Scaled Product Launch™

Cogmedix helps medical device capital equipment innovators become global leaders by successfully launching new medical devices with unmatched flexibility, speed and regulatory compliance.

BRING YOUR MEDICAL DEVICE TO MARKET WITH UNMATCHED FLEXIBILITY, COMPLIANCE AND SPEED

Scaled Product Launch™ (SPL™) is a proprietary reinvention of the standard New Product Introduction (NPI) process. It incorporates all aspects of the product launch process in a collaborative, phase-gate approach designed to bring medical devices to market while stringently adhering to FDA and ISO 13485 requirements. Under the leadership of a dedicated SPL™ Manager, SPL™ leverages key organizational resources and defined processes to ensure your medical device is launched on time, on budget and with unwavering compliance.

 

STREAMLINE THE PRODUCT LAUNCH PROCESS WITH EXPERT GUIDANCE FROM AN EXPERIENCED MEDICAL DEVICE MANUFACTURER

New medical products can fail to launch successfully when unidentified risks create holes in regulatory requirements, facility requirements and capacity, resource capacity and training, material availability, proper documentation, and manufacturability. Cogmedix Caring Associates used their decades of combined experience launching new medical devices to develop a comprehensive strategy that mitigates risk and streamlines the traditional NPI process.

The in-depth SPL™ process enables our team to expose and address manufacturing issues before they become costly. The primary goal is to streamline the transfer of information, regardless of the stage your product is in, and prevent inconsistencies that can become serious issues down the line.

cogmedix associate working on cynosure medical device

small components for aluminum pulley

cogmedix associate transporting cart of home healthcare monitoring devices

 

 

Positive attitudes, treating people with respect and delivering an unmatched friendly, flexible and personalized client experience is what we strive for every day. It’s a full team commitment and we will never stop iterating and improving. We call it Commercialization Personalized™.

Chris Coghlin

President and CEO

HOW SPL™ WORKS

When a customer approaches Cogmedix with a new medical device design, we work with them to develop a strong understanding of their goals and production timeline. It all starts with defining the Success Team, which includes a primary point of contact Program Manager and representatives from each critical function internally. During the scale up process, the SPL™ Manager drives the process, meetings and action items, as well as continuously improves the SPL™ process itself.  All aspects of the initial product design are reviewed, including drawings, bill of materials (BOM), schematics, assembly documentation, quality requirements, applicable regulatory requirements, packaging and labeling, fixtures, testing requirements, facility requirements, and more.

The SPL™ system is designed as a phase-gate approach. Each step of the process is documented and reviewed before it is allowed to formally move forward, although the process also offers the flexibility to allow concurrent critical tasks to occur between phases.

Our SPL™ Manager manages a team of experts we refer to as our Customer Success Team, and oversees every product launch. This position supports and monitors the entire process throughout the various stages of the production scale up. Every phase is recorded via a highly detailed checklist that requires individual accountability from members in each respective department. This ensures the product progresses as planned and that the source of any delay or risk is addressed immediately with appropriate mitigation plans.

Each checklist must be approved by the SPL™ team and SPL™ Manager, who reviews progress to ensure all prerequisites have been met before the product proceeds to the next phase.

Detailed process information is maintained as a single, unified document that compiles interdepartmental progress and priorities. Specialized SPL™ Success Teams maintain departmental ownership so that every step is accounted for. Teams are assigned based on their areas of expertise and they continue with the project until it is completed.

In a competitive market like the medical device industry, remaining on the cutting edge requires speed, precision and maximum compliance. With SPL™, you can trust Cogmedix to ensure your innovative medical device launches ahead of the competition, every time.