Rick Smith
Strategic Leadership & Consulting
+1 508.320.4861
Email:
Address:
25 Summer Street
Northborough, MA 01532
Phone:
Hello! I'm Rick
I am an experienced multi-functional leader and operator across a broad range of technologies. Having worked in CT imaging, diagnostics, surgical devices, implantables, robotics and drug delivery devices in small-sized companies has required adapting knowledge to new situations and applying it to new challenges.
Five years as an officer in the US Navy's nuclear submarine force gave me a solid technical and leadership foundation for entry to industry in 1999. I then progressed through roles in quality, regulatory affairs, operations and strategy while also picking up responsibility in areas such as: product development, pre-clincal and clinical affairs.
EXPERIENCE
2018-2022
Senior Vice President
PORTAL INSTRUMENTS
Instrumental in setting strategic direction and providing oversight to various functions in the company, including: quality, regulatory, operations, pre-clinical, clinical, product development and alliance management. Personally led several key initiatives, including development of a human clinical protoytpe device through human clinical testing. Served as alliance partner for critical customer relationships at the leadership level.
2014-2018
Sr. Director, QA/RA
BIONX
Senior leadership team member responsible for all aspects of quality and regulatory affairs. Led initiative to mature the quality system, supporting an aggressive product re-design effort that led to successful commercial launch and subsequent company acquisition. Instrumental in transfer of technology and operations post-acquisition.
2011-2014
CONFORMIS
Director, Quality
Responsible for all aspects of quality for a permanent implant system, leading a team of 20 employees. Led successful completion external audits by both FDA and ISO registrar.
2005-2011
Director, Quality
HOLOGIC
Increasing responsibility in quality and regulatory roles. Performed PMA submissions, overhauled QMS elements, managed department.
1999-2005
Quality Manager
ANALOGIC
Led quality department for medical CT scanner division after starting as a quality engineer.
1994-1999
Nuclear Submarine Officer
US NAVY
Navy-trained nuclear engineer serving as a division officer onboard a Los Angeles class submarine.
EDUCATION
1990 - 1994
BS - Physics
WORCESTER POLYTECHNIC INSTITUTE (WPI)
Major Qualifying Project: Used Quasi-Elastic Light Scattering Spectroscopy (QELSS) to determine the size and shape of molecules in solution.
● Physics Department awards in both scholarship and research
● Sigma Pi Sigma (physics) and Tau Beta Pi (engineering) honor societies
1994 - 1995
NUCLEAR POWER SCHOOL / PROTOTYPE
Intensive graduate-level coursework in Mathematics, Physics, Chemistry, and Engineering. Qualified to supervise the operation of a naval nuclear reactor.
Qualification
1998
Qualification
NUCLEAR ENGINEERING OFFICER SCHOOL
10-week course of study in the detailed theory, design and operating parameters of a Naval nuclear power plant. Successfully completed two-days of extensive oral and written examinations at the Naval Reactors organization in Washington, D.C.; the technical qualifications necessary to become the Engineering department head of a nuclear submarine.
Advances in Large Volume Subcutaneous Injections: A Pilot Tolerability Study of an Innovative Needle-Free Injection Platform
https://journal.pda.org/content/early/2022/03/16/pdajpst.2021.012670 , March 2022
A pilot study with a needle-free injection system to evaluate the delivery of a 2.0 mL volume in human subjects. The results demonstrated that injections of up to 2.0 mL were well tolerated, and often preferred over two separate 1.0 mL injections using the needle-free injection system
Advances in subcutaneous injections: PRECISE II: a study of safety and subject preference for an innovative needle-free injection system
https://doi.org/10.1080/10717544.2021.1976309, December 2021
Portal Instruments Inc. has been developing needle-free medication delivery using a well-designed hand-held device, PRIME, that is safe, intuitive to use, and utilizes advanced electronic control of a focused, high velocity, pressurized liquid injection stream. The PRECISE II human study demonstrated that the PRIME needle-free injection system was safe, well tolerated, and strongly preferred by participants for self-injections over a standard needle and syringe
Aggregation Number and Hydrodynamic Hydration Levels of Brij-35 Micelles from Optical Probe Studies
George D. J. Phillies, R. H. Hunt (Smith), K. Strang, and N. Sushkin
Langmuir 1995 11 (9), 3408-3416
DOI: 10.1021/la00009a023 https://pubs.acs.org/doi/abs/10.1021/la00009a023
PUBLICATIONS
SKILLS
Strategic Planning
Operations Management
Quality Management
Product Development
Cross-funtional Leadership
Alliance Management
Regulatory Affairs
Device / Combination Product
Clinical Operations
EXPERTISE
Executive Leadership
Assist senior leadership teams in defining and maintaining a holistic view of the organization and the internal systems that support it. Work to establish a long term strategy, then drill down into shorter term goals and actionable objectives throughout the organization.
Operations Management
In alignment with company strategy and maturity level, drive establishment of all the necessary internal systems, processes and infrastructure to support the organization. Focus on clearly defining the systems needed today vs. those that will be required in the future, while keeping a clear view of the costs and tradeoffs associated with those decisions.
Quality Management
Extensive experience managing all aspects of Quality in small organizations. Particular expertise in esablishing and maintaining quality management systems (QMS) to fit the particular organization in alignment with the company's lifecycle.
CLIENTS
