Enticing investors with a good exit strategy for your medical device
When developing a medical device, you need to have a sound exit strategy that paints a clear financial and marketability picture for prospective investors. Your exit strategy should be heavily influenced by your product development cycle. As such, it’s important to make the right decisions as early as possible, like choosing the right prototyping services provider.
Defining your product
Investors need to have a clear idea of what your product entails. A vaguely defined device that can be somewhat useful—but doesn’t offer any innovative or markedly better alternatives to existing products—will not attract investors.
- Your medical device must solve a clear medical problem.
- The real-life applications need to be versatile enough to benefit as many healthcare sector stakeholders as possible.
- You need clear documentation and comprehensive training modules to ensure a smooth roll-out.
- Packaging, distribution, shipping, and storage must be well thought out and commercially viable.
Your production process must be carefully planned
Time to market is essential to secure financing. This means that your production process must be optimized to maximize margin profits and ROI, while minimizing the time and resources required to get your device on the shelves.
- Components and raw materials should be easy to obtain or manufacture.
- Standardization and automation must permeate every step of the production process. The more standardized and automated your production cycle, the shorter your time to market and the more likely you’ll be to secure investment.
- The resources needed for production should be outlined fully. Is the process outsourced or can it be dealt with in-house? What is the production turn-around? As stated in the previous point, automation and standardization will simplify this process.
Compliance is key
The healthcare sector is heavily regulated—every part of the world has its own regulatory body with specific health and safety requirements. In the United States, the FDA governs premarket submissions for any medical device. If your device product development strategy does not take these requirements into account, your medical device will not be granted access to the market.
Prototyping service providers help define your exit strategy
Outsourcing some or all your development to prototyping services providers can optimize your production process. Choosing the right partner offers many benefits:
- They have the human resources and infrastructure to develop the optimal production cycle.
- They have the expertise to work with companies of any size and can adapt their processes to your requirements.
- They are aware of regulatory compliance requirements and can help you prepare for future submissions.
- They offer great flexibility and can be hired on a per-project basis, which eliminates in-house production costs.
By hiring prototyping services providers, you are taking additional know-how on board that will help fine-tune and optimize your device’s production cycle and time to market. With the resources freed through using prototyping services, you can dedicate time to building a compelling case for your medical device. This case will help attract investors, and should include:
- Product definition and real-life applications;
- Production and distribution processes;
- Training and product documentation;
- Compliance requirements and market approval;
- Overall cost to investor;
- Forecasted profit margin and return on investment;
- Time to market.
Technosoft is a prototyping services provider that offers in-house development procedures for prototyping, small scale pre-production, device testing, and clinical trial management. We are fully equipped to help you prepare for your FDA 510(k) submission or any other regulatory compliance requirements specific to your market and product.
To know more: download our guide
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