Medical Device Prototyping & Pilot Production
DeviceLab believes medical device prototyping is essential to development. We make prototypes at several stages in most projects, using a combination of in-house fabrication and trusted vendors. Prototypes can be just appearance mockups or units with partial or total functionality. They are often made by processes different from the final product, as they are needed for testing, and other purposes before production tooling and assembly operations are set up.
The prototyping and piloting of medical devices are driven by a five-step FDA process for both guidance and access to the pathway for approval. Your products represent a significant investment that must have a positive return on that investment. DeviceLab understands that five-step process very well. We ensure that your device is on the right path in meeting FDA’s regulatory requirements and its subsequent approval for use.
5 Important Steps from the FDA on Prototyping and Piloting Medical Devices
The FDA device development method guides you on what the FDA is looking for. We at DeviceLabs will only be discussing the first two steps in describing how prototyping and piloting should be done to enhance the client’s path to success. Use the link above to discover more details about the FDA process.
- Device Discovery and Concept – ideation and need for the product
- Preclinical Research-Prototype – first article production and piloting (testing)
- Pathway to approval
- FDA Device Review
- FDA Post-Market Device Safety Monitoring
The first thing to understand is how and why medical devices are categorized. It is based on the risk to the patient in having that device used as part of his healthcare effort. How devices get classified is determined by a data-driven scientific process conducted by the FDA. The trigger for that review is to submit your device discovery and concept documentation to the FDA.
DeviceLab can take the results of your discovery and concept for a medical device and turn it into a prototype first article and test it in a pilot effort to gather the data necessary for FDA review and approval. DeviceLab knows the “how” to respond to the FDA’s “what” contained within their five-step process.
Medical device design and development for submission to FDA review are complex processes rife with regulations, specifications, application requirements, and end-user needs. All of these factors are part of a finely balanced and integrated process that breeds success. The device itself is only the end product. It is the process that meets FDA expectations that wins the day.
Thus, the job of DeviceLab is a complicated project in how to satisfy FDA regulations. We must work as a team with you to evaluate needs carefully, derive functional requirements, create specifications, and more while adhering to the IEC and ISO standards the FDA mandates be satisfied. The DeviceLab process will follow the waterfall chart below.
4 Key Steps in Prototyping and Piloting Medical Devices
DeviceLab’s medical device prototyping services include:
- Plastic part rapid prototyping (SLA, SLS, FDM, etc.)
- Quick-turn sheet metal fabrication
- Prototype machined parts (CNC machining from solid models)
- Metal castings and 3D printed metal parts
- Soft tooling molded plastic parts
- Finished appearance models (paint, faux screens, etc.)
- Quick-turn PC board assemblies
- Assembly & integration
- Crating & shipping
We also offer pilot production of medical devices to support your testing, promotional, and other needs. Pilot production typically means dozens to thousands of units and materials and processes close or equal to those to be used in production. Beyond Pilot production, DeviceLab will help you transition to in-house or contract manufacturing.
Design Controls for Prototyping and Piloting
The FDA’s Quality System Regulations (QSR) serves as the compliance standard for manufacturing a prototype medical device. Revised design controls were signed into law in 1990 via the Safe Medical Devices Act that necessitated changes to the QSR and the underlying ISO 9000.1:1994 standard. The result was a new, more consistent ISO/CD 13485 standard that served to supplement the ISO 9000.1:1994 standard.
DeviceLab is meticulous about staying current with changes in both the published standards and the FDA’s interpretation of those standards as a framework for how manufacturers should go about in designing prototype devices and pilot testing them for compliant functionality. The QSR is that framework and allows for DeviceLab to develop compliance best practices that take advantage of emerging technology in the medical device field while maintaining both safety and efficacy requirements levied by the FDA. Thus, the QSR defines the end goal and leaves the roadmap of getting to that goal in the hands of DeviceLab and other manufacturers. DeviceLab follows a complaint workflow process, as shown in the QSR.
Important Considerations for Medical Device Pilot Production Addressed by DeviceLab
- QC/QA acceptance testing
- Contract sterilization
- Technical support (at our facility)
Medical Device Piloting and Test
As you can see in the workflow process, the DeviceLab follows a rigorous system engineering approach to complying with FDA guidelines and standards. That process incorporates design best practices, safety requirements, and quality throughout. We understand that patient lives hang in the balance of ensuring these medical devices have the highest safety and efficacy standards in protecting their health. That’s why DeviceLab follows a continuous testing regimen that we iterate through many times until the medical device does precisely what it was intended to do. A system-level validation and verification procedure ensures that you get all the objective evidence you need to complete the FDA review process on the path to medical device approval.
4 Key Factors in Medical Device Risk Management
The design and manufacturing of any medical device carries a certain amount of risk. We live in a world of emerging technology driven by an Internet of Things (IoT) mentality. This always leads to questions about the maturity and stability of many of the technological advances that we see every day in the news. The goal of any IoT effort is to get the product to market as fast as possible. Many times, the verification and validation efforts are lacking rigor and discipline. For that reason, the FDA invokes the ISO 14971:2007 standard as an internationally accepted risk management standard. DeviceLab and every manufacturer of medical devices must have established risk management procedures that bring them into compliance with ISO 14971.
Fundamental Guidelines & Requirements for Prototypes
- Identify hazards associated with medical devices
- Estimate and evaluate associated risks
- Control identified risks
- Monitor the effectiveness of risk-management controls
Risk management applies across the entire lifecycle of medical device manufacturing, including any associated software.
DeviceLab stays current with any standard from the ISO/IEC family of standards because they are reviewed, evaluated, and updated every five years as a minimum. Important events also drive out-of-cycle updates as supplements, as we saw with the quality assurance standard. You must be on your toes, and DeviceLab always is.