Suttons Creek is Your Full-Service Combination Product Device Team

The first steps in creating a combination product start at the Executive Suite level. They are: identifying a cost-effective CP strategy that meets short- and long-term corporate goals, ensuring your leadership has the best practices inputs and practical knowledge needed to manage CP programs effectively, and setting up the organization’s structure and systems for success. Common deliverables include:

• Combination Product Strategy
• Executive CP Coaching
• Organizational Development

Once the Executive Team is armed with the knowledge and strategies that will guide the organization’s combination product development, attention must turn to the rest of the combination product team to ensure the appropriate CP knowledge base, team culture and collaboration system, and quality management system are in place. Our experts have taken many a Pharma start up from combination product idea to implementation and will help guide and execute the steps needed to get your company ready to begin. Common deliverables include:

• Education + Training
• Corporate Readiness + Change
• Quality Systems

Once combination product systems and team are in place and ready, the real work begins. Often, we are integrated into combination product organization startups to guide and support execution of device design and clinical development. Selecting the right device and vendors can be the deciding factor in the success of a combination product program and are almost always on the critical path. Our experts have worked on, and some have even regulated from within the FDA, most drug delivery device types in the market, and we have experience working with the industry’s top vendors , emerging technologies, and innovative companies. 

With your desired timeline, technical and program needs, and supplier global risk management goals in mind, we help determine key metrics to select the partner(s) who will best meet your needs in current and future lifecycle steps, determine the most effective regulatory and clinical development pathways, and support execution of these strategies and management of vendors. And, most importantly, a full device team can be built to complete combination product development including preparation of relevant regulatory submission(s). Common deliverables include:

• Device Selection
• Regulatory Preparedness [Clinical Submission]
• Clinical CP Development

Our team supports Pharma and their vendors in transition from clinical testing to commercial device readiness and through regulatory filing. As scale up and regulatory approval is in the works, our commercial experts step in to prepare your team for commercial launch and support your Commercial team’s postmarket responsibilities. Additionally, we can ensure your Quality Systems and processes are built to enable commercial success, including postmarket quality and safety events, postapproval change management, manufacturing changes, etc. Common deliverables include:

• Commercial Development
• Regulatory Preparedness [Commercial Submission]
• Commercial Launch + Postmarket Activities