316 Product Development
Engineering and product-development consultancy offering end-to-end product design, prototyping, manufacturing transfer, and sustaining services. Services emphasize regulated medical device development, mechanical and electromechanical design, embedded and software engineering, simulations (FEA/CFD), rapid prototyping, manufacturing engineering, human-factors research, and IP/regulatory strategy. Provides project management and vendor integration from concept through production and sustaining.
Industries
Nr. of Employees
small (1-50)
316 Product Development
11850 Brookville Road, Indianapolis, IN 46239
Products
Vacuum assisted breast biopsy device
Led development from concept to launched product; created second-generation device that increased market share from under 10% to over 50% in under three years and supported a multi-million-dollar company exit.
Percutaneous implantable venous valve
Product development that advanced a client to a leadership position in the implantable venous valve market; improved valve efficacy in animal studies from ~1 month to beyond 6 months; primary inventor on multiple patents associated with human trials.
Flow meter and alarm
Complete product development delivered to market in approximately four months, including tooling and vendor management; transferred product into production.
Vacuum assisted biopsy device with inline specimen radiograph
Early-phase development and proof-of-concept work for a biopsy device integrating inline specimen radiography; supported progression toward launch.
Minimally invasive medical devices (portfolio)
Design and launch of multiple minimally invasive products such as wire guides, guiding catheters, PICC lines, needles, nitinol needles, balloon catheters, and disposable accessories.
Articulating arm and custom gripper
Design of lift-assist articulating arm and custom gripper to support shock loads and gauging operations for production environments.
Vacuum assisted breast biopsy device
Led development from concept to launched product; created second-generation device that increased market share from under 10% to over 50% in under three years and supported a multi-million-dollar company exit.
Percutaneous implantable venous valve
Product development that advanced a client to a leadership position in the implantable venous valve market; improved valve efficacy in animal studies from ~1 month to beyond 6 months; primary inventor on multiple patents associated with human trials.
Flow meter and alarm
Complete product development delivered to market in approximately four months, including tooling and vendor management; transferred product into production.
Vacuum assisted biopsy device with inline specimen radiograph
Early-phase development and proof-of-concept work for a biopsy device integrating inline specimen radiography; supported progression toward launch.
Minimally invasive medical devices (portfolio)
Design and launch of multiple minimally invasive products such as wire guides, guiding catheters, PICC lines, needles, nitinol needles, balloon catheters, and disposable accessories.
Articulating arm and custom gripper
Design of lift-assist articulating arm and custom gripper to support shock loads and gauging operations for production environments.
Services
Concept development through launch and sustaining: customer research, ideation, prototyping, detailed design, test, tooling, vendor selection, and transfer to production.
Regulated product development including design controls, regulatory-pathway planning, implantable and minimally invasive device design, and GMP/GLP testing coordination.
Embedded firmware, wireless integration, GUI and mobile applications, systems architecture, and automated test systems.
3D printing (SLA, FDM, SLS), CNC prototypes, RTV/urethane castings, vacuum molding, quick-turn tooling and soft tooling for low-volume parts.
DFM/DFA, PFMEA, process validations, pilot manufacturing, supplier integration, tooling coordination, and production automation.
User-centered research, ethnography, usability testing, surveys, task analysis, and translation of findings into design requirements.
Concept development through launch and sustaining: customer research, ideation, prototyping, detailed design, test, tooling, vendor selection, and transfer to production.
Regulated product development including design controls, regulatory-pathway planning, implantable and minimally invasive device design, and GMP/GLP testing coordination.
Embedded firmware, wireless integration, GUI and mobile applications, systems architecture, and automated test systems.
3D printing (SLA, FDM, SLS), CNC prototypes, RTV/urethane castings, vacuum molding, quick-turn tooling and soft tooling for low-volume parts.
DFM/DFA, PFMEA, process validations, pilot manufacturing, supplier integration, tooling coordination, and production automation.
User-centered research, ethnography, usability testing, surveys, task analysis, and translation of findings into design requirements.
Expertise Areas
- Product ideation and concept development
- Mechanical and electromechanical design
- Embedded and IoT software development
- Rapid prototyping and low-volume tooling
Key Technologies
- Finite Element Analysis (FEA)
- Computational Fluid Dynamics (CFD)
- Embedded firmware and RTOS
- Bluetooth and Wi‑Fi connectivity
News & Updates
Second-generation vacuum-assisted breast biopsy device contributed to increasing a client's market share from under 10% to over 50% in under three years and supported a subsequent $250 million sale of the company.
Development work improved valve efficacy in animal studies from approximately 1 month to beyond 6 months; primary named inventor on multiple patents associated with human trials.
Second-generation vacuum-assisted breast biopsy device contributed to increasing a client's market share from under 10% to over 50% in under three years and supported a subsequent $250 million sale of the company.
Development work improved valve efficacy in animal studies from approximately 1 month to beyond 6 months; primary named inventor on multiple patents associated with human trials.