Suttons Creek is Your Full-Service Combination Product Device Team

COMBINATION PRODUCT DEVELOPMENT

Regulatory pathways aren’t always clear, which can lead to guesswork—or overcomplicating a submission. Alternatively, after investing time and money into the design and development of your combination product, few things are as frustrating as having your work rejected by the Food and Drug Administration (FDA), or other regulatory agencies, as they ask for more data, or more testing. Rejections cause delays—and resubmissions cost time, money, and effort. One key reason behind rejections is that companies do not fully understand regulatory expectations.

Full-service drug delivery system development: Our team of experts has the know-how to elevate device-related aspects of development in every phase of your combination product lifecycle. With your business goals in mind, we create adaptive strategies and customized processes for faster entry to market. Popular services include:

• Product Strategy & Planning
• Regulatory Strategy & Planning
• Regulatory Submission Authoring
• Device Selection Support
• Vendor Selection & Negotiation Support
• Supply Chain Management & Quality Assurance Support
• Software as a Medical Device (SaMD) Support
• QMS Assessment
• QMS Development & Integration
• Primary Container Spec Development
• Sustaining Engineering Support
• Human Factors / Formative & Summative Studies

HUMAN FACTORS & USABILITY ENGINEERING

One of our core competencies is the FDA process for Human Factors Engineering and Usability Engineering. HFE/UE integration is critical, as regulatory authorities place significant emphasis on the safety and usability of your devices and software. We support our clients’ post-summative validation by navigating the FDA submission process, and can assist if the FDA requests additional information. This includes (Responses to Questions) RTQ’s or developing supplemental studies if necessary. Our key services include:

• Planning & Strategy Sessions
• Market Research
• Team Trainings
• Design History File (DHF) Documentation
• Contextual Inquiries
• Gap Analyses / Program Assessment
• Risk-Based Task Analysis
• User Needs / Intended Use
• Packaging & Labeling Development
• Task-Based IFU Design Development
• Expert / Heuristic Review
• Formative Study Protocol, Execution & Report
• Summative Study Protocol, Execution & Report
• Usability Engineering File Summary (UEFS) Report
• Regulatory Submission & Feedback Support
• Post-Market Evaluations

STRATEGY CONSULTING

Combination Product projects are successful when leadership is knowledgeable on the device constituent part regulatory and development processes, and when effective strategies are set in place at inception to guide their team through the product life cycle. Benefit from our vantage point, having worked across both big and small pharmaceutical companies, and having hands-on experience with a vast array of drug delivery systems and software as a medical device (SaMD).

Our strategy consulting supports your product from inception through its full lifecycle, including services such as:

• Executive level guidance prior to critical decisions and deployment
• Organizational development to align resources & assign roles and responsibilities
• Portfolio drug delivery system and platform selection
• Regulatory strategy: mapping out low-risk, low-cost, high-success pathways to approval
• Human Factors strategy
• Vendor introductions & selection
• Commercial launch readiness through global marketing strategy support

TRAINING AND EDUCATION

Suttons Creek training and education topics include, but are not limited to:

• Design Control
• Regulatory Approval Pathways
• Portfolio Management
• Human Factors
• MDR Preparedness
• Combination Product Development
• Device Selection
• Requirements
• Control Strategy
• Commercial Team Strategy
• Communication Strategy

We offer many ways to share our knowledge:

Expert-developed training documents: Manuals that support the various phases of your combination product have been created by medical device specialists and are ready for delivery upon your request.

One-on-one executive development training and project team training: We share our knowledge, so your own employees can lead self-sustaining combination product projects from inception through commercialization.

Creation of custom educational and training materials and videos: Programs specially designed for your corporate goals, current projects and future initiatives, that will guide your team through all of the device-related systems necessary to carry you through to the end of your combination product projects.

“Ask Me Anything” VC Sessions: Pick a topic, gather your colleagues and stakeholders, and receive one hour (or more if desired) of targeted training, guidance and problem-solving from our experts via video conference.

Knowledge-share and thought leadership speaking engagements: We love to act as educational advocates, and we are also available to share the learnings we have collected through each of our many client engagements at internal company functions, planning sessions and training exercises.  Click here for a list of previous speaking engagement and keynote address topics.

READINESS IMPROVEMENT

We have the agility and flexibility to step in quickly, even later in the game. We can support you at any phase to get your program audited, on track, and executed in a timely and cost-effective manner. Popular services include:

• Design History File (DHF) & Process Audits
• Retrospective Development Support
• Retrospective Process Evaluation
• Retrospective Strategy Consulting
• Medical Device Regulation (MDR)
• Remediation Strategy Support
• Design History File (DHF)
• Remediation Support