Smithwise was founded in 2009, with a focus on translating novel medical concepts and nascent technologies into medical devices meeting functional, regulatory, usability, and manufacturing requirements. The firm has grown to 16 professionals with expertise in industrial design, ergonomics, electro-mechanical engineering, DFM, and transfer into manufacturing. The Smithwise team includes specialists in product configuration concept development, use case prototyping for formative human factors studies, functional bread-boarding for performance and reliability testing, industrial design encompassing form development and brand integration, design for manufacturability and assembly (DFMA), Alpha/Beta prototyping, supply chain development, pre-production device building, verification & validation (V&V), and design transfer into production. Much of our work has been to support development of new and improved technology for various laparoscopic, interventional and open surgical procedures. Moreover, Smithwise routinely conducts risk management inclusive of design control and design history file (DHF) management for device programs.
Resources and Services
1 SMITHWISE ENGINEERING
2 MCGOWAN INSTITUTE
The University of Pittsburgh’s McGowan Institute is a global Class III medical device development enterprise which has been at the forefront of researching, testing and translating medical devices which have played a critical role in repairing or replacing damaged tissue and organs for the past twenty-five years. McGowan’s partnership brings two strategic advantages to the PPDC. First, McGowan’s Class III device development resources. McGowan has a pediatric device initiative where a large number of their 250+ faculty are either focused on the development of pediatric-centric technologies or where faculty are exploring the adaptation of well-developed adult devices for the pediatric population. Second, McGowan has been a mainstay in the biomedical landscape of Southwestern Pennsylvania for twenty-five years.
3 CENTER FOR SIMULATION, ADVANCED EDUCATION AND INNOVATION
The Center for Simulation, Advanced Education and Innovation at CHOP facilitates the translation of scientific discoveries into practical implementation for both research and clinical care. Centralized classroom and skills lab training, satellite skills labs, and unit-based "virtual" lab exercises adjacent to patient care settings are routinely conducted. The Center for Simulation, Advanced Education and Innovation at CHOP offers more than 950 teaching sessions with at least 11,000 attendees, including education encompassing recognition of shock and/or cardiac/respiratory failure, vascular access, chest tube care and hemodynamic monitoring, advanced and difficult airway assessment and intervention, pacemaker evaluation, EKG interpretation, critical incident debriefing, and crew resource management. The staff includes multidisciplinary center directors, full-time administrative staff, full-time clinical educators, and additional volunteer faculty.
4 BEN FRANKLIN TECHNOLOGY PARTNERS
Ben Franklin Technology Partners combines the best practices of early stage investing with a higher purpose – to lead the region’s technology community to new heights, creating jobs and transforming lives. For over 30 years, Ben has been the leading seed stage capital provider for the region’s technology sectors, investing over $175 million in more than 1,750 regional technology companies, many of which have gone on to become industry leaders. Ben Franklin has also launched university/industry partnerships that accelerate scientific discoveries to commercialization, and has seeded regional initiatives that strengthen our entrepreneurial community.
5 BRESSLERGROUP
Bresslergroup was first founded as “Design for Medicines” with a strong emphasis on medical device development and over the past 48 years the group has brought to market hundreds of medical devices ranging from small injection devices to large lab diagnostics instruments. In addition, Bresslergroup has the ability to leverage its in-house usability lab to conduct usability testing to the FDA standard, 75% of all its User Research work is conducted in full compliance of FDA standard and requirements which reduced risk for iteration loops and rework and ultimately result in faster path to market and lower development costs. Bresslergroup has designed quite a number of new devices such as the BK Ultrasound venipuncture device which won and MDEA Gold award in 2016 the highest recognition there is in medical device design.
6 NAMSA
NAMSA is the only medical research organization (MRO) focused exclusively on device, including combination products and in vitro diagnostics. In its 50 years, NAMSA has contributed to bringing thousands of medical devices to patients in need. With backgrounds that include careers at small start-up companies, large industry leaders, FDA and other regulatory agencies prior to joining NAMSA, the breadth and depth of expertise available at NAMSA is unparalleled. NAMSA’s Associates are also active participants in shaping the broader medical device industry – participating on numerous ISO working groups with respect to biological and clinical safety. NAMSA Associates are active on AvaMed working groups, and the Medical Device Innovation Consortium – a joint FDA-industry organization focused on innovations in the medical device space.
7 PENN HEALTH TECH
Penn Health-Tech unites the University of Pennsylvania’s strengths in Medicine, Engineering, Business and Education to create technologies that address the world’s pressing health care needs. It catalyzes medical device innovation at Penn, by providing a connected community and key resources that will maximize the number of medical device innovations that improve patient’s lives.
Consortium Service Proposals
Year round, the PPDC will offer mentoring services to all potential medical device developers from anywhere in the world. Upon receiving a mentoring request, the Consortium Leadership will form mentoring teams to address the unique needs of a particular innovator. We recognize that innovations do not necessarily come packaged, nor do inventors always know the steps involved in moving their innovations forward. Thus, our rigorous Step Zero Mentoring process will facilitate the development of excellent Consortium Service Proposals (CSP).
CSPs have no monetary budget submitted by the innovator, and no funds are transferred from the PPDC to the innovator or their company. Rather, the innovator submits a brief CSP for one or more Consortium Services in the PPDC network (examples shown above). The PPDC resources and in-kind contributions from Consortium members are used to support the service provided, as well funds from the Innovator’s Institution or Company. CSPs are evaluated by the PPDC Entrepreneur-In-Residence, Seth Goldenberg, for commercial merit and to identify the regulatory pathway. CSAC members assigned by the CSAC Chair also reviews the CSP, but for clinical and scientific merit.
