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Medical device company, Sterling, delivers remarks to Japanese business leaders

At the forefront of Japan's medical device sector, executives from Sterling Medical Devices showcased their innovations to an elite Japanese business community.

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Sterling Medical Devices' top brass shared insights on their leading role in Japan's medical device...
Sterling Medical Devices' top brass shared insights on their leading role in Japan's medical device industry to an elite gathering of Japanese corporations.

Medical device company, Sterling, delivers remarks to Japanese business leaders

In a bid to educate Japanese companies about accessing the US medical device market, Sterling Medical Devices, a leading Japanese medical device company, held exclusive briefings in Tokyo and Osaka in June 2014. The sessions were organized at the request of the US Embassy in Japan.

Dan Sterling, CEO, and Erik Hilliard, Director of Business Development, presented the nuances of the software development process for medical devices—a crucial aspect that minimizes the chances of delays during the FDA approval process.

"Engaging with Japanese businesses eager to expand in the medical device industry of the US was a fantastic experience," said Sterling. "Our years of expertise in navigating the FDA approval process effectively, saving time and resources, were on full display." Throughout his illustrious career, Sterling has collaborated with some of the biggest names in the aerospace, telecommunication, and medical device industries, including McDonnell Douglas, Motorola, Honeywell, and Guidant.

Much of the presentation revolved around risk management and quality system adherence in software for mobile medical device apps. "The rising trend of incorporating apps on smartphones into the medical system, making these apps either medical devices or accessories, creates both opportunities and risks for manufacturers," explained Hilliard. "The market is indeed exciting, but understanding the entire process is the key to success."

Since its inception in 1998, Sterling has served as the CEO of Sterling Medical Devices, a company offering software and electronics development, testing, and quality systems services exclusively to the medical device industry.

Key Takeaways from the Presentation

While Sterling Medical Devices did not share its specific methodology for software development, the discussion underscores essential aspects for managing risks and ensuring quality compliance in mobile medical device app development:

1. Regulatory Compliance

  • MDR and other regulations: Ensure your business model aligns with regulatory requirements, including risk management and quality system adherence.

2. Risk Management

  • Risk Classification: Identify potential hazards and implement controls to mitigate risks.
  • Clinical Investigations: Validate safety and efficacy through thorough clinical investigations.

3. Quality System Adherence

  • Quality Management Systems (QMS): Implement a QMS that adheres to international standards like ISO 13485.
  • Continuous Improvement: Regular audits and continuous improvement processes for compliance.

4. Technology and Innovation

  • AI & Automation: Leverage AI and automation to boost efficiency and reduce errors.
  • Integration & Interoperability: Ensure seamless integration with other healthcare systems and devices.

5. Data Management and Security

  • Secure Data Flow: Utilize secure online platforms for data collection and management.
  • Reporting and Analytics: Implement robust reporting features to support decision-making and identify areas for improvement.

While Sterling Administration's case study focuses on the benefits of digital transformation in healthcare, it does not provide specific insights into Sterling Medical Devices' software development strategy for mobile medical devices. However, the emphasis on innovation, efficiency, and compliance is applicable across the healthcare technology sector.

The presentation by Sterling Medical Devices highlighted the importance of regulatory compliance, risk management, quality system adherence, technology, and data management in the development of mobile medical device apps. To ensure alignment with regulatory requirements, it's essential for businesses to follow risk management strategies and adhere to quality system standards. Additionally, the use of AI and automation, seamless integration with other healthcare systems, and secure data flow are key elements for success in this field. Lastly, robust reporting features are critical to support decision-making and identify areas for improvement in the medical-conditions sector. Furthermore, the discussion underscored the need for continuous improvement processes and compliance with international standards like ISO 13485. This focus on innovation, efficiency, and compliance is applicable across the health-and-wellness, finance, and business sectors that involve the use of technology.

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