Leveraging Med Device Expertise to Develop Combination Products 20 th Annual Drug Delivery Partnership Conference January 20, 2016 Dirk Smith VP of Technology Solutions Minnetronix, Inc.
250 employees, 20 years in business 100+ engineers with over 1.5M development hours on complex electromechanical medical devices, including drug delivery devices FDA-registered, ISO 13485 Certified Our medical device background: Development partner Med device manufacturer Technology developer
Minnetronix Experience with Combination Products Ultrasound nebulizer Design for manufacturability, test development and scale-up Photodynamic drug therapy light source Ground up design, concurrent with drug research Iontophoresis stimulator Next generation design and manufacturing Anesthesia delivery via battery-power device Multiple drug infusion pumps and systems Development of large volume and ambulatory pumps Insulin, chemotherapy and TPN applications
The Combination Product Development Paradigm From Early Development Considerations for Innovative Combination Products Guidance (FDA Office of Combination Products): When combining products such as drugs or biologics and devices that are customarily delivered using different regulatory paradigms, certain critical development issues, such as the interaction of the drug/biologic and device constituents, may not be readily apparent.
The Combination Product Development Paradigm Drug/Biologic Constituent Development cycles Pre-clinical/clinical testing Drug safety & compliance Device Constituent Design controls Usability / human factors Device safety & compliance Combination Product Drug/device interactions Clinical / Validation approach - IND or IDE Approval path (CBER, CDER, CDRH) System risk management - safety & efficacy Balanced/comprehensive QMS
Combination Product Resources Office of Combination Products: www.fda.gov/combinationproducts FDA Guidance Documents 01/2015 Current GMP Requirements for Combination Products 06/2011 Classification of Products as Drugs and Devices and Additional Product Classification Issues 04/2011 How to Write a Request for Designation 09/2006 Early Development Considerations for Innovative Combination Products Additional Work on the Challenges of Combination Products Articles, websites, courses, books, etc
The Device Constituent Perspective A Shared Mission Bringing new therapies to patients & clinicians with a Different Frame of Reference Development Cross-functional teams and technologies Time and Cost months and 7 figures($) Manufacturing High complexity, low-to-moderate volumes Anticipated product evolution Regulatory Process 510(k)/PMA Limited clinical trials w/small sample sizes
Complex Medical Device Regulatory Landscape Quality Systems QSR - 21 CFR Part 820 ISO 13485 Device Master Records & Design History Files Design controls - planning, requirements, design, verification & validation, risk management (ISO 14971), change management Compliance EN60601, Safety of Medical Electrical Equipment Software - IEC 62304 Usability and Human Factors - IEC 62366 EMC & Wireless, compliance and licenses Sterilization and biocompatibility
Challenges Unique to Device Development Complex, multi-technology systems and teams Multiple, concurrent engineering efforts Manufacturing, supply chain, quality & regulatory Third-party testing/certification/compliance DFM and scale-up Designing and building the first one is the easy part.. System testing, development through production How to test a combination product Critical requirements and essential performance Process validation Technology evolution Availability and obsolescence Leveraging new technology and balancing risk
Critical Combination Product Success Factors: The Device Partner Should Bring. Design through Manufacturing Expertise Proven design controls Experienced/professional/technical project managers DFx ( Design for Success mentality & processes) Prototyping & NPI Flexible, efficient manufacturing capabilities (Lean, SS, integration w/design)
Critical Combination Product Success Factors: The Device Partner Should Bring. A Positive Regulatory & Compliance Track Record Comprehensive quality system Successful FDA and ISO audit history Proactive standards and guidance document knowledge Regulatory submission experience & expertise
Critical Combination Product Success Factors: The Device Partner Should Bring. A relevant portfolio of products & technologies Applicable technologies for complex electromechanical devices Microfluidics Miniaturized pump and fluid control systems Safety critical software for life sustaining systems Wireless, implantable power and communications Track record of getting to the clinic
An Effective Device Partner will. Mitigate your device risks - technology/quality/reliability/ usability/safety/compliance/etc Bring knowledge and expertise - gained from an established track record of relevant technology & products Partner with you to manage the complex, cross-functional & concurrent demands of combination product development Prioritize critical business objectives and constraints bring a market appreciation with a systems perspective
Minnetronix A Unique Resource for Combination Product Commercialization Medical Device Systems Innovators Systems engineering and integration Software, hardware, electronic, and electromechanical design Valuable Technology for Better Outcomes Accelerating time to market and reducing development risk Creating market-focused solutions to maximize product value Providing Strategic Options Offering new types of engagements and partnerships Creating tailored strategies such as co-development ventures, spin-outs, or Newcos Developing new therapy solutions to unmet clinical needs
Questions and Discussion www.minnetronix.com Saint Paul, MN USA 651 917-4060