HaA PD has the experience to bring your device to market.

A group of people in a meeting, with one man in a striped sweater and beanie writing on paper at a table, others listening and standing in the background.

Our collaborative environment is a place where innovation thrives.

HaA PD’s multi-disciplinary teams help you develop the best version of your medical device and bring it to market.

Our comprehensive knowledge of medical device development means that during every phase of strategy, design, and engineering, we anticipate the needs of manufacturing and regulatory approval.

This leads to an efficient development cycle from concept to commercialization.

Who We Are

At HaA PD, our goal is simple: make medical device development seamless, cost effective and efficient, while creating products that make the world a safer, better place. 

With our years of experience and expertise, we create innovative ideas and guide our clients through the process every step. This ensures their vision has the ability to achieve commercialization. 

Our team of experts use our proprietary FORGE process to work with clients. Our process is designed so that every medical device we develop keeps core factors such as patient safety, usability, quality, compliance, and cost-effectiveness at the forefront throughout the project. 

We have been a  trusted and valued partner to hundreds of medical device companies over the past 30 years to bring their ideas to life. Our expertise allows us to help our clients bring devices that change the lives of patients and practitioners, to market faster and more cost effectively than our competitors.

Our Mission 

We are a full service ISO-13485 and ISO-9001 certified international product development company. From the start, we work with you to clarify goals and objectives. Our mission is to help expand your business, provide true innovation and offer cost-effective solutions.

Our Management Team

  • Steven Lepke


    President & Founder

    30+ years in product development across consumer electronics and medical industries. Expert in leading teams as Principal Mechanical Engineer and Director of Engineering.

  • Eric Hyman


    Vice President,  Engineering

    20+ years in medical device development, driving speed and innovation. Key player in leading Boston engineering teams with a focus on detail and results.

  • Steve Hwang


    Director, Industrial Design

    25+ years in product development, leading concepts to market. 11 years at HaA, known for managing cross-functional teams and projects efficiently.

  • Cindy Larkin


    Vice President, Client Services

    20+ years in medical device client relations and project management. Skilled at aligning business goals with innovative product solutions, delivering exceptional client experiences.

  • Stephanie McFadden


    Director,  Marketing & Industrial Design

    10+ years in industrial design, human factors, usability and marketing strategies. Detail-oriented in concept refinement and design for usability. 

  • Julie Constantinescu

    Quality Manager

    2+ years in quality management and quality system implementation projects. Leader in generating detailed documentation and ensuring regulatory compliance.

  • Andrea Lundquist

    Business Development Manager

    Brings 10+ years of event production, logistics, finance, pandemic biotech startup, fintech and marketing tech from Northern California. Specializes in networking, lead generation, and people pleasing.

What We Do

The HaA PD design development philosophy focuses on creating solutions that meet clinical needs while being commercially viable and positioned for regulatory clearance. We emphasize a comprehensive approach that includes everything from ideation and obtaining user feedback, to engineering, prototyping, testing, troubleshooting, research, cost reduction strategies, industrial design, UI/UX, and manufacturing support. This philosophy ensures that our products are not only innovative but also reliable, scalable, economical and user-friendly, reducing late-stage redesigns and accelerating time to market.

Why Clients Work With Us

At HaA PD, we believe that collaboration, transparency, and focus drive excellence. We work closely with clients to understand their goals and challenges. We separate ourselves not only by our final device iterations, but also by providing hands-on support, expertise and coaching that goes far beyond what traditional medical device development companies offer. 

Our culture is built on decades of real world experience, a passion for problem-solving, and a dedication to building lasting relationships with both clients and partners. 

Every project we take on reflects these values, ensuring that every medical device we develop meets the highest standards of quality, safety, and performance so that you can ensure a smooth path to clearance and launch.

Our Impact

At HaA PD, we help companies of all sizes turn ideas into reality. From innovative startups  and inventors to some of the world’s largest medical device companies, such as Johnson & Johnson, Boston Scientific and Smith & Nephew, our clients demand that we are aligned with their teams and know how to build their devices for regulatory and commercial success.

The result of our experience?  Medical devices that gain expedited FDA clearance, reach the market faster, work flawlessly, and make a real difference in the lives of both clinicians and patients.ADD MORE ABOUT time and money

Let’s Work Together

Contact HaA PD today or schedule a free strategic consultation to learn how we can help bring your vision for a medical device to life!