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Business Proposal Overview

Medtronic is interested in collaborating with pharmaceutical and biotech companies to develop new drug-device therapies for neurodegenerative diseases and other conditions of the central nervous system.

By partnering with us, you receive access to our infusion solutions, technical expertise, and functional support. The partnership allows you to leverage your expertise and resources, lead the clinical trial, and maintain all drug/biologic manufacturing operations.

Ultimately, you manufacture and sell the drug, and Medtronic sells and supports the device. The presentation below describes a range of other benefits.

Module 5: Business Proposal and Opportunity Definition
The presentation below describes the opportunities available to partners.

Partner Roles

In a partnership for developing a drug-device therapy, each company typically plays these roles. The responsibilities may vary depending on resource availability and capabilities.

Activities of Medtronic, in Full or Supportive Role	Suggested Activities of Pharma/Biotech Partner
Device development, testing, and analysis Design control development process Biostability and biocompatibility Device verification testing (DVT)	Pharmaceutical Identification of candidate Formulation
Drug-device testing and analysis In-pump stability Materials compatibility Leachables and extractables	Pharmaceutical testing and analysis In-vial stability Stability-indicating methods
Pharmacometric modeling and scale-up Generate distribution model Scale to predict human requirements Distribution modeling	Demonstrated proof of concept Relevant rodent model Mechanism of action Efficacy
Pre-clinical studies, large animal In vivo efficacy Toxicology studies PK/PD studies Drug distribution	Pre-clinical studies, small animal In vivo efficacy Toxicology studies PK/PD studies
Device manufacturing Quality system regulation Design history file	Pharma/biologic manufacturing Good manufacturing practices Chemistry, manufacturing, and controls (CMC)
Device master file	Investigational new drug/Clinical trial applications
Infusion system-related support role in clinical studies: Protocol preparation Site selection Training Monitoring Other device-related activities	Lead role in clinical studies

• Medtronic does not provide financial support.
• Specific details about the compatibility and infusion system stability process are proprietary. A high-level process outline and right-of-reference will be provided for those details as needed.
• All drug/biologic manufacturing operations are the sole responsibility of the pharma/biotech partner.
• Devices and therapeutic uses require regulatory approval prior to commercialization.

Process and Timeline for Forming Partnership

Action	Estimated Timeframe
After initial contact:
Non-confidential high-level discussion of interest, capabilities, expectations of each party	1 week
If decision to proceed:
Generate confidential disclosure agreement	2 weeks
Conduct confidential technical discussion with functional and scientific/engineering experts of each party	2 weeks
If decision to proceed further:	3-4 weeks
Establish primary points of contact for each party Program manager Business development Conduct preliminary business discussions Develop high-level cost and timeline estimates (project managers of each party) Exchange non-binding concept sheet
Following agreement on concept sheet:	4-6 weeks
Draft formal collaboration agreement, defining business relationship Develop detailed roles, responsibilities, work plan Scientific/engineering scope Objectives Deliverables Timelines Preliminary cost estimates

See Important Safety Information on the market-released Medtronic products and therapies discussed in the presentations on this website: SynchroMed^® II and DBS Therapy.

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