On any given day, at any given hospital, there are countless surgeons providing patients with another chance at life – all thanks in part to the advances made in medical devices. These advances by manufacturers have led to producing devices that are smaller, have more precise features, require less invasive surgeries for implanting, and result in better patient outcomes.
According to the Association for the Advancement of Medical Instrumentation (AAMI), one of the most significant trends in the medical device industry in 2017 through 2020 includes innovative product development. The AAMI reports, “Medical device companies spend an average of 7% of their revenue on research and development, with many increasing their spending as a percentage of revenue. The United States will dominate medical device revenues in 2017, in part because of challenges in reimbursement and reduced growth in Europe.”
To keep pace with meeting these development needs, as well as the requirements of doctors and hospitals, companies are looking for different manufacturing technologies and solutions to rapidly take their medical devices from the design phase to manufacturability (often in mass quantities), while maintaining quality and profitability.
To meet these varied demands, many companies looking for precision manufacturing are trending away from traditional processes such as Swiss machining (automated lathes) and electrical discharge machining (where a shape is obtained by using electrical discharges), and turning instead to laser micromachining. And for a very smart reason.
A 2016 article in “Manufacturing Engineering Publication” explains that, “Breakthrough devices are continually being developed with the potential to raise the quality of treatment and produce better outcomes for patients. The challenge facing the industry, however, is developing the manufacturing techniques to allow dramatically miniaturized devices to be produced in sufficient volume and at attractive enough prices so they are available to the majority of people requiring them.”
Smaller is better; and these tiny medical devices are performing better than ever. This is due, in part, to laser manufacturing solutions that provide the precision, quality and output unmatched by many common manufacturing approaches. As “Manufacturing Engineering Publication” states, “Traditional machining techniques are reaching their practical limits, leading to a rapidly growing adoption of laser-based micro-machining tools.”
Manufacturing Engineering Publication goes on to point out that, “Laser micro-machining of metals, plastics, composites, glass, ceramics, and bioresorbable polymers supports the miniaturization trend in a number of ways, including reduced contamination and burring when cutting materials, increased strength of bonds and improved quality of secure and trackable markings.”
Design, materials, prototypes and speed to market.
One of the major hurdles manufacturers face is attempting to get a medical device to market in the fastest way possible. This is easier said than done. Roadblocks to this goal can include parts that, once at the manufacturing stage, are not performing as designed. This could be due to a material selection that can’t hold a specified tolerance or the manufacturing cost and timeframes originally estimated can’t be met without major redesigns and testing. This not only hampers any hope of meeting a desired timeframe, if a medical device can’t get out the door quickly it can actually derail other essential things, such as outside funding sources and investors.
According to Medical Product Outsourcing (MPO), “In the medical device market, especially with regulatory burdens and cost oversights, speed is everything: speed of design, speed to prototype, speed to market – another advantage lasers typically have over other machining methods [such as Swiss machining and electrical discharge machining].”
For any new medical product, the development process centers on successfully, and without delay, getting through the FDA requirements. That’s why a manufacturer that can quickly provide quality prototype parts is critical to this process. What’s more, the ability to manufacture and deliver parts within the required timeframes for life saving use in a hospital operating room is just as essential to the success of any medical device.
While speed to market for a medical device is one of the ultimate goals, there are periods during product development to take it slow and work out the details to avoid problematic issues later on at the manufacturing stage.
According to a recent article about risk mitigation in Med Device Online, “Medical device product development can go very fast – up until design verification and design validation. These stages are common points where development slows a bit. This is logical, because verification and validation (V&V) often involve a lot of formal testing activities … you want V&V to be smooth and somewhat predictable. Specifically, spend more time defining design inputs. Design inputs are the key to your success.”
The article concludes by stating, “Here’s the big secret: You should be using prototypes to help define your design inputs and, as you are creating those design inputs, you should know how you plan to verify. Furthermore, you should be using those prototypes to conduct “mini” bench tests and evaluations to help establish design verification methods.”
The Laser Light Technologies difference for your medical device.
Laser Light Technologies utilizes high-technology laser micromachining solutions to solve the most complex problems faced by our medical device clients.
We work with you through a consultative process to deliver the right solution that best meets your requirements. This is why every part or device micromanufactured at Laser Light is proven ready to succeed in the most demanding medical environments.
As a full service, laser micro manufacturing solutions provider, we achieve success by taking your design and validating part manufacturability. It’s a collaborative effort with your team and ours. It includes in-depth design consultation and prototype development that takes your medical device from idea to working prototype within our laser laboratory – all to make sure your part performs as designed.
Whether it’s metals, polymers, alloys or even proprietary material, we have solutions for laser micromachining virtually any material. Our solutions deliver precision drilling and cutting features such as holes, slots and curved patterns down to 3µm.
We even conduct a manufacturability assessment. Here we gather information on costing, timing, and feasibility data in order to advise the best path to take for ideal manufacturing outcomes. The results also allow us to recommend the right materials to use and what laser system solution (contract manufacturing or laser systems integration) is best for your desired objectives. Only then can production begin and your manufacturing objectives be achieved.
The Laser Light Difference is that we leave nothing to chance or guesswork. We put a lot of thinking, backed by 30 years of experience, into every medical device for a very important reason: it provides the lifesaving chance every patient deserves. That’s exactly what we deliver at Laser Light Technologies.