Kymanox® is currently providing complete product development lifecycle support to a medical device company to bring a novel autoinjector to commercialization.  Kymanox has worked across a number of workstreams including product design and development, Human Factors (HF), project management, and regulatory affairs. Support includes preparation for and leading pre-submission meetings, regulatory pathway strategy development, Design History File (DHF) creation, Electronic Quality Management System (eQMS) selection, startup, and implementation, product design, device prototyping, device testing, product packaging, sterilization engineering, Instructions For Use (IFU) and labelling updates, contract manufacturer selection and oversight, clinical product manufacturing support, and commercial product manufacturing support. Now, this client is on track for regulatory submission within two years of project initiation.

 

Challenge

This medical device company needed help taking their whiteboard concept for a novel autoinjector to commercialization.

Solution

Kymanox experts helped take this device from concept to reality by providing support across many different workstreams.

Results

Kymanox created CAD and prototypes for three device iterations,​ performed hundreds of technical analyses to support scalable design​, built almost 1,000 fully functional molded prototypes, and produced 250 clinical trial devices for three site clinical trial​. We performed a risk-based technical assessment​ of the product. Kymanox also provided support for onboarding a clinical device Contract Manufacturing Organization (CMO) as well as identification of and tech transfer to a commercial CMO. Other deliverables included a turnkey eQMS with a fully electronic document management system, support for submission of two FDA pre-submissions and agency feedback, and completion of an n=150 device injection trial. Within 12 months of project initiation, Kymanox helped this client go from a whiteboard concept to clinical trial with their device. Now, they are on track for regulatory submission within two years of project initiation.