Suttons Creek
Suttons Creek is a company dedicated to helping pharmaceutical and biotech companies bring drug/biologic + device combination products to market efficiently and successfully. They offer expertise in combination product development, regulatory guidance, system engineering, human factors, and commercialization strategies, with a focus on reducing costs, improving product success rates, and supporting clients from strategic planning through post-market activities. The company emphasizes the importance of human factors and usability testing in device development, integrating a systems lens to reduce medication errors and improve patient safety. Suttons Creek also provides guidance on FDA interactions, designing user-friendly devices, and navigating regulatory standards, ensuring their clients' products meet safety and efficacy requirements.
Industries
Nr. of Employees
small (1-50)
Suttons Creek
Westlake Village, California, United States
Products
Human Factors overview (one-page PDF)
One-page human factors overview intended as an introductory summary of HF/UE considerations for medical devices.
Combination Product
Full-service combination product device team offering program execution, consulting, and training across the entire product lifecycle from strategic planning through development to launch and postmarket activities.
Combination Product Development
Modular cross-functional development support spanning device vendor selection, clinical development, and regulatory preparedness.
Combination Product Startup
Startup service package focused on executive-level strategy, identifying cost-effective combination product strategy, executive coaching, and organizational development.
Combination Product Readiness
Readiness service package focusing on team culture, knowledge base, collaboration systems, and quality management systems setup.
Combination Product Commercialization
Commercial readiness and postmarket support for combination products transitioning from clinical testing to commercial launch.
Human Factors overview (one-page PDF)
One-page human factors overview intended as an introductory summary of HF/UE considerations for medical devices.
Combination Product
Full-service combination product device team offering program execution, consulting, and training across the entire product lifecycle from strategic planning through development to launch and postmarket activities.
Combination Product Development
Modular cross-functional development support spanning device vendor selection, clinical development, and regulatory preparedness.
Combination Product Startup
Startup service package focused on executive-level strategy, identifying cost-effective combination product strategy, executive coaching, and organizational development.
Combination Product Readiness
Readiness service package focusing on team culture, knowledge base, collaboration systems, and quality management systems setup.
Combination Product Commercialization
Commercial readiness and postmarket support for combination products transitioning from clinical testing to commercial launch.
Services
Advisory and execution for drug/biologic plus device programs including device selection, phase-appropriate planning, vendor oversight, and launch readiness.
Formative and summative HF/UE studies, usability test protocols, simulated- and actual-use testing, IFU design and comprehension assessment, observational data collection, and regulatory-grade HF/UE report preparation.
Regulatory strategy development, focused question drafting, meeting package preparation for agency interactions (including Q-Submissions and Type A/B/C meeting types), and EU MDR transition planning.
Implement systems engineering practices, requirements management, design-control workflows, and cross-functional decision frameworks to improve development efficiency and reduce rework.
Market research input, packaging and IFU guidance, promotional material development, reimbursement considerations, and patient support hub planning to support launch and adoption.
Analysis of adverse event reports and public safety databases to identify trends, inform corrective actions, and update designs or labeling to reduce medication errors.
Advisory and execution for drug/biologic plus device programs including device selection, phase-appropriate planning, vendor oversight, and launch readiness.
Formative and summative HF/UE studies, usability test protocols, simulated- and actual-use testing, IFU design and comprehension assessment, observational data collection, and regulatory-grade HF/UE report preparation.
Regulatory strategy development, focused question drafting, meeting package preparation for agency interactions (including Q-Submissions and Type A/B/C meeting types), and EU MDR transition planning.
Implement systems engineering practices, requirements management, design-control workflows, and cross-functional decision frameworks to improve development efficiency and reduce rework.
Market research input, packaging and IFU guidance, promotional material development, reimbursement considerations, and patient support hub planning to support launch and adoption.
Analysis of adverse event reports and public safety databases to identify trends, inform corrective actions, and update designs or labeling to reduce medication errors.
Expertise Areas
- Combination product development and lifecycle management
- Systems engineering and requirements management for medical products
- Human factors engineering and usability testing
- Regulatory interactions and Q-Submission strategy
Key Technologies
- Systems engineering
- Human factors and usability testing (formative and summative)
- Requirements and design controls management
- Risk management aligned to ISO 14971
News & Updates
Steven Badelt, PhD, Managing Partner of Suttons Creek, was invited to speak at the Incose IW 2016 Conference on applying systems engineering to healthcare.
Suttons Creek announced its growth and expansion of its team to meet industry trends and client needs, especially in Commercial, Human Factors, EU MDR, and In Vitro Diagnostics.
A case study on how Suttons Creek helped a small pharma company develop a combination product program, bridging the knowledge gap and establishing effective processes.
Guidance on how teams can adapt to remote work effectively, including setting expectations, creating boundaries, and maintaining human connection.
Advice on how to craft regulatory requests and improve communication with FDA to facilitate approval processes.
Guidance on preparing human factors reports for FDA submissions, emphasizing storytelling and contextual details.
Steven Badelt, PhD, Managing Partner of Suttons Creek, was invited to speak at the Incose IW 2016 Conference on applying systems engineering to healthcare.
Suttons Creek announced its growth and expansion of its team to meet industry trends and client needs, especially in Commercial, Human Factors, EU MDR, and In Vitro Diagnostics.
A case study on how Suttons Creek helped a small pharma company develop a combination product program, bridging the knowledge gap and establishing effective processes.
Guidance on how teams can adapt to remote work effectively, including setting expectations, creating boundaries, and maintaining human connection.
Advice on how to craft regulatory requests and improve communication with FDA to facilitate approval processes.
Guidance on preparing human factors reports for FDA submissions, emphasizing storytelling and contextual details.