids in the peritoneal cavity or for collection of fluids within the pleural cavity. While these solutions are often successful, their modifications make them unpredictable. However, a regulated kit from the West for fluid collection can cost up to 10–15 times as much as these simple solutions. These jugaads (quick fixes) are even used in life-threatening emergencies, such as the management of postpartum haemorrhage. Clinicians utilise imitations for standardised balloon tamponade devices by fixing condoms to Foley's Catheters and inflating them with saline (figure 1).10 ,11 But what type of condom should be used? How much saline should be used for inflation? While one must applaud the ingenuity of these clinicians, these self-made solutions typically vary from hospital to hospital and do not have a path through which they can be scaled up to reach the target patient population in a standardised manner. There is a strong need to develop technologies that are intentionally designed to suit the Indian healthcare system. These technologies must take into consideration the clinical need, the stakeholders, the reimbursement system and the regulatory standards. Having a structured design process inculcated in the healthcare system, which ensures all of the above, will spur the development of technologies that can fit the Indian ecosystem. This system will subsequently reduce our requirement to import overly expensive and inappropriate technologies, and will also prevent clinicians from using unregulated solutions to address our healthcare needs.

Figure 1

A side-by-side comparison of a standard Foley's catheter and a saline-filled condom.10 ,11

The authors have received formal training in a process called biodesign (in 2012), which was developed by Stanford University (2001) as a part of a year long fellowship funded by the Government of India's Department of Biotechnology. The biodesign process identifies compelling clinical needs while taking into consideration all of the various factors that ensure the development of a regulatory compliant technology. The authors used the process to develop over 12 medical technologies in India—five of which have been successfully licensed to indigenous medical device companies and three of which have formed into Indian start-up companies—within a short span of 3 years. By utilising the authors’ training and experience in implementing the process in India, along with the business acumen of an Indian medical technology acceleration company, we have modified the implementation of the biodesign process for the Indian ecosystem. In this trial, we have applied our India-specific biodesign process to identifying unmet clinical needs in the field of emergency medicine at a tertiary referral hospital in southern India. In this article, we present our process, the results and our experiences during the implementation of this process.

Materials and methods

Unmet clinical need analyses

The process developed is based on the traditional biodesign process (figure 2), which includes the following three phases: identify, invent and implement.

Figure 2

A graphic of the three distinct stages of the biodesign process as described by Stanford Biodesign.16

Phase of identification: This phase is used to identify unmet needs that are clinically validated. A multidisciplinary team comprising of a doctor, an engineer, a product designer and a business graduate, perform clinical observations at a hospital in a strategic focus area for a period of 6–8 weeks. During this time, the team shadows clinicians and patients, and observe the procedures and care provided. The team is instructed to note inefficiencies and poor health outcomes. After collecting observations for 2 months, the team sits down to filter these observations by applying a structured filtering process. Once a top need is identified, a document containing a set of needs criteria is compiled. These needs criteria are essentially a list of must-haves and nice-to-haves, which are objective parameters expected to be met from the prospective solution.

Phase of invention: During the phase of invention, the team brainstorms all the possible ways in which the need can be addressed. This brainstorming session focuses on generating a large quantity of ideas that build cumulatively on each other. The concepts are then selected based on fulfilment of the needs criteria outlined in the need specification document. Next, the teams focus on constant prototyping and validation with stakeholders.

Phase of implementation: This phase includes evaluation of the IP, regulatory compliance, stakeholder validation and marketing strategy. It also takes into account the preclinical and clinical testing of the prototype. Finally, manufacturing, finance and operations are an integral part of the implementation phase.

Applying the biodesign process in an Indian setting (see online supplementary file for table on modifications made to the process and their respective rationale).

Selection of a strategic focus area: The area of emergency medicine and trauma was selected to be the focus area for the fellowship programme due to its high level of criticality, interdisciplinary treatments, diverse patient population and seamless flow into all areas of medicine. This focus area gave fellows a unique view into the critical needs of each field and allowed them to gain a comprehensive view of the tertiary referral hospital.

Clinical immersion and documenting observations: A structured clinical immersion was conducted for 6 weeks by a team of three non-clinical professionals—an engineer, a designer and a business graduate—along with three clinicians in the department of emergency medicine. The team documented observations, underlying problems, negative outcomes, need statements, patient demographics, patient pathways, critical insights, frequency of cases, patient impact and market size. The team also spent a week with an ambulance service to observe point of care management provided in emergency situations.

Need statement creation and refinement: The team identified the process that led to the negative outcome seen in the observation and then incorporated this into a problem statement. One observation may lead to zero, one, or multiple problem statements. A succinct need statement that describes the need of the target population is generated from the problem statement. This process of creating and refining need statements helps the team accurately identify the problem that needs to be addressed so that prospective solutions effectively address the correct problem.

Needs filtering process: The teams then took all the need statements collected during the period of the clinical immersion and applied four rounds of filters to arrive at the top needs that would be selected for the phase of invention (figure 3). The voice of the customer was determined through interviews with clinicians, patients and administrators.

Figure 3

The four tiered process used to filter clinical needs.

Need specification document creation: The teams selected four needs from the filtered list and created a document called the ‘need specification document’. This comprehensive document contains the observation notes, need statement, disease state fundamentals, existing treatment options, treatment gap, ideal solution statement, market size, business competitors, IP landscape assessment, regulatory requirements, business model and reimbursement strategy.

These documents are utilised by the team as they progress into the phases of invention and implementation to guide their development of India-specific solutions that take into consideration all of the parameters collected during the phase of identification.

Results

At the completion of 2 months of clinical immersion by the team at a tertiary referral hospital, 100 unmet clinical needs with significant negative outcomes were collected from 120 detailed observations. The level 1 filter eliminated all those needs that were redundant, process related or that were pharmaceutical needs. Figure 4 shows a pictorial representation of the need distribution after applying the first round of filtering.

Figure 4

An infographic of the needs identified, their relative numbers and their anatomy after application of the first filter.

An observation docket was created for each of these 60 needs based on the information collected during the immersion process. Figure 5 shows a sample observation docket for one of the observations made during the clinical immersion.

Figure 5

An observation docket describing paediatric intubation generated during clinical immersion.

The level 2 filter used the information collected in the observation docket to whittle the list of needs down to 44. This level of filtering focuses on the severity of clinical need (in the perception of observers and clinicians) and the frequency of the problem during the clinical immersion experience. The team then collected incidence and prevalence data via a detailed literature review, and applied the third level of filtering, to arrive at the top 24 needs. Lastly, the team applied the fourth level of filtering, which evaluates the buyer environment and competitive landscape, to determine the top 10 needs (table 1).

Table 1

List of the top ten needs

The team then selected two needs to work on for the phase of invention and the phase of implementation. These two needs were selected based on the team's personal interest, their combined skillset and the trending preferences of various funding sources. At this point in the process, it is assumed that any of the top 10 needs are compelling. In addition, all 10 needs have moderate regulatory challenges and a healthy buyer environment. Hence, selecting two needs based on personal interest ensures that a passionate drive as well as a sense of ownership—essential requirements for the development of a successful product—exist.

Discussion

This article describes a structured process adapted for the Indian healthcare system, intended to identify and solve unmet clinical needs. If successful, this process will lead to the development of indigenous products that are well suited for our patients, healthcare professionals and hospital systems. However, there are multiple factors, specific to the Indian healthcare systems, that pose challenges to implementing a structured process for unmet need identification conventionally.

Shortage of clinicians as innovators

The Indian healthcare system is ridden with overworked and underpaid clinicians. These clinicians often deal with low doctor-to-patient ratios (1:1800 in India vs 1:1000 in the West).12 Along with rising competition to make a livelihood, these conditions add to the increasing stress among clinicians.13 This context makes it risky for physicians to halt their clinical commitments and explore innovating medical devices. Moreover, conventional programmes that train clinicians in the process of innovation require the doctor to be involved full-time for 1–2 years. This lengthy commitment prevents many clinicians from exploring Medtech careers. However, it is clear that doctors have unique insights into needs, and the ability to innovate when it comes to managing life-threatening situations (see: Saline-filled condom and Foleys catheter).14 Therefore, it is essential that physicians play a role in the unmet needs analysis process. These factors were taken into consideration and the clinicians selected as fellows were able to maintain their clinical positions in their hospitals while serving as guides for their teammates undergoing medical immersion. Using this method, clinicians contributed to observations, provided essential medical insights, and counselled the non-clinical fellows. By making a simple alteration, we can reduce the perceived risk of participation in Medtech for Indian physicians, and allow them to contribute without discontinuing their clinical commitments.

Shortage of accurate clinical data

Poor documentation of clinical data in a standardised format within hospitals and clinics has led to a shortage of reliable information on disease epidemiology. This is a result of the diversity of the Indian healthcare system, the inconsistent usage of electronic medical records and the lack of a centralised data management system to record clinical data across the country. Nevertheless, accurate information related to diseases and procedures is critical to developing an invention. To address the lack of reliable data, we have developed an observation docket that encourages fellows to collect relevant information pertaining to the observation at the time of the clinical immersion. Fellows are constantly questioning physicians, nurses and administrators, about the prevalence of issues and the magnitude of such problems. Fellows also gather information on the cost of patient management. Unfortunately, gathering accurate data is time-intensive and thereby decreases the total amount of observations that fellows can make. But, the information gathered is essential and is used to generate educated estimates that are critical for market sizing and needs filtering.

Complex stakeholder and business model strategies

The Indian healthcare system contains many stakeholders with varying interests. The doctor-to-patient ratio is approximately 1:500 in urban India and 1:2500 in rural India. Furthermore, there are approximately 920 000 allopathic doctors in India and around 750 000 doctors practising ‘alternative’ medicine (ie, AYUSH). There are also over 2000 nursing institutes registered with the Indian Nursing Council, with over 80 000 nurses graduating every year. The Pharmacy Council of India has approved over 600 colleges, with about 36 000 students graduating in pharmacy, every year. The healthcare system has ancillary supportive staff such as the auxiliary nurse midwife, anganwadi workers, asha workers, ambulance paramedics, dais and class 2/3 workers who are involved in hospital waste management and cleanliness.

In addition, India delivers healthcare through complicated levels of private and public pathways. Under the Indian Constitution, health is a state subject. Each state, therefore, has its own healthcare delivery system in which both public and private (for profit and non-profit) actors operate. While states are responsible for the functioning of their respective healthcare systems, certain responsibilities also fall on the federal government, namely policymaking, planning, guiding, assisting, evaluating, coordinating the work of various provincial health authorities and providing funding to implement national programmes.

To take into consideration these various stakeholders and the diverse business models that work in the Indian healthcare system, we create a need specification document that balances stakeholder and business interests. This document also clearly defines our target population and ensures that the interests of all key stakeholders are seriously considered.

Prolonged development cycle prior to commercialisation

Another challenge specific to the Indian Medtech ecosystem is the perceived difficulty of developing medical devices in India. Many young entrepreneurs would prefer to form start-up companies in healthcare IT rather than medical devices because of the prolonged development pathway for medical devices. In their case studies of innovative medical device companies in India, Jarosławski et al highlighted that five of the six companies discussed in the article develop their products within 2–3 years.14 ,15 This compares well to the average product lifecycle of 18–24 months estimated by the medical technology industry body in Europe.3

The availability of funding and human resources necessary to access the market with finalised products has been one of the major impediments to Medtech companies in India. Regulatory compliance is an additional struggle. Whereas advanced technological knowledge can be accessed via links to global academic and business communities, the lack of local regulatory guidance poses a major challenge for product development. Although FDA, CE and WHO certifications are an option, interviewed companies assert that the high cost of such certifications and/or distant location of these agencies are serious obstacles and result in delays.3 In our process, we educate aspiring entrepreneurs about previous development cycles, and also provide experts to guide them through the funding and regulatory pathways.

We believe that we can match international standards and maintain a developmental cycle of 18–24 months without hampering the quality of the proposed solution. By developing successful Medtech companies through our process, we hope to change the Indian perspective on the feasibility of starting an indigenous Medtech firm.

Conclusion

This modified process for unmet need analysis considers a comprehensive list of factors that are specific to the Indian healthcare system and identifies key clinical needs. In order to be successfully implemented in India, this proven need analysis process needed to be significantly altered to fit the Indian ecosystem. The needs developed through our trial programme have been validated by physicians, intellectual property has been filed and companies have been incorporated to lead the product development cycle.

Acknowledgments

The authors are grateful to St John's Medical College and Hospital for providing access for clinical immersion. The authors are thankful for the large clinical contribution that Nitesh Kumar Jangir, Ramakrishna Pappu, Nachiket Deval, Dr Vimal Kishore Kakani, Dr Raghuveer Rao and Dr Sajid Mohammed gave to this project. The authors acknowledge Stanford Biodesign for the process on unmet need analysis. The authors also acknowledge Stanford India Biodesign, a programme funded and successfully implemented by Department of Biotechnology (DBT), Ministry of Science and Technology, Govt of India, for Biomedical technology innovation at the All India Institute of Medical Sciences (AIIMS) and Indian Institute of Technology (IIT), Delhi, in collaboration with Stanford University, USA, and in partnership with Indo-US Science and Technology Forum. The programme aims to create novel medical technology to promote innovation in affordable healthcare and to train the next generation of innovators and med-tech leaders in India. DBT has authorised Biotech Consortium India Limited (BCIL), New Delhi, as the primary management agency for this programme, responsible for intellectual property management as well as licensing and transfer of technologies developed under this initiative.

References

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  • Supplementary Data

    This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

Footnotes

  • Twitter Follow Jagdish Chaturvedi at @jagdish

  • Contributors JC proposed and executed the study and wrote the manuscript. AL cowrote the manuscript and analysed the process. GR and SK provided expert clinical inputs and proofread and edited the manuscript. All authors have read and approved the final manuscript.

  • Funding This study is funded by InnAccel consulting services private limited (IA), which has financial interests in the medical technology industry. However, IA did not play any role in designing this study, or in any other aspect related to it, other than providing general funding, as indicated below.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; internally peer reviewed.

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