Medical devices help treat diseases and save lives, making quality and safety paramount for their manufacturers. Even the tiniest defect or flaw in a medical device can render it harmful to the end user. Precision matters the most in the industry because it translates into quality and safety. It is like an ethical responsibility rather than a business requirement.
The medical device industry in the US has 6,500 players, with most of them being small- and mid-sized enterprises. The competition is likely less stiff, but regulations and laws still make the industry challenging. With the FDA regulating medical device sales in the US and monitoring the safety of regulated products, manufacturing companies have to be on their toes.
As a manufacturer, you must commit to following best practices to ensure high-quality products comply with the regulatory requirements. Fortunately, implementing them is easier than you imagine. Here is a checklist of best practices to ensure the quality and safety of medical devices.
Start With an Actionable Quality and Safety Plan
An actionable quality and safety plan is the cornerstone of a successful manufacturing process. With a well-defined and documented plan, you can verify whether your process matches the standards and metrics of quality. It also establishes the policies, procedures, and guidelines you must follow to stay on the right side of the regulations.
These plans are subjective, depending on your products and processes. For example, laser manufacturers have to follow a different set of guidelines than conventional ones. Quality and safety metrics for them include the efficacy of the laser manufacturing equipment they use for the process.
According to Novanta Photonics, the delicate applications of the laser processing industry require precision and control. Only a high-quality laser and beam steering solution can deliver a high level of control for the production process.
Ensure Top-Notch Design
Quality and safety of medical devices boil down to product design. Ensure that product designs cover the patient’s needs and deliver comfort and safety for them. At the same time, practitioners should not struggle to understand and use the device.
Design flaws can lead to penalties and recalls, affecting brand reputation and business prospects. Most device recalls in the US are linked to faulty manufacturing, with a recent survey claiming that manufacturing defects are the top reason for recalls.
Careful tracking and control during the manufacturing process can help you ensure top-notch design. Adopting advanced manufacturing technologies like laser processing solutions can help in this context. For example, laser cutting can drive precision and quality in design, resulting in safe and effective medical devices.
Traceability should be a part of the production process as it enables you to understand where the product met obstacles and how they were results.
Create a Feedback Loop
Medical device manufacturers cannot take a set-and-forget approach to the production process. There is always a scope for improvement as better technologies emerge. But adopting them is possible only if you know where you lag. Audits, inspections, and creating a feedback loop set the stage for continuous improvement of the device.
Based on the findings of these audits, you can eliminate problems with the device and mitigate the risks it poses to patients. Additionally, audits keep your business ahead of the compliance guidelines as the FDA necessitates them for manufacturers.
Beyond compliance, internal audits help you implement better quality assurance procedures and create flawless products.
Maintain a Healthy and Safe Work Environment
Workplace hazards are an integral part of the manufacturing industry. The risk is higher for medical device manufacturers because they need to deal with threats like environmental contamination besides conventional worker safety issues. Maintaining a healthy and safe work environment should be a priority.
Begin with the basics, such as identifying risks and implementing mitigative measures to minimize mishaps. For example, you can rethink plant organization to reduce falls and trips. Providing personal protective equipment to workers can eliminate the risk of toxic exposures. Adopting technologies like laser processing can eliminate contamination during product patterning and labeling.
A proactive approach to worker safety does more than improve worker health and safety. It also enhances worker engagement, trust, and loyalty. Engaged and loyal employees go the extra mile to deliver quality.
Wrapping Up
For medical device manufacturers, there are no shortcuts to quality and safety. You need to ensure both for every product moving out from the production line. The task sounds challenging, but these best practices can make it doable. Adopt them as a part of the manufacturing process to prevent defects and non-conformances in the long run.
