MedSpark
Consultancy offering medical device product development services from concept through prototyping, verification, regulatory submission and preparation for production. Core services include multidisciplinary engineering, medical electronics and embedded firmware, industrial design and human factors, prototype and small-batch manufacturing, regulatory and quality-system support, intellectual property assistance, and coordination of preclinical and clinical evaluations.
Industries
Nr. of Employees
small (1-50)
MedSpark
Products
Therapeutic mobility training device (featured project)
Clinical therapeutic mobility training device developed as a portfolio example illustrating prototyping, testing and commercialization support.
Orthopedic surgical instruments and implant tooling (portfolio examples)
Examples of surgical instrument and implant tooling projects including drill guides, alignment guides and impactors demonstrating orthopedic device engineering and prototyping capabilities.
Therapeutic mobility training device (featured project)
Clinical therapeutic mobility training device developed as a portfolio example illustrating prototyping, testing and commercialization support.
Orthopedic surgical instruments and implant tooling (portfolio examples)
Examples of surgical instrument and implant tooling projects including drill guides, alignment guides and impactors demonstrating orthopedic device engineering and prototyping capabilities.
Services
Multidisciplinary engineering for medical devices, implants, instruments and capital equipment including mechanical, biomedical, electrical and manufacturing engineering, CAE and reverse engineering.
User-centered industrial design, ergonomics and human factors engineering to optimize usability, safety and manufacturability.
Embedded electronics, sensor systems, power electronics, wireless communication, FPGA/firmware development and in-house PCBA prototyping and inspection.
Rapid prototyping, tooling, pilot manufacturing and small-scale contract manufacturing including additive processes, machining, molding, casting, welding and surface treatments.
Regulatory planning and preparation for 510(k), PMA, CE and other submissions; support for QMS implementation, ISO 13485 and audit readiness; coordination of standards and safety testing.
Management and coordination of prototype testing, mechanical/environmental testing, preclinical studies and clinical testing activities to produce evidence for verification, validation and regulatory submissions.
Multidisciplinary engineering for medical devices, implants, instruments and capital equipment including mechanical, biomedical, electrical and manufacturing engineering, CAE and reverse engineering.
User-centered industrial design, ergonomics and human factors engineering to optimize usability, safety and manufacturability.
Embedded electronics, sensor systems, power electronics, wireless communication, FPGA/firmware development and in-house PCBA prototyping and inspection.
Rapid prototyping, tooling, pilot manufacturing and small-scale contract manufacturing including additive processes, machining, molding, casting, welding and surface treatments.
Regulatory planning and preparation for 510(k), PMA, CE and other submissions; support for QMS implementation, ISO 13485 and audit readiness; coordination of standards and safety testing.
Management and coordination of prototype testing, mechanical/environmental testing, preclinical studies and clinical testing activities to produce evidence for verification, validation and regulatory submissions.
Expertise Areas
- Medical device product development
- Multidisciplinary device engineering
- Medical electronics and embedded systems
- Industrial design and human factors
Key Technologies
- Additive manufacturing (SLA, SLS, FDM, DMLS/EBM)
- CNC machining, milling and turning
- Injection molding and tooling
- Metal injection molding (MIM)
News & Updates
Attendance and outreach at clinical and industry conferences including participation at events such as ASPAN 2018, ASLMS 2018, SIR 2018 and RSNA 2014.
Provided meetings with clinicians at the American Society of PeriAnesthesia Nurses 2018 annual meeting in Anaheim, CA to discuss medical device ideas and development support.
Attendance at the ACSM Annual Meeting in Orlando, FL (May 27–31, 2014) covering topics including concussion management, preventive cardiology, exercise as medicine, musculoskeletal exam techniques, ultrasound-guided injections, and related clinical workshops.
Attendance and outreach at clinical and industry conferences including participation at events such as ASPAN 2018, ASLMS 2018, SIR 2018 and RSNA 2014.
Provided meetings with clinicians at the American Society of PeriAnesthesia Nurses 2018 annual meeting in Anaheim, CA to discuss medical device ideas and development support.
Attendance at the ACSM Annual Meeting in Orlando, FL (May 27–31, 2014) covering topics including concussion management, preventive cardiology, exercise as medicine, musculoskeletal exam techniques, ultrasound-guided injections, and related clinical workshops.