Jacob Caldwell Email and Phone Number

Returning to the Hips New Product Development team, I am working cross-functionally to deliver next-generation implant innovation to our patients and surgeons!✢ Organizing and guiding the execution of Design Verification and Validation activities that ensure we meet regulatory standards and user needs✢ Developing new process solutions to our biocompatibility testing strategy to leverage our broad portfolio for streamlined product development✢ Leading cross-functional engagement with our partners in China to prepare for their unique and intensive regulatory landscape

As a member of the reverse shoulder arthroplasty R&D team project, I executed investigational testing and prepared biocompatibility test strategies for both current and future projects. ✢ Led the biocompatibility strategy for both implants and instruments across multiple internal and external manufacturing suppliers✢ Modeled and prototyped the test fixtures for key testing to provide evidence of competitive differentiation✢ Developed and executed protocols for verification testing in preparation for regulatory submission✢ Collaborated cross-functionally to develop new biocompatibility-specific processes to assist future projects increase their efficiency when executing project-specific testing

Worked with the Supply Chain Readiness team for Joint Reconstruction. I orchestrated the supply chain development of multiple hip and knee implant projects to ensure a robust market introduction.✢ Launched Corail™ short neck stems into US while maintaining robust supply chain to OUS markets✢ Prepared launch of two additional hip line extensions into Chinese and Japanese markets✢ Mitigated pre-launch supply chain challenges for Attune™ Revision LPS Inserts, exceeding previously established end-of-year production estimates✢ Managed fluctuating worldwide market needs to best serve patient population✢ Assisted additional hip NPI team with biocompatibility test strategy as a stretch assignment

Worked with the R&D team in the development of a new primary Total Hip Arthroplasty femoral stem. I drove design controls to design freeze while preparing for verification and validation testing.✢ Executed successful Technical Design Review following development of Requirement Traceability Matrix (RTM) and Design Failure Modes and Effects Analysis (DFMEA) to appropriate level of efficacy to achieve implant design freeze✢ Organized and executed Surgeon Design Team design evaluation of novel instrumentation to gather customer perspectives, and assess relative accuracy compared to current state of the art methods.✢ Engaged with Surgeon Design Team and other orthopaedic surgeons during cadaveric labs (both design and formative usability) to validate femoral implant and instrument designs✢ Researched and delivered product portfolio review of competitive hip systems to Hip R&D team✢ Coordinated investigational fatigue testing of prototype femoral stems to assess worst-case implant function against regulatory standards and inform strategy for initial product launch✢ Developed test strategy for verification and validation testing of femoral stem that simultaneously addresses all standard-driven testing requirements for eight major regulatory bodies

Worked with a team of passionate global healthcare advocates in a start-up developing solutions to emergency surgical auto-blood transfusions centered on the needs of low-resource medical environments. ✢ Led summative usability study of Hemafuse™ device, including user recruitment, study development and execution, and final compilation, analysis, and reporting of results✢ Adapted customer training protocols based on Voice of Customer feedback to translate stakeholder needs and workflow into final training curriculum✢ Authored final validation and verification reports in preparation for product launch in Q4 2018

M.S.E. US Health Project: SurgiSight, an EMR-integrated mobile health platform that connects patients to their physicians to help monitor for the onset of surgical site infections (SSI’s).✢ Performed over 200+ hours of clinical ethnographic research in Johns Hopkins Hospital✢ Identified 250+ unmet clinical needs in cardiac, spinal, IR, gynecological, and GI procedures✢ Distilled needs into six market insights and performed assessments of business case and patient impact✢ Designed and performed repeated formative usability studies with over 40 key clinical stakeholders✢ Developed solution concepts, experimental design, and key business plan development✢ Presented a pre-submission with the FDA at their White Oak officeAchievements: 3rd Place at 2018 Medical Capital Innovation Competition ($11,000 in cash and in-kind services), 3rd Place at 2018 JHU Design Competition in Health IT Track ($2,000 cash), Finalist at 2018 George Mason University Deans' Business Competition

M.S.E. Global Health Project: Halo/Endovibe, endoscopic medical devices developed in partnership with Boston Scientific to deskill a complex gastrointestinal procedure to increase market access for rural Indian physicians. ✢ Performed 125+ hours of clinical immersion in Indian hospital systems to understand standard of care✢ Structured and conducted formative usability study with Indian physicians, technicians, and fellows✢ Designed and implemented hardware and optical components of experimental testing setup✢ Designed and executed benchtop testing, ex-vivo tissue testing, and a porcine model animal study✢ De-risked solution through validated proof-of-concept studies✢ Generated IP for potential solution embodiments (patent pending)

The Johns Hopkins Biomedical Design Team program guides several five-person undergraduate BME's as they perform a year-long project innovating in the medical space. The program will lead them through the innovation process, from needs development and market analysis to ideation, prototyping, and publication or patent application. As a Design Team Teaching Assistant, I perform the following tasks:✢ Mentor undergraduate team on year-long design project in gynecological surgery✢ Facilitate group dynamics and project progress✢ Assist course instructors with course material, interactive presentations, and class demonstrations

The Orthopaedic Research Laboratory, led by PI Dr. Mark Ehrensberger, focuses on the efficient and minimally invasive elimination of implant-based biofilm infections via electrical stimulation.While working as a Research Assistant, I performed the following tasks:✢ Anodized microelectrodes to prepare pH-sensitive three-electrode voltage arrays✢ Characterized sensitivity and long-term accuracy of micro-electrode arrays✢ Analyzed experimental data to normalize optimal microelectrode fabrication techniques

The Engineering Principles seminar is a two-semester series of classes taken by all first-year engineering students at UB. During these classes, students learn universal foundational engineering skills, hands-on prototyping and testing, and experimental/project design.As a Teaching Assistant, I performed the following tasks:✢ Guided students through classwork and laboratory activities and projects✢ Taught lessons on basic engineering techniques, including conceptual models, decision matrices, and quantitative analysis✢ Graded student assignments and provided feedback on individual and group development and interactions✢ Held extra lab hours as necessary for ambitious students to develop prototype designs

The Laser and Ultrasonic Imaging Laboratory, led by PI Dr. Jun Xia, focuses on the application of new and innovative techniques to advance the capabilities of photoacoustic tomography.While working as a Research Assistant, I peformed the following tasks:✢ Tested efficacy of high power LED light as alternative to lasers for photoacoustic tomography✢ Constructed and tuned lens arrangement experiments to gather and analyze leaf phantom imaging✢ Communicated with outside companies to determine and acquire optimal equipment and supplies for testing

I served on a team of 24 Resident Advisors (RAs) for a building of 720 first-year students. I personally focused on a community of 30 Honors students.While working as an RA, I held the following responsibilities:✢ Fostering safe and inclusive community among first year residents✢ Organizing and performing educational and social programming✢ Skillfully mediating professional and social conflicts among peers and residents✢Fulfilling on-call emergency response rotation

Orientation Leaders (OLs) are responsible for preparing incoming first-year students for the transition to the college lifestyle. I worked with 31 other OLs across 8 2-day sessions to prepare 5000 incoming students for a successful introduction to their college experience.As an OL, I performed the following tasks:✢ Performed group ice-breaker activities and Q&A discussions✢ Raised and maintained high energy and morale among incoming students✢ Provided education and guidance as to safe and effective transition to college life

The Jacobs Institute connects medtech engineers, entrepreneurs, and industry partners with leading clinicians to accelerate the growth of innovation in the cardio- and neurovascular space.While at the Jacobs Institute, I performed the following:✢ Performed 3D-modeling and 3D printing of patient specific neurovascular aneurysm models✢ Wrote a medical imaging manual to increase technical understanding of imaging modalities used by neurosurgeons. In this manual I presented succinct explanations and examples that were accessible to both technical and non-technical industry partners.✢ Delivered a final presentation to company executives, clinicians, and guests on the future impact and utility of the manual.A recording of my final presentation (and that of my peers) can be found at the link below. A short introduction of the program can be found in minutes 0:00-6:00, whereas my presentation can be found at 13:30-30:10.

The Residence Hall Association (RHA) is a student government organization devoted to providing advocacy, entertainment, and a sense of community to the on-campus student body.While President, I accomplished the following:✢ Handled operation, planning, and development of $70,000 campus organization✢ Planned and executed two leadership development conferences for 100+ students✢ Organized a seminar discussion on the state of women's rights locally, nationally, and abroad✢ Sat on the Campus Dining and Shops Board of Directors✢ Re-wrote and amended the organization's constitution