Currently, India is one of the top three nations with respect to the number of startups. The medical devices sector is gaining attention owing to increased demand for high quality medical devices and large market size. High cost of imported medical devices and increased government support for this sector are fuelling the medical device manufacturing industry. Thus, entrepreneurs are focusing on establishing groundbreaking medical device startups.  Novel solutions that can transform patient care are driving the growth of the medical device startup in India. A strategic approach and careful execution are pivotal for the success of medical device startups. In this blog, we will present some tips for starting a medical device company in India.

Landscape of medical device startups in India

A medical device startup in India aimed at providing affordable high quality medical devices is the need of the hour. Medical device startups with the goal of transforming the health care sector is attracting considerable attention. The government, industry, and academia are trying to foster an environment supporting medical device startup companies. Currently, most of the medical devices are imported making them expensive. Thus, these are unaffordable for certain segments of the society. Hence, the government is incentivising the growth of biomedical device startups intending to reduce healthcare cost and improve access to early diagnosis and effective treatment. With a fast-evolving healthcare landscape, a medical device startup in India has immense potential.

However, it is important to note that medical device startup in India is heavily regulated. Obtaining clinical validation, medical device manufacturing license, and other regulatory document prior to starting medical device startup companies is crucial.

Some key highlights of the Indian medical devices industry

• The current market size of this sector is $11 bn. 
• The medical devices industry in India has been growing at a compound annual growth rate (CAGR) of 15% over the last 3 years.
• The market size of this sector is expected to touch $50 Bn by the year 2025.
• Make in India Campaign of 2014 designated this market as the Sunrise Sector of India.

Typical journal of medical device startup companies

Only having a vision and mission is not sufficient for launching medical device startups. The following list contains certain major steps in launching medical device startups:

• Identification of an unmet clinical need based on market research
• Ideation
• Proof-of-concept  
• Functional prototyping
• Laboratory testing
• Field testing (initial and detailed)
• Mass production
• Market launch

The success of medical device startups depends not only on the innovative idea but also the business model and execution. Seeking guidance from mentors with first-hand experience in medicine and engineering as well as management goes a long way.

14 tips for establishing a medical device startup in India

1. Identify the gap in healthcare needs: First and foremost, identify the unmet clinical need based on market research. It is important to determine real challenges in the healthcare industry. Discussing with healthcare professionals, clinicians, experts, and patients, will help you identify the critical needs of the industry. This information will form the foundation for developing novel medical devices.
2. Market research: An in-depth market research will help validate your idea in real time. The target market size, competitive landscape, potential adoption barriers, regulatory requirements, and reimbursement policies need to be evaluated. This information will help adapt and modify your business model as per market requirements.
3. Creating the prototype and concept validation: This step involves realizing your idea into tangible prototypes and proof of concept based on user feedback and expert evaluations.
4. Avoiding excessively complex technology: Medical devices with advanced technology need to be developed but overtly complicated technology will reduce its impact. The medical device developed may revolutionize the health care industry. However, if the technology is complex and difficult to use, medical practitioners and patients will avoid it. The medical device should be innovative as well as relatively easy to use. If the medical device is difficult to use, then the product will fail in the market, ultimately killing the startup. While developing a product, its user-friendliness should be one of the top priorities.
5. Avoid overinvesting in the pilot program: Pilot programs are very important for testing the product. However, excessive time and resource investment in pilot programs, which can lead to financial setback, should be avoided.
6. Proper planning: Strategic and stepwise planning is required for the success of medical device startups. Proper planning will help you overcome any unforeseen challenges and hurdles.
7. Proper documentation: Proper documentation is not only necessary to support claims but also to apply for medical device manufacturing license. Specific and well-documented cases and data will support the claims. Lack of proper documentation can lead to significant losses and legal implications. Our team of experts at the Pharmadocx Consultants is adept at preparing the necessary documentation to support your business. The team will assist you with crafting the documents necessary for obtaining medical device manufacturing license.
8. Abiding by regulatory requirements for medical devices: Regulatory bodies have complex guidelines and regulations for medical devices. In India, the CDSCO regulates the manufacture and sale of medical devices. The CDSCO has separate regulations and guidelines depending on the class of medical devices. The CDSCO medical device manufacturing licensing process requires various documents and has different requirements that need to be fulfilled. Compliance with the CDSCO requirements is a must to start a medical device startup in India. Getting assistance and support from experts will help understand and navigate the complex regulatory landscape. Pharmadocx Consultants has the expertise to guide you with CDSCO medical device regulations and requirements. 
9. Budget allocation and medical device startup funding: Planning and allocating specific budgets for the different phases of developing and manufacturing medical devices can prevent financial loopholes. Attracting potential investors and obtaining funding are important for any startup, including medical device startups. Highlighting market potential, competitive advantages, and a clear commercialization path can help attract investors. Government grants and programs, angel investors, and crowdfunding are some of the medical device startup funding options to explore.
10. Building a diverse and skilled team: A proficient and efficient team will form the basis of your medical device startup’s success. Diverse team containing product development, clinical research, marketing, finance, and regulatory affairs experts is essential for medical device startup companies. The team members, with expertise in the relevant field, can solve problems that will crop up while establishing the startup. The credentials of the team members will influence the scalability of the startup. Quality leadership with clear cut vision will drive the team.
11. Marketing strategy: Developing an effective marketing strategy is as important as developing an innovative product. Without effective marketing, your medical device startup will fail. An all-encompassing marketing, sales, and distribution strategy will play a pivotal role in the success of medical device startups.
12. Approval and acceptance from a broader circle: Approval and acceptance beyond your close network will establish the device in a wider market. This will establish the medical device’s true worth.
13. Effective communication: The innovative medical device startup idea needs to be effectively communicated to investors and consumers. Proper pitching will attract potential investors that will provide the necessary funding. The potential and groundbreaking impact of the medical device need to be communicated to the patients for the success of the product.
14. Staying updated: It is important to stay updated and adapt and innovate as per market needs. The Indian medical device industry is dynamic and demanding. Continuous learning and innovation are essential for meeting the changing needs of the consumers. Innovative medical devices modified as per market trends and user feedback can ensure sustained growth and relevance of the company.

We at Pharmadocx Consultants simplify the medical device registration and licensing process. This process is the first step for setting up medical device startup companies. Let us help you obtain the medical device manufacturing license for starting a medical device startup in India. Call/Whatsapp us at 9996859227 or drop an email at [email protected].