Staying ahead of the competition as a medical device manufacturer

The world of medical device manufacturing has undergone tremendous change over the last decade. A number of factors have contributed to these changes.

 

Increase in complexity and precision of modern-day devices

As device companies innovate and look to continuously improve healthcare outcomes for patients, the complexity of modern-day medical devices is also increasing. There is often a need:

• For intricate part cutting to create high precision micron-sized features with tight tolerances.
• To cut through various metallic and non-metallic raw materials.
• To improve bond strength between plastic and metal surfaces on a component or assembly.

 

Need for faster product launches to maintain competitive edge

As global competition increases, medical device companies are looking to innovate faster to maintain their competitive edge. In a KPMG study conducted:

• 55% of medical device respondents categorized their strategic focus as Engineering/Innovation led.
• 42% of medical device respondents mentioned intense competition and pricing pressure as their biggest challenges.

So, even though product complexity is increasing, device manufacturers are looking for faster product launches to maintain a competitive edge.

 

Increasing quality and traceability standards

While product complexity is increasing, the bar is being continuously pushed up on quality and traceability as patient safety is of utmost importance. Medical device quality system requirements as defined by US FDA’s 21 CFR 820 and ISO 13485 have very stringent requirements that device companies have to adhere to. With devices getting smaller, advanced technologies are needed to meet traceability requirements.

 

Pricing Pressure

As the United States moves to a value-based healthcare system, there is increased pricing pressure on medical device companies. Reimbursements are decreasing as more procedures move to Ambulatory Surgery Centers. For example, outpatient orthopedic procedures at ASC’s cost around 40% less on an average than in a hospital setting. Lower reimbursements in turn increase the pricing pressure on medical device manufacturers.

 

Maintaining a competitive edge in today’s challenging environment

So, how can medical device firms manage this changing landscape seamlessly? Leveraging a contract manufacturer with advanced laser capabilities allows modern device manufacturers navigate some of the challenges that they are facing.

State-of-the-art laser capabilities can help:

• Launch products faster with faster lead-times by eliminating additional finishing steps.
• Repeatedly produce high quality precision machined parts with the ability to hold submicron tolerances.
• Cut cut through a variety of biocompatible materials.
• Improve bond strength on metal to plastic bonds when required.
• Improve product identification and traceability by creating corrosion and sterilization resistant marking.

 

Pulse Technologies, your one-stop shop for everything laser

At Pulse Technologies, we provide a one-stop shop solution for all laser needs of a medical device company. With expertise(s) in Laser Machining, Laser Texturing, Laser Etching and Laser Welding, we are a partner of choice for several medical firms as they look to launch high quality products faster.

Laser Machining
Laser machining has become increasingly popular as the next generation medical devices are getting smaller with more complex geometries and tight tolerances. Laser machining can help companies meet these design requirements cost effectively. For example, laser Machining is being used extensively in the world of Cardiac Rhythm Management space (pacemakers and ICD devices).

Our depth of expertise in laser machining allows us to:

• Seamlessly meet highly customized requirements of the medical device industry.
• Perform high precision cuts and features with very tight tolerances on a wide variety of materials (metallic and non-metallic).
• Run processes involving both pulse and continuous wave operations.
• Utilize these processes on either piece or continuous feed configurations
• Offer a kerf width of 40-microns.

 

Laser Texturing
Laser texturing is used to create controlled surface roughness for improved bonding strength, particularly for bonding between plastic and metal surfaces of a component or assembly. This is achieved by using CNC controlled lasers to texture a surface for bonding. Our proprietary process around laser texturing :

• Can increase bond strength by 3X on metal to polymer bonds.
• Helps medical device companies improve component quality and reduce costs.
• Has been successfully used in several in cardio and vascular devices.

 

Laser Etching
Traceability of medical devices is a critical quality requirement. However, in today’s age as device designs become more complex, marking devices for traceability and identification needs also becomes more complex. Complexity is due to devices getting smaller, more precise and using a wider range of biocompatible materials. Any marking done on devices for traceability needs to also be sterilization and corrosion resistant.
Our in-house laser etching capabilities allow medical device companies to:

• Seamlessly meet traceability requirements across a wide range of plastics, rubbers and metal.
• Engrave both vector and greyscale markings.

 

Laser Welding
At Pulse Technolgies, we have developed advanced capabilities around laser welding that differentiates us from other manufacturers. Our in-depth expertise allows us to:

• Have a wide range of in-house equipment such as Spot and CNC welders.
• Tackle multiple use cases and weld most alloys.
• Control critical parameters like weld overlap.
• Weld similar and dissimilar metals.

Pulse Laser Capabilities – Sample Use Cases in Device Manufacturing

We have been a trusted partner for several medical device firms to help them launch complex, high-quality products faster and more cost effectively. Below are some sample use cases where medical device firms leveraged our laser capabilities:

Orthopedic implants and instruments

• Improved product identification and traceability via laser etching on knee and hip implant systems for an Orthopedic implant company. Etching required adding a CE mark and product family identifier on a complex design.
• Laser welded a tight tolerance assembly for a product used for hand tendon repair.

Cardiovascular devices

• Increased the life-time of an acute cardiac device. We applied our CNC-controlled proprietary laser texturing process to increase the bond strength between a polymer cannula and a metallic subcomponent.
• Laser cut complex features on a minimally invasive heart pump product for a cardiac device manufacturer
• For electrophysiology mapping catheter applications, we retextured the surface for increased electrochemical performance.

Cochlear implants

• Electrochemical performance enhancements to improve device functionality for a cochlear implants company. Our patented Hierarchical Surface Restructuring (HSRTM) technology was used to significantly improve electrode performance. Providing smaller electrodes with enhanced electrochemical performance, durability, selectivity and resolution has numerous benefits as seen with HSRTM.

Neuromodulation devices

• Improving electrochemical performance applications for better device performance and selectivity for a neuromodulation device. Our patented Hierarchical Surface Restructuring HSRTM used ultra-short pulse lasers to increase surface roughness and electrochemical surface area to achieve desired objectives.

 

At Pulse Technologies, we offer:

• 25+ years of medical device manufacturing experience.
• Industry-leading in-house metrology and testing capabilities
• 70,000 sq.ft facility.
• 100+ CNC machine tools.
• Data conveniently formatted for DHFs/DHRs, and much more.

Want to learn more? Get in touch: sales@pulsetechnologies.com.