Business Models and Plans

Final Business Plan - Group Project

Course Facilitator: Prof.Subhashish Mazumdar &

Dr.Bala Krishnamoorthy

Date of Submission: 26th Feb 2023

Submitted by Group 1:

Roll No. Name SAP ID

HRA011 Twinkle Bhimani 80522100162

HRA027 Arsh Gupta 80522100011

HRA030 Ilyaan 80522100074

HRB003 Pankti Agarwal 80522100152

HRB040 Teja Prakash 80522100076

 1

Table of contents

S.NO TOPIC PAGE.NO

1. Introduction - Setting the context 2

2. Identifying all aspects of business planning and formation set up 3

( Market analysis , Product Design , Manufacturing ,
Manufacturing cost , Market segmentation , Sales and Marketing ,
Online marketing, Offline marketing , Sales , Revenue model )

3. 12
Identifying the challenges and opportunities in the context of the
business models and business planning/execution ( Pain points in
existing market )

4. Organizational design and organizational challenges in 12

implementing/addressing the business plan

5 Contingency and risk management 15

6. Entrepreneurship and leadership in the context 18

7. References 19
 2

Introduction- Setting the Context:

The global blood testing market was valued at USD 73.9 billion in 2020 and is expected to
expand at a compound annual growth rate (CAGR) of 8.3% from 2021 to 2028. Government
and key organizations are constantly engaged in encouraging patients to undergo regular
diagnostic examinations. A blood test is referred to as a medical procedure of analyzing blood
samples in a laboratory. Factors such as increasing need for the identification of infectious
agents, increased healthcare spending by the government and regulatory bodies is expected to
drive the market during the projected time frame.Additionally, the growing prevalence of
infectious diseases such as diabetes, COVID-19, and cardiovascular diseases is expected to boost
the market growth.

The major factors propelling the growth are substantial rise in the chronic diseases along with
high demand for products for assessment of health. The rising instances of people suffering from
various infectious diseases will create a good opportunity for the market to grow. Additionally,
growing patient awareness about home diagnostic tests and self-testing is expected to boost
market adoption of significant products in the blood testing market.

The company has a lofty mission: to transform the healthcare industry to allow people to better
afford and manage their healthcare. Its technology is aimed at alleviating people’s pain and
discomfort with blood tests.​ This new tech would provide a full workup from a single drop of
blood. This would make drawing blood easier, cut out the middle man, and democratize lab tests
(making them much more affordable for everyone).Rapid diagnosis, effective treatment options,
and future prevention plans are essential in the management of COVID.

What excites people is the prospect of having more control over their own health care. The
equipment would consist of two medical devices - the first will be a nanotainer which would be
used to store and collect the blood sample from a finger-prick and the second would be a portable
device that would be used to run the tests.

People from remote locations cannot frequently visit hospitals or medical facilities due to the
high expense of routine testing. In Bangladesh, healthcare services are lacking, especially in rural
regions. To receive medical tests and treatment, people must travel a great distance. Those who
are unable to pay for routine examinations such as blood pressure, oxygen saturation, and body
temperature would benefit from this system. Not only is this technology affordable, but it is also
simple to operate. All ages of individuals will benefit from our approach, but elderly or intensive
care unit (ICU) patients would especially benefit. The patient's body temperature, heart rate, and
oxygen saturation level and many other things will all be measured, with the results being sent to
a web server and mobile apps. In the future, we may also develop a website that functions
similarly to a smartphone application, allowing users to visit it and view the results by glancing
at the date and time. In addition, the medical professional or the patient's relative assesses the
 3

patient's circumstances in case of a crisis. Our goal is to create a system that is very accurate and
affordable so that anybody may use it and control the expense.

Identifying all aspects of business planning and formation set up ​

Market Analysis:

The home health checkup device market has been growing steadily over the past few years, and
is expected to continue to grow in the coming years. This is primarily due to the increasing
demand for personalized healthcare and the growing awareness about the importance of
preventative healthcare.

The market is segmented based on type of device, which includes blood pressure monitors,
glucose meters, pulse oximeters, temperature monitors, ECG monitors, and others. Among these,
blood pressure monitors and glucose meters are the most commonly used devices, due to the
high prevalence of hypertension and diabetes.

Geographically, the Asia-Pacific region is expected to have the highest growth rate in the home
health checkup device market, due to the increasing aging population, rising healthcare costs,
and growing awareness about the benefits of self-monitoring. North America and Europe are also
significant markets, due to the presence of a large geriatric population and favorable
reimbursement policies.

In 2020, the Indian home healthcare market was valued at approximately USD 6.2 B.It is
expected to grow at a CAGR of 19.2% and reach USD 21.3 Billion by 2027(NITI)

Key players in the home health checkup device market include Omron Healthcare, Philips
Healthcare, GE Healthcare, Johnson & Johnson, Abbott Laboratories, and Roche Diagnostics.
These companies are investing heavily in research and development to develop innovative and
technologically advanced products, as well as expanding their product portfolios through
mergers and acquisitions.

The market for home healthcare is anticipated to reach a value of US$ 3.2 billion in 2023 and to
increase to US$ 4.4 billion by 2033. Throughout the projection period, it is predicted that the
market will grow at a CAGR of 3.1%.

Leading manufacturers are creating cutting-edge medical equipment to improve the standard of
care for patients. Patients' desire for at-home healthcare is rising as a result of these
manufacturers' creation of highly supportive equipment that are simple to obtain. Market
 4

prospects are driven throughout the projected period by manufacturers' focus on producing
environmentally friendly medical equipment.

The worldwide home healthcare market is anticipated to grow at a respectable 1.1% CAGR over
the projected period, according to Future Market Insights. In the past, the market saw a CAGR of
2.6% from 2017 to 2022

●​ Short Term (2023 to 2026): Increasing need for home healthcare as a result of an ageing
population and affordable therapies
●​ Mid-term (2026 to 2029): there will be a rise in the use of home healthcare services to
preserve comfort, cut down on emergency room visits, and take more complicated
medications.
●​ Long Term (2029 to 2033): Market prospects are being driven by the development of
enhanced healthcare technologies, robotic services, and remote patient monitoring.

Challenges in the market include the high cost of devices, lack of awareness and access to
healthcare in some regions, and concerns about the accuracy and reliability of home health
checkup devices compared to professional medical equipment. However, the increasing demand
for telehealth services and remote patient monitoring is expected to drive the growth of the home
health checkup device market in the coming years.

Product Design:

The device we created will monitor a patient's body temperature, heart rate, blood oxygen
saturation (SpO2) levels, and all other necessary blood cell and impurity measurements required
to diagnose a disease, and it will Bluetooth-transmit the information to a mobile application. The
three levels that make up the system are the physical, logical, and application layers. The data
gathered by the sensors in the physical layer is processed by the logical layer.

The logical layer handles intersensor communications and media access management. The
application layer takes judgements in response to the logical layer's processed data. The primary
goal is to make things more affordable for average people. In addition to financial sustainability,
patients will have simple access to private treatment. T The measures used to establish the
patient's health parameters are subject to a 95 percent confidence interval with a 5 percent
maximum relative error. The general public's employment of these gadgets as auxiliary aids in a
particular circumstance may have a significant effect on their own life.

The components of this health monitoring system include sensors and a microprocessor. As
microcontrollers, we may use Arduino Uno or Raspberry Pi, and sensors such as MAX30100
(pulse rate and SPo2 measurement sensor) and LM35 (body temperature measurement sensor),
among others. In addition, we are utilising other components, including an HC-05 (Bluetooth
module), to connect the Arduino to the mobile application and LCD display.
 5

The system's schematic diagram. The circuit consists of an Arduino Uno microcontroller, two
sensors (MAX30100 and LM35), a 16 2 I2C LCD display, and a Bluetooth module. The entire
system operates on 5V. The Arduino Uno microcontroller is connected to the computer through
USB (Universal Serial Bus), which provides orders to the device. The circuit was constructed
using the internet application circuito.io for constructing circuits.A USB connection between the
microcontroller and the laptop transmits orders to the sensors. In addition, a Bluetooth module
enables mobile apps to retrieve data from the system.

A connected message will be seen after connecting the Bluetooth device to the application by
scanning the device with the mobile smartphone. Afterwards, after completing the necessary
procedure, we may display the collected data on the screen. Users will construct applications
using the visual block language by dragging and dropping components into the design view. This
application enables users throughout the globe to develop digital solutions to important issues.
The microcontroller will now be connected to the mobile application with the aid of the
Bluetooth module HC-05.

Manufacturing:

Producing a device for various illness home monitoring demands technological competence,
quality control procedures, and a focus on addressing the requirements of patients and healthcare
professionals. The equipment must be precise, dependable, and user-friendly. Manufacturers
must also remain current with regulatory standards and evolving technology in order to maintain
market competitiveness.
 6

The production of a home checkup equipment for many diseases, such as diabetes, high blood
pressure, etc., entails a number of crucial procedures, including:

1.​ Creating the product specs, designing the user interface, and implementing the software
to measure different health factors such as blood glucose, blood pressure, heart rate, etc.
2.​ Sourcing of Raw Materials: The firm obtains raw materials from vendors. Electronic
components, sensors, batteries, and packaging materials are included. The raw materials
must be of good quality, comply with safety regulations, and be economical.
3.​ Manufacture Components: The different gadget components are made. This covers the
fabrication of the housing, display, sensors, and printed circuit boards. This procedure
may need the use of specialised tools and technology, such as injection moulding or
printed circuit board assembly.
4.​ Assembly: The different gadget components are assembled. This involves the installation
of sensors and electronic components, the assembly of the casing, and the attachment of
the display and buttons. Depending on the device's complexity, this operation may be
automated or performed manually.
5.​ The software for the gadget is created in order to gather and evaluate the data from the
numerous sensors. The programme must be intuitive, accurate, and trustworthy.
6.​ Testing is an integral aspect of the production process to verify that the product fulfills
quality and safety requirements. This involves both functional testing, which checks the
device's functionality, and performance testing, which evaluates the device's accuracy and
dependability.
7.​ Quality Control: Quality control is essential to verify that produced medical devices fulfil
the appropriate safety and effectiveness criteria. This requires monitoring the production
process, checking the completed products, and recognising and resolving any difficulties
that develop.
8.​ Clinical Trials: Clinical studies may be done to validate the device's usefulness in
measuring and monitoring a variety of health factors. Before a medical device may be
sold to consumers, regulatory organisations may demand this step.

The final medical devices are packed and labeled in accordance with regulatory regulations. The
gadgets are thereafter delivered to stores, healthcare practitioners, or customers directly.

Manufacturing Cost:

Components Price

R&D Cost 500-100

Sensors 2000-3000

Microcontrollers 3000-3500
 7

Display 500

Insulation Material 400-500

Assembly Cost 250-300

Software Cost 1000-1100

Packaging 100

Labour 200

Facility Expense 300

Miscellaneous 500

Total Manufacturing Cost 10-11000 Rs

Marketing/Sales 1000

Distribution Cost 500

Overhead Expenses 500

Total Cost Per Device 12-13000 Rs

Market Segmentation:

Depending on factors such as the device's complexity, manufacturing method, materials utilised,
and regulatory compliance requirements, the production cost for a home checkup health gadget
for many diseases such as diabetes, high blood pressure, etc. might vary. However, the following
are common cost drivers for such a device:

1. Demographic segmentation: This is the process of breaking down the market into
segments according to demographic factors including age, gender, income, education,
and occupation. For instance, anyone over 40 who have been given a diabetes or high
blood pressure diagnosis may be your target market.

2. Geographic segmentation: This divides the market into sections according to region.
As we are doing now, we will choose to concentrate on Tier 1 cities with high rates of
diabetes or high blood pressure.
 8

3. Psychographic segmentation: This divides the market into groups according to

characteristics including values, interests, and lifestyles. For instance, our target market
can consist of people who are concerned about their health and value convenience.

4. Behavioral segmentation: This divides the market according to customer behaviours

including usage frequency, brand loyalty, and buy propensity. We want to specifically
target those who have a history of buying health-related items, are actively looking for
methods to control their condition, are at ease using technology, and are looking for
cutting-edge ways to manage their health.

Sales and Marketing:

The brand names should become synonymous with the product categories they represent. The
appropriate brand messaging may propel your business to the next level. Bad branding choices
might result in permanent harm.Our brand should emanate expertise, trustworthiness, and
dependability. In the field of medicine, failure is not an option. Otherwise, we risk confusing our
consumers (and losing them to a competitor).

Organizations' logos are occasionally an afterthought. Developing them with a seasoned expert
might be costly, but they are worthwhile. The proper logo will become synonymous with our
company, and we will be able to utilise it for decades.

Online Marketing :

Website :THE CENTRAL HUB FOR ALL ONLINE MARKETING ACTIVITIES

Websites of today are highly effective inbound lead generating platforms that act as the heart of
all your internet marketing efforts. Every marketing strategy we do will aim to drive visitors to
our website. Then, it is the responsibility of our website to turn this traffic into leads or, in the
case of eCommerce sites, sales.Unlike in the "online brochure" era, your website should convey
the correct information about our goods and people to convert website visitors by: • Subscribing
to your email newsletter • Scheduling an appointment by phone

Communicating with you in real time using live chat to ask further questions • In the case of
eCommerce websites, actually making a purchase. In conjunction with a robust inbound
marketing approach, our website will produce more and better sales leads for your sales staff to
convert.

Blog : PROVIDING VALUE WHILE GENERATING TRAFFIC

At their most fundamental, blog postings are internet essays that discuss particular themes. They
might be quite general (and often rather lengthy; see this post) or extremely specialised.One of
the most essential aspects of blogs is that they must always deliver value.
 9

Social media : Engaging customers in their "backyards".

Facebook has more than two billion monthly active users. LinkedIn has about 562 million
registered members. Instagram? In excess of 800 million. A successful social media strategy
connects consumers and prospects, delivers additional value, and creates trust through
conversations and the sharing of relevant, engaging, and helpful material.

In the early stages of our inbound marketing activities, social media may be a significant source
of website traffic. In addition, it has the potential to humanise our brand and establish strong
relationships with prospects before they reach our website.

Email Marketing : STAYING TOP OF MIND WHILE PROVIDING VALUE

It's time to go to work now that we've created a website that attracts attention, blog material and
social media techniques that drive organic traffic, and landing pages to convert this traffic into
leads.

Customers-to-be who downloaded premium material deemed your business and the information
we give valuable enough to invite our emails into their inboxes. Very interested are prospects
who visited your website for whatever reason and opted up directly to get our communications.

With this trust and curiosity without spamming or constantly pitching to your subscribers, you
may begin to turn these leads into purchases.

Targeted Internet Advertising Campaigns :

Creating an online presence and inbound marketing plan that incorporates the above-mentioned
strategies is a significant step towards increasing our company's income.

●​ Search engine advertisements, often known as pay-per-click ads (PPC). PPC

advertisements are those that appear at the top of search engine results on Google, Bing,
and other search engines. These advertisements are acquired utilising keyword research
to discover which keyword combinations are most likely to be searched by your target
leads. These advertisements can be extremely effective since they are tailored to show
when our prospects are seeking for answers and are prepared to take action.
●​ Banner adverts These advertisements are what have been generally referred to as "banner
advertising" for years; they are the advertisements that display at the top of web pages
and consist of a visual or graphic coupled with brief text. Sometimes they are square and
located in a sidebar, other times they are part of a website's scroll or feed, or they are
placed at the top of the page. Display advertisements are effective by being somewhat
invasive.
●​ Mobile advertisements. As individuals spend so much time on their phones, it is logical
for advertising to develop strategies to reach them. Mobile advertisements are built
 10

particularly for small displays, hence boosting the possibility that your advertisements
will work successfully.

Offline Marketing:

TRADITIONAL OUTLETS STILL OFFER VALUE : Internet marketing is the most effective
way to contact and engage prospective consumers today, and medical device makers throughout
the world are using it effectively. But, offline advertising still provides a wonderful chance to
reach potential clients.

PRINT ADS : Despite the demise of the newspaper industry, print advertisements in newspapers
across the country can be effective, particularly for B2C medical equipment makers seeking to
attract an older demographic.

In addition to this tried-and-true method, specialty periodicals that target your personas can be an
excellent approach to attract potential clients. For B2B makers of medical devices, trade journals
are an additional valuable resource.

BILLBOARDS: Depending on our industry, billboards may be a great and cost-effective

approach to reach a huge number of people.

TELEVISION: Conventional media advertising, particularly television, demands a substantial

initial outlay. Often, we will be required to purchase frequent advertisements over an extended
period of time. Of course, most corporations aren't gunning for a million-dollar, 60-second Super
Bowl advertisement (though some think they're still a bargain). There are many methods for
advertising on television. In certain areas, morning programmes frequently feature parts where
"experts" are invited on to answer questions or discuss their products.

RADIO :Radio and television are quite similar in that achieving results requires a big
expenditure, a high frequency, and a lengthy commitment. Radio stands out because it may be a
cost-effective and effective method to leverage traditional media to reach both B2B and B2C
prospects.

Sales:

Distribution Channel : The device services would be available at leading pharmacies and
companies that do blood testing.Tie up with hospitals and clinics to use the device and the
services provided by the company.

Strategic Partnership :Establish tie ups with reputational pharmaceutical companies such as
Pfizer, Zydus, Lupin etc Partnership with technology companies to develop application or
external devices that can link the blood test result with mobile phones.
 11

Revenue Model:

Direct Sales: This entails offering the product directly to customers, either online or at a physical
location. Usually, this brings in money through the selling of the item.

Subscription Based: Customers that use the software and access related services like remote
monitoring, data analytics, and coaching pay a regular cost under the subscription-based model,
which offers the service and software on a subscription basis.

Commission structure: With this structure, the business will collaborate with healthcare
organisations including clinics, hospitals, and pharmacies to sell the device as a component of
their patient care services. Every time a gadget is sold by means of these alliances, the business
receives a commission.

Licensing Model: In this strategy, the device technology is licenced to other businesses that
already have an established clientele or distribution system. Royalties and licence fees are the
main sources of income for the business.

Data Monetization:The data gathered by the device is used in this model's data monetization to
provide insights that may be sold to healthcare providers, insurance, or pharmaceutical firms.
These insights and analytics are sold to create the income.

Cost Price 12-13000

Margin 20%(2500-2800)

Selling Price 15-16000

Market Size $ 6.2 B

Penetration Rate 0.5% - 2%

Expected Revenue INR 60 - 70 B

 12

Identifying the challenges and opportunities in the context of the business models and
business planning/execution​

Pain points in the existing marketplace:

Adverse drug reactions reduce sales and keep some drugs off the market which causes loss of
market share.

With this device customer can track their health. The dream is to eliminate trips to the lab by
doing diagnostics on small, portable machines and on smaller amounts of blood. Blood tests can
do a lot: assess how well organs are working, diagnose immune disorders, and flag changes that
could hint someone about cancer.

Contingency and risk management

Stringent regulatory approval process is hampering the market growth. For instance, in U.S, the
development of commercial tests is regulated by the U.S. Food and Drug Administration (FDA).
They are considered medical devices. FDA is responsible for approving the use of clinical
laboratory tests.

Lack of awareness about development of new technologies and process related to blood testing is
restraining the market growth.Ambient temperature to be created for storing of blood samples.

People try to diagnose themselves for symptoms in which they don’t have any medical training
or understanding (there is a reason why doctors are sent the report and they act as a middle
man)Data protection of the user is a big challenge.

​ ​ ​ ​ ​ ​ ​ ​ ​
Organizational design and organizational challenges in implementing/addressing the
business plan​
​ ​ ​ ​ ​ ​
As we try to move the product in the market we need to have a functional organizational design.
The functional structure will allow company to achieve higher economies of scale and
productivity through specialization. Each function will require specific knowledge and skills.
People in the department become more and more skilled as they have specific jobs and tasks.
Functional structure will work best in the company as it delivers products and services
continuously. People hired will specialize in their fields, and top executives will coordinate them,
ensuring they are on track to achieve company goals.Some of the functions that the company will
require are Operations, Marketing, Human Resources, Production, Finance, R&D, Purchase,
Information and Technology, Customer Service.
 13

(Example of Functional Organizational Design)

Each department will be headed by a functional director. Now, let’s take the marketing
department as an example. The marketing director represents the top position in this department.
He performs his specialist function by directing and coordinating the company’s marketing
function. He has no authority over people outside their jurisdiction.Within the marketing
department, a manager acts as the head. He is responsible for and reports to the marketing
director and oversees several positions.

Moving forward the company would transition to a Global functional division where each
country will have their own hierarchy which would be under the supervision of a global division
leader who will head and lead the overall operation.
 14

Some of the advantages of having a functional organization structure are :-

●​ Specialization :The functional organizational structure helps in achieving the benefits of

specialization of work. Every functional in charge is an expert in his area and can help the
subordinate to perform better in his area.
●​ Production of Workload:It reduces the burden on the top executives. There are pointed
supervision in the enterprise, and every function in charge looks after his functional area
only.
●​ Scope of Expansion:It offers greater scope for expansion as compared to line
Organization. It does not face the problem of the Limited capabilities of a few line
managers.
●​ Greater Efficiency:It creates a high degree of efficiency as the groups of employees and
the functional heads perform their limited and specialized operations. Thus, Thereby
bringing expertise in performance and reduction in costs.
●​ Better Control:The expert knowledge of the functional managers facilitates better control
and supervision in the Enterprise.

Some of the organizational structure challenges would be as follows :-

●​ Ego :Departments have their own goals. Finally, they act in their own interests. So, ego
can creep in this organizational design, when this kind of hindrance impedes the growth
of the organization. During the initial stages of the company we want to build a clan
culture where all employees can thrive and are given opportunities to grow, build and
innovate as we need to garner all the innovation in this business, at the growth phase.
●​ Organizational silos: Each department operates independently. Thus, people in one
department are reluctant to share information or knowledge with people in other
departments. The conflict between departments. Each department has different and
sometimes conflicting targets. For example, the marketing department targets increasing
sales, which requires more budget. On the other hand, the finance department has an
efficiency target, saving more budget. And often, these contradictions can lead to
disharmony and conflict.
●​ Coordination problems: Each department is often more concerned with the ego and its
functional area. Eventually, it leads to poor coordination. Such problems become a
danger when the business environment requires companies to change. And, coordination
problems make it slow for companies to respond to changes appropriately.
●​ More difficult priorities : Companies find it more difficult to prioritize allocating
resources. Take the example related to the budget. Individual departments compete for
bigger budgets to reach their targets more easily.
●​ Concentrated decisions : Department heads and functional directors may monopolize
decisions within the department. They have decision-making power and may delegate
little or no autonomy to those under them. In the end, it demotivated the staff.
 15

Contingency and Risk management:​

Regulatory compliance :

Before manufacturers of certain medical devices can sell within India, they need to be in
compliance with India’s medical device regulations. Indian authorities overhauled the medical
device regulatory process in 2017 with the publication of the Medical Device Rules. The rules
came into force in January 2018 and devices are regulated by the Central Drugs Standard Control
Organization (CDSCO), an agency of the Ministry of Health and Family Welfare

A large chunk of the Indian medical device market is serviced by imports, which currently stand
at 70 – 75 percent of total demand. Therefore, it is important that processes are clear and in line
with the Indian regulations.When expanding to different geographies the company must ensure
the regulatory considerations of various countries.

Possible solution : Make a list of all the geographies the company is planning to expand to and
then find the commonalities and differences in the regulations and then try to fit the device and
plan for

Investment :

The sector is highly capital intensive with a long gestation period and requires continuous
induction of new technologies and training of healthcare professionals to adapt to new
technologies for rapid innovation. Medical devices undergo safety, quality, and efficacy tests
through processes defined by the regulator before they hit the market for sale which means that
the industry requires huge investments in scientific facilities.

Manufacturers of medical devices in India grapple with balancing between the time-to-market,
cost and quality of the product, and optimal trade-offs in the light of tightening regulatory norms
for the devices. Most of the time medical devices are overpriced and are not affordable by many
because of the cost overruns during the development phase. The high cost of financing also acts
as a barrier to setting up a medical device company.

Possible solution could be to create a great elevator pitch so that it can have access to investors

Reliability:

It is imperative for any medical device to become a trusted brand among the masses in order for
it to be accepted by people. Quality issues rightly concern every stakeholder in the medical
device value chain, from manufacturers and regulators to payors, doctors, and patients. Media
attention has increased, and investors have severely punished some companies with quality
issues.

A company’s quality performance can affect its business performance in multiple ways. For
example, quality issues or the lack of them can enhance or impair market reputation; quality
 16

failures or failure prevention efforts affect costs; and the impact of quality on customer
satisfaction can alter revenues. In extreme cases, quality issues can force the removal of a device,
or a company, from the market.

The accuracy of the device is the main proprietary and could become a potential legal liability
for the company if not taken care of. Medical device consumers invariably claim that quality is a
key consideration in purchasing decisions.

Possible solution is to have focus on quality and reliability throughout product design,
manufacturing, and marketing

Pricing:

Continuous innovation in the R&D segment is needed because of focusing on R&D efforts on
developing affordable medical devices for the lower and middle-income segments of the Indian
market and operating predominantly in the low-priced, high-volume market segments.

Some advantages:

Despite the hurdles the sector faces, enabling policies like PLI, export incentives, R&D support,
and incentives and support for innovation can boost the medical device industry in India. The
government is aware that demand and supply-side dynamics provide an unprecedented
opportunity for the manufacture of medical devices in India. It believes the Indian medical
devices industry has the potential to grow at 28% annually to reach $50 billion by 2030. The
government is planning to further boost India’s strengths of skilled manpower, and ease of
business through its industry-friendly rules. According to the government’s draft policy, import
dependence on medical devices will be halved in the next 10 years.

The imperatives for the medical devices industry are aligned with the objectives of ‘Make in
India’ that include investment, innovation, skill, and infrastructure under the new manufacturing
policy that seeks to boost the contribution of manufacturing to the GDP from 16% in 2013 to
25% in 2025. The Make in India vision calls for investment in capital and technology
investments for setting up manufacturing facilities while India-specific innovation would help
improve the accessibility and affordability of medical devices. It also calls for training and
development of human resources for manufacturing, operations, and services, and best-in-class
infrastructure for supporting the high-technology industry.

The Internet of Medical Things (IoMT), a connected infrastructure of medical devices, software
applications, and health systems and services to deliver improved patient outcomes efficiently,
can help company in reducing these costs.

Risk Management:

Risk management involves the identification, understand, control, and prevent failures that can
result in hazards when people use medical devices. Manufacturers are expected to identify
possible hazards associated with the design in both normal and fault conditions. The risks
associated with the hazards, including those resulting from user error, should be calculated in
 17

both normal and fault conditions. If any risk is judged unacceptable, it should be reduced to
acceptable levels by appropriate means.

(Risk Management Flowchart to be used)

(Source :
https://www.wipro.com/medical-devices/basic-principles-of-risk-management-for-medical-devic
e-design/#:~:text=of%20Risk%20Management-,Risk%20management%20involves%20the%20i
dentification%2C%20understand%2C%20control%2C%20and%20prevent,both%20normal%20
and%20fault%20conditions.)

Risk control and monitoring activities:

Actions intended to eliminate or reduce each risk to meet the previously determined risk
acceptability criteria.One or more risk control measures may be incorporated.
Risk controls may begin as early as design input and continue over the medical device life
time.Some regulatory schemes prescribe a fixed hierarchy of risk controls that should be
examined in the following order:
●​ Inherent safety by design
●​ Protective measures in the device or its manufacture
●​ Information for safety, such as warnings, maintenance schedules, etc.
Throughout the life-cycle of the device the manufacturer monitors whether the risks continue to
remain acceptable and whether any new hazards or risks are discovered.
 18

An effective and well defined Quality Management System is key Information typically obtained
from the quality management system, for example, production, complaints, customer feedback,
should be used as part of this monitoring.
Risk Control Measures:
Use of protective measures, e.g. default operating modes should be given. Information for safety,
e.g., warnings in labeling etc should be provided and device use video (self help videos can be
used)
Many measures require intervention
●​ The correct response for the circumstances, e.g. a patient-specific response
●​ Timeliness

Entrepreneurship and leadership in the context

The leadership in the context should be well aware about the healthcare industry and the trends
that are emerging in the industry even if the leadership has less experience they need to surround
themselves with people who have experience in the industry and understand the market and
regulations. The leadership should work with a three box approach, which encompasses the
following boxes.

Box 1 - Manage the present

Box 2 - Selectively forget the past

Box 3 - In order to create the future

Medical devices include the interdisciplinary application of technology from the fields of clinical
medicine, electrics, electronics, mechanics, materials, and optics as one of its characteristics.
With the advent of digital healthcare, u-health, wearable medical devices, and other innovations,
the medical device industry has recently been growing into the new convergence sector in line
with the Fourth Industrial Revolution. Regulation and government clearance are required
because medical devices have a direct and indirect impact on people's ability to promote their
health and protect their health rights.

As a result, the government controls the production of medical devices as well as the safety
guidelines for clinical trials, distribution, and retail sales. The business has a high barrier to entry
since hospitals, who make up the majority of the market for medical equipment, are cautious
about using current models due to dependability and safety concerns. Before research findings
are commercialized, the medical device sector needs a lot of time and money. Success-related
uncertainties are likewise relatively significant.
 19

References

https://www.mordorintelligence.com/industry-reports/blood-testing-market

https://www.marketwatch.com/press-release/blood-testing-market-2022-industry-size-share-tren
ds-opportunities-growth-analysis-and-forecast-to-2030-2023-01-03?tesla=y

https://www.biospace.com/article/blood-testing-market-top-trends-and-key-players-analysis-repo
rt-with-forecast-to-2030/