Minnetronix: Leveraging Medical Device Expertise to Develop Combination Therapies

During the 2017 Drug Delivery Partnerships Conference (DDP), Dirk Smith, Co-founder of Minnetronix, spoke about key factors to consider when integrating a drug delivery system into a combination therapy. Understanding the medical device mindset and framework—including timing, risk management, design controls, and systems complexity—can help leverage concurrent development processes to a successful market introduction.
When integrating a drug and delivery system into a combination therapy, developers need to consider a number of factors beyond their traditional processes. Understanding the medical device mindset and framework—including timing, risk management, design controls, and systems complexity—can help leverage concurrent development processes to a successful market introduction. Dirk will discuss key factors from a medical device perspective. Topic points include:
Key capabilities/qualities in a medical device delivery partner

• Medical device process know-how
• Medical device quality and regulatory expertise
• Systems thinking, integrating and addressing challenges with multiple technologies
• Usability – improving delivery accuracy, simplicity and compliance while reducing risk
• Scalability from prototype to trial to delivery system manufacturing

State-of-the-art med device technologies beneficial to the pharmaceutical industry

• Sensors, connectivity, wireless power, miniaturization, complex software/hardware integration, batteries, data analysis, human factors, etc.

Unique aspects an experienced device partner brings to pharmaceutical delivery device development

• Proven design controls from requirements through verification
• System architecture and integration of complex systems
• Embedded software, electronics and electromechanical design
• User interface and human factors design
• DFx – design for manufacturing, test, safety, usability, etc.
• Project management