Our services range from product strategy to market realization, making HSD a complete collaborative team to complement client needs.
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Medical + Life Science Device & Instrumentation Focus
Medical and Pharmaceutical packaging is where we started over 40 years ago. We understand the unique and rigid medical industry and have developed products ranging from surgical tools, diagnostic instruments, to pharmaceutical packaging and consumer healthcare products. Our designers have been in the OR, surgical suites, and central labs; as a result, they understand the sensitive nature surrounding medical development.
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.
Human Factors, Usability & FDA Guidelines
The HSD Research 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.
Design standard development and use is in our DNA. Our leadership has served on the AAMI Human Factors Committee since 2005, along with serving as a co-author for HE75. Currently, we are active in the development of a Contextual Inquiry Standard as well as revisions to HE75. HSD’s Research and HF Principal, Mary Beth Privitera, PhD, FIDSA, currently serves as Co-Chair of the AAMI Human Engineering Committee, and has served as faculty, specifically instructing an advanced human factors training course.
New Technology Development & Adaptable Approach
For a new product to be successful in today’s marketplace, it needs to solve a problem and do it well. We know a product will fail without a strategic core. What is the goal or purpose of this new technology? How does it solve problems for the end user and improve their day-to-day life?
We approach new technology development with a holistic process, from the first impression to solving a basic task, in order to define the requirements that make a good product great and answer market demand. All of our clients are different; therefore we customize our approach based on the client’s targeted goals in order to satisfy the development milestones that must be met along the way.
HSD holds an extensive network of development partners. Our team collaborates with our trusted partners to make your product a reality. Our partnerships include system engineers with broad expertise, regulatory experts, and an expansive clinical network.
Are you a Start Up? If you are looking for design capabilities and customized solutions for your company, HSD partners with startups to accelerate new ideas to market. Learn more about how HSD can help you.
Learn more about HSD Start-ups