Every medical device begins with an idea. Turning that idea into a tool for helping treat, cure and heal takes skill, knowledge, and expertise. MedFab is a powerhouse of just the kind of help you need to get your ideas designed, built, and into the hands of those who can put them to use in making life better for patients everywhere.
From proof-of-concept prototyping to full-scale production, MedFab can be your guide and partner every step of the way. Here is a detailed look at the journey from concept to delivery when you partner with MedFab:
Step 1: Rapid Prototyping
Whether you bring us a digital model, a napkin sketch, or a vaguely recollected dream, MedFab can begin to give shape to your idea in a 3D-printed plastic model. Non-functioning, these quickly produced prototypes are helpful as proof-of-concept models that begin to show your idea manifested as a physical object.
Successive Alpha, Beta, and Pilot prototypes are developed for functionality testing and to optimize manufacturability. Methods may include CNC machining, urethane casting, stamping, EDM, micromachining, laser cutting, and other processes, with each version refining design and functionality in production-grade materials.
Step 2: Design for Manufacturing (DFM)
Along the way, MedFab engineers are analyzing the design to ensure optimal efficiency and streamlining of production. Our DFM analysis will identify cost-saving alternatives, warn of potential tolerance issues, and highlight opportunities for design simplifications without compromising functionality, performance, or compliance. We will advise on material selection, surface finishes, ideal geometries, and more, in the name of reducing lead times and maximizing scalability. At this stage of the process, we also introduce quality assurance, applying protocols such as First Article Inspection (FAI) and Failure Mode Effect Analysis (FMEA).
Step 3: Capability Studies and Process Validation
Prior to starting production, MedFab performs capability studies to ensure every critical dimension is achievable within required tolerances. We apply Gage R&R, PPAP, and SPC methods to validate that our manufacturing process is precise and repeatable. Medical manufacturing leaves no room for error, and we want to make sure your MedFab-produced parts comply with all regulations and perform to the highest standards every time.
Step 4: Production Manufacturing:
With the process fully validated, MedFab moves to full-scale production in our ISO 13485:2016-certified facility. Parts are produced using the same high-precision technologies used in prototyping, but now within robust process control systems. Throughout the production run, quality is continuously monitored with in-process inspections, automated measurement systems, and statistical tracking to ensure consistency from the first piece to the last.
Step 5: Final Quality Assurance and Delivery
Each finished part undergoes a final inspection and documentation review. Traceability reports and certificates of compliance are produced, and additional services are performed, if required.
You’ve Found the Best Way Forward, with MedFab
From concept to production, MedFab delivers more than a finished product. Our experience and expertise bring you certainty at every stage of the process. You can count on our guidance and quality control, and move forward with the confidence that your idea is in the best possible hands.