Frequently Asked Questions.

At HaA PD, we specialize in full-cycle medical device product development. With decades of experience and expertise across Class I, II, and III devices, our team helps innovators bring compliant, manufacturable, and commercially viable devices to market. Explore the FAQs below to learn how we support every step of the journey—from concept through commercialization.

  • HaA PD is a full-service medical device development firm with expertise across Class I, II, and III devices. We specialize in surgical instruments, therapeutic devices, precision equipment, diagnostics, infusion systems, and wound care solutions. We also accept select non-medical device projects that align with our engineering and compliance capabilities.

  • Yes. We support the entire product development lifecycle through our proprietary FORGE process, covering every phase from idea to market launch:

    Foster (Research & Strategy)

    • Market Research: Identify user needs and market gaps.

    • Regulatory Strategy: Create timelines and clearance paths for FDA and CE mark approval.

    • Human Factors Engineering: Align designs with FDA usability standards.

    Optimize (Design & Prototyping)

    • UI/UX Design: Ensure safe and intuitive user interaction.

    • Industrial Design: Craft ergonomic, brand-aligned devices.

    • Prototyping: Rapid validation of design and usability.

    Refine (Engineering & Testing)

    • Engineering: Functional, manufacturable device design.

    • User Feedback & Testing: Gather insights to refine performance.

    • Quality Assurance: Identify risks early and ensure compliance.

    Guide (Regulatory & Compliance)

    • Regulatory Compliance: Align with FDA, ISO 13485, and MDR standards.

    • Formative & Summative Testing: Validate usability and safety.

    • 510(k) Submissions: Navigate regulatory approval processes.

    Execute (Manufacturing & Post-Market)

    • CE/UL Certifications: Meet international safety standards.

    • Manufacturing Optimization: Enable scalable, cost-effective production.

    Post-Market Surveillance: Ensure compliance and performance after launch.

  • HaA PD’s headquarters are in Boston, with a core team of 33 professionals and a global network totaling 55. Our team regularly travels to collaborate with clients onsite when needed.

  • We integrate seamlessly with your engineering, marketing, and clinical teams to ensure efficient and aligned development. Whether you’re a startup or an enterprise, we tailor our support to your business model and growth goals.

  • Our philosophy is rooted in creating clinically impactful, user-friendly, and commercially viable medical devices. We combine creativity, human-centered design, and regulatory rigor to minimize redesigns and accelerate your time to market.

  • A QMS (Quality Management System) ensures your device meets all safety and regulatory standards. We use an electronic QMS powered by Greenlight Guru and can also integrate with your existing system.

  • To begin, we typically need:

    • A summary of your concept and target users

    • Existing designs or prototypes (if available)

    • Regulatory goals and intended markets

    • Budget, timeline, and prior R&D (if any)

    If you’re unsure of your regulatory path, our team can guide you.

  • HaA PD is ISO 13485-certified and brings over 30 years of experience, having developed and launched hundreds of Class I–III devices. Our FORGE process, deep regulatory knowledge, and strategic manufacturing guidance reduce delays and position your device for successful market entry.

  • Compliance is built into every stage of our FORGE process. We work with FDA QSR, ISO 13485, and EU MDR standards and educate our clients along the way. We’re experienced with:

    • Class I devices (low risk)

    • Class II (moderate risk; 510(k) submission required)

    • Class III (high risk; PMA required)

    • De Novo pathways

    • CE mark preparation for EU market entry

  • We apply human factors engineering from the start. Our process includes:

    • Clinical observation and stakeholder interviews

    • Mapping use cases and workflows

    • Iterative testing (storyboards, wireframes, clickable prototypes)

    Testing to FDA and IEC 62366 standards

  • Yes, we specialize in medical device prototyping and design for manufacturability. While we don’t manufacture in-house, we connect clients with vetted specialty manufacturers and manage pre-production planning to ensure a smooth transition from design to production.

  • Costs and timelines depend on project complexity:

    • Startups & Inventors: Packages starting at ~$29,000

    • Mid-Large Companies: Projects typically start at ~$500,000

    • Enterprise Programs: Up to $10M for full-scope management and commercialization

    We deliver faster, more cost-efficient outcomes than most competitors by aligning early with regulatory and manufacturing needs.

  • We provide budget estimates by phase but bill on a time and materials basis every two weeks. This allows flexibility and efficiency while keeping budgets controlled.

  • We don’t manufacture directly, but we offer manufacturing support. We:

    • Identify ideal manufacturers for each component

    • Engage partners early for feedback before design freeze

    • Save costs by avoiding large general manufacturers with excess overhead

    • Ensure all parts work in assembly and are optimized for quality and speed

  • Yes. We’ve developed medical devices that incorporate AI, machine learning, and diagnostic algorithms, and we ensure HIPAA compliance throughout. Our team stays ahead of evolving AI regulations and standards.

  • Yes. From concepting and engineering to prototyping, usability testing, and regulatory support — all core product development is handled in-house. For specific needs like study recruitment, we collaborate with trusted partners while managing the full process internally.

  • Contact us to schedule a consultation and learn how HaA PD can support your medical device journey.