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4 Reasons Why Laser Optimization Is Essential for Medical Device Manufacturing

Factory-level optimization ensures the high-quality outcomes producers need to maintain and expand their client lists and capabilities.

July 3, 2024

By: Emily Newton

Editor-in-Chief, Revolutionized

Lasers feature throughout medical device manufacturing facilities, making it necessary for plant technicians to keep them optimized for best performance across various tasks. Why and how do these technologies improve the quality of products used in the healthcare industry?

1. Enable Effective Tracing

Medical device manufacturers must optimize their lasers to support the necessary traceability of the produced components and devices. Laser marking makes goods easier to track once they leave factories. Additionally, regulations require specific medical devices to bear identifying details.

The European Union will finalize regulations for the European database on medical devices (EUDAMED) within the next few years. It is an IT system for registering and managing medical devices and in-vitro diagnostics. The earliest phases of the new regulation require active implantable objects—such as glucose pumps and pacemakers—to include serialization and identifying marks.

Laser marking is a biocompatible method because it will not cause adverse effects in patients, and the marks last for years. One company is ahead of the EUDAMED regulation because it has numerous fiber lasers to mark implantable pacemakers.

Regardless of where medical device companies operate and which regulations apply there, decision-makers should strongly consider using lasers for better traceability. After all, federal regulations in the U.S. mandate medical device manufacturers to establish tracking mechanisms for several product categories:

Those for which failure would cause serious, adverse health effects
Those that will be inside patients’ bodies for at least one year
Those that are life-sustaining or life-supporting and used outside specific settings

The specific settings in the last bullet point are called “device user facilities” in the applicable federal regulations. That is an umbrella term for locations where people regularly use medical devices, such as hospitals, nursing homes, and outpatient care centers.

With the wider availability of patient monitoring devices used at home, relying on devices elsewhere has become much more common. These products can alert providers to abnormalities and may identify disease markers. Adding identifying marks before they leave factories supports patient safety and trust.

2. Support Better Productivity

Manufacturers use lasers in numerous purposeful ways to save time and provide precise outcomes. For example, lasers can handle tiny-scale welding tasks to join parts of endoscopic devices or surgical instruments. They also use them to shape products ranging from needles to meshes.

Users may not think about the impact of lasers on these goods. Still, they would likely notice differences in their work and quality of life without these laser-based processing steps that make the products highly functional and reliable.

Additionally, laser cutting and micromachining can handle specific processing or finishing steps, and they work with thicker metals, such as those used for surgical saws. Specialized laser cutters can also uphold medical device tolerances to the millimeter scale, aligning with quality control requirements.

Laser cutting generates heat, and areas that get excessively warm may need polishing or other post-processing steps before the item leaves the factory. Lasers assist with these requirements, and manufacturers optimize different types depending on whether the item features metals, polymers or organic materials.

These options reduce production time frames, increasing factory output and keeping companies competitive in a challenging industry. Forward-thinking researchers have also determined new ways to unlock lasers’ benefits for productivity.

A professional team from Heriot Watt University developed a laser-based approach to accelerate the manufacturing of medical devices containing tiny lenses, prisms, and mirrors. Production time frames used to span days and now comprise minutes with this option.

Once manufacturers confirm which production steps require lasers, they can investigate ways to optimize those processes, if necessary. That is a practical way to ensure producers harness all available productivity opportunities.

3. Maintain Safe Manufacturing Conditions

Successful medical device manufacturing revolves around upholding tight safety standards. Many processes occur in clean rooms, and high-functioning air filtration systems are some of the most critical aspects of these controlled environments. Assessors from third-party certification companies also inspect a company’s manufacturing environment, checking that it meets the required standards.

Stringent contamination controls support the safety of patients who will eventually use the produced medical devices. However, there is another, more immediate reason to control contaminants. Airborne particles can affect lasers’ functionality by accumulating on optical components or degrading the coatings on those parts. This is a good example of how best practices provide multiple benefits.

Additionally, industrial laser cleaning supports factory safety since it uses ablation to remove surface contaminants. This non-contact method can eliminate sub-micron particles from surfaces that are difficult to address through other options.

Moreover, because laser cleaning does not contaminate the environment, it is an excellent choice for medical device manufacturing. This technique is well-established in the pharmaceutical and food and beverage industries, which also must follow safety procedures, abide by regulations and manage contamination risks.

4. Earn Patient and Provider Trust

Laser optimization supports what happens in a production facility and how well the manufactured devices work once patients and healthcare professionals begin using them. When all relevant parties feel assured the items will work as anticipated, they will show confidence about using and recommending them.

Besides being integral to symptom maintenance and treatment, laser-powered devices assist medical professionals in making more efficient, accurate diagnoses. Researchers are also interested in how lasers support innovation by solving known problems.

A University of Birmingham group created a handheld device to diagnose traumatic brain injuries that works by shining a safe laser into a patient’s eye. The criticality of the 60 minutes following those events is well-known because it influences care decisions that impact a person’s survival and risk of long-term disabilities.

The laser light reveals molecules’ biochemical and structural characteristics, revealing known brain injury biomarkers. This diagnostic method’s portability makes it ideal for ambulance crews, sports coaches, or any other parties that may support people after head injuries.

Elsewhere, MIT researchers built a portable, laser-based ultrasound system that shows patients’ organs, muscles and other features. The invention also uses a non-contact method, making it work well for people with infectious diseases or those with highly sensitive or painful areas that practitioners must examine. The team said this device has capabilities similar to MRI and CT scans but includes automated features to save time and increase accuracy.

Research professionals will need to partner with medical device manufacturers if they want to scale these inventions. When producers can prove they have optimized their lasers and the relevant processes, those assertions create trustworthiness.

Emily Newton is the Editor-in-Chief of Revolutionized. She’s always excited to learn how the latest industry trends will improve the world. She has over five years of experience covering stories in the science and tech sectors.

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