Wednesday 30 December 2020
Friday 25 December 2020
Friday 11 December 2020
HEALTH ECONOMICS – AN OVER VIEW – A WAY FORWARD
-Dr. S. Vijay Kumar
Health economics
is the study of how scarce resources are allocated among alternative uses for
the care of sickness and the promotion, maintenance, and improvement of health,
including the study of how health care and health-related services, their costs
and benefits, and health itself are distributed among individuals and groups in
society. It can, broadly, be defined as “the application of the theories,
concepts and techniques of economics to the health sector”. The Studies of
“Health Economics” provide information
to decision makers for efficient use of available resources for maximizing
health benefits. Economic evaluation is one part of health economics, and it is
a tool for comparing costs and consequences of different
interventions. India is currently pursuing several strategies to improve
health services for its population, including investing in government-provided
services as well as purchasing services from public and private providers
through various schemes. As per the World Health Organization (WHO), in
countries such as India, people who pay for their health care services suffer
“catastrophic costs.” While millions suffer and die in absence of access or
inability to afford medical care, many others suffer because they end up paying
through debts, selling assets, and so forth. Citizens’ expectations for health
care are becoming high in India. The proportion of insurance in health care financing in India is very low, when compared with the developed
countries. In such a situation, I want to present “Health Economics – An Over View - A Way Forward” in
the context of India and world at a glance.
Health economics is important in
determining how to improve health outcomes and lifestyle patterns through
interactions between individuals, healthcare providers and clinical settings.
In broad terms, health economists study the functioning of healthcare systems
and health-affecting behaviors such as smoking, diabetes, and obesity. A
seminal 1963 article by Kenneth
Arrow is often
credited with giving rise to health economics as a discipline. His theory drew
conceptual distinctions between health and other goods. Factors that
distinguish health economics from other areas include extensive government intervention, intractable uncertainty in several dimensions, asymmetric information, barriers
to entry, externality and the presence of a third-party
agent. In healthcare, the third-party agent is the patient's health insurer,
who is financially responsible for the healthcare goods and services consumed
by the insured patient. Health economists evaluate multiple types of financial
information: costs, charges, and expenditures. Uncertainty is intrinsic to
health, both in patient outcomes and financial concerns. The knowledge gap that
exists between a physician and a patient creates a situation of distinct
advantage for the physician, which is called asymmetric information. Externalities
arise frequently when considering health and health care, notably in the
context of the health impacts as with infectious disease or opioid abuse . For
example, making an effort to avoid catching the common
cold affects
people other than the decision maker or finding sustainable, humane, and
effective solutions to the opioid epidemic.
Health economics is
used to promote healthy lifestyles and positive health outcomes through the
study of health care providers, hospitals and clinics, managed care, and public
health promotion activities. Health economists apply the theories of
production, efficiency, disparities, competition, and regulation to better
inform the public and private sector on the most efficient, cost-effective, and
equitable course of action. Such research can include the economic evaluation
of new technologies, as well as the study of appropriate prices, anti-trust
policy, optimal public and private investment and strategic behavior. The
researchers of International Health are currently conducting research on a wide
variety of topics, including the impact of health care, health insurance and
preventative services on health lifestyles, as well as providing research and
advice to governments around the globe to enable a more effective and equitable
allocation of resources.
Scope of Health Economics: Health Economics falls under the topics:
·
What
influences health? (other than healthcare)
·
What
is health and what is its value?
·
The demand for healthcare.
·
The supply of healthcare.
·
Micro-economic evaluation at treatment level.
·
Evaluation
at whole system level.
·
Planning, budgeting and monitoring mechanisms.
Principles of Health Economics: From a Public Health point of view, health
economics is just one of many disciplines that may be used to analyze issues of
health and health care, specifically as one of the set of analytical methods
labelled Health Services Research. But from an economics point of view, health
economics is simply one of many topics to which economic principles and methods
can be applied. As Morris, Devlin Parkin, and Spencer (2012) put
it: Health economics is the application of economic theory, models, and
empirical techniques to the analysis of decision-making by individuals, health
care providers and governments with respect to health and health care. Practical application
of health economics can be considered in two settings, which is identical to
the schism with reference to epidemiology in public health and clinical
medicine. Clinical health economics is the application of principles of
economics in the bedside setting for maximizing the benefit of the patient.
Health Economics – Physician: Like the concept of prevention in practice of medicine,
concept of cost also should be the concern for every practicing physician.
Every doctor should be conscious about cost for ensuring efficiency of practice
of medicine. The concepts of efficacy, effectiveness and efficiency are
important in health economics. Achievement of stated goal for an intervention,
when used in optimal conditions is called efficacy. The demonstration, that an
intervention does better than harm when used in usual or actual circumstances
is effectiveness. When a patient or the physician takes a decision, the
important concern is whether the patient gets the best outcome for the
resources incurred. This is efficiency, which is the maximum level of
effectiveness obtained at the lowest cost. Generally, clinicians need to make
choice to favor the most efficient option. Efficiency at the individual level
can be considered as utility maximization for the consumer. Thus, health
economics is important for the physician, primarily because of efficiency
concerns.
Health Economics in the Context of India: Health economics
is a growing subject in India. In the international scenario, health economics
had its conceptual origin long back with the support of organizations like WHO
and International Clinical Epidemiology Network. During subsequent
decades, the practical applications of this got conceived slowly in the
industrialized countries. In India, health economics is a nascent discipline
waiting for popularity even among the academia. Health economics needs
convergence of thoughts of health professionals as well as pure economists. In
many western schools of medicine pure economists work as regular faculty and
are seen involved in research and teaching. Physicians are benefitted by this. World
Health Organization recognizes health as a human right and the common
denominators for ensuring social well-being. We know that there exists a
positive correlation of economic growth with improved health indicators.
However, such a trend has not been observed in India despite a high economic
growth rate of 7 per cent even during world economic slowdown. For capital to
be translated into positive healthcare outcomes policy goals should be clear
and healthcare should be given priority in the budget; less than 1 per cent of
GDP (Gross Domestic Product) is grossly inadequate. Health makes an important
contribution to economic progress, as healthy populations live longer, are more
productive, and save more. This has huge human and economic costs: India is
losing more than six per cent of its GDP annually due to premature deaths and
preventable illnesses. India encapsulates a paradox; its relatively
unimpressive performance in healthcare; inability to deliver affordable health
services to its over 1.3 billion citizens co-exist alongside biggest generic
drugs industry which exports affordable medicine to more than 100 countries and
which has earned India the sobriquet of "pharmacy of the world"; also
booming healthcare industry and thriving medical tourism. A weak public sector
infrastructure includes non-availability of drugs, lack of advanced laboratory
facilities and equipment, a severely constrained health workforce, poorly financed
public health system (less than 1.04% of the GDP), along with poor delivery
mechanism for health care are the bottlenecks of Indian healthcare system which
prevent health system to provide appropriate and affordable care. Therefore,
India's healthcare needs radical changes. Healthcare is a growing industry in
India and is valued at nearly $40 billion. The private sector accounts for more
than 80% of the total healthcare spending, which is mostly out-of-pocket.
Increasing population, longer life-expectancy, decline in infant mortality,
more disposable income and therefore, ability to afford private healthcare
facilities, and Government's emphasis on eradicating diseases have triggered
this growth. Indian healthcare sector is at a crossroad, on one hand there are
emerging opportunities for growth and on the other hand, there are challenges
in ensuring consistently uniform facilities to all.
India’s Position in Health Care in the World
& Compared with other Countries:
·
World
Physicians Density: 14 per 10,000 population.
·
Number
of Physicians in the world: 8,747,790.
·
India
would need about four lakh more doctors by this year i.e., 2020 to maintain the
required ratio of one doctor per 1,000 people.
·
Presently
the nurse physician ratio in India is 1.5:1 as against international norm of
3:1. Current annual training capacity for nurses is 1.75 lakh. Number of
registered nurses in the country is 1.70 lakh out of which around 4 lakh are
active.
·
In
India 50% of all villagers have no access to healthcare providers.
·
In
India 38% are chronically starved
·
In
India 10% of all babies die before their first birthday.
·
In
India 50% of all babies are likely to be permanently stunted due to lack of
proper nutrition.
·
In
India 33% people have no access to toilets, while 50% defecate in the open.
·
India
spends 4.1 of GDP for health care while, US spend 17.9% of its gross domestic
product (GDP), or $8,362 per person.
·
Cuba
has some of the highest government health spending in the world – 91.5% of all
health spending. It has 67.23 doctors per 10,000 population, the highest of any
major country
·
UK
on nurses – it has 101 per 10,000 people, only behind countries like Norway and
Germany.
·
Qatar
has the lowest health spending in the world, 1.8% of GDP, followed by Burma
(Myanmar) and Pakistan at 2.2%.
·
The
WHO says Myanmar (Burma) government spends only $4 per person on healthcare.
Indian government spends (% of GDP) are lower than that of Nigeria.
·
The reviews says that India's health
care spending is comparable to other countries like Sri Lanka, China, and
Thailand. The country's public spending on health as a proportion of GDP is
lowest in the world. One of the consequences of this low public spending is the
remarkably high out of pocket spending for health. Ninety percentage of world's
population is estimated to suffer from catastrophic health spending which is
defined as spending more than forty percentage of the household income directly
on health care, after basic needs have been met.
Economic Evaluation in Health Care: Economic evaluation is the artillery in the armamentarium of
clinical health economist. A physician who treats an individual patient by
opting for a cost-effective intervention is making the trade-off, beneficial
for the patient. This cost effective decision making is the case of economics
in clinical medicine. Most of the economic evaluations are undertaken in the
bedside setting and helps physician to arrive at the most acceptable incremental
cost effectiveness ratio. Incremental cost effectiveness ratio tells us the
extra quantity of outcome attributed to the change in unit cost, taking
standard treatment as comparator. The bunch of quantitative methodologies for
establishing cost effectiveness and analytical tools for justifying choice by
fixing uncertainty is now becoming more and more popular. This has become
mandatory with drug trials in few western countries. Among these techniques
cost minimization is the simplest one but is considered as a partial economic
evaluation. Among the full economic analysis, cost effectiveness analysis is
the most familiar technique attempted by physicians. Outcome in cost-effective
analysis is expressed in natural units of measurement. Outcome measurement in
cost-utility analysis is quality adjusted life years gained. This is complex
and is based on principles of game theory. Cost benefit is considered as a
better method because comparison with sectors other than health is possible
with this technique.
Public Health Economics: This helps physicians, ‘physician–administrators’, and
health policy officials in decision making concerned with broader view point of
resource allocations. This is generally at societal interest, where
social marginal opportunity cost is the one considered. Marginal cost is
defined as the increase in total cost resulting from raising the rate of
production by one unit. The consideration at societal interest is more of
allocative than technical efficiency and equity considerations also matters.
The linkages between efficiency and equity in health system can be better
understood at the societal level, where efficiency is considered as
Pareto-efficiency. This is defined as the point in the budget line at which
nobody can be made better off without making others worse off. This welfare
economic principle of Pareto-efficiency is the theoretical foundation of
economic evaluation. Health of individual is the primary concern of any
organized civil society. Access to health care is considered as a fundamental
right ensured through the constitution of India. The commitment to provide
universal health care as a right of the citizen is being considered seriously
by many governments but there are criticisms also. Practice of evidence based
public health policy has incorporated cost effectiveness aspect in decision
making and literature explaining methods for supporting health policy
development toward this direction are available.
Classical
economics now moved far ahead toward neo-liberal theories which explain the
current market behavior. The theories of globalization, liberalization,
regulation, and structural reforms are the focus of such discussions in
economics. Regulation is considered as one of the solutions for market failure
and since health system is a typical example for market failure this may be an
appropriate prescription to improve internal efficiency in health sector
markets. Reforms allow the Government to take friendlier attitude toward
external investors and hence can invite more trade. More harmonious and
fruitful private public partnership is expected, and this can improve the
overall performance and efficiency of public health systems resulting in
improved access, quality, and cost savings.
Emerging Opportunities: India has become one of the prime destinations
for Medical tourism; it is currently a $2 billion industry. The country has
many super-specialty hospitals, highly qualified medical professionals,
tele-medicine, and Government incentives to promote health tourism. The large
population, good genetic pool and multitude of diseases make it conducive to
conduct clinical trials and studies on personalized medicine. India will be the
most populous country in the world by 2030, and nearly 200 million Indians will
be at least 60 years of age by 2025. However, the growing elderly population is
placing an enormous burden on the healthcare system. Urbanization has, also,
led to stress on public infrastructure with the rise in communicable and lifestyle
diseases.
Health Economics Research Areas:
·
Economic Evaluation and Health Technology
Assessment.
·
Health Systems Research.
·
Simulation Modelling
and Risk Prediction.
·
Health Inequality.
·
Methodological and
Other Research.
·
Child Health.
·
Genomics.
·
Global Health.
Challenges: One of the main challenges is that health
spending in India is mostly out-of-pocket; nearly 70% of hospitals and 40% of
hospital beds are private. Health insurance is largely private, and the urban
poor cannot afford private care. Our healthcare budget is inadequate; the total
healthcare expenditure at only 4.1% of gross domestic product, is the lowest in
the BRICS group. There is a disparity in provisioning of infrastructure and
resources between rural and urban areas in India. India has approximately 860
beds/million population as compared to WHO's estimate of the world average,
which is 3,960 beds/million population. These challenges create constraints in providing
adequate healthcare in India, due to which making choices become difficult. One of the most disturbing challenges for any researcher
attempting health economic analysis is the non-availability of relevant data
for analysis. The prevailing culture in our country is to get satisfied with
accountancy practice. Cost accounting is a totally different field which lacks
the theoretical underpinnings and assumptions of economics. Accountancy deals
with the practical side of planning to spend money and assessing the returns
while economics deals with the rhetoric but scientific explanations or
predictions on resource use. In general economists especially from the academic
departments are more in the practice of using secondary data, while public
health people prefer to resort to primary data collection in the form of
surveys. One of the sparkling hopes about insurance industry is the insistence
on documentation through information technology enablement. In some parts of
India, e-health has become an equally enjoyable partnership model for both
engineering as well as medical profession and the bonus is being enjoyed by
health economist. India's healthcare challenges and poor health indicators are
widely discussed at various public health forums; but rarely acknowledged in
political discourse. For the first time, in the history of India all the main
political parties have prioritized healthcare in their manifestos. Government
promised radical reforms in healthcare with "National Health Assurance
Mission (NHAM)". Healthcare must be made a core priority for the next
decade, to enable transformation of the healthcare system, while promoting
pro-health policies in other sectors.
A Way Forward: Worldwide, health technology assessments (HTAs) are an important
means to assess the economic value of healthcare interventions. It is used to
allocate healthcare expenditure fairly and efficiently. India does not have a
central health reimbursement process, no willingness-to-pay thresholds, no
consensus statement, policies, or guidelines on economic evaluations in health.
Moreover, the delivery of health services is nonuniform. However, we could
still use HTAs to guide public reimbursement of healthcare interventions, to
inform pricing strategy for new drugs or drug classes and also to help
healthcare decision makers to formulate clinical practice guidelines to ensure
consistency of provision and evidence-based interventions for maximum
efficiency. Most of the health economic studies conducted in India are
collaborations with researchers outside the country. There is a lack of
awareness about the concepts and methods for conducting pharmacoeconomic
evaluations in India. There are several practitioners of health economic
analyses at academic and research institutes in India, but these are isolated
pockets of knowledge. We require training workshops and sharing of best
practices at the national level. This will help create awareness and also a
pool of skilled researchers. The input into an analysis determines the output.
Therefore, data collection methodology for such analyses has to be robust. We
need government-approved policy guidelines for health economic evaluations in
India. Though the first-ever pharmacoeconomic guidelines have been formulated
and presented to the stakeholders in the Drug Price Control Order, 2013, we
still have a long way to go.
Conclusion: As
health economics is becoming more and more visible, the application in health
sector is more appreciated than that in any other contemporary fields. This
will certainly lead to more debates and dialogs. Policy makers should
facilitate capacity building of health professionals through creating more
training opportunities and making infrastructure facilities readily available.
In that case the physicians will be happier to collaborate with a pure
economists who approaches the former for studying health sector. Such
partnerships only will benefit the society through development of health
economics as an august discipline.
References:
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Monday 23 November 2020
AN OVERVIEW OF CLINICAL TRIALS FOR MEDICAL DEVICES
-Dr. S. Vijay Kumar, Professor
(Associate) & HOD (Retd.)
Medical devices play a critical role in
the lives and health of millions of people worldwide. They
play an important role in the practice of medicine, with the creativity and
diversity of this sector contributing to enhancement in the quality and
efficacy of healthcare. MDs cover a wide range of products, from simple
bandages to life-supporting devices such as stents, and play a crucial role in
the diagnosis, prevention, treatment, and care of diseases. From everyday household items such as oral thermometers to complex
implantable such as deep-brain stimulators, patients and the general public
rely on regulators to ensure that legally marketed medical devices have been
shown to be safe and effective. The Medical Device sector
has become increasingly important for the healthcare of citizens, with an
immense influence on expenditure. Medical devices play an
important role in the diagnosis, prevention, treatment, and care of diseases.
However, compared to pharmaceuticals, there is no rigorous formal regulation
for demonstration of benefits and exclusion of harms to patients. In many countries, the medical technology industry is
dominated by large numbers of SMEs.
Medical Device – WHO
Full Definition:
‘Medical device’ means any instrument,
apparatus, implement, machine, appliance, implant, reagent for in vitro use,
software, material or other similar or related article, intended by the
manufacturer to be used, alone or in combination, for human beings, for one or more
of the specific medical purpose(s) of:
·
Diagnosis, prevention,
monitoring, treatment, or alleviation of disease,
·
Diagnosis, monitoring,
treatment, alleviation of or compensation for an injury,
·
Investigation,
replacement, modification, or support of the anatomy or of a physiological
process,
·
Supporting or
sustaining life,
·
Control of conception,
·
Disinfection of
medical devices
·
Providing information
by means of in vitro examination of specimens derived from the human body.
Clinical Research –
Clinical Trials:
Clinical
research is a branch of healthcare science that determines the safety and
effectiveness (efficacy) of medications, devices, diagnostic products, and
treatment regimens intended for human use. These may be used for prevention,
treatment, diagnosis or for relieving symptoms of a disease. Clinical
trials are a type of research that studies new tests and treatments and
evaluates their effects on human health outcomes. The medical device
industry argues that the classical evidence hierarchy cannot be applied for
medical devices, as randomized clinical trials are impossible to perform. Three
major barriers identified for randomized clinical trials on medical devices,
namely: (1) Randomization, including timing of assessment, acceptability,
blinding, choice of the comparator group and considerations on the learning
curve; (2) Difficulties in determining appropriate outcomes; and (3) The lack
of scientific advice, regulations, and transparency. Regulators expect data that are
provided by device manufacturers to reflect the risk profile of the device and
need more crucial clinical evaluation before market approval. Higher-risk and
innovative moderate-risk devices (approximately 4%of all medical devices),
which generally require the clinical evidence to show that the benefits of
technology outweigh its risks are the primary focus. Clinical evidence of
medical devices is often critical not only for showing the safety and
effectiveness of the device but also for informing clinicians and patients
about the preferred use of the device in the marketed clinical setting.
Regulators are demanding more clinical evidence because they want to see more
of it before granting market approval. Not only regulators but payers are also
requiring more of it to substantiate product value claims and approve
reimbursement. Even healthcare systems and physicians are asking for more of it
when making purchasing decisions. This demand for clinical evidence from
various stakeholders is forcing medical device companies to amass more clinical
data on their products than ever before. Companies are responding to
this pressure by running more clinical trials, focus group studies, and
responding in real-time by making changes to the beta version (a version of a piece
of software that is made available for testing, typically by a limited number
of users outside the company that is developing it, before its general release)
of their medical devices. The
latest trend is medical device companies increasingly are turning to clinical trials to
differentiate their products from competitors and improve their odds of
adoption in the marketplace.
Clinical Trials for
Medical Devices:
1. Blinding: Blinding is an important
element in all clinical trials; it reduces measurement bias related to the
observer’s, doctor’s, or patient’s subjectivity. For ethical or practical
reasons, blinding is often more difficult to perform in randomized clinical
trials on medical devices compared to pharmacological randomized clinical
trials. Medical device companies need to remember that when it is not possible
to blind healthcare professionals, a blind assessment of the outcome should be
planned with experienced and trained staff as outcome assessors. The data
managers, the adjudication committee, the independent data monitoring, and
safety committee, the statisticians, and the conclusion drawers should also be
blinded. In case blinding is not used, medical device companies and their
clinical trial correspondent need to give the reasons for not blinding and
discuss the limitations when reporting the results. As blinding of patients and
trial personnel may be less often achievable in some medical device trials,
objective outcomes must be chosen. Recently, regulatory agencies have
emphasized for medical device companies to search for creative methods to blind
individuals in their trials, if they choose to incorporate a novel technique,
they must ensure that the blinding process itself does not introduce bias by
impairing the ability to accurately assess the outcome. Any novel blinding
technique should have three qualities: (1). Successful concealing of the group
allocation, (2). No impairment in the ability to accurately assess outcomes;
and (3). Acceptance by the individuals that will be assessing outcomes. Despite
careful consideration of methods to blind individuals in medical device clinical
trials, situations will invariably
arise when some or all groups of individuals simply cannot ethically be
blinded. Medical device companies must accept this reality and incorporate
other strategies to minimize bias when blinding is not possible.
2. Outsourcing Work to Experts: It is an industry-wide trend
that most device makers lack the internal resources and expertise to run a
complete clinical trial operation in-house. It might be possible for a large
medical device company to have an in-house clinical development team which can
help in facilitating the clinical trials, however, for small medical device
companies, which have little bandwidth, experience, and margin for error, the
success of clinical trial or failure can be very crucial and sometimes clinical
trial means life or death for the small company. As a result, we are witnessing
a corresponding rise in the outsourcing of clinical services to contract
research organizations (CROs). Medical device companies are turning to CROs for
assistance with clinical operations management, investigator recruitment,
clinical monitoring, data management, biostatistical analysis,
health economic and outcomes strategy, quality assurance, regulatory approval,
and other needs. The single most important factor to consider when choosing
clinical service providers or a CRO is experience in the medical device
clinical trials or expertise in the field. A
new way of working is outsourcing work to on-demand experts. This is
particularly beneficial to small companies who cannot afford the heavy costs
and management spends on working with CROs or traditional consulting
firms. Hiring individual medical device consultants can help to save time and
costs, while working with experts directly to customize deliverables. Specialists
in the medical device industry are offering their services on a freelance
basis.
3. Outcome Assessment for Clinical
Trials on Medical Devices: Defining
relevant outcomes for clinical trials on the medical device is complex. This is
partly due to the great variation in complexity and application for the
different types of medical devices such as pacemakers, insulin pumps, operating
room monitors, defibrillators, and surgical instruments, and partly due to a
large variety of potentially relevant outcomes. A barrier specifically related
to the medical device industry is that a common understanding of the concept of
outcomes is missing. In clinical trials with medical devices, traditional
outcomes such as survival, complication rates, or surrogates (biomarkers,
imaging techniques, and omics) are used instead of the more appropriate
hermeneutic outcome measures such as quality of life, autonomy, discomfort,
disability, and life satisfaction. This does not mean to exclude specific
outcomes for the functionality of medical devices such as device failure,
device breaking, device slipping, migrating of the device or screw loosening,
etc. Trials on medical devices funded by industry are prone to report positive
outcomes and to conclude in favour of experimental interventions when obtaining
non-significant test results. While industry involvement is necessary to
improve technology and to drive innovation of medical devices, it must be based
on scientific grounds and fully transparent. The
outcome measures selected for MDs should reflect the whole procedure, and all
different kinds of settings that the MD can be used in. According to the expert
panel, the choice for the most appropriate outcome measure depends on the (1). Primary
objective (increase of benefit, reduction of harm); (2). State of development
of the technology (feasibility, effectiveness, efficiency); (3). Quality
criteria (validity, reliability); (4). Acceptance (by patients, physicians, and
scientific community); and (5). Acknowledgement of the value of better
tolerability or convenience.
4. Early Scientific Advice and Expert
Panels: The medical technology industry
is dominated by large numbers of Subject Matter Experts (SMEs). They are not
trained in running trials or in trial methodology but have a high output of
diverse and innovative products. Access to early scientific advice, especially
for smaller companies and academia, needs to be as easy and affordable as
possible. Early scientific advice about the clinical development strategy and
clinical trials for their devices is wished for. Engaging in the relationship
in a meaningful way early helps align on SOP (standard operating procedure) and
technology.
5. Regulatory Requirements for Medical
Device Clinical Trials: The
above tips represent only a fraction of the best practices of clinical trials
for medical device manufacturers. Apart from these key tips, compliance with
regulatory and ethical requirements is also very important. The new Regulations
on Medical Devices imposes increased responsibilities and well-defined
interactions between all economic stakeholders involved, like medical device
manufacturers, authorized representatives, importers, and distributors. Last,
but not the least, trust, and transparency
in clinical trials of medical devices is vital. Reviewing clinical trial data. Regulatory review and peer-review
of clinical trial results have different objectives, but final published
results for either process should conform to the approved clinical trial
protocol and specify major deviations and amendments. There
should be strict “Regulatory Mechanism”
to check the performance and
authenticity of the medical devices manufactured in a country.
Regulatory Strategy: In India, at present only
notified medical devices are regulated as Drugs under the Drugs and
Cosmetics Act 1940 and Rules made thereunder in 1945. Under these, 14 medical devices were notified as ‘Drugs’. These
ranged from disposable hypodermic syringe and needle, perfusion sets, cardiac
and drug eluting stents, catheters, intraocular lens, intravenous cannulae,
bone cement, heart valve, scalp vein, orthopedic implant, internal prosthetic replacement,
and in vitro diagnostic kits for human immune deficiency virus (HIV), Hepatitis
B surface antigen (HBsAg) and Hepatitis C virus (HCV). The Medical Devices
Rules, 2017 of the Drugs and Cosmetics Act, 1940 came into force with effect
from January 1, 2018. The rules are applicable for (i) substances used for in
vitro diagnosis and sterile surgical dressings, surgical bandages, surgical
staples, surgical sutures, ligatures, blood, and blood component collection bag
with or without anticoagulant, (ii) substances including mechanical
contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and
insecticides; and (iii) devices notified from time to time. A regulatory strategy is
often a formal plan that aligns regulatory activities to business strategy, so
as to bring a new or modified medical device product to market. Formulating
this plan would require, consideration of various regulatory issues in the
target markets one wish to place the product. When well planned, a regulatory
strategy should be balanced, realistic, achievable, and in support the organization’s
mission and vision. It identifies important regulatory requirements to be
addressed and provides overall definition and clear direction for the product
development team, even outlining the reasons for the path to be taken. Planning
regulatory strategy should be done at the earliest possible stage of product
development, while putting D&D (Design & Development) work structure in
place. There are three points to consider with specific regard to regulatory
concerns: (1). Target markets for commercialization. (2). Medical Device
Classification and (3). Overall project milestones and timeline.
1) Target Markets for Commercialization:
“In which countries product to be sold ?”It
is important to know in which markets the products to be sold and prioritize
the various market entries. Different markets have varying market size, medical
practices, pricing, and reimbursement, as well as distribution activities.
Furthermore, regulatory regimes differ between markets. One would need to
evaluate all these different factors when considering regulatory strategy. It
can be helpful for D&D plans as well. An example of regulatory difference
is the risk classification of medical devices, where the same product might be
classed slightly differently under different regulatory regimes. With this
differentiation, the timing and ease of product release could be affected as
well.
2) Medical Device Classification: “Which
risk classification does one’s medical device belong to? “As
mentioned above, medical device classification is important in establishing the
pathway to a specific market. When one has clearly established the options and
requirements for “route to market”, one can better plan your product
development with a “go-to-market” strategy. Identifying medical device
classification correctly can allow to clearly establish the relevant
controls for the product development and risk management. It is also useful for
understanding the risk profile of the product, as well as the competitors’.
Based on regulatory requirements for the medical device risk classification, one
can determine the required scope of verification and validation, and thus
estimate the cost and timeline to bring the product to the market.
3) Overall Project Milestones And Timeline: “What
milestones one can look to gauge the
progress of his project? “Tying in with the above
points, one would be able to craft regulatory strategy when one have a clear
idea of his target market’s regulations and requirements that need to be met.
For example, one might find that certain markets require more extensive
pre-clinical and clinical trials to be done, while others might request for
relevant comparisons of his product. Knowing this would also give a good gauge
of the time needed for each step of the certification and product registration
process. One can then align his product development and business plans
accordingly, to maximize his team’s efficiency. With proper consideration of
the key information mentioned, one can have a good grasp on timeline for market
entry and product development, as well as the cost involved. Accordingly, this
means one able to craft his regulatory strategy to bring his device to the
market. Crucial to meeting regulatory requirements throughout the world is
having a proper QMS (Medical Device Quality Management System). The ISO
13485:2016 standard is often the reference for best practice QMS processes. One
can read and learn more about the ISO 13485.
To conclude, the Study protocol and
a summary of the results are to be made publicly available in databases for
clinical trials of medical devices. Moreover, access to individual patient data
should also be secured. Trust and
transparency of MDs is very important. In many countries, the medical
technology industry is dominated by large numbers of SMEs. The
global medical devices market size was valued at USD 425.5 Billion in
2018 and is expected to reach USD 612.7 Billion by 2025, grow at a Compound
Annual Growth Rate (CAGR) of 5.4% 2018 to 2025. According to a Deloitte report,
the growth rate of India’s medical-device industry is
around 15 per cent which is more than double of the global industry
growth rate of 4-6 per cent, and is expected to become a $ 25-30
billion industry in India by 2025.
References:
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European Commission. Growth. Internal Market,
Industry, Entrepreneurship and SMEs; Medical Devices. 2016. Accessed 24
May 2020.
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Eikermann M, Gluud C, Perleth M, Wild C,
Sauerland S, Gutierrez-Ibarluzea I, et al. Commentary: Europe needs a central,
transparent, and evidence based regulation process for devices. BMJ. 2013.
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Karanicolas PJ, Bhandari M, Walter SD, et al.
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