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