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Burning Down Technical Risk: A Critical Step for Medical Device Startups

  • Writer: Frank Jaskulke
    Frank Jaskulke
  • 5 days ago
  • 2 min read

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Technical risk, the potential for technological challenges or failures that could hinder development or commercialization, is a significant concern for medical device startups. Proactively addressing and mitigating technical risk is essential to attracting investors and achieving long-term success.


1. Invest in Research and Development

Allocate sufficient resources to research and development (R&D) to ensure your device's technical feasibility and viability. A robust R&D process can help identify and address potential technical challenges early on.


2. Develop a Comprehensive Development Plan

Create a detailed development plan outlining milestones, timelines, and resource allocation. This plan will provide a roadmap for your project and help you stay on track.


3. Build a Strong Engineering Team

Assemble a team of experienced engineers with the necessary skills and expertise to develop and manufacture your device. A talented engineering team can significantly reduce technical risk.


4. Conduct Rigorous Testing

Implement a comprehensive testing regimen to identify and address potential technical issues before they become major problems. Conduct various types of testing, including:

  • Design Verification and Validation (DVV): Ensure your device meets its intended design specifications.

  • Reliability Testing: Assess the device's ability to perform as intended over time.

  • Compatibility Testing: Evaluate the device's compatibility with other systems and equipment.


5. Protect Intellectual Property

Safeguard your technology with patents and other forms of intellectual property protection. This will help prevent competitors from copying or exploiting your innovations.


6. Manage Supply Chain Risks

Evaluate and manage potential risks within your supply chain, such as component shortages, quality issues, or disruptions. Develop contingency plans to mitigate these risks.


7. Stay Updated on Industry Trends

Keep up-to-date with the latest technological advancements and industry trends. This will help you identify potential risks and opportunities.


By proactively addressing technical risk, medical device startups can enhance their credibility, attract investors, and increase their chances of successfully bringing their innovative products to market.


Startups are hard. We get it. Avio was born in the startup trenches. Founded by a medtech innovator, for medtech innovators, we understand the unique challenges you face. Let us leverage our firsthand experience to accelerate your journey to market.


It will never be easy or stressless, but it can be easier and less stressful.

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