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BMJ Innovations Publish Ahead of Print, published on May 28, 2015 as doi:10.1136/bmjinnov-2014-000010
MEDICAL DEVICES
ORIGINAL ARTICLE
A structured process for unmet
clinical need analysis for medical
device innovation in India: early
experiences
Jagdish Chaturvedi,1 Andrew Logan,2 Girish Narayan,3
Shakuntala Kuttappa3
▸ Additional material is
published online only. To view
please visit the journal online
(http://dx.doi.org/10.1136/
bmjinnov-2014-000010).
1
Department of Otolaryngology,
Apollo Hospitals, Bangalore,
Karnataka, India
2
Department of Human Biology,
Stanford University, Palo Alto,
California, USA
3
Department of Emergency
Medicine, St John’s Medical
College & Hospital, Bangalore,
Karnataka, India
Correspondence to
Dr Jagdish Chaturvedi,
Department of Otolaryngology,
Apollo Hospitals, NO 15, Type
5, NIMHANS Quarters, Dairy
Circle, BRC Campus, Bangalore
560029, Karnataka, India;
[email protected]
Received 30 September 2014
Accepted 24 April 2015
To cite: Chaturvedi J,
Logan A, Narayan G, et al.
BMJ Innov Published Online
First: [ please include Day
Month Year] doi:10.1136/
bmjinnov-2014-000010
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.
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
Chaturvedi J, et al. BMJ Innov 2015;0:1–7. doi:10.1136/bmjinnov-2014-000010
Copyright 2015 by All India Institute of Medical Sciences.
1
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MEDICAL DEVICES
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.
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
Figure 1
2
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.
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
A side-by-side comparison of a standard Foley’s catheter and a saline-filled condom.10 11
Chaturvedi J, et al. BMJ Innov 2015;0:1–7. doi:10.1136/bmjinnov-2014-000010
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MEDICAL DEVICES
Figure 2
A graphic of the three distinct stages of the biodesign process as described by Stanford Biodesign.16
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
Chaturvedi J, et al. BMJ Innov 2015;0:1–7. doi:10.1136/bmjinnov-2014-000010
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.
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.
An observation docket was created for each of these
60 needs based on the information collected during
3
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MEDICAL DEVICES
Figure 3
The four tiered process used to filter clinical needs.
the immersion process. Figure 5 shows a sample
observation docket for one of the observations made
during the 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
Figure 4
4
evaluates the buyer environment and competitive
landscape, to determine the top 10 needs (table 1).
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—
An infographic of the needs identified, their relative numbers and their anatomy after application of the first filter.
Chaturvedi J, et al. BMJ Innov 2015;0:1–7. doi:10.1136/bmjinnov-2014-000010
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MEDICAL DEVICES
Figure 5
An observation docket describing paediatric intubation generated during clinical immersion.
Table 1
List of the top ten needs
No
Need statement
1.
An effective way to prevent ventilator-associated pneumonia in
intubated patients in the intensive care unit (ICU) to ensure
long-term ventilator support
A definitive way to prevent foot ulcers that can develop into sepsis,
gangrene or cellulitis, leading to foot amputations in patients with
diabetic neuropathy
An affordable way to manage middle ear infections in order to
prevent intracranial complications
A way to prevent necrosis and tracheal stenosis in patients with
prolonged endotracheal tube or tracheostomy tube in the ICU
A more effective way to detect ectopic pregnancy in sexually active
women of reproductive age who present with abdominal pain at the
first point of care in order to prevent rupture of the ectopic POC
(product of conception)
A way to temporarily manage traumatic brain injuries in patients
who are not able to access definitive neurosurgical management
(lack of ICU beds/availability of surgery) in order to prevent coning
of the brain stem, herniation and subsequent respiratory arrest or
death
A non-invasive way to measure intracranial pressure in patients with
mild to moderate head injury with intracranial bleeding in the ICU in
order to prevent subsequent mortality
A faster way to detect silent myocardial infarctions (MI) in order to
prevent irreversible cardiac damage in non-hospitalised patients who
are at high risk for MI (diabetes, high blood pressure)
A faster way to accurately detect rising intracompartmental pressure
in the musculoskeletal compartment due to soft tissue injuries at the
emergency room in order to prevent an impending compartmental
syndrome
A safer way to provide definitive management of urethral
obstruction in patients with enlarged prostate glands in the
emergency department
2.
3.
4.
5.
6.
7.
8.
9.
10.
Chaturvedi J, et al. BMJ Innov 2015;0:1–7. doi:10.1136/bmjinnov-2014-000010
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
5
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MEDICAL DEVICES
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
6
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
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MEDICAL DEVICES
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.
Twitter Follow Jagdish Chaturvedi at @jagdish
Acknowledgements 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.
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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A structured process for unmet clinical need
analysis for medical device innovation in
India: early experiences
Jagdish Chaturvedi, Andrew Logan, Girish Narayan and Shakuntala
Kuttappa
BMJ Innov published online May 28, 2015
Updated information and services can be found at:
http://innovations.bmj.com/content/early/2015/05/28/bmjinnov-2014000010
These include:
Supplementary Supplementary material can be found at:
Material http://innovations.bmj.com/content/suppl/2015/05/27/bmjinnov-2014000010.DC1.html
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