HSD wins Pediatric Open Innovation Challenge for a System for Dosing and Dispensing Multiparticulate Formulations of Pediatric Drugs

HSD wins Pediatric Open Innovation Challenge for a System for Dosing and Dispensing Multiparticulate Formulations of Pediatric Drugs

The Institute for Pediatric Innovation (IPI) recently collaborated with Pfizer in a historic opportunity to branch out into pediatric global health. Pfizer has developed a state-of-the-art solid multiparticulate (MP) drug reformulation technology. This technology addresses taste, storage, and other factors essential for safe, accurate, and adherent administration, making it ideal for administering medicines to children in low-resource settings.

IPI and Pfizer partnered in an open innovation challenge to solicit and support innovative ideas for a system consisting of a package and dispensing device that will be used to deliver oral solid MP-formulated medicines to children. A panel led by IPI composed of engineers, end users, and experts from the Gates Foundation, New England Pediatric Device Consortium, PATH, and Pfizer, reviewed submissions to decide which proposals would receive funding. Proposals were evaluated on four main criteria: dose accuracy, cost, end user ease of use, and cultural appropriateness. Pfizer offered up to $50,000 to the winner. The challenge attracted 25 submissions. The panel awarded $50,000 grants to two applicants.

HSD’s novel design features a proprietary collapsible bag in which to store the multiparticulates and a syringe for dosing. This novel system is was designed to be used similar to existing liquid oral syringes and vials, which minimizes the time required to learn to use the product properly. HSD has partnered with The Röchling Group; a global contract manufacturer specialized in drug’s delivery devices manufacturing, to fully develop the delivery system.

IPI will be working with HSD and The Röchling Group as they advance their concepts to working prototypes, which is expected to occur over the next 24 months.

Meeting Clinical Needs in Human Factors Engineering

Meeting Clinical Needs in Human Factors Engineering

Check out the recent article on the MDDI Device Talk Blog discussing the new challenges involved in demonstrating use and usability of medical devices as required by the FDA.

The recent white paper, co-authored by Dr. Mary Beth Privitera, M.Des, PhD, FIDSA and Tor Alden, MS, IDSA, of HS Design, discusses the close similarities of device testing and that of clinical trials. Collaboration between the clinical and development communities is more important more than ever to meet the clinical needs in Human Factors Engineering.

HSD featured in IDSA Medical Design Conference 2016: From Volume to Value

HSD featured in IDSA Medical Design Conference 2016: From Volume to Value

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Join HSD on Nov. 11–12, 2016 at the University of California, San Francisco (UCSF) Medical Center’s Mission Bay Conference Center for the IDSA Medical Design Conference 2016: From Volume to Value.

Join HSD in a panel moderated by Tor Alden, IDSA, and featuring Dr. Privitera, Principal of HFE, HSD and Diana Gunnarson, Sr. Principal HFE, Medtronic and Pierre Theodore, MD, vice president of medical devices at Johnson and Johnson, discussing the growing complexity of gaining access to contextual research. The combination of HIPAA constraints, the Sunshine Act and other recent legislation has greatly contributed to the inability of hospitals and corporations to provide access for observation in surgical and hospital facilities. This growing trend is a profound burden on innovation in the healthcare space. A panel of key of key opinion leaders will discuss the challenges and work through ideas on what improvements could be implemented to aid in providing open access and research in a shared community environment.

Join HSD at the Design for Manufacturing Summit October 6th in NYC

Join HSD at the Design for Manufacturing Summit October 6th in NYC

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Join HSD and other at the October 6th DMS in NYC. The summit brings together product developers, industrial designers, engineers, makers and manufacturers for a more decentralized, leaner manufacturing ecosystem.

Tor Alden will be on the capstone product development panel discussing the challenges faced by high technology startups entering the medical and healthcare space. We look forward in networking with you! Doors open at 3pm and registration is located here.

HS Design, Inc. Expands its Expertise in Usability and Human Factors Engineering

HS Design, Inc. Expands its Expertise in Usability and Human Factors Engineering

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HS Design, Inc. (HSD), a leading full-service design and product development firm specializing in medical, healthcare, and life sciences, is excited to announce its formal partnership with Dr. Mary Beth Privitera. This new partnership will expand HSD’s current research, usability and human factors capabilities that will allow the team to be a global leader in use and usability.

Mary Beth Privitera, PhD, FIDSA brings broad, extensive, hands-on experience in medical device design and a unique approach to collaborative teamwork. As Co-Chair of the AAMI Human Engineering committee, she is widely recognized as an expert in human factors and is positioned at the forefront of FDA guidance. In 2015, she published Contextual Inquiry for Medical Device Design, which focuses on the value of early and thorough immersion into all aspects of the problem the medical device seeks to solve. As a leading faculty member in the University of Cincinnati Biomedical Engineering program, she has led the strategic design of innovative devices for endovascular procedures, various types of surgery including vascular, urology, cranio-facial and plastic surgery, emergency medicine and diabetic care. Mary Beth’s industry practice and academia experience recognizes and is based on the integrative value of teamwork and collaboration with healthcare professionals, which produces superior results. “Working with Mary Beth in the field has given me an appreciation of her vast knowledge base in research. Her unique approach to collaboration allows her to explore, remove and overcome barriers and biases and allows for innovative ideas to emerge. This talent makes her an indispensible member of the HSD team”, said Olivia Ford, Lead researcher at HSD.

Tor Alden, Principal of HSD further commented, “We are extremely excited about Dr. Privitera joining the HSD family. We have indirectly partnered and collaborated with Mary Beth for many years and it is an easy decision now to create a formal relationship. Her expertise in user research, combined with HSD’s existing usability knowledge, presents an enormous opportunity for our current and future clients. This partnership allows us to strengthen and broaden our base of contextual research, human factors engineering, formative and summative studies which ultimately benefits our clients and strategic partners. HSD now stands as one of a handful of ISO 13485 certified product development firms with this much knowledge in current usability standards under one roof.”