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