A new medical innovation that can deliver effective and accurate clinical outcomes at a reduced cost is positioned to secure a significant share in the current and future target markets. The healthcare industry requires improved medical technologies to deliver patient care and improve the physician’s workflow. A medical device developer with an innovative idea and business acumen can deliver better healthcare solutions. A revolutionary medical device can significantly change procedures, processes, medical facilities, and patient’s quality of life.
If an innovator desires to contribute to the healthcare industry, it requires a solid medical device startup business plan and services of medical device consulting firms at all medical device development lifecycle stages. It requires knowledge and highly valuable data to develop a concept into a functional medical device that can meet or exceed the target market expectations. The innovator should also have a successful medical commercialization and exit strategy. From the voice of the customer analysis and medical device business startup plan to commercialization strategy, consulting firms’ contribution is critical to the medical device company success.
Starting a medical device company requires:
1. Adhere to Regulatory Compliance :
As medical devices are used to deliver effective and accurate patient care, the medical device industry is highly regulated. Each country has its own regulatory body. Medical devices in the U.S. are subjected to FDA regulations and international regulatory bodies. The medical device company has to adhere to all the regulations to develop and market innovative healthcare technology. A startup may not be familiar with regulatory compliance. For this reason, the startups rely on medical device regulatory & compliance consulting firms. These firms help in managing medical device compliance risks.
Note: A medical device startup has to work with different consulting firms. Medical device regulatory & compliance consulting firms ensure that the company follows all the regulations. Another type of consulting firm offers a full suite of strategic medical device consulting services, including:
- Voice of the customer analysis
- Market analysis
- Value analysis
- Key opinion leader identification
- Risk analysis
- Competitive analysis
- Positioning analysis
- Financial valuation
- Exit strategy
- Business plan
- Portfolio analysis
Note: Strategy Inc. is not involved in regulatory consulting
2. Apply for Intellectual Property :
Once the startup has an innovative idea, it should protect IP rights to get a competitive advantage in the target market. The company should get intellectual property rights to protect the ideas, logos, brand name, methods, and phrases. IP rights keep competitors from using the company’s medical device idea.
3. Market Analysis :
Market analysis is critical for target market identification and successful medical device commercialization. This analysis determines market size in terms of disease incidence and prevalence and procedure volume. Medical device consulting firms use primary sources for research and analysis. Other sources include market share statistics, reports, published literature, and secondary resources. Consultants customize the market analysis to define the medical device market and opportunities through:
- Scope and drivers identification
- Revenue driving market trends identification
- Target customer profile identification for the selected clinical area
- Current and emerging treatment modalities delineation
- Competitive technology advantages and limitations identification
- Projected barriers and market adoption threat identification
4. Product Idea Comparison :
A medical device startup requires a realistic approach to launch the medical device in the target market. Medical device consulting firms conduct a competitive analysis to compare the technology under consideration for development with the on-market and pipeline medical devices. The medical device startup can identify the value proposition of its idea.