Spec Developer ELEVATOR®
Medical device product development has never been easier. NAGL MedTech’s™ proprietary development model lowers time and cost to market.
Medical device product development has never been easier. NAGL MedTech’s™ proprietary development model lowers time and cost to market.
The Spec Developer ELEVATOR® at NAGL MedTech™ is ideal for the client who needs development services for a best-in-class medical device product. From early-stage concepts, through design controls, our team will manage every aspect of your project to reach your company’s end goal.
Within the Spec Developer ELEVATOR®, you have access to Systems, Equipment, and Workforce services, and your project is run within the NAGL MedTech™ Quality System to ensure best in class products.
Phase A
Identify the strategic considerations for product development beyond the product itself – clinical, regulatory, reimbursement, production, packaging, etc. – to help create a blueprint for success.
Phase 1
Fully defining your product and providing that the design is feasible by passing all product specifications.
Phase 2
Implement product design and development while continually refining and verifying product design details to optimize success. For Class II products, NAGL MedTech™ will prepare and submit 510k documentation and data to the FDA.
Phase 3
Ensure the final design meets intended needs along with all safety, regulatory, and technical requirements. In addition, certify that scale-up manufacturing processes are clearly defined and qualified to consistently meet established production quality specifications.
We deploy experts in every aspect of product development to ensure your project has the best chance to achieve successful commercialization.
A seasoned executive team understands the intricacies of product development and leads associates towards innovative solutions that solve the tough problems.
NAGL MedTech™ offers state-of-the-art design technologies including product prototyping, a full in-house machine shop, 3-D printing capabilities, a dedicated R&D lab space, and more. All work is done at our integrated facility to free up space in yours for other projects.
NAGL MedTech™ provides access to an in-house team of experts in product development, regulatory, quality management, and more. From design to production, you can be sure that the people on your project carry the expertise required to complete your project efficiently and effectively.
NAGL MedTech™ utilizes extensive business and quality management systems (FDA and ISO 13485:2016) to ensure document quality, core development process tracking, ongoing client communication, asset review and disposition, information security, and IT systems.
NAGL MedTech™
NAGL MedTech™ takes complete control of managing everything needed for your development project, allowing the client to breath easy that things will be handled in line with all regulations. All clients are assigned a dedicated project manager who will work with you to develop a timeline of deliverables by project phase and take full responsibility for keeping everything on time and on budget.
With NAGL MedTech™ running your product development, you’re adding a level of project accountability and process expertise that will increase product quality and consistency, resulting in faster market launch at a lower cost.
Timeline of completion for a full development project can vary based on a number of different factors such as device class, complexity, and more. A typical timeline for bringing a Class I medical device from concept to 510k submission is roughly 12 months.
The cost of a full development project will depend on a number of factors such as device class, complexity, timelines, and more. A typical price for bringing a Class I medical device from concept to 510k submission can range from $700,000 and $1.5M.
Although we encourage close engagement with your project, Spec Developer ELEVATOR® projects follow our tried and true recipe for product development. If you want to change this recipe, the Consulting ELEVATOR® is right for you!
Nope! All projects within the Spec Developer ELEVATOR® are run within NAGL MedTech’s™ quality system that is managed by our QAE Department.
Absolutely! We encourage every ELEVATOR® client to come in and be hands on with our team of development engineers!
Each Spec Developer ELEVATOR® project is managed by one of our Project Managers. Project Managers will meet with you on a weekly basis to keep you updated. Additionally, you will have access to a dedicated SmartSheet™ Dashboard that houses all critical information you need to know!