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Received February 20, 2020, accepted May 8, 2020, date of publication May 19, 2020

A Model for Priority Setting in Health Technology 
Innovation Policy 

By J. Sharma1,2; J. Bunders2; T. Zuiderent-Jerak2; B. Regeer2  

1 CEO, AP Med Tech Zone & Executive Director, Kalam Institute of Health Technology, Visakhapatnam, India. 
2 Athena Institute, Vrije Universiteit Amsterdam.

ABSTRACT
Health Technology Assessment focuses on the equal appraisal of health technologies introduced into the market. This has made 
regulators and the governance of innovation reactive and dependent on the initiatives that innovators take for technology de-
velopment, thus making it supply-driven. The policy-makers’ role has become one of appraising technologies that are already 
developed rather than guiding the development agenda. This severely limits the possibility to ensure that health technologies 
sufficiently address major issues such as the burden of disease, trade deficit, and health inequalities. It places governments outside 
of the actor arena that co-shapes technologies in the early stages, restricting the involvement in facilitating whether to scale up 
or not. It makes it hard to achieve health technology governance practices that maximally contribute to ensuring technological 
developments that address public concerns. What is the potential of the framework for changing this dynamic and how can 
evidence shape technology development agendas without falling into the traps of regulator lock-in or social engineering? The 
methodology presented in this study takes the first important steps toward an evidence-based framework for priority setting 
to guide innovations, particularly in the health and social sectors.

Keywords – Assessment, health technology, medical technology, regulation, innovation, development, priority setting. 

Copyright © 2021. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY): Creative Commons - Attribution 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 permitted which does not comply with these terms.

INTRODUCTION
The appraisal of health technologies introduced in the 

market is of utmost relevance for healthcare governance. 
One of the greatest challenges that governments face is 
aligning the agenda of technology development with social 
indicators like the burden of disease and macro-economic 
indicators like trade. However, the role of evidence-based 
policy restructuring in guiding medical device development 
has remained an overlooked possibility. Understanding 
the necessities and gaps in medical device development 
could have major consequences for sectoral advancement 
and its benefits to the society instead of being locked in a 
supply-driven mode. As the current COVID-19 pandemic 

painfully shows, it is also necessary to take into account a 
country’s capacity for self-sufficiency in terms of manufac-
turing the devices used in their territories and becoming 
more independent from importing medical devices and the 
economic impacts of such import. The pandemic shows 
that countries across the world, lower-middle-income 
countries (LMICs) as well as high-income countries 
(HICs), have all become largely dependent on the import 
of medical devices and that self-sufficiency by no means 
is a concern for emerging economies alone. This study 
aims to provide an evidence-based framework for priority 
setting in guiding innovations by developing a practical 

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25 J Global Clinical Engineering Vol.2 Issue 3: 2020

Sharma, Bunders, Zuiderent-Jerak, Regeer: A Model for Priority Setting in Health Technology Innovation Policy  

model that can be implemented using country-specific 
data that reflects the actual territorial needs and can be 
related to the countries’ economic capabilities. A set of 
composite indicators have been identified and used for 
the priority setting exercise. Firstly, the quality of human 
life is a major indication of national economic progress 
and human development index.1 The corollary of Gross 
Domestic Productivity as a human health welfare index 
is an indication of national health,2 both economic and 
contextual. One major parameter for the identification 
of wellness of populace is public health data records.3 

All countries have their specific manner of maintaining 
public health records4 and analysis methodologies5 to 
use evidence from such records. 

While minor variations in the analytical tools might be 
present, one common consensus among all government 
structured health analytics is the importance of mortal-
ity records.6 Of the common parameters of assessing 
disease-affected livelihood, the Quality-Adjusted Life-Year 
is a generic measure of disease burden, including both 
the quality and the quantity of life lived. The Institute of 
Health Metrics and Evaluation (IHME) at the University 
of Washington published a report titled WHO Global 
Burden of Disease (GBD) which considered Disability-
Adjusted-Life-Year (DALY) as the point of consideration 
for disease-affected livelihood.7,8 

To consolidate the data of the major disease burden for 
India, this study focused on interpolating the diseases that 
are of immense concern. Each disease has a large number 
of diagnostic, therapeutic, rehabilitative, and palliative 
procedures meant for combating the condition. While 
the diseases are classified under the International Clas-
sification of Disease (ICD-11) by WHO, the interventions 
to tackle such diseases are listed under the International 
Classification of Health Interventions also by WHO. The 
interventions are thereafter dependent on various health 
technologies, and while pharmaceutical products often 
come with varied alternatives, most medical devices do 
not have an alternative for the patient nor operationally 
for the care provider. For example, while several lines of 
drug therapy exist for non-communicable diseases such 
as renal failure or diabetes, there are no alternatives to 
a dialysis machine, a dialyzer, a glucometer, or an insu-
lin pump. There lies an important distinction between 

medical devices, with both devices and drugs being health 
technologies. 

Furthermore, by conceptually combining the evidence 
from the burden of disease estimates for a country to the 
export-import trade data on medical devices, a model list 
could be enumerated to estimate which medical devices 
could be developed in a country, which would be reflective 
of its health as well as economic impact. This reasoning 
was applied in this study to India’s context. As a country, 
India currently imports >80% of its medical device needs.9 

This ranges across all healthcare paradigms as well as 
all domains of devices.10 It greatly affects the healthcare 
cost attributed primarily to capital expenditure on com-
modities as essential as health technologies.11 The overall 
medical devices market in India is estimated to be USD 
7 billion,12 however the country imports over 80% of its 
needs, making medical technology acquisition costlier 
which negatively impacts the healthcare costs. The medi-
cal device market in India is growing at a 15.8% CAGR 
(compound annual growth rate) and is postulated as the 
fourth largest potential globally.

The methodology described in this paper, using a model 
that could cross-pollinate information from both disease 
burden and trade deficit has several advantages. Firstly, 
avoidable death or disabilities from disease or ailments 
that could be possibly cured by medical technology is an 
effective indicator of meaningful technological and scien-
tific progress. Secondly, the import dependency on such 
devices including life-saving ones has a direct impact on 
the country’s trade deficit impacting its macro-economic 
growth and therefore societal progress. Needless to say, 
United Nations in its 17 Sustainable Development Goals 
has given equal importance to these by keeping poverty 
elimination as Goal 1; Good Health and well-being as Goal 
3; and Industry, Innovation, and Infrastructure as Goal 9. 

Aligning these goals for priority setting in medical 
technology innovation could, therefore, result in health 
improvement and economic sustainability. This would also 
help realign the trade and export-import decision-making 
processes to encourage domestic manufacturing, which is 
increasingly important in light of world-wide outbreaks 
of infectious diseases. To the best of our knowledge, this 
study presents the first-ever attempt in correlating these 



Sharma, Bunders, Zuiderent-Jerak, Regeer: A Model for Priority Setting in Health Technology Innovation Policy 

J Global Clinical Engineering Vol.2 Issue 3: 2020  26

essential principles to establish a pathway for medical 
technology development and drive innovation policy to 
improve healthcare access, economic sustainability, and 
societal impact. 

METHODS AND RESULTS
In this section, the creation of a model or methodology 

to enumerate the priority list of medical devices that need 
to be developed is explained. The methodology is also a 
part of the results themselves, given that this study focuses, 
first, on the creation of a model and then application of 
the model to do the priority listing. For this reason, the 
authors opted to merge the methods and the results in 
the same section. 

To estimate disease burden, the main causes of mortal-
ity compared over a decade for India, estimated by the 
IHME was used and are tabulated below (see Table 1). 
Trends from 2005 to 2015 signify that while there has 
been a substantial decline in mortality due to neonatal 
complications, mortality due to metabolic disease and/
or lifestyle diseases has overtaken the mortality due to 
communicable diseases – a classic trend across develop-
ing economies. 

Table 2 signifies similar parameters in the disability 
or morbidity estimates since mortality can be indicative 
but does not singularly affect GDP or macro-economic 
progress in a population. 

The aspects under study were disease models which 
required significant medical device intervention, hospi-
talization, or otherwise. To outline the relevant causative 
factors and disease conditions, the major disease burdens 
were classified as communicable and non-communicable. 
The top five from both were enlisted and relevant treat-
ment procedures that required technological interventions 
were detailed. 

Concomitantly each of the medical devices used for 
diagnosis and treatment were mapped for each of the 
therapies corresponding to the diseases. Further, the 
segmentation of medical devices was charted by bringing 
in common devices used for these diseases. This had a 
relationship of one-to-many (e.g., cardiac and pulmonary 
diseases require more than one medical device) but also 
of many-to-one (hollow fiber membrane finding applica-
tion in dialysis, oxygenator, ECMO and the like) (Figure 1). 

Table 3 entails the communicable diseases list and 
technological interventions required to tackle such disease 
conditions. Table 4 enlists the non-communicable diseases 
and their diagnostic methods involving technological 

TABLE 1. Top 10 Causes of Death in 2015 and Percent 
Change From 2005 (Data from Institute of Health Metrics 
and Evaluation, India)

Cause of Death 2015 
(rank)

2005 
(rank)

% change

Ischemic heart diseaseHeart 
Disease 1 1 (+) 16.7%

Chronic Obstructive Pulmonary 
Disorder 2 2 (+) 4.3%

Cerebrovascular diseaseDisease 3 3 (+) 7.3%

Lower Respiratory Infection 4 5 (−)(-) 22.6%

Diarrheal diseaseDisease 5 4 (−)(-) 31.7%

Tuberculosis 6 6 (−)(-) 30.7%

Diabetes 7 11 (+) 34.8%

Chronic Kidney Disease 8 10 (+) 20.6%

Neonatal prePre-term birthBirth 9 7 (−)(-) 39.5%

Road injuriesInjuries 10 9 (−)(-) 2.7%

Neonatal encephalopathy 11 8 (−)(-) 31.0%

TABLE 2. Top 10 Causes of Disability in 2015 (Data from In-
stitute of Health Metrics and Evaluation, India)

2015 Rank Disability Causes

1 Iron Deficiency Anemia

2 Low Back and Neck Pain

3 Sense Organ Diseases

4 Depressive sDisorders

5 Musculoskeletal Disorders

6 Migraine

7 Skin Diseases

8 Diabetes

9 Anxiety Disorders

10 Chronic Obstructive Pulmonary Disorders



27 J Global Clinical Engineering Vol.2 Issue 3: 2020

Sharma, Bunders, Zuiderent-Jerak, Regeer: A Model for Priority Setting in Health Technology Innovation Policy  

interventions that are critical to disease treatment or 
mitigation.

FIGURE 1.  Model flow diagram of Burden of Disease to Categories 
of Interventions to Medical Devices Involved. Starting from the 
left: (1) Make a list of non-communicable and communicable 
diseases in order of highest burden (see Tables 1 and 2). (2) 
Identify diagnosis methods and device-related interventions 
for the top 5 diseases (see Tables 3 and 4). (3) Create a con-
solidated list of essential medical technologies (see Table 7) by 
combining the priority lists of medical and diagnostic devices 
for communicable and non-communicable diseases (Tables 5 
and 6). Next, starting from the right: (4) Tabulate export and 
import data of categorized medical devices (see Table 8). (5) 
Consolidate high import and low export-dependent devices 
(see Table 9) as they require the increase or improvement in 
internal manufacturing capability to create self-dependency, 
higher affordability, and greater access.

TABLE 3. Classification of Communicable Diseases and their 
Corresponding Technological Dependencies

Rank
Communicable 

Disease or 
Infectious Disease

Diagnosis Methods and Device-Related 
Interventionsdevice related interventions 

and uses

1

Malaria, dengue, 
parasitic infections 

like filariasis, 
and hookworm 

infestation

Microscopic examination
Rapid diagnostic tests

Molecular testing
Antibody testing (IgG and IgM)

Fecal matter testing with PCR assays 
Endoscopy of intestinal tracts 

DNA testing
Surgery

Serological techniques

2 

Diarrheal diseases 
along with 

amoebiasis and 
cholera, and similar 
gastroenteritis, and

typhoid

Microscopic examination
Cyst search in fecal matter

Serological techniques
DNA testing

Rapid dipstick urine testing
Swab samples

Laboratory examinations
Endoscopy and colonoscopy

Blood culture
Stool culture

Bone marrow culture
Widal testing

Typhidot medical testing (for detection of 
IgG and IgM antibodies)

3

Tuberculosis, and 
fever-associated 
complications 

like influenza and 
leptospirosis

LED microscopic examination
Commercial culture and DST

Testing TB and drug resistance using Xpert 
MTB/RIF assay

Diagnosis and screening of active 
tuberculosis in people living with HIV, 

using lateral flow urine lipoarabinomannan 
assay

Detection of resistance to second-line anti-
tuberculosis drugs using molecular line 

probe assays 
Diagnosis of pulmonary TB using loop-

mediated isothermal amplification 
Detection of resistance to isoniazid and 
rifampicin using molecular line probe 

assays 
Latent TB infection testing (TST or IGRA)

Ultrasound imaging
Sputum cultures

Mantoux tuberculin skin tests
Nucleic acid amplification tests

Adenosine deaminase tests
Serology, virus isolation and culture, 

antigen detection, RNA detection by PCR
endoscopy

Examination using flashlight
X-ray

Examination using tongue depressors
Serum tests
Blood tests

Kidney function tests
Liver function tests

ELISA tests
PCR tests

Microscopic agglutination tests



Sharma, Bunders, Zuiderent-Jerak, Regeer: A Model for Priority Setting in Health Technology Innovation Policy 

J Global Clinical Engineering Vol.2 Issue 3: 2020  28

Data were collected by taking into account the top five 
communicable and top five non-communicable diseases 
which account for the most lives lost as per the latest 
data available. 

With the perspectives of disease paradigm enlisted 
on priority, our methodology brought in the next compo-
nent of these diseases and their possible intervention to 
prevent prevalence or provide treatment. Matching was 
done between diseases and relevant medical devices of 
the relevant intervention procedure from the prior lists 
removing overlapping entities if any. Table 5 lists the 
priority medical and diagnostic devices in communicable 
diseases subset, while Table 6 details the priority medical 
and diagnostic devices list for non-communicable ones. By 
merging the two previously referred lists and removing 
overlapping entities, a common list of essential medical 
technologies was created as shown in Table 7, consoli-
dating this entire dataset. This list is referred to as the 
“priority list of medical and diagnostic devices on the 

Rank
Communicable 

Disease or 
Infectious Disease

Diagnosis Methods and Device-Related 
Interventionsdevice related interventions 

and uses

4 

Jaundice and 
hepatitis, and 

similar diseases 
which affects the 

liver

Blood tests
Urine tests
Fecal tests

LFT
Ultrasound imaging

Computerized tomography scan
Magnetic resonance imaging scan

Endoscopic retrograde 
cholangiopancreatography with the help of 

X-ray
Liver biopsy

LFT
Hepatitis A, B, D, and C marker tests

5

Venereal diseases 
like STDs 

(gonorrhea, syphilis, 
HIV, etc.,)

Blood tests
Urine samples
Fluid samples

Diaphragm or cervical cap
Male condom

Female condoms
Cervical cap

DST = drug susceptibility testing; HIV = human immunodeficiency 
virus; LED = light-emitting diode; PCR = polymerase chain reaction; 
STDs = sexually transmitted diseases; TB = tuberculosis.

TABLE 4. Classification of Non-communicable Diseases and 
their Corresponding Technological Dependencies

Rank
Non-

Communicable 
Disease

Diagnosis Methods and Device-Related 
Interventionsdevice related interventions 

and uses

1 CAD or IHD and 
their abnormalities

CAD and IHD diagnosis and monitoring 
using ECG

Holter monitoring
Event monitoring

Cardiac stress testing
Ultrasonic imaging of the heart using 

echocardiography 
Nuclear stress testing (radioisotopes 

injected into the bloodstream)
Heart CT scan (CT coronary angiogram), 

which requires high-speed CT scanner 
Coronary catheterization (diagnosis and 

interventional purpose, invasive)
Intravascular ultrasound

Intracoronary optical coherence 
tomography
Fluoroscopy

2

COPD, lower 
respiratory tract 

infection, and 
asthma

Spirometry
Chest radiography

CT scan
Complete blood count

Arterial blood gas analysis
Other pulmonary function tests 

3
Cerebrovascular 

disease and 
strokes

Carotid angiogram
CT scan

Magnetic resonance imaging scan
ECG

Cerebral angiogram
Vertebral angiogram

4

Diabetes and 
obesity-associated 

disorders like 
hypertension

Glycated hemoglobin (A1C) test
Random blood sugar test
Fasting blood sugar test

Oral glucose tolerance test

5
Iron deficiency 

and protein 
malnutrition 

Complete blood count (using microscope 
or analyzers)

Endoscopy (to check for internal bleeding 
in the upper gastrointestinal tract)

Colonoscopy (to check for internal bleeding 
in the lower gastrointestinal tract)

Ultrasound imaging

CAD = coronary artery disease; CT = computed tomography; COPD 
= chronic obstructive pulmonary disease; ECG = electrocardiogram; 
IHD = ischemic heart disease. 



29 J Global Clinical Engineering Vol.2 Issue 3: 2020

Sharma, Bunders, Zuiderent-Jerak, Regeer: A Model for Priority Setting in Health Technology Innovation Policy  

disease burden context.” This formed half of our dataset 
for this study. 

A second dataset was also created, referred to as the 
priority list in medical devices from the perspective of 
trade using export-import data as available in the public 
TABLE 5. Priority List of Medical and Diagnostic Devices 
Communicable Diseases

Communicable Disease Priority List of Medical Devices

• Malaria, dengue, 
parasitic infections like 
filariasis, and hookworm 
infestation

• Diarrheal diseases along 
with amoebiasis and 
cholera, and similar 
gastroenteritis, and 
typhoid

• Tuberculosis, and fever-
associated complications 
like influenza and 
leptospirosis

• Jaundice and hepatitis, 
and similar diseases 
which affect the liver

• Sexually transmitted 
diseases (gonorrhea, 
syphilis, human 
immunodeficiency virus, 
etc.)

• Microscopes
• Rapid diagnostic test kits
• Antibody testing (IgG and 

IgM) kits
• Fecal matter examination kits
• Complete Blood Testing kits 

(viz. kidney function test, liver 
function test)

• DNA and protein-based test 
assays

• Devices for serological 
techniques and Widal tests

• Kits for biopsy including fluid 
and tissue 

• Endoscope, Colonoscope, 
Duodenoscope, and 
Sigmoidoscope

• Ultrasound imaging Devices
• X-ray imaging devices
• Computed tomography 

scanner
• Magnetic resonance imaging 

scanner
• Female condom and cervical 

cap

TABLE 6. Priority List of Medical and Diagnostic Devices 
Non-communicable Diseases 

Communicable Disease Priority List of Medical Devices

• Malaria, dengue, 
parasitic infections like 
filariasis, and hookworm 
infestation

• Diarrheal diseases along 
with amoebiasis and 
cholera, and similar 
gastroenteritis, and 
typhoid

• Microscopes
• Rapid diagnostic test kits
• Antibody testing (IgG and 

IgM) kits
• Fecal matter examination kits
• Complete Blood Testing kits 

(viz. kidney function test, liver 
function test)

• DNA and protein-based test 
assays

Communicable Disease Priority List of Medical Devices

• Tuberculosis, and fever-
associated complications 
like influenza and 
leptospirosis

• Jaundice and hepatitis, 
and similar diseases 
which affect the liver

• Sexually transmitted 
diseases (gonorrhea, 
syphilis, human 
immunodeficiency virus, 
etc.)

• Devices for serological 
techniques and Widal tests

• Kits for biopsy including fluid 
and tissue 

• Endoscope, Colonoscope, 
Duodenoscope, and 
Sigmoidoscope

• Ultrasound imaging Devices
• X-ray imaging devices
• Computed tomography 

scanner
• Magnetic resonance imaging 

scanner
• Female condom and cervical 

cap

CAD = coronary artery disease; CT = computed tomography; COPD 
= chronic obstructive pulmonary disease; ECG = electrocardiogram; 
IHD = ischemic heart disease.

TABLE 7. Priority List of Medical and Diagnostic Devices 
on the Disease Burden Context for both Communicable and 
Non-communicable Diseases

Priority Common Medical and Diagnostic Devices

• Microscopes

• Rapid diagnostic test kits

• Antibody testing kits (IgG and IgM)

• Examination kits for fecal matter 

• Complete blood tests (viz. kidney function tests, liver 
function tests)

• DNA and protein-based test assays

• Serological techniques and Widal tests

• Kits for biopsy including fluid and tissue 

• Endoscope, colonoscope, duodenoscope, and 
sigmoidoscope

• Ultrasound imaging devices and probes (including 
intravascular ultrasound)

• X-ray imaging device

• CT scanner (including heart CT scanner)

• Magnetic resonance imaging scanner



Sharma, Bunders, Zuiderent-Jerak, Regeer: A Model for Priority Setting in Health Technology Innovation Policy 

J Global Clinical Engineering Vol.2 Issue 3: 2020  30

domain. This list looked at medical devices apropos their 
HS codes. The Harmonized Commodity Description and 
Coding System, also known as the Harmonized System (HS) 
of tariff nomenclature is an internationally standardized 
system of names and numbers to classify traded products.

The entire export and import data of categorized medi-
cal devices were tabulated as per recent import figures 
compared against the past few years of export (Table 8). It 
was postulated that threshold or higher exports indicated 
self-dependency, higher affordability, and greater access. 
By opposition, the extreme or high import dependency 
denoted greater costs and lower accessibility. Figure 2 
illustrates the two types of scenarios mentioned, A and 
B, respectively. The consolidated high import and low 

export-dependent devices (driven from the illustrative 
scenario B) were then highlighted and tabulated into 
segments that required an increase or improvement in 
internal manufacturing capability. Table 9 forms the other 
half of the dataset of the study from the trade perspective.

Further, two of the aforesaid priority lists (Table 5 and 
Table 9) were overlapped in a Venn diagram format, creat-
ing an intersection area of the priority list. The outcome 

of this entire exercise (Figure 3) was then subjected to 
expert discussion. The expert group included public health 
experts, epidemiologists, academia, research scientists, 
and user specialists.

Using the listed medical devices in the priority list that 
qualified expert group approval, these medical devices 
were mapped to their current domestic manufacturing 

Priority Common Medical and Diagnostic Devices

• Female condom and cervical cap

• Heart monitoring devices (ECG, Holter monitor, and event 
monitor)

• Echocardiogram device

• Nuclear stress test (radioisotope)

• C-arm (for cerebral angiogram, vertebral angiogram, 
carotid angiogram)

• Stents (drug eluting for angioplasty, cerebroangioplasty)

• Balloon catheters (angioplasty, cerebroangioplasty)

• Spirometer

• Mechanical ventilators and accessories

• Nebulizers and accessories

• Disposable resuscitators

• Portable oxygen units

• Automatic insulin pumps

• Syringes with needles

• Sutures and surgical instruments

• Blood bags and accessories

• Portable oxygen concentrators

CT = computed tomography; ECG = electrocardiogram.

FIGURE 2.  Diagram of the import and export data relationship in 
a country. Scenarios A and B are depicted, as resulting in a lower 
medical device (MD) cost and higher accessibility (Scenario A) 
and greater MD device cost and lower affordability. Illustrative 
scenario B is the focus model of the trade data in this study.

 

Burden of 
Disease  

Import 
Dependency  

National 
Priority List 

FIGURE 3.  Consolidated modeling of the priority lists from the 
burden of disease and trade dataset to arrive at the national 
priority list.



31 J Global Clinical Engineering Vol.2 Issue 3: 2020

Sharma, Bunders, Zuiderent-Jerak, Regeer: A Model for Priority Setting in Health Technology Innovation Policy  

capability. This was named as the Priority List of Health 
Technology and was used as a key approval criterion by a 
public agency for providing financial support for further 
research. 

As some devices in the list could have domestic pro-
duction viability for some of its components but would be 
completely dependent on exports for other components, 
it was also critical to understand which critical parts of 
components needed additional or focused research. To 
understand the key components of these technologies, 
two-day technology consultation was organized. This was 

named as “FIRST” (Formative Industry Leaders Research 
Institutes Start-up Partners Technology Meet) to identify 
essential components for focused research. The technology 
consultation included innovators, researchers, academia 
and industry, in which the shortcomings were highlighted 
and the technology development pathway discussed.

As part of the consultative process, a list of 108 Core 
Technology Components was identified. The list was then 
submitted to the concerned agencies within the government 
that provide funding for technology research. Requests 
for proposal for these were subsequently released by the 

TABLE 8. High Import Category of Medical Devices (Year 2014 – 2015, reference Directorate General of Foreign Trade, Govern-
ment of India)

S No. HS Code Commodity
EXPORT - 

Year 2013-14 
(million USD) 

EXPORT - 
Year 2014-15 

(million USD)

IMPORT - 
Year 2013-14 

(million USD)

IMPORT - 
Year 2014-15 

(million USD)

1 90189099 Other surgical instruments and appliances 
(including veterinary)  59.50  56.08  235.32  246.98 

2 90185090 Ophthalmic surgical instrument and appliances  11.09 12.57  117.76 139.15

3 90272000 Chromatographs and electrophoresis instruments 5.03 5.04 104.34 132.97

4 90181990 Other electro - diagnostic apparatus  83.52 68.01 89.84 93.36

5 90181300 Magnetic resonance imaging apparatus 3.23 5.37 74.23 84.48

6 90181290 Other electro - diagnostic apparatus 30.10 83.65 68.31 80.02

7 90213100 Artificial joints 0.68 1.97 63.21 78.50

8 90221200 Computed tomography apparatus 0.52 0.67 70.84 65.03

9 90273010 Spectrometers 1.84 2.52 71.74 59.43

10 90271000 Gas analysis apparatus 4.27 11.00 46.96 58.10

11 90221490 Other X- ray machines for medical uses 84.13 40.14 53.77 52.71

12 90189019 Other diagnostic instruments 17.34 43.94 55.27 51.34

13 90223000 X-ray tubes 20.83 32.78 31.88 43.36

14 90189044 Endoscopes 4.32 6.17 31.14 40.09

15 90184900 Other instruments and appliances, USD in dental 
science 5.26 5.14 32.80 36.76

16 90189029 Other surgical tools 15.86 12.94 39.35 36.31

17 90221900 Apparatus based on use of x-rays, for other use 
including radiography/ radiotherapy apparatus 0.86 1.39 32.68 35.70

18 90183100 Syringes, W/N with needles 27.02 30.06 32.92 34.06

19 90183920 Cardiac catheters 1.66 4.22 33.75 32.24

20 30063000 Preparation material for X-ray exams; Diagnostic 
reagents designed to be administered to patient 8.55 7.96 23.07 23.62



Sharma, Bunders, Zuiderent-Jerak, Regeer: A Model for Priority Setting in Health Technology Innovation Policy 

J Global Clinical Engineering Vol.2 Issue 3: 2020  32

public funding agency under the categories established as 
part of Priority List of Medical Devices for Research. The 
categories include: (1) Biochemistry, (2) Immunology (3) 
Hematology, (4) Histopathology, (5) Molecular Biology, (6) 
Genetics, (7) Imaging, (8) Catheters, (9) Ultrasound, (10) 
Neonatal Equipment, (11) Ventilators, (12) Renal Care, 
(13) Sutures and Scaffolds, (14) Non-cardiac Implants, 
(15) Endoscopy, and (16) Muscular dystrophy treatment.

The list elaborates three distinct categories of research 
priorities. 
1. Health Technologies that are not domestically engi-

neered and add to substantial import, high economic 
costs, and extremely relevant clinical utility.

2. Health Technologies that forms solutions for diseases 
that have not had solutions globally, such as muscular 

dystrophy and their research would be of both national 
as well as global significance.

3. Health Technologies that focus on disease/clinical 
conditions reflective of LMICs/specific geographies 
and whose research would not be priorities in any 
other geography – such as snake bites.

DISCUSSION
This study aimed to provide an evidence-based 

framework for priority setting to guide innovation in the 
healthcare sector. By analyzing a combined dataset of the 
top ten diseases that account for the most lives lost and 
trade impact in India, this study specifically developed a 
method to determine a priority list of medical devices to 
address both the rising burden of diseases and growing 
trade deficit in the medical technology sector. Tradition-
ally, the role of policy-makers has been to focus mainly on 
appraising technologies that are already selected by the 
innovators for research due to knowledge or engineering 
capabilities available with the innovators. Therefore, the 
policy maker’s role has been reactive and necessarily not 
reflective of actual healthcare needs. This methodology 
allows the policy maker’s approach to shifting from being 
merely reactive to actively driving the agenda of technology 
development. To do this, it is necessary to find, based on 
data, what the sectoral needs for development are. To the 
best of our knowledge, this study is the first to develop a 
transparent and intuitive method to establish the National 
Priority List of Medical Devices Research. The results 
of this study are twofold. Firstly, the formulation of the 
model can be considered a result in itself. Secondly, the 
medical device list that resulted from the application of 
the model/method developed for India is another result. 

For the first set of findings, such as the method/model 
creation, it is important to consider that given its intuitive 
steps it can easily be adapted to other national settings, for 
LMIC or even HICs. Similar models could also be applied 
in other contexts besides the medical device sector, after 
further testing, like for instance, in agriculture. 

In this study, a group of 10 diseases (top five com-
municable and top five non-communicable diseases) 
was selected. For other broader studies, this number can 
also be higher, thus resulting in different scale of results. 

TABLE 9. Priority List of Medical and Diagnostic Devices 
from a Trade Deficit Perspective

S. No. HS Code Medical and Diagnostic Device Category 

1. 90272000 Chromatographs and electrophoresis Instruments

2. 90221200 Computed tomography apparatus

3. 90221900 Apparatus based on use of X-rays, for other use 
including radiography/ radiotherapy apparatus

4. 90273020 Spectrophotometers

5. 90189011 Instrument and apparatus for measuring blood 
pressure

6. 90183220 Hollow needles for injection, aspiration, biopsy and 
transfusion

7. 90192010 Oxygen therapy apparatus

8. 90278010 Viscometers

9. 90278030 Instruments and apparatus for measuring the 
surface or interfacial tension of liquids

10. 30062000 Blood-grouping reagents

11. 90275010 Photometers

12. 90275030 Polarimeters

13. 90189024 Surgical tools, chisels, gauges, elevators, osteotome, 
craniotomy, bone cutters, etc.

14. 90229020 Radiation generation units

15. 90189033 Hemofiltration instruments

16. 90189097 Nephrostomy/lithotripsy instruments



33 J Global Clinical Engineering Vol.2 Issue 3: 2020

Sharma, Bunders, Zuiderent-Jerak, Regeer: A Model for Priority Setting in Health Technology Innovation Policy  

Despite the high incidence of communicable diseases, 
non-communicable diseases account for more than half 
of the health crisis and are more life-threatening in nature 
in India.13 The comparative weight of the type of diseases 
(communicable versus non-communicable) could also be 
taken into account when developing national priorities for 
research. To the best of the author’s knowledge, the only 
comprehensive study to estimate summary measures of 
population health for the world, by cause, is the Global 
Burden of Diseases, Injuries, and Risk Factors (GBD) en-
terprise, which was updated by WHO for the years 2000 
and WHO estimates were subsequently updated for the 
year 2004.7 Later, WHO developed a comprehensive and 
consistent set of DALY estimates for years 2000–2012 for 
population, births, all-cause deaths and specific causes of 
death as well as WHO estimates for some specific diseases 
and analyses carried out for the Global Burden of Disease 
2010 study. Thus, using data on causes of premature 
death, loss of health and disability in different popula-
tions’ mortality and disability, other than a disease, would 
be valuable to enrich the model itself and the resulting 
list of priority medical devices. Thus, this methodology 
could be further improved depending upon the contexts 
and breadth of the application intended.

CONCLUSION
The findings of this study outline extrapolative pro-

jections for the future for population health,14 based on 
certain demographic and trade assumptions. We use the 
word assumption with measured responsibility because 
irrespective of the plausible uncertainty, this is only an 
application of epidemiological data and its convergence 
with macro-economic indicators. This is expected to impact 
a generation of indigenous manufacturing and innovation 
that are need-driven, market-driven, as well as highly 
relevant for self-reliance in the context of pandemics. In 
turn, such innovation policy could guide the government 
to make strategic resource allocation, positively impact 
healthcare indicators besides improving manufacturing and 
employment. Similar models for other sectors/programs 
that require to be fueled by innovations is suggested for 
further research. 

Governance of innovation has been influenced by very 
few methods and decision making is reactive to the under-
standing of technology at the point of product submission. 
Such proactive methods, one described through this study, 
could initiate a wider dialogue on resilient innovation 
policy which has become so much more pressing in times 
where all nations simultaneously experience enormous 
dependencies on the import of crucial medical devices.

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