Leadership
Project leadership that aligns strategy and execution to deliver product success for you.
Diatomic Product Development has a Seattle-based team of Project Leaders who combine an engineering background with extensive business insight and the experience of having successfully led the development of countless products. They are experts in business and product strategy, proactive planning and re-planning, removing obstacles to development along the way, enabling our multi-disciplinary project teams to focus and work efficiently.
- Product Strategy and Business Planning
- Product Definition and Development Planning
- Schedule and Budget Management
- Project Risk Analysis and Management
- Regulatory Assistance and Guidance
Product development is hard. Starting with a great idea and a good product strategy is an important first step. A strong product strategy lays the foundation for successful development — it clarifies what you’re building, why it matters, and how it will compete and succeed in the market. Without a defined strategy, teams risk investing in features users don’t need, underestimating complexity, or missing key regulatory, technical, or commercial requirements.
A thoughtful strategy should consider market opportunity, user needs, competitive landscape, technical feasibility, regulatory constraints (if applicable), cost targets, and the path to commercialization. With clear alignment on goals and constraints upfront, development becomes faster, more confident, and ultimately more successful.
The reality is that there will be unanticipated events along the way that require decisive and nimble action. Product and project success will rely on how well these challenges are navigated. Having an experienced team on your side makes all the difference.
“Everyone has a plan, until they get punched in the mouth.”
– Mike Tyson
Product Strategy
Our product strategy services help clients define a clear path from opportunity to execution. We align user needs, business goals, and technical feasibility to establish a focused product vision and development roadmap.
Through market analysis, competitive benchmarking, and early risk assessment, we identify where design and engineering can create real value.
The result: a strategy that informs design direction, guides investment, and positions the product for successful development and launch. Helping ensure that it is positioned for market success.
Product Strategy Services & Capabilities:
- Market and competitive landscape analysis
- User needs research and persona development
- Product definition, requirements, and feature prioritization
- Use-case mapping and workflow development
- Risk identification, early feasibility assessment, and mitigation planning
- Clinical / regulatory pathway considerations for medical devices
- Value proposition development and product positioning
- Product roadmap and development planning
- Technical architecture scoping and subsystem definition
- MVP and phased rollout planning
Project Management
Successful product development requires more than great engineering. It demands clarity, coordination, and disciplined execution. Our collaborative and iterative approach ensures client expectations are met and often exceeded.
We work to maintain close contact with our clients to facilitate timely, concise and organized communication. Our project managers make sure your needs are considered every step along the way, so you can sleep well at night.
We actively manage project cost, schedule and performance and we also provide a depth of experience in product development that enables us to present many options for meeting project goals, allowing you to choose the path that works best for your specific situation.
Our project managers bring structure and leadership to every phase of development, ensuring that mechanical, electrical, firmware, and manufacturing teams move together toward a shared goal.
Program Planning & Definition
Every project begins with a clear, achievable plan. Our project managers work with your leadership and technical teams to define objectives, scope, milestones, and success criteria. The aim is to balance innovation with schedule and budget realities.
- Project charters, schedules, and budgets
- Stage-gate planning (CR, EVT, DVT, PVT, launch)
- Risk and dependency mapping
- Roles, responsibilities, and resource planning
- Metrics dashboards and progress reporting
This early alignment ensures all stakeholders share the same vision and measurable targets.
Cross-Functional Coordination
Project managers serve as the connective tissue across disciplines to align engineering, design, operations, and suppliers through proactive communication and collaboration.
- Leading design reviews and technical syncs
- Tracking interdependencies between teams
- Coordinating documentation, change control, and approvals
- Managing communication between clients, vendors, and manufacturing partners
- Maintaining traceability between requirements, deliverables, and test results
By driving clarity across functions, we prevent gaps, minimize friction, and maintain momentum.
Risk Management & Decision Support
Anticipating and mitigating risk is central to successful product delivery.
- Technical and schedule risk registers
- Contingency and mitigation planning
- Root-cause analysis and corrective action tracking
- Compliance and quality-system alignment (ISO 13485, FDA 21 CFR 820)
- Decision-making frameworks for leadership reviews
We transform complex data into clear, actionable insights for informed decision-making.
Schedule, Budget & Performance Control
We maintain real-time visibility into project progress through continuous monitoring and reporting.
- Gantt and critical-path scheduling
- Budget tracking and cost analysis
- Weekly status reports and executive summaries
The result: predictable progress and measurable accountability at every stage
Project Management & Phase-Gate Execution
From concept validation to full-scale production, our project managers guide products through every development phase.
- Concept Review (CR)
- Engineering Validation Test (EVT)
- Design Validation Test (DVT)
- Production Validation Test (PVT)
- Launch Support
We coordinate deliverables, testing, and documentation at each gate, ensuring readiness and compliance.
Leadership, Communication & Alignment
Project management is ultimately about leadership.
- Multidisciplinary team leadership
- Conflict resolution and consensus building
- Transparent, proactive communication
- Executive reporting and stakeholder updates
- Motivation and culture of accountability
Our project managers understand the complexities of hardware, software, and regulated product development. This enables them to anticipate challenges and keep the entire team moving forward with focus, clarity, and purpose.
We don’t just track progress – we drive it.
Quality + Regulatory
Bringing a wearable health monitor, medical device or life sciences product to market requires more than innovative design. It requires compliance, traceability, and confidence that every requirement has been met. Navigating the regulatory landscape is no small feat. Our team is here to help every step of the way. Our quality engineers ensure that your products are developed, tested, and documented according to the highest standards of safety, reliability, and global compliance.
We integrate quality engineering throughout the product development lifecycle, ensuring that innovation and compliance move hand in hand.
Expertise includes the creation of design documentation to support medical device regulatory submissions, including risk management, quality planning, and verification.
Capabilities include supporting the implementation of quality systems in compliance with the FDA medical QSRs and ISO 13485.
• Product Requirements Specifications
• Hardware Requirements Specifications
• Software Requirements Specifications
• Product Risk Analysis and Management
• Design Failure Modes and Effects Analysis
• Fault Tree Analysis (FTA)
• Verification Plans, Procedures and Reports
• Design and Software Verification Testing
• Reliability Planning and Testing
• Process Validation (IQ/OQ/PQ)
• Regulatory Guidance and Support
• Safety Agency and Compliance Testing
Quality by Design
Quality isn’t added at the end, it is engineered from the start.
- Defining product requirements and verification criteria
- Establishing design controls and traceability matrices
- Implementing quality plans aligned with ISO 9001 or ISO 13485
- Ensuring document control and configuration management
This proactive approach reduces risk, improves reliability, and streamlines audits and submissions later in the process.
Design Controls & Documentation
For regulated products, especially medical devices, design controls are critical to compliance and product approval.
- Design history file (DHF) and device master record (DMR) management
- Product requirements and design input/output documentation
- Verification & validation (V&V) planning and reporting
- Risk management per ISO 14971 and FMEA development
Our documentation aligns with applicable standards, including FDA 21 CFR Part 820 and ISO 13485..
Verification & Validation (V&V)
We provide support for product verification and validation, confirming that the design meets both engineering specifications and user needs.
- Test plan and protocol development
- Environmental, mechanical, and electrical testing coordination
- Test fixture design and data collection
- Statistical analysis and report preparation
- Integration with design control and regulatory documentation
We ensure that verification results are structured, reproducible, and audit-ready. Whether for internal design reviews or formal submission.
Regulatory Compliance & Certification Support
Our engineers help navigate the complex landscape of compliance standards, enabling smooth market entry for your product.
- FDA and ISO 13485 medical device quality system compliance
- IEC 60601-1 safety and IEC 60601-1-2 EMC testing coordination
- CE, FCC, IC, and CB certification support
- Risk management and usability engineering integration
- Regulatory submission documentation and technical file preparation
We bridge engineering and compliance, ensuring technical data and documentation meet both regulatory and market expectations.
Our quality engineers work hand-in-hand with design teams to create products that are not only functional and elegant; but proven, documented, and compliant.
By integrating compliance thinking early, we reduce delays, minimize risk, and deliver products that are ready for audit, approval, and scale.
From Concept to Commercialization
Our leadership team ensures that design, engineering, and execution stay connected and aligned with your goals from the first sketch to the final build. The result: products that are developed to meet your technical and business goals.
Why Diatomic?
Diatomic’s Seattle-based team provides strategic product leadership and project management from concept ideation through product delivery.