Medical Device Qualified Supplier Directory

HS Design Inc.

HS Design Inc. Company Profile
T: (908) 234-2331
F: (908) 234-9706

17 Mendham Rd., P.O. Box 613, Gladstone, NJ, 07934, United States
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Qualifications: ISO 13485, ISO 9001, FDA Registered, CGMP Certified, Supplier to Medical Manufacturers, Exhibitor in at least 2 MD&M and/or MEDTEC shows

Markets Supplied: North America, Europe, Worldwide



HS Design, Inc. (HSD) utilizes a systems-based approach with a QMS relevant ISO 13485 design control certification for medical device design and life science instrumentation, including high volume consumer medical devices and disposables. Our expert designers, researchers, and engineers form a collaborative, cross discipline team allowing us to capture innovation, reduce time to market, and maximize the impact of product solutions in multiple areas including Design Research, Graphic User Interface (GUI) Design, Industrial Design, Mechanical Engineering, Electrical Engineering, Software Engineering, Systems Engineering, Rapid Prototyping, Documentation Control, Pilot Production and Manufacturing Transfer. A superior network of QMS relevant partners offers a turn-key experience from design though full production, including design verification and validation, molding, packaging, and contract manufacturing.

User-Centered Process and Core Capabiltiies

For over four decades, HSD has been integrating insight, experience, and innovation with user needs & client core competencies to develop products that improve the human experience. HS Design has focused on the humanizing and multi-faceted integration of groundbreaking technology to solve complex problems, while enabling a technology transfer across multiple industries. Our process captures users’ unmet needs and uncovers valuable patent opportunities as projects are rapidly channeled through development in a formal design-controlled environment. The HSD team operates under the guidance of IEC 62366 and AAMI/ANSI HE75 Human Factors Principles for Medical Device Design, and examines a product’s potential risks use through heuristic evaluations, verification and validation studies, and other comprehensive investigative methods. HS Design’s expertise and capabilities include:

  • Research / Contextual Inquiry
  • Human Factors - Usability Testing and Ergonomics
  • User Experience & Interface Design
  • Industrial Design
  • Mechanical Engineering
  • Electrical Engineering
  • Software Engineering
  • Manufacturing Engineering
  • Prototyping
  • Quality Management
  • Concept Ideation
  • Product Strategy
  • Intellectual Property
  • Mechanical Development
  • Technology Transfer
  • Implementation
  • Testing and Validation
  • Project Management
  • Contract Manufacturing
  • Materials & Molding
Award-Winning Solutions

With over 400 successfully designed products, HS Design is a recognized leader in Medical and Life Science product development. An award-winning portfolio of surgical tools, medical devices, diagnostic instruments, and consumer health care products showcases the firm’s wide range of clients— from emerging new ventures to Fortune 100 firms. HSD’s product design experience also includes packaging design, consumer, commercial, and national security products. HSD’s commitment to innovation and user-centered form and function has earned the firm 8 Medical Design Excellence Awards (MDEA) Winners and Finalists, 3 IDEA awards, and 2 CES Best of Innovation recognitions.

QMS Relevant Certifications:
  • ISO 13485:2003 Medical Design Certification
  • ISO 9001:2008 Industrial and Consumer Product Certification
  • AAMI Members and Leadership

Contextual Inquiry / Human Factors

Translating user behavior into design requirements

HSD’s Research and Human Factors expertise enables our designers and engineers to examine a manufacturer’s capabilities in conjunction with the needs of the product’s end user. We believe user research requires close collaboration with our clients because understanding a client’s core competencies and manufacturing preferences is essential in order to accelerate the development process and reduce time to market.



Medical and Life Science Device Focus

Our designers have been in the OR, surgical suites, and central labs; as a result, they understand the sensitive
nature surrounding medical development.

Medical and Pharmaceutical packaging is where we started over 40 years ago. Working in this realm has given our company experience in understanding the proprietary and human issues surrounding medical product development. We understand documentation control, FDA requirements, delivery systems, patient compliance, and the increased risk testing needed for efficacy.

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