The type of safety protocols needed for product manufacturing depends on the industry. A company that makes pencils has a significantly different risk profile than one that makes aerospace components. For medtech, manufacturers have to traverse a complicated set of requirements for patient safety and product quality. Following the standards of other high-risk industries can help manufacturers improve device integrity and reduce the chance of recalls.

Center Company Culture on Quality and Transparency

In order to have a manufacturing facility that consistently provides quality products for medical applications, companies must create a culture that centers on quality and transparency. Staff members may choose to make decisions that enforce quality and provide necessary transparency. Manufacturers can increase the positive outcomes from the design and manufacturing processes by ensuring the following:

• Routine training in best design and production practices, with regular refresher courses
• Positive reactions to reports of problems with products or processes
• Rewards for employees who consistently go above and beyond to improve quality

Businesses may need several months to change a company culture from punitive to positive, but the effort can yield long-term advantages.

Optimize the Supply Chain

The supply chain is a key component to manufacturing quality, affecting everything from delivery timelines to the function of components. Supply chain volatility is a common discussion in the manufacturing sector at present, as industry businesses seek to minimize the effects of inflation, tariffs, labor shortages, political upheaval, and climate change on their ability to meet production demands. For many, optimizing the supply chain involves searching for materials and components closer to the manufacturing facility, as well as creating multiple pathways to getting parts of equivalent quality.

For manufacturers of orthopedic devices that rely on preconstructed parts, checking the quality of the supply chain is an important component as well. Confirming that the organization providing the components has robust processes for quality control and other factors can help to ensure the viability of the products and the relationship.

Integrate Risk Assessment into Design/Manufacturing Strategies

Before starting any new project, even one that does not require much change to the standard operating procedure, businesses should check their risk assessment processes. Risk assessment involves a detailed analysis of a variety of factors, including:

• Potential for supply chain disruption
• Equipment maintenance needs and downtime
• Possible safety hazards at the manufacturing facility
• Consequences of failing to comply with industry guidelines
• Negative effects from changing a design
• Loss of reputation due to faulty manufacturing

Analyzing the risk of making a big change, such as redesigning a product or using different materials during the manufacturing process, can help companies determine if the rewards outweigh the risks of going in a new direction.

Increase Oversight

Although governmental oversight organizations often provide incentives for companies to maintain tight quality control over their products and processes, these efforts may be insufficient. For example, the FDA provides some regulation over the production and sale of medical devices, particularly before each device makes it to the market. These regulations may not be comprehensive, however, and can miss design or manufacturing flaws that cause problems once put in use. Additionally, the FDA relies on consumers or medical professionals to complete adverse event reporting to discover faults after the release of a product.

To avoid the complication and hassle of a product recall or other consequences, companies can implement their own oversight programs. Oversight can be part of the quality control process, ideally a component of greater transparency within the organization. Hiring analysts to evaluate testing and quality control reports can help identify issues with products before they leave the facility.

Validate Design Changes Before Manufacturing

Periodically, manufacturers will decide to change the design of an orthopedic device to improve long-term use, health outcomes, placement, and more. Before a new design makes it to the factory floor, however, companies should perform a comprehensive validation of the design changes. Sometimes designs work better than before, but it is not a guarantee. Robust testing of each prototype can make it easier to determine if the new design will work at least as well or better than the original, with a decrease in negative effects. Creating a response team to evaluate the design, provide comments, request adjustments, and approve changes can create a trail of transparency that helps to maintain quality over time.

Streamline Quality Control Processes

Manufacturers usually have quality control processes, but those processes may not be optimized or streamlined across the company. Quality control is a mindset, not simply a set of tasks that teams check off as they go through manufacturing. Streamlining quality control looks like:

• Concrete steps that each team has to follow, performed consistently throughout the process
• Proactive standards for equipment use, maintenance, and repair
• Testing procedures designed to highlight faulty or failing equipment
• Reporting structures that workers can use when they find problems
• Central decision-making teams, so that lower-ranking staff are less likely to pass the buck

Consistency in the creation and execution of quality control processes can increase device integrity and repeatability of positive outcomes.

Perform Comprehensive Testing

During the manufacturing process, companies should complete testing to make sure that each device meets requirements for proper use. Manufacturers should do the following:

• Confirm that equipment and materials have proper storage to minimize warping, oxidation, or other stressors.
• Test materials and pre-manufacturing components for quality and safety.
• Thoroughly test new designs before manufacturing in volume.
• Complete post-production evaluation before shipping.
• Perform testing to make sure that the device will work for the patient without increasing risks like allergic reactions, toxicity or irritation.

Inclusive testing processes can minimize the risk of occasional product failure.

Provide Robust Training and Support Guides

Manufacturing a device or part that is intended to be used in a medical capacity may require extensive training and support for manufacturing teams and medical personnel using or promoting the devices. Best practices suggest these aspects:

• Standardize training for manufacturing staff and medical professionals in the proper implementation of the device.
• Empower manufacturing team members to report issues promptly and effectively.
• Document design changes in new releases of existing products, highlighting the differences.
• Provide detailed documentation for the use of the device, including risks and contraindications.

These processes can help to reduce confusion or incorrect use of the device by clarifying proper operation and maintenance, such as when to use equipment calibration services.

Complete a Thorough Failure Analysis

Parts and devices fail on occasion, and these failures should trigger a comprehensive investigation. A failure analysis should include a variety of aspects, such as:

• A list of staff members working on the manufacturing of the failed device
• Sources of materials and components, noting any changes to the supply chain
• Existing processes for manufacturing, quality control and oversight
• Missed warning signs, such as an equipment sensor going off
• Prior reports of a malfunction related to the device
• Equipment functions during manufacturing, noting downtime for maintenance, repairs, or other problems

This information can help manufacturers isolate the likely causes of the failure, providing the tools necessary to make changes and prevent the problem from happening again.

Conclusion

Building a device that can help orthopedic patients improve their health and mobility is full of risks that manufacturers must manage. Many industries face such obstacles to production, providing opportunities for cross-industry learning. By integrating practices such as supply chain optimization, robust testing, quality control, and training, manufacturers can improve their long-term outcomes.

Sources (for further reading)

• https://www.meddeviceonline.com/doc/what-can-the-medical-device-industry-learn-from-the-boeing-max-crashes-0001
• https://www.patientsafety.com/en/blog/what-can-the-aviation-industry-teach-us-about-safety-in-the-healthcare-sector
• https://www.bonesinvectors.com/post/testing-of-orthopaedic-implants-a-comprehensive-overview-of-stakeholders-and-processes
• https://www.congress.gov/crs-product/R47374
• https://safetyculture.com/topics/risk-assessment/manufacturing-risk-assessment
• https://www.pearlpathways.com/boeing-737-max-design-control-takeaways-medical-device/
• https://www.ainonline.com/aviation-news/aerospace/2025-05-21/ainsight-boeing-737-max-crashes-and-lessons-learned
• https://www.mddionline.com/qa-qc/medtech-lessons-in-the-boeing-737-max-debacle

Steve Gonzales is the founder and technical advisor of Technical Safety Services, which provides testing, certification, and calibration of equipment and controlled environments crucial to the success of the biopharma, medical device, academic research, and food production industries.