Description_21

Problem

India accounts for about a quarter of the global TB burden. Tuberculosis was declared a global health emergency in 1993. TB is causing millions of deaths every year globally. It is suspected that TB has killed more people than COVID-19. It is a serious infectious disease that mainly affects the lungs.

The major issue is the delay in the diagnosis of pulmonary tuberculosis in India. Patients with low socioeconomic status do not report to qualified health personnel. Patients start self-medicating by unregistered drugs from unreliable sources. A large population of patients are left undiagnosed or not admitted to well-equipped health systems. Therefore, there is a need to increase the amount of investment in the diagnostic sector which will result in the rise of new diagnostic devices with higher accuracy and sensitivity.

Stakeholder Analysis

Through the process of integrated human practices, we had discussions with stakeholders from a variety of sectors which have a major impact on our project in the real world. The diagram below depicts the distribution of needs of stakeholders for the common purpose.

The stakeholders:-

Hospitals
Private clinics
Research labs
Doctors
Testing centres
International organisations

The arrow represents the increase in the need of stakeholders from low to high in the direction of the arrow.

Business Plan

Product Design:- Our project is a rapid diagnostic device that uses molecular techniques to detect MDR-TB. For this, we designed an automated hardware device that can be used even at places with little diagnostic resources. We designed the device keeping in mind the problems faced by patients in rural areas to access better diagnostics. We identified key things to include in our design - cheap, easy access to parts, ease of operation, minimal use of resources and reliability. Since we are using isothermal amplification, our device requires less energy to operate compared to other devices. Hence it can operate on a rechargeable battery. This makes it energy efficient and also portable. Most of the steps will be automated hence anyone can operate the device without any special training. Results are processed by the microchip and can be displayed in an easy to interpret manner. Once the prototype is ready, we plan to patent the design.

Nature of Business

With Suppliers
Phase 1:- At the initial stage, since we don’t have the power and resources to set up a manufacturing plant we plan to start our company as a primarily R&D based company. We will be designing and optimizing the medical diagnostic devices (with the debut of CODE-M) for various diseases starting with MDR-TB and then expanding towards other infectious diseases, cancer and genetic diseases. Our assets will be intellectual properties, meaning the relationship we will be having with other companies will be based on contracts and rights to manufacture our products. The nature of the contract can be either licensing the patent to other biotechnology companies or the manufacturing companies will manufacture our devices for us.

Phase 2:- Once we have established ourselves, we plan to acquire some manufacturing power to manufacturing our products independently.

With customers
A major way to reach customers is through advertisements. But for certain customer segments, advertisements are not enough. We need to establish ourselves with good services which will attract customers via good recommendations and government endorsements.
1. Government:- Governments encourage use of modern diagnostic devices by endorsing them. Once we have established our product as a safe and better alternative by thoroughly testing it, we can get government support. Since our product is designed considering government interests in developing rural areas, we are confident enough to get government contracts to manufacture devices for diagnostic centres and Primary health care centres.
2. Private Hospitals and labs:- Business with major hospitals/ foundations can be in the form of long term contracts where we provide our product along with maintenance services. Our product can also be available to small and medium scale diagnostics labs planning to buy a few devices. We plan to create our own website where our potential customers can buy our products. Online commerce is a well-established tool in the medical device market to reach small scale customers.

Current Progress

To understand the basics of business and find a point to start working, we interviewed some of the people experienced in the industrial sector. We interviewed Dr. Rajesh Gokhale, who is a scientist at NII, ICMR. He is also co-founder of a start-up M/s Vyome BioSciences Pvt. Ltd.
We got valuable advice from him on where to start planning a business. He told us to assess the strengths and weaknesses of our product, identify the Unique Selling Points (USPs) and do a cost estimation for our project. We also got to interview Prof. TS Sridhar, currently the R&D dean and HoD of biological sciences at IISER Berhampur. He helped us a lot in identifying potential sponsorships and also reviewed our business plan. In multiple meets, he tracked our project’s progress and advised on some important issues related to commercialization.
During this time we also had a talk with Dr. Aviseka Acharya. He has a start-up in Bhubaneshwar - Dr. Acharya’s Lab. He offered to help us design the hardware components of our device. We applied for the commercial grant from TheraCUES Innovation Pvt. Ltd. and were selected for an interview.

Future Plans

We learnt a lot while starting this journey and there is a lot to plan and do to take this venture ahead. For this we divided our goals -

Divide the roles - In industry there are additional roles to be carried out in a team. So we will identify those and divide them accordingly. Furthermore, we will recruit new members with skills that will be an asset to our startup.
Apply for funding - We will be needing a large amount of capital to keep the project going. We identified grants that can help us meet the amount we require of our venture. The “BIG grant” provided by BIRAC fits our needs perfectly. We plan to apply for the grant in the January session when the application opens. Prof. TS Sridhar agreed to guide us through the process.
Joining the incubation centre - The best place to start a start-up is the incubation centres. There we can get the best environment to progress with our project. For this, we identified the nearest incubation centres that we can join. We found ILS Bhubaneswar and KIIT Bhubaneshwar have active incubation centres.

Market Analysis

Introduction

Market analysis is the qualitative and quantitative assessment of a market. It is performed by startups and businesses to identify risks and opportunities and develop the strategy for entering a market.

There has always been competition between companies to snatch the majority of the customers and gain more profit. It always helps a competitor to stay in the game. It not only helps identify the key players but also identify the problems with the products which we are trying to sell.

Secondly, testing the product on real grounds will help us save additional expenses. It is always better to understand our competitors in the process. A thorough analysis will help us build the perfect campaign to give the organization a track. All the big brands with pre-established market value know the proper way of staying in the market. It is important to know the trends of change and evolve the design with new challenges.

Porter’s 5 Forces framework takes into account the level of market competition by estimating the danger of new entrants and alternatives, as well as the bargaining power of consumers and suppliers.

Market Size

World market size

The market volume shows the entirety of all acknowledged deals volume of an uncommon market. The rapid growth in the population and prevalence of TB has necessitated the need for technologically advanced medical diagnostic tools such as molecular medical diagnostic tools. The global market for in-vitro diagnostics (IVD) should increase from USD 74.1 billion in 2020 to reach USD 102.4 billion by 2025, at a compound annual growth rate (CAGR) of 6.7% during the period of 2020-2025. Molecular diagnostics account for about 6% of the global market.

However, things are about to change as molecular diagnostics is poised to take a larger share of the in vitro diagnostics in the years to come. As indicated by WHO gauges, 38.0 million people across the globe were living with HIV contamination in 2019. In addition, rising drives by market players to further develop acceptance to effective assets are expected to drive the market for molecular diagnostics.

Why did we focus on the Indian market?

The Indian in vitro diagnostics market was valued at USD 1.24 Billion in 2019, and is projected to reach USD 2.06 Billion by 2027, registering a CAGR of 7.5% from 2020 to 2027. The demand in the Indian market for IVDs is expected to grow in the long run.

POC diagnostics are progressively turning into a significant piece of the medical diagnostics scene. POC testing carries testing closer to the patients and acquires results rapidly for the medical care supplier to speed up analysis and ensuing therapy. This is probably going to increase the demand for in-vitro diagnostics in India.

Growth of diagnostic market

The in vitro diagnostics market is comprehensive of all medical devices and consumables that are used to act in vitro tests on different natural examples, utilized for the analysis of different diseases. The technical progressions in this segment have been huge, and the expense of these molecular diagnostic tests have decreased consistently, to make them available to more patients experiencing chronic and infectious diseases. Moreover, the episode of COVID-19 in the region has expanded the interest in molecular diagnostics, which is boosting market development.

Current market share

As shown in the figure below. Currently, Roche has the largest market share in Point of Care Diagnostics (POCT) with 20% followed by Siemens with 10% shares, Abbott 8%, Danaher 6%, Alere 5%, Ortho Clinical Diagnostics 4%.
If there is anything to learn from these companies it is that these companies have strong R&D departments. From the foundations of these companies to the expansion, R&D has played an important role in the success of these companies. They identified the potential of new technologies and commercialized them to solve problems. Another aspect is diversification. These companies are not only involved in POCT but also have stakes in other medical and biotechnological sectors. To create a significant share of our company in this market in future, we have a strong R&D network (being in a research institute) and we have the potential to diversify.

Customer segment

Our consumers can be broadly divided into two categories -

Government
Government Hospitals - Government hospitals are usually very busy places on whom a lot of poor patients rely. Our product is fast and cheap which will prove to be very helpful to such entities that aim to save time and serve poor patients.
Primary Healthcare Centres - Our product is specially designed for use by Primary Health Care centres. These are present in Rural areas where there is an accessibility problem of modern testing equipment. Our product requires minimal equipment and facilities and hence can easily be set up in such settings.
Private
Diagnostic Labs - Private labs that solely work as diagnostics can rely on our highly sensitive equipment. The feature of detecting drug resistance will be an asset to such labs.
Multispeciality Hospitals - Similar to government hospitals, the interest of these hospitals lies in saving as much time as possible in diagnostics with high-quality tests. Our product provides both.

Competition

Thermo Fisher Scientific Inc
Abbott laboratories
Bio-Rad Laboratories
Danaher Corporation
Ortho clinical diagnostic

Existing techniques are lacking important aspects that the customers seek for. Some are expensive while others are not available in every part of the world. Accuracy of these techniques have always been a major concern, till now diagnostics could not satisfy all the factors.

Therefore, the need for a more accurate and target specific diagnostic kit which meets the customers needs for an affordable and easily accessible point-of-care TB diagnostic kit.

Economic Environment

Funding - Good amount of Funding. Since molecular diagnostics has the potential of direct application in medicine, funding agencies and various foundations are willing to invest. There is also Government support in the form of various grants and sponsorships. Big biotechnology companies also sponsor such projects.

Entry barriers (regulations, approvals) - Diagnostic market in India is heavily regulated. Central Drugs Standard Control Organization (CDSCO) is the regulatory authority responsible for devising guidelines for medical devices. Clinical trials require prior approval of ICMR - a regulatory body for medical research.

CDSCO guidelines -

Step 1

Medical devices and IVDs are regulated by the Drug Controller General of India (DCGI) within the Central Drugs Standard Control Organization (CDSCO), part of the Ministry of Health and Family Welfare. The regulatory structure for clinical devices is based on the Medical Device Rules, 2017. A full rundown can be found in the CDSCO's Notice on the classification of medical devices and IVDs. his is definitely not a comprehensive rundown. CDSCO does not maintain a single list of regulated devices, but rather subjects devices to regulation through the Drugs and Cosmetics Rules, the Medical Device Rules 2017, and subsequent Gazette Notifications, which should be reviewed prior to making a final determination of a device’s regulatory status.

Step 2

Selection of an India Authorized Agent to interact with the CDSCO on our behalf. Our Agent must have a valid wholesale license (Forms 20B and 21B/21C), and be granted Power of Attorney to manage Our registration and device importation in India.

Step 3

Class B, C, and D IVDs need in-country performance testing through the National Institute of Biologicals (NIB) or an accredited lab. Class D IVDs require performance testing through the National Institute of Biologicals (NIB). Class B and C IVDs require performance testing through an accredited Indian lab, however CDSCO may rather acknowledge existing reports for such items with approval in a significant regulatory market.

Step 4

Compile device application (Form MD-14), including manufacturing facility information, device technical information, ISO 13485 certificate, IFU, testing results (if applicable), clinical data (if applicable), proof of approval in the US, EU, Australia, Canada, or Japan, plus proof of approval in your home country (satisfied by CFS/CFG).

Step 5

File application for registration/Import License with the CDSCO and pay fees. All documents must be in English.

Step 6

The CDSCO audits applications and may require a Technical Presentation. The Technical Presentation is an in-person meeting with the CDSCO to examine the product in more detail.
Novel devices will likewise go through a Subject Expert Committee (SEC) review. Devices novel to the Indian market (new technology, material, intended use) may confront extra regulatory hurdles. CDSCO might require clinical examinations conducted in India preceding approval, or the agency may issue a restricted approval. A restricted approval could incorporate a necessity to effectively gather and submit post-market information.

Step 7

The CDSCO issues an Import License in Form MD-15. Following the implementation of the Medical Device Rules, 2017, the processes for obtaining device registration and import licensing were combined in India. Accordingly, the CDSCO does not issue Registration Certificates under the Medical Device Rules, instead issuing market authorization for foreign devices through the Import License (Form MD-15).

The License does not lapse; however, license retention fees are due every five years.

Step 8

Once approved, only our India Authorized Agent may import products. However, we can obtain multiple registrations for the same device through different Authorized Agents.

High initial investment (R&D, Equipment)
Tools and techniques used in molecular diagnostics are cutting edge and require a lot of research to be implemented in a diagnostic device. Same goes for setting up manufacturing facilities. However, the high initial investment is a major factor restraining the growth of the market.

SWOT analysis

Business Model Canvas

Timeline

2021

alk with companies and funding agency (C-CAMP, Dr Achary’s Lab, TheraCues)
Do preliminary market analysis
Develop preliminary product design
Design manufacturing process
Preliminary manufacturing study
2022

Developing prototype + integrating detection for other disease
Build and test prototype.
2023

Final prototype + Approval for clinical trial
Pre-clinical tests.
2024

Clinical tests
Risk Assessment.
2025

Clinical trials + start of production + risk assessment starts

Team:IISER Berhampur/Entrepreneurship