(Newswire.net — November 4, 2022) —
All You Need to Know About Medical Device Pilot Production
The introduction and development of new medical equipment is a challenging task that encompasses multiple risks. Medical device pilot production is carried out to recognize potential blunders in the preliminary stages of medical device development.
Evaluating end design, function, and material at the prototype level is essential. A minor fault or negligence at the prototype level can set hurdles in the manufacturing process, elongate production time, and can cause considerable financial loss.
Medical Device prototyping entails analyzing the medical device design on multiple efficiency parameters in the end-user environment. The product may appear innovative at first glance, but holding it in 3-D design brings actual problems to the forefront. This article will help you understand medical device pilot production and its need.
What is Pilot Production?
In general, pilot production entails producing dozens to thousands of units, as well as materials and processes similar to those that will be used in actual production. For medical devices that will be tested in clinical trials or pilot markets before moving to full-scale production, pilot production is critical.
Why Is Pilot Production Needed?
If your medical device performs well in a pilot market or clinical trial, it will most likely move to full-scale production. However, if flaws in the medical device are discovered during the pilot production phase, it may need reworking. Modifying a medical device in reworking will take more time and money.
Your product embodies a significant investment, so it must offer a positive return on investment. Outsourcing medical device pilot production to professional expert engineers or contract manufacturers is practical. You must look for a medical device company that ensures the integrity of the process.
Pilot Production Services
Some of the services offered by medical device companies are as follows:
- Drawing and building assembly tools and equipment
- Process FMEA
- Device master records
- Transferring designs to manufacturers
- Process development and validation
- Manufacturing of the clinical and low-volume commercial units
Medical Device Prototype Development
Medical device prototyping is a multistage process that tests the design’s robustness before moving it to the mass production stage. Prototype engineers can use their knowledge at this stage to create multiple iterations of the product design. The hit-and-trial method is effective in determining the best prototype to transfer.
In general, the development of a medical device prototype involves four stages:
Alpha Prototyping
Alpha prototypes are non-functional and are used to test product dimensions. The device’s design dimensions must correspond to the device’s user intent. This stage assesses the product’s ease of use for the end user.
Beta Prototyping
Beta prototypes are an improvement over the predecessor prototype. These are a little more sophisticated. The beta prototypes are used to test the durability of the parts or components. If an error is discovered, it is immediately brought to the attention of primary stakeholders for correction.
Pilot Prototyping
Soft launches and clinical trials require pilot prototypes.
Final Product
This is the point at which the design is ready for mass production. The final product includes all necessary modifications to address all challenges identified during the prototyping process.
Design Controls for Prototyping, Piloting, and Full-Scale Production
The Quality System Regulations (QSR) of the Food and Drug Administration (FDA) serve as the compliance standard for the pilot production of medical devices. The Safe Medical Devices Act, which required changes to the QSR and the underlying ISO 9000.1:1994 standard, was signed into law in 1990. As a result, a new, more consistent ISO/CD 13485 standard was created to supplement the ISO 9000.1:1994.
The FDA Approved Piloting Medical Devices Process
A five-step FDA process governs the prototyping and piloting of medical devices. This process provides you guidance on what the FDA is looking for.
- Device Discovery and Concept – product ideation and need
- Preclinical Research-Prototype – production of the first article and piloting (testing)
- Approval Process
- FDA Device Evaluation
- Post-Market Device Safety Monitoring by the FDA
Adherence to the above process must be done to augment the client’s path to success.
Benefits of Medical Device Pilot Production
Medical device pilot production offers you multiple benefits discussed in detail below.
Modification Potential
Assume you’re creating a competitive medical product to increase your acceptance rate. One method is to compare the designs theoretically, while another is to hold the visualized design of your future product in a 3D model and compare it to the competing product. Which of these alternatives do you believe is more effective?
The prototype model clarifies the necessary changes or enhancements. The possibility of identifying modifications and scope of improvement in prototyping is far greater than in other methods of analyzing design feasibility.
Time And Money Are Saved
Every new product design is subject to changes at a later stage in the production process. Pilot production saves time and money on modifying everything over a single prototype. Because the issues are identified at the primary level, errors can be reduced. The error would have spread to the entire batch of production. As a result, the whole set would have been useless and a waste of time and resources.
Customization Possibility
Pilot manufacturing provides a great deal of flexibility. The prototype can be modified into different shapes and designs without affecting the other components. As a result, an idea can be shaped into various forms and tested for economic, industrial, and manufacturability. While doing customization, make sure to keep quality control in check.
Communication
A physical model communicates far more effectively than a virtual design. With a 3D Model in hand, it’s simple to display design, manufacturing, or concept challenges.
Efficiency In A User-Friendly Environment
While developing an idea in your head, it may appear to be the most useful invention. However, you can test the product in the end-user environment when you get your pilot product. Most importantly, you can determine whether the product fulfills the intended user
Regulatory Compliance
During the pilot production stage, you can also determine whether the processes comply with the ISO 13485: 2016 and US-FDA regulatory guidelines. If the process does not comply with regulatory guidelines, you can change the process or part of the process that does.
Patent Infringement
Pilot production is essential when you want to manufacture a product for a competitive market. There may be several occasions when you want your product identity to be distinct. During this stage, the design can be easily checked and evaluated for overlap with similar existing technologies.
Conclusion
Medical device pilot production is an essential step toward full device commercialization. It is an excellent opportunity for measuring and recording the device’s build time and quality performance.
The pilot product line will be iteratively improved, with process changes implemented to confirm that the design can be manufactured to meet the client’s business needs for price and performance.
The lessons learned from the pilot manufacturing process will be used to make decisions to scale and refine production processes.