common thread
strategy & Design

Product Development Strategy and Systems Consulting for Medical Device Organizations

Common Thread Strategy & Design helps startups, founders, and growing teams clarify product direction, strengthen development systems, and move cross-functional work forward.

Approach

Strategy through synthesis.Common Thread is named for the connective work at the center of meaningful product development — seeing the relationships between strategy, systems, people, and execution.We work with organizations where product direction, operational systems, and team dynamics need to come together. Our role is to help identify patterns, clarify priorities, and create practical paths forward.The practice is principal-led and intentionally collaborative, drawing on senior experience across product development, engineering, design, systems, and operations.

Consulting Focus

Focused support where product strategy, systems,
and execution come together.

Common challenges we tackle:
Unclear development pathways, underperforming PLM/eQMS workflows, cross-functional misalignment, scaling R&D teams, and regulated product initiatives.

SERVICE categories

Development Systems & PLM/eQMS
Process optimization, workflow clarity, design controls, documentation practices, and product lifecycle infrastructure that help teams work with greater alignment and efficiency.Product Development Strategy
Roadmaps, prioritization, product planning, and development pathways that connect business goals with user needs, technical realities, and commercialization priorities.Cross-Functional Program Leadership
Guidance for complex initiatives requiring coordination across engineering, quality, manufacturing, marketing, sourcing, software, leadership, and external partners.Team & Organizational Development
Support for product development teams through growth, transition, role clarity, skills development, mentoring frameworks, and stronger cross-functional collaboration.Medical Device Innovation & Human-Centered Development
Experience-informed support for regulated product development, usability, softgoods/textiles, orthopedic products, and user-centered innovation.

How we work

Flexible support based on the organization’s needs.Advisory Support
For founders and leaders who need strategic guidance, prioritization, or an experienced product development sounding board.Project-Based Consulting
For defined initiatives such as PLM/eQMS optimization, development process improvement, product strategy, value engineering, or cross-functional execution planning.Embedded Strategic Partner
For teams needing senior-level product development, R&D, or operational systems leadership without a full-time role.

experience

Grounded in operating experience.Common Thread’s work is informed by 30+ years of combined senior experience inside medical device and product development organizations — spanning the systems, teams, and decisions that move products from idea to commercialization.That perspective allows us to support both focused projects and broader development challenges with practical judgment, technical fluency, and organizational awareness.

Representative Expertise:

  • Leading medical device product development from early strategy through commercialization, including design transfer, production launch, and post-launch improvement.

  • Implementing and optimizing PLM/eQMS systems, design controls, and product development processes so teams can work with greater clarity, consistency, and efficiency.

  • Creating alignment across technical, operational, commercial, and leadership teams to support clearer decision-making, shared priorities, and coordinated execution.

  • Connecting product strategy, value engineering, portfolio decisions, and manufacturing realities to improve quality, cost, and operational performance.

  • Strengthening engineering and product development teams through role clarity, skills development, mentoring frameworks, intentional culture, and clearer ways of working through change.

  • Translating usability, human factors, softgoods, and textile expertise into medical device solutions that improve fit, function, and user experience.

  • Applying certified program management, Design for Six Sigma, and structured problem-solving methods to support practical, disciplined product development.

Principals:

Serena Oaks
Founder & Principal Consultant

Serena is a strategic and innovative engineering leader with two decades of experience leading teams and developing softgoods and hardgoods products for medical device and consumer product organizations. She is tenacious in identifying solutions and strategies that create meaningful impact.

Erika Blair
Principal Consultant

Erika brings deep experience in value-based medical device product development across different regulatory classes. She leverages User-Centered design and a Design for Six Sigma Black Belt to shape products, process redesign, and digital transformation to improve speed-to-market, team collaboration, and product outcomes.

Contact

Start a conversation.Tell us briefly about your organization, challenge, or project.