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Received November 8, 2023, accepted December 1 2023, date of publication January 22, 2024

A Landscape Study to Determine the Innovation Mortality Rate 
in Health Technology Innovations Across the Globe

By Sambhu Ramesh1, Annie Nithyavathani J1, Moinudeen Syed1, Kavita Kachroo1, Jitendra Kumar Sharma2, Priyadarshini. 
A2, Penta Sneha Latha1, Sushmita Roy Chowdary2

1 Kalam Institute of Health Technology, India 
2 Andhra Pradesh MedTech Zone, India

ABSTRACT

Introduction: Health technology innovation encompasses many areas, such as medical devices, diagnostics, pharmaceuticals, 
digital health solutions, telemedicine, health informatics, and more. These innovations aim to enhance healthcare delivery, im-
prove patient outcomes, increase access to services, reduce costs, and advance medical research.
Methodology: We have analyzed health technology innovations reported between January 2011 and December 2022. Regulatory 
approval for the innovative products was determined based solely on official open-access websites of health agencies, disregard-
ing information from company websites or third-party sources. The search process utilized identified innovation agencies and 
sources like Primary Health Care (PHC) Tech Challenge, World Health Organization (WHO) compendium, Global Grand Chal-
lenges (GGC), and Biotechnology Industry Research Assistance Council (BIRAC).   Innovations were thoroughly examined from 
these sources, focusing on health technologies, and success was gauged through regulatory approval.
Results: The WHO Compendium includes 200 health innovations primarily intended for low-resource settings, with the USA ac-
counting for the highest number, followed by India, the only low- and middle-income country (LMIC) with significant innovations. 
However, 58% of the listed innovations did not obtain regulatory clearance. Medical devices dominated the listed innovations, 
while scalable assistive technologies were limited. Global innovation agencies, particularly Grand Challenges, supported many 
innovations, but the regulatory approval rate remained low. In India, BIRAC supported 92% of the mapped innovations, with a 
similar trend of low regulatory approval rates. 
Conclusion: The study observed the highest number of innovations during 2015-2017, with medical devices being the most 
prominent category. However, most innovations from both global and domestic agencies were unapproved, raising concerns 
about regulatory clearance for these health technologies. 
Manuscript Highlights: The manuscript presents several important highlights concerning health technology innovation and 
regulatory approval. It highlights the evaluation of health innovations from 2015 to 2022, focusing on their success rate based 
on health agency approval. It reveals an uneven distribution of innovations from different countries and emphasizes the need 
for critical interventions to improve the process. This study emphasizes the significance of innovations in achieving healthcare 
equity and sustainable development goals.

Keywords – Health technology innovation, Regulatory approval, Medical devices, WHO Compendium, BIRAC, Global innova-
tion agencies.

Copyright © 2024. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY): Creative Commons - Attribu-
tion 4.0 International - CC BY 4.0. The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) 
are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is 
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Ramesh, Nithyavathani J, Syed, Kachroo, Sharma, Priyadarshini, Latha, Chowdary: A Landscape Study to Determine the 
Innovation Mortality Rate in Health Technology Innovations Across the Globe 

J Global Clinical Engineering Vol.6 Issue 2: 2024  6

INTRODUCTION

Innovation is fundamental to progress and develop-
ment in various sectors, including business, healthcare, 
technology, and agriculture. It encompasses integrating 
fresh ideas, concepts, and creativity into tangible and 
usable products or services that cater to the needs of 
the public at large. Moreover, innovation is not limited to 
creating entirely new products; it also involves enhanc-
ing and improving existing offerings, resulting in better 
customer experiences and increased efficiency.1

Though various fields have distinct breakthroughs 
based on their domain, our analysis will be based on 
the product innovation of health technology innovation 
across different countries. Healthcare innovation can be 
as simple as changing a form to check out a patient five 
minutes faster or as complex as immunotherapy targeting 
specific cancer cell types. Simple or complex develop-
ments that lead to improvements in health outcomes and 
patient experiences are considered healthcare innova-
tions. Health technology innovation refers to developing 
and implementing new and improved technologies in the 
healthcare sector.2 It involves the application of scientific 
knowledge, engineering principles, and innovative ideas to 
create tools, devices, systems, and software that enhance 
the prevention, diagnosis, treatment, and management of 
diseases and improve overall healthcare delivery.3

In healthcare, innovation holds immense potential for 
revolutionizing patient care, disease prevention, diagnos-
tics, treatment, and monitoring.4 The healthcare sector 
thrives on innovations that can significantly improve health 
outcomes, enhance access to services, reduce costs, and 
contribute to advancements in medical research in the real 
world.5 Innovations in medical devices, such as implant-
able devices, robotic surgery systems, prosthetics, and 
wearable sensors, have substantially impacted patient care 
and medical interventions. Similarly, diagnostic tools and 
techniques, like genetic testing, point-of-care diagnostics, 
imaging technologies, and lab-on-a-chip devices, have 
revolutionized early detection and accurate diagnosis of 
diseases, leading to better treatment outcomes.6

Despite the remarkable potential of health technology 
innovations, the innovation process can be arduous and 
challenging. Many innovators invest significant efforts 

into transforming their ideas into commercially viable 
products; however, many of these innovations eventu-
ally face failure. This failure could occur at any stage of 
the innovation process, and the reasons behind it can be 
multifaceted.5,7

It is laborious to think about a product from the initial 
seed of a concept through its commercialization. Even 
though many innovators need their innovations to complete 
this laborious procedure successfully, most fail after some 
period. Any stage of the invention process might fail.8,9

Start-up companies often confront a higher risk of 
failure, especially during their initial years of operation. 
The competitive landscape and rapidly evolving consumer 
needs and preferences can lead to shorter product life 
cycles, necessitating continuous innovation and adaptation 
for survival. As a result, organizations must constantly 
reinvent and improve their products or services to stay 
relevant in the dynamic market.10,11

Considering this, many start-up companies have a 
significant chance of failing, with many failing after a 
few years. This is attributed to intense competition and 
rapidly changing consumer needs, resulting in shorter 
product life cycles.12 companies must continuously in-
novate and improve their products or introduce new ones 
to survive.  Not all innovations are successful, and failing 
to commercialize them wastes important investments.5 
Acquiring company-level data on innovation failure is 
challenging. The study focuses on macro-level data at 
the country level to acquire insights into the information 
provided. Compared to well-established organizations, 
start-ups are more prone to failure, with a considerable 
proportion failing to survive beyond their first few years.13 
This is primarily due to their intense rivalry, exacerbated 
by the rapidly changing consumer needs. As a result, the 
market lifespan of items has been considerably reduced, 
necessitating ongoing innovation and adaptation.7

According to studies, the ratio of successfully com-
mercialized discoveries to failed ones could be as low as 
1:300.14 This means that a significant amount of investment 
in innovation may be squandered. The financial expense 
of innovation adds another degree of complexity. Innova-
tion activities are frequently expensive, involving research 
and development (R&D) costs, experimentation, and 



7 J Global Clinical Engineering Vol.6 Issue 2: 2024

Ramesh, Nithyavathani J, Syed, Kachroo, Sharma, Priyadarshini, Latha, Chowdary: A Landscape Study to Determine the 
Innovation Mortality Rate in Health Technology Innovations Across the Globe 

market testing. These costs can be enormous, and when 
combined with the risk of failure, they create a difficult 
environment for new businesses.15,16 Innovation mortal-
ity refers to the rate at which new products or ideas fail 
to gain traction in the market or within an organization. 
It measures the failure rate of innovations or ideas and 
can be used to evaluate the success of an organization’s 
innovation efforts.

While existing research has primarily focused on the 
positive impact of innovation on a company’s survival, our 
study takes a different approach. It seeks to understand 
how innovation has attained the rate of mortality  . Due 
to the numerous micro-level data regarding innovation, 
this research relies on macro-level data on specific agen-
cies and organizations. By analyzing broader trends and 
patterns, the study aims to shed light on the relationship 
between innovation activities and the ultimate failure of 
health technology innovations.17,18

MATERIALS AND METHODS

The methodology includes the mapping of health 
technology innovations across the various countries in 
the world. There were pre-defined criteria for including 
the health technologies. The inclusion criteria include any 
health technology innovations within a period of January 
1, 2011, to December 31, 2022. 

We depend on open access to official regulatory agency 
websites to determine health agency approval. We do not 
consider the information on the company website or any 
third-party websites, including newspapers. 

The search includes list of already identified innova-
tion agencies across the world, PHC (Primary Health 
Care) Tech Challenge, which is a search for innovations 
in a primary healthcare setting, WHO (World Health Or-
ganization) compendium of innovative health technolo-
gies for low-resource settings (2011 to 2020) and Global 
Grand Challenges, and Biotechnology Industry Research 
Assistance Council (BIRAC). Innovation agencies shall be 
of any entity, i.e., government, private, non-governmental 
organization, independent, a collaboration with UNDP 
(United Nations Development Program), charity organi-
zation, or any university collaborative agencies. We have 
selected five innovation agencies in total for this study. 

Among them, three were global, and two were from In-
dia. PHC Tech challenges was a special call for mapping 
innovations specific to primary health care. The rest are 
agencies aiming to find and support innovations from 
different areas.   

We identified the website of each of the innovation 
agencies from a browser. We thoroughly investigated 
the English-language calls for proposals, grants, current 
initiatives, and services. We narrowed our search to just 
health innovations on the websites of individual innova-
tion agencies based on the inclusion criteria.   Irrespec-
tive of the agency’s website, we also searched the health 
innovations from the “Global Grand Challenges,” “WHO 
Compendium of innovations for low-resource settings,” 
“PHC Tech Challenge,” and “BIRAC.”

Various innovations were found from the GGC, a fam-
ily of initiatives fostering innovation to solve key global 
health and development problems, while the PHC Tech 
Challenge includes the compendium of health innovations 
for primary healthcare settings. These innovations are 
exclusively shown to bring promising health innovations 
across the globe to support PHC planning, management, 
and quality improvement. We also identified the health 
technology innovations from WHO Compendium of Inno-
vative Health Technologies for low-resource settings from 
the year 2011 to 2020,19 which consists of commercially 
available medical products and finally the BIRAC20 and 
PHC Tech Challenge in India21 in where the innovation and 
the company’s name has been identified for the further 
collection of macro-level data. 

The success of an innovation is decided based on the 
regulatory approval received from health agencies. All 
the health technology innovations mapped had been 
cross-verified to check the regulatory approval of the 
same products. 

STATISTICAL ANALYSIS

In this study, a descriptive assessment of the findings 
was conducted to summarize and present the results 
clearly and informally. The results of the analysis were 
represented in the form of summaries, tables, and fig-
ures.   Descriptive graphs in bar charts, pie charts and 
histograms were used to provide visual insights into the 



Ramesh, Nithyavathani J, Syed, Kachroo, Sharma, Priyadarshini, Latha, Chowdary: A Landscape Study to Determine the 
Innovation Mortality Rate in Health Technology Innovations Across the Globe 

J Global Clinical Engineering Vol.6 Issue 2: 2024  8

data’s patterns, trends, and distribution. Tables were also 
used to identify the trends and to provide comparisons. 
Bar charts were utilized to illustrate the frequency or 
distribution of categorical data. Pie charts were also used 
to present the proportion of each category within a whole 
to provide an understanding of relative components. 

RESULTS

The WHO Compendium represents the list of health 
technology innovations that are commercially available. 
The total number of commercially available products are 
152 in number, and prototype products mentioned in 
the compendium are 48. Of 152 products, 114 received 
approvals from their respective countries of origin. The 
WHO Compendium identifies the manufacturer-reported 
information and the evaluation of innovation results. 
It focuses on health technologies that can potentially 
improve health outcomes and quality of life, or offer a 
solution to an unmet medical/health technology need. 
It acknowledges success stories and raises awareness of 
the pressing need for appropriate, affordable design solu-
tions. It also promotes innovation in the field of health. 
This effort aims to promote interaction among ministries 
of health, procurement officers, donors, technology de-
velopers, manufacturers, clinicians, academics, and the 
public. Ultimately, it ensures greater investment in health 
technology towards universal access to essential health 
technologies. The table represents the date of commer-
cialization of the product, country of origin of the product, 
and category of the product. All these innovations are at 
8 to 9 technology readiness levels. This emphasizes that 
this has entered the regulatory approval pathway, got ap-
proved by their respective country’s regulatory approval 
authority, and entered the commercial market. These 
innovations mentioned here are successful.

The innovations under PHC Tech Challenge are a 
platform that brings together promising MedTech, digi-
tal health, and cold chain innovations for strengthening 
primary healthcare. The PHC Tech Challenge document 
was published in 2018 where they mentioned the overall 
products as 22. It was rolled out to supply a platform 
that brings together promising MedTech, digital health, 
and cold chain innovations from across the globe to key 
stakeholders (government, health agencies, donors, 

development partners, private sector companies and 
providers, etc.). PATH India with its partners embarked 
on a global search for innovators and entrepreneurs in 
the healthcare sector with the ‘PHC Tech Challenge.’ The 
success of a comprehensive PHC program by bringing 
together all the relevant stakeholders to advance efforts 
towards improving primary healthcare quality, access, 
and affordability and introducing transformative solu-
tions/innovations that could be proven and scaled are 
found in this review. 

A group of programs known as Grand Challenges pro-
motes creativity to address significant global health and 
development issues. Every endeavor is a test of how to use 
difficulties to direct innovation towards having an effect. 
The Bill & Melinda Gates Foundation introduced Grand 
Challenges in Global Health in 2003. The first focus of this 
initiative was on 14 significant scientific problems that, if 
resolved, could make substantial progress in preventing, 
treating, and curing the illnesses and health conditions 
that contribute most to global health inequity. It was re-
introduced in 2014 under the moniker Grand Challenges, 
reflecting its broadened focus to include problems with 
global development.22 

We have considered 10 major Grand Challenges for 
identifying health innovations. The Majority were country-
specific, and few were exclusively for specific innovations 
(such as Grand Challenges for development).

The Department of Biotechnology (DBT), Government 
of India, established the BIRAC, a not-for-profit Section 8, 
Schedule B, Public Sector Enterprise, as an interface agency 
to support and enable the emerging biotech enterprise to 
engage in strategic research and innovation, addressing 
regionally pertinent product development needs. BIRAC, 
an industry-academia interface, conducts its mandate 
through a wide range of initiatives that have an impact, 
such as providing access to risk capital through targeted 
funding, technology transfer, IP management, and sup-
port programs that help biotech companies become more 
innovative and competitive on a global scale.20 We have 
mapped a total of 253 innovations on medical devices 
from 2012 to 2021. The WHO Compendium included 
noticeable innovations in the healthcare arena, intending 
to seek more support and aid for the same. 



9 J Global Clinical Engineering Vol.6 Issue 2: 2024

Ramesh, Nithyavathani J, Syed, Kachroo, Sharma, Priyadarshini, Latha, Chowdary: A Landscape Study to Determine the 
Innovation Mortality Rate in Health Technology Innovations Across the Globe 

All the innovations named by WHO, PHC Tech Chal-
lenges, were considered. However, innovations mapped 
from other agencies were included after considering 
technology readiness levels, scope, and novelty from a 
global perspective. 

We have categorized our findings into three sections.
1. The WHO Compendium listed health innovations.
2. Health innovations supported through global innova-

tion agencies.
3. Health innovations supported by India’s major domes-

tic innovation agencies and health innovation calls. 

The WHO Compendium listed health innovations

We have mapped a total of 200 health innovations from 
WHO innovation compendium. The compendium incor-
porates innovations intended for low-resource settings. 
The WHO Compendium lists manufacturer-reported data 
and WHO evaluation findings for health technologies that 
can enhance the quality of life or health outcomes or ad-
dress an unmet medical or technological need. It clarifies 
the benefits and difficulties of using cutting-edge medical 
technology in low-resource environments. It may be uti-
lized by non-governmental organizations, governments, 
and other stakeholders to support purchasing choices.

The USA accounts for more than a quarter of the in-
novations listed by the compendium. India is the only 
LMIC comprising many health innovations (18 of 200). 
Innovations from a total of 44 countries were considered 
for assessment. Of them, 37 countries accounted for less 
than 5% of health innovations. 

The health innovations from African countries were 
exceptionally low. The analysis finds that 58% of the 
health innovations did not obtain regulatory clearance. 

Although Canada, China, and Switzerland found a high 
proportion of regulatory agency approved health innova-
tions, the country-wise approval rate remains the same 
in absolute numbers. 

Medical devices account for nearly three-fourths of 
the overall health innovations listed in the WHO Com-
pendium (140 of 200). The innovations in scalable assis-
tive technologies were very few (3 of 200). The absolute 
number of innovations categorized as medical devices 
was significantly high (86 of 140). 

Health innovations supported through global 
innovation agencies 

Medical devices account for the maximum number 
of health innovations (32 of 67). E-health and assistive 
devices were the lowest (1 of 67). Regulatory agency 
approval for innovations mapped from global agencies 
was significantly low (6 of 67). The regulatory approval 
for GGC (1 of 43) was significantly low. 

TABLE 1. Innovation Agencies Considered for Mapping

Sl No Innovation agency Country

1 WHO (Innovation compendium) Global

2 Grand Challenges Global Global

3 Innovation Agencies Global

4 PHC Tech Challenge India 

5 BIRAC India

FIGURE 1. Distribution of health innovations with respect to 
country of origin.



Ramesh, Nithyavathani J, Syed, Kachroo, Sharma, Priyadarshini, Latha, Chowdary: A Landscape Study to Determine the 
Innovation Mortality Rate in Health Technology Innovations Across the Globe 

J Global Clinical Engineering Vol.6 Issue 2: 2024  10

The 2015 to 2017 period showed the highest number 
of innovations supported by innovation agencies. Medi-
cal devices were the highest reported health innovation, 
followed by other technology and digital health. The 
analysis also found certain process innovations. Process 
innovations success rate cannot be determined based on 
health agency approval status.

A deep dive into the health innovations supported 
by India’s major domestic innovation agencies

We have analyzed innovations supported by the major 
innovation agencies BIRAC, the Ministry of Biotechnology, 
and the Government of India, and innovations supported 
through a grand challenge call for PHC Tech Challenge. We 
have mapped a total of 273 health innovations. BIRAC-
supported health innovations accounted for 92% of the 
total innovations mapped. Our analysis found that around 
92% of the health innovations supported by domestic in-
novation agencies are not receiving regulatory clearance. 
The highest number of innovations were supported dur-
ing 2015-2017. Although the reduction is insignificant, 
the COVID-19 pandemic could be accountable for the low 
support rate in the subsequent period. Medical devices 
accounted for the most supported medical innovations 
(58%). Other technology includes innovations in cold 
chain, infection control, etc. 

The net regulatory agency approval was the lowest for 
the health innovations supported by global health innova-
tion agencies. Innovations listed in the WHO Compendium, 
on the other hand, included many regulatory agencies’ 
approved health innovations. Another noticeable finding 
was that the health innovations from low- and middle-
income countries were significantly lower compared to 
high-income counterparts.

DISCUSSION

The study mapped health innovations supported by 
six innovation agencies and used regulatory approval to 
measure success. Surprisingly, over one-third of the sup-
ported innovations failed to obtain regulatory clearance. 
Cross-verifying regulatory agency approval from respec-
tive countries was done. Still, some innovations developed 
in high-income countries for different populations could 
not be assessed due to a lack of regulatory data. The peak 
of innovation support was observed during 2016-2018. 
However, innovations beyond 2021 were not included 
in the study, except for pandemic-driven ones. While the 
focus was on medical devices, other categories like digital 
health and assistive devices were also considered if they 
played a crucial role in healthcare. Despite this, many 
innovations lacked supporting documents on regulatory 
approvals on open websites.

There is currently no widely acknowledged compre-
hensive definition of innovation, and many fields (such 
as economics, public health, geography, and sociology) 
use somewhat different definitions. One of the earliest 
economists to recognize the importance of innovations 
to all economic systems, from small businesses to entire 
countries and the global economy, was Schumpeter. 
He defined innovation as any modification to the way 
something is produced, the creation of new goods, the 
organization of businesses, the entry into a new market, 
and the “creative destruction” that drives all develop-
ments under a capitalist market framework.1 According 
to Manuel García-Goñi, innovations in health care can 
be classified into objects, the relationship to the existing 
standard, the system affected, the extent of change, and 
the readiness level. The World Economic Forum, in its 
latest report, mapped five innovations that could change 

FIGURE 2. Distribution of innovation agency-wise regulatory 
agency approval status.



11 J Global Clinical Engineering Vol.6 Issue 2: 2024

Ramesh, Nithyavathani J, Syed, Kachroo, Sharma, Priyadarshini, Latha, Chowdary: A Landscape Study to Determine the 
Innovation Mortality Rate in Health Technology Innovations Across the Globe 

global health, which include artificial intelligence, 3-D 
printing, gene editing, virtual reality, and sensor devel-
opment. Most of the health innovations mapped through 
the process were found to have some association with the 
forum-reported innovation domains.23 David W. Feigal et 

al., in their paper titled “Impact of the Regulatory Frame-
work on Medical Device Development and Innovation” 
states that the rate of innovation for regulated items is 
a function of how quickly research and engineering are 
developed to make choices about regulations based on 

TABLE 2. List of Health Innovations and Its Regulatory Agency Approval Status

Innovations Mapped from Global Agencies

Category of Health 
Innovation 

Approved by regulatory agencies Not approved by regulatory agencies 

Number Percentage Number Percentage

Medical device 5 16 27 84

Digital health Nil Nil 15 100

Other technologies 1 7 14 93

Assistive device Nil Nil 1 100

E-health Nil Nil 1 100

Innovations Mapped from WHO Compendium

Category of Health 
Innovation 

Approved by regulatory agencies Not approved by regulatory agencies 

Number Percentage Number Percentage

Medical device 86 61 54 39

E-health 13 37 22 63

Other technology 2 13 14 88

Digital health 2 33 4 67

Assistive device 1 33 2 67

Innovations Mapped from India (BIRAC & PHC Tech Challenge) 

Category of Health 
Innovation 

Approved by regulatory agencies Not approved by regulatory agencies 

Number Percentage Number Percentage

Medical device 11 7 146 93

Other technology 2 4 46 96

Digital health 7 16 38 84

Assistive device 2 11 17 89



Ramesh, Nithyavathani J, Syed, Kachroo, Sharma, Priyadarshini, Latha, Chowdary: A Landscape Study to Determine the 
Innovation Mortality Rate in Health Technology Innovations Across the Globe 

J Global Clinical Engineering Vol.6 Issue 2: 2024  12

science. New scientific and public health concerns also 
have a life cycle, from conception to obsolescence, just 
as breakthrough medical products. Since the two are 
interwoven, delayed scientific advancement and a lack 
of a flexible, science-based regulatory decision-making 
process can hinder growth.24 The author highlights that 
the slower the pace of regulatory agencies in approving 
the innovation, the more it affects the development of 
innovative medical devices. The World Trade Organiza-
tion, in its Trade-Related Aspects of Intellectual Property 
Rights, is an international legal agreement between all 
the member nations of the World Trade Organization), 
states that the regulation of medical products has become 
difficult because of the globalization of product research, 
manufacturing, and supply as well as the rapid rate of 
technical and societal change in the setting of limited 
financial and human resources.25 The Sixty-Seventh 
World Health Assembly approved resolution WHA 67.20, 
“Regulatory system strengthening for medical products,” 
to recognize the value of strong regulatory frameworks. 
The resolution states that “effective regulatory systems 
are an essential component of strengthening the health 
system and contribute to better public health outcomes,” 
“regulators are an essential part of the health workforce,” 
and “inefficient regulatory systems themselves can be a 
barrier to access to safe, effective, and quality medical 
products.”26 A study titled “Innovation and Death Rate 
of Enterprise” identified the mortality rate of companies, 
where it also aims to analyze how the influence of innova-
tion activities measured through R&D expenditures and 
the number of resident patent applications on the death 
rate of companies in member countries of OECD.27,28

The evaluation of cutting-edge medical devices is 
where technological uncertainty is most evident because 
the regulator must comprehend the scientific principles 
underlying the operation of the device but fails to have 
a clear understanding of the information needed to be 
persuaded of the product’s efficacy and safety before the 
product entered into the regulatory review the line.29 Ad-
dressing the uncertainty over the structure and format of 
the data necessary for a given medical device’s regulatory 
clearance. The lack of clear guidelines for the protocol 
for evaluating an innovative product causes content and 
format uncertainty, which affects how the applicant firm 
should present and how regulators should evaluate the 

findings of clinical studies and other tests (like biocom-
patibility and engineering tests). Without the creation of 
precise assessment criteria, this form of uncertainty, which 
always coexists with technological uncertainty for inno-
vative products, may continue.30 As there may be several 
reasons why innovation has failed at any stage where we 
are not accumulating information about the failure, the 
mortality of innovations is any health innovations that 
are not commercially available and did not pass through 
the regulatory authorized channels. A remarkably diverse 
range of goods fall under medical devices, including pace-
makers, coronary stents, and silicone breast implants.31 
Obtaining regulatory approvals for innovations takes much 
longer than the average approval process of follow-on 
innovations. This could increase the cost of the approval 
process. There are many efforts from different parts of 
the globe to ensure appropriate implementation of the 
innovations. However, many such efforts fail to deliver the 
intended benefits to the end user. Government regulations 
can have dual effects when it comes to promoting health 
innovations. Ensuring a positive regulatory environment 
is important, and should consider regulation affects in-
novation as well as the consequences of technological 
development for their justification and regulatory design. 
The OECD report32 on regulations and innovation states 
that regulatory reforms should be considered whenever 
needed to accommodate technological developments. 
Strict competition policy might restrict the rate of tech-
nological process. Competition policy may result in only 
the approval of innovations from large firms in con-
centrated industries. As they could finance themselves 
for the R&D.32,33 According to the NHS UK, to innovate 
successfully in the health field, several major problems 
must be resolved. Budgetary considerations.33 Hospitals 
have a notably sluggish adoption rate for technological 
advancements. One explanation is that their IT staff are 
already overworked with installing, upkeep, and improv-
ing electronic health record (EHR) systems. However, 
hospitals’ unbalanced budgeting and incentive structures 
might be mainly held responsible.34,35 Currently, challenges 
are hindering the progress and widespread adoption of 
medical innovations, which are crucial for addressing gaps 
in global healthcare provision. One major obstacle is the 
slowdown in productivity within healthcare R&D, leading 
to prolonged timelines for discovering new treatments 



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Ramesh, Nithyavathani J, Syed, Kachroo, Sharma, Priyadarshini, Latha, Chowdary: A Landscape Study to Determine the 
Innovation Mortality Rate in Health Technology Innovations Across the Globe 

for emerging diseases.36 Consequently, numerous acute 
and chronic conditions such as cancer, depression, and 
Alzheimer’s still lack groundbreaking cures. Another 
challenge lies in the comparatively slower diffusion of 
healthcare innovations compared to other industries. 
Translating medical innovations from the research stage 
to practical implementation is often protracted, spanning 
several decades. This delay can be attributed to the intricate 
nature of the healthcare innovation ecosystem and the 
divergent motivations of various healthcare stakehold-
ers involved. Overcoming these challenges is imperative 
to accelerate medical progress and ensure widespread 
access to innovative healthcare solutions.37

The study had some limitations that affected its scope 
and data collection. Examining various organizations was 
limited, potentially leaving out relevant health innova-
tions. Innovations were identified using organization or 
company names when generic names were unavailable, 
which might have impacted data accuracy. Additionally, 
the study faced challenges in identifying health technol-
ogy innovations and distinguishing between established 
businesses and start-ups. As a result, certain health in-
novations, including process innovations and non-medical 
product categories like digital health, e-health, cold chain, 
and prototypes, were not considered for health agency 
approval. Moreover, the study did not assess the outcome 
of patents granted as a measure of success for health in-
novations. Moving forward, qualitative research could shed 
light on factors contributing to the failure of regulatory 
approval for specific innovations, helping stakeholders 
address barriers to clearance. This knowledge would assist 
stakeholders in creating a more supportive environment 
for health innovation and encourage innovation agencies 
to provide appropriate assistance for regulatory clearance. 
Broader consideration of health innovations, including 
process innovations and non-medical product categories, 
could enhance our understanding of the health technol-
ogy landscape’s impact on healthcare. Future research 
should also explore the relationship between patenting 
and innovation success, recognizing the potential role 
of intellectual property protection in health technology 
development and commercialization.

CONCLUSION

This review emphasizes the success of health innova-
tions for the innovations mapped through our pre-defined 
inclusion criteria. We have considered health innovations 
mapped from 2015 to 2022 for this study. The distribution 
of health innovations as per the country of origin showed 
an uneven pattern and suggested that many innovations 
were incubated from high-income countries by the global 
agencies and WHO. The analysis also found specific innova-
tions scaled up from high-income countries but intended 
for low and LMICs. The success of such innovations could 
not be determined only through health agency approval 
status. Health innovation support during the selected time 
duration showed an uneven pattern in supporting health 
innovations from the innovation agencies. Medical devices 
were the highest-mapped category of health innovation. 
Assessment of success for process innovations and e-health 
interventions could not be assessed for their success status 
as they do not require health agency approval. The report 
found that over three-fourths of health innovations fail to 
obtain regulatory clearance. This suggests the need for 
critical intervention interventions in health innovation 
facilitation by the innovation agencies. Innovations are 
paramount regarding healthcare equity and achieving the 
United Nation’s sustainable development goals. However, 
meager support could result in redundant resource wast-
age. Hence, the global health agencies should streamline 
the process of innovation support. 

ACKNOWLEDGMENT

The authors thank Mr. Keerthan RM and Ms. Sesetti 
Harshitha for their valuable input on developing this paper. 

REFERENCES
1. Flessa S, Huebner C. Innovations in Health Care—A 

Conceptual Framework. Int J Environ Res Public Health. 
2021 Sep 24;18(19):10026. 

2. Kelly CJ, Young AJ. Promoting innovation in healthcare. 
Future Healthc J. 2017 Jun;4(2):121–5. 

3. David Y. Medical Technology - an overview | ScienceDirect 
Topics [Internet]. [cited 2023 Oct 3]. Available from: 



Ramesh, Nithyavathani J, Syed, Kachroo, Sharma, Priyadarshini, Latha, Chowdary: A Landscape Study to Determine the 
Innovation Mortality Rate in Health Technology Innovations Across the Globe 

J Global Clinical Engineering Vol.6 Issue 2: 2024  14

https://www.sciencedirect.com/topics/social-sciences/
medical-technology

4. Amjad A, Kordel P, Fernandes G. A Review on Innova-
tion in Healthcare Sector (Telehealth) through Artificial 
Intelligence. Sustainability. 2023 Jan;15(8):6655. 

5. Herzlinger RE. Why Innovation in Health Care Is So Hard. 
Harvard Business Review [Internet]. 2006 May 1 [cited 
2023 Oct 3]; Available from: https://hbr.org/2006/05/
why-innovation-in-health-care-is-so-hard

6. Kasoju N, Remya NS, Sasi R, Sujesh S, Soman B, Kesavadas 
C, et al. Digital health: trends, opportunities and chal-
lenges in medical devices, pharma and bio-technology. 
CSI Transactions on ICT. 2023;11(1):11–30. 

7. Dziallas M, Blind K. Innovation indicators throughout 
the innovation process: An extensive literature analysis. 
Technovation. 2019 Feb 1;80–81:3–29. 

8. Yadav V, Goyal P. User innovation and entrepreneurship: 
case studies from rural India. Journal of Innovation 
and Entrepreneurship. 2015 Apr 22;4(1):5. 

9. World Health Organization. Innovation Institute. [cited 
2023 Oct 3]. Why Commercialize? Available from: 
https://www.innovation.pitt.edu/for-inventors/
why-commercialize/

10. Blank S, Eckhardt JT. Why the Lean Start-Up 
Changes Everything [Internet]. [cited 2023 Oct 
3]. Available from: https://hbr.org/2013/05/
why-the-lean-start-up-changes-everything

11. Saarikko T, Westergren UH, Blomquist T. Digital 
transformation: Five recommendations for the digi-
tally conscious firm. Business Horizons. 2020 Nov 
1;63(6):825–39. 

12. Yangyi M, Ma Y. Innovation Ecosystem Analysis 1986-
2017: A Citation-Based Literature Survey [Internet]. 
2018 [cited 2023 Oct 3]. Available from: https://www.
scirp.org/(S(351jmbntv-nsjt1aadkposzje))/journal/
paperinformation.aspx?paperid=88796

13. Bala Subrahmanya MH. Competitiveness of High-Tech 
Start-Ups and Entrepreneurial Ecosystems: An Over-
view. JGBC. 2022 Jun 1;17(1):1–10. 

14. Stevens GA, Burley J. 3,000 Raw Ideas = 1 Commer-
cial Success! Research Technology Management. 
1997;40(3):16–27. 

15. Pisano GP. You Need an Innovation Strategy. Harvard 
Business Review [Internet]. 2015 Jun 1 [cited 2023 
Oct 3]; Available from: https://hbr.org/2015/06/
you-need-an-innovation-strategy

16. Datta A, Reed R, Jessup L. Commercialization of in-
novations: an overarching framework and research 
agenda. American Journal of Business. 2013 Oct 21;28. 

17. UNCTAD. Technology and innovation report 2021:: 
catching technological waves, innovation with equity 
[Internet]. UN,; 2021 [cited 2023 Oct 3]. Available 
from: https://digitallibrary.un.org/record/3926808

18. Cefis E, Marsili O. Survivor: The role of innovation in 
firms’ survival. Research Policy. 2006 Jun 1;35(5):626–41. 

19. World Health Organization. WHO Compendium of in-
novative health technologies for low-resource settings 
2021. COVID-19 and other health priorities [Internet]. 
[cited 2023 Oct 3]. Available from: https://www.who.
int/publications/i/item/9789240049505

20. BIRAC-Home [Internet]. [cited 2023 Oct 3]. Available 
from: https://www.birac.nic.in/

21. PATH. PHC Tech [Internet]. [cited 2023 Oct 3]. Available 
from: https://www.path.org/p/phc-tech/

22. Grand Challenges. Grand Challenges [Internet]. [cited 
2023 Oct 3]. Available from: https://www.grandchal-
lenges.org/

23. van den Hoed MW, Backhaus R, de Vries E, Hamers JPH, 
Daniëls R. Factors contributing to innovation readiness 
in health care organizations: a scoping review. BMC 
Health Services Research. 2022 Aug 5;22(1):997. 

24. Process I of M (US) C on the PHE of the F 510(k) C, 
Wizemann T. Impact of the Regulatory Framework 
on Medical Device Development and Innovation. In: 
Public Health Effectiveness of the FDA 510(k) Clear-
ance Process: Balancing Patient Safety and Innovation: 
Workshop Report [Internet]. National Academies Press 
(US); 2010 [cited 2023 Oct 3]. Available from: https://
www.ncbi.nlm.nih.gov/books/NBK209794/

25. World Trade Organization. WTO | Understanding the 
WTO - Intellectual property: protection and enforce-
ment [Internet]. [cited 2023 Oct 3]. Available from: 
https://www.wto.org/english/thewto_e/whatis_e/
tif_e/agrm7_e.htm

https://www.sciencedirect.com/topics/social-sciences/medical-technology
https://www.sciencedirect.com/topics/social-sciences/medical-technology
https://hbr.org/2006/05/why-innovation-in-health-care-is-so-hard
https://hbr.org/2006/05/why-innovation-in-health-care-is-so-hard
https://www.innovation.pitt.edu/for-inventors/why-commercialize/
https://www.innovation.pitt.edu/for-inventors/why-commercialize/
https://hbr.org/2013/05/why-the-lean-start-up-changes-everything
https://hbr.org/2013/05/why-the-lean-start-up-changes-everything
https://www.scirp.org/(S(351jmbntv-nsjt1aadkposzje))/journal/paperinformation.aspx?paperid=88796
https://www.scirp.org/(S(351jmbntv-nsjt1aadkposzje))/journal/paperinformation.aspx?paperid=88796
https://www.scirp.org/(S(351jmbntv-nsjt1aadkposzje))/journal/paperinformation.aspx?paperid=88796
https://hbr.org/2015/06/you-need-an-innovation-strategy
https://hbr.org/2015/06/you-need-an-innovation-strategy
https://digitallibrary.un.org/record/3926808
https://www.who.int/publications/i/item/9789240049505
https://www.who.int/publications/i/item/9789240049505
https://www.birac.nic.in/
https://www.path.org/p/phc-tech/
https://www.grandchallenges.org/
https://www.grandchallenges.org/
https://www.ncbi.nlm.nih.gov/books/NBK209794/
https://www.ncbi.nlm.nih.gov/books/NBK209794/
https://www.wto.org/english/thewto_e/whatis_e/tif_e/agrm7_e.htm
https://www.wto.org/english/thewto_e/whatis_e/tif_e/agrm7_e.htm


15 J Global Clinical Engineering Vol.6 Issue 2: 2024

Ramesh, Nithyavathani J, Syed, Kachroo, Sharma, Priyadarshini, Latha, Chowdary: A Landscape Study to Determine the 
Innovation Mortality Rate in Health Technology Innovations Across the Globe 

26. Khadem Broojerdi A, Baran Sillo H, Ostad Ali Dehaghi 
R, Ward M, Refaat M, Parry J. The World Health Orga-
nization Global Benchmarking Tool an Instrument to 
Strengthen Medical Products Regulation and Promote 
Universal Health Coverage. Front Med (Lausanne). 
2020 Aug 19;7:457. 

27. Setyawan O, Rahman S, Santoso PH. INNOVATION, AND 
DEATH RATE OF ENTERPRISE. International Conference 
of Business and Social Sciences [Internet]. 2020 Oct 4 
[cited 2023 May 19]; Available from: http://61.8.77.171/
index.php/icobuss1st/article/view/92

28. Ellwood P, Williams C, Egan J. Crossing the valley of 
death: Five underlying innovation processes. Techno-
vation. 2022 Jan 1;109:102162. 

29. Stern AD. Innovation under Regulatory Uncertainty: 
Evidence from Medical Technology. J Public Econ. 2017 
Jan;145:181–200. 

30. Ventola CL. Challenges in Evaluating and Standardizing 
Medical Devices in Health Care Facilities. P T. 2008 
Jun;33(6):348–59. 

31. Harvard Business Review. Innovation Risk: How 
to Make Smarter Decisions [Internet]. [cited 2023 
Oct 3]. Available from: https://hbr.org/2013/04/
innovation-risk-how-to-make-smarter-decisions

32. Science, technology and innovation policy - OECD [In-
ternet]. [cited 2023 Jun 14]. Available from: https://
www.oecd.org/sti/inno/

33. Arora A, Wright A, Cheng TKM, Khwaja Z, Seah M. In-
novation Pathways in the NHS: An Introductory Review. 
Ther Innov Regul Sci. 2021 Sep 1;55(5):1045–58. 

34. Haas DA, Jellinek MS, Kaplan RS. Hospital Budget 
Systems Are Holding Back Innovation. Harvard Busi-
ness Review [Internet]. 2018 Mar 29 [cited 2023 
Jun 12]; Available from: https://hbr.org/2018/03/
hospital-budget-systems-are-holding-back-innovation

35. Ajami S, Bagheri-Tadi T. Barriers for Adopting Elec-
tronic Health Records (EHRs) by Physicians. Acta 
Inform Med. 2013;21(2):129–34. 

36. McKinsey & Company. The next wave of healthcare 
innovation | McKinsey [Internet]. [cited 2023 Oct 
3]. Available from: https://www.mckinsey.com/
industries/healthcare/our-insights/the-next-wave-
of-healthcare-innovation-the-evolution-of-ecosystems

37. Global Innovation Index. Global Innovation Index 
| What is the future of innovation-driven growth? 
[Internet]. [cited 2023 Oct 3]. Available from: https://
www.globalinnovationindex.org/Home

http://61.8.77.171/index.php/icobuss1st/article/view/92
http://61.8.77.171/index.php/icobuss1st/article/view/92
https://hbr.org/2013/04/innovation-risk-how-to-make-smarter-decisions
https://hbr.org/2013/04/innovation-risk-how-to-make-smarter-decisions
https://www.oecd.org/sti/inno/
https://www.oecd.org/sti/inno/
https://hbr.org/2018/03/hospital-budget-systems-are-holding-back-innovation
https://hbr.org/2018/03/hospital-budget-systems-are-holding-back-innovation
https://www.mckinsey.com/industries/healthcare/our-insights/the-next-wave-of-healthcare-innovation-the-evolution-of-ecosystems
https://www.mckinsey.com/industries/healthcare/our-insights/the-next-wave-of-healthcare-innovation-the-evolution-of-ecosystems
https://www.mckinsey.com/industries/healthcare/our-insights/the-next-wave-of-healthcare-innovation-the-evolution-of-ecosystems
https://www.globalinnovationindex.org/Home
https://www.globalinnovationindex.org/Home

