In today’s highly competitive manufacturing environment, there’s a ‘speed-to-market’ urgency that drives companies to output products faster, cheaper and still maintain the highest level of quality. The inertia behind this rush is caused by a wide range of factors. It could be due to trying to keep pace with increased consumer buying demands or attempting to not get left behind as competitors make product advancements.
Within the medical device category, combining speed to market and part quality is a constant challenge that has its rewards and risks. A 2016 article in Medical Technology Design points out that this thriving industry “exceeds $200 billion yearly and nearly 20% of all adults have received an implant of one type or another.”
While that’s good news, the bad news is, according to a recent McKinsey Report, “Non-routine quality events (such as recalls, warning letters, and lawsuits due to flawed parts) cost the medical device industry on average $2.5-$5 billion per year. Costs of a single non-routine quality event, like a major recall, have been as high as $600 million in medical device companies. In the past 10 years, there was an average of one major defective part quality event per year that resulted in a 13% stock price drop across the industry.”
So, while manufacturers released the medical devices to market in a timely manner to meet demand, it’s safe to ascertain that essential steps to ensure to prevent failure were rushed, not thorough enough, or simply not in place.
Electronic devices and the woes of particle contamination.
Similar to the medical device industry, companies manufacturing electronics, such as mobile devices, feel market pressure to constantly release new and innovative products. That’s probably why it feels like every other week there’s a new cell phone being introduced featuring a thinner profile, a camera with higher image quality, or even one that’s powered by the sun (this is actually an advancement introduced by a company out of India).
In the rush to meet ever-increasing consumer demands, the electronics industry becomes susceptible to failure. While the causes are many (such as inadequate test development) many defects are often due to contamination from unwanted particles present within the device.
Contamination as it applies to electronic devices is defined by Electroiq.com as, “Unwanted matter [such as] particles that may originate from the materials of construction or created during fabrication.”
Electroiq.com continues by surmising that particles created during manufacturing can lead to hardware failures on a mobile phone and can be “centers of chemical contamination, leading to corrosion or loss of insulation due to ionic contamination and electromigration.” The key point here to remember is that ‘particles created during fabrication’ cause ALL these problematic issues.
Electronic device failure due to particle contamination – that was a direct result of manufacturing – and the resulting recall nightmares is nothing new for companies. Case-in-point is in 2006 when Apple laptop batteries were catching fire because of what the New York Times describes as, “Contamination by metal particles inside the lithium-ion battery cells. The microscopic particles were able to bridge a porous separator between the positively and negatively charged zones of the cell and cause a short.” It not only resulted in phones imploding into flames, but a massive recall of 700,000 battery packs at an estimated cost of $258 million.
Clean room packaging: keeping unwanted particles, and failures, out of products.
J.D. Powers consumer research showed that the most critical determinant of consumer satisfaction with microelectronics is one thing: product reliability. Product reliability is exactly what Laser Light Technologies delivers. As a proven micro-manufacturer of components with critical features less than 2 microns, our success and our clients’ success hinges on delivering a product free of particle contamination.
Our focus on delivering particle-free components is evident in our on-site, clean room technology comprised of a 1,100 square foot, ISO Class 5 facility (Fed Std. 209E, Class 100 equivalent). We also maintain compliance with FDA standards by utilizing Class 100 or better laminar flow benches and ionized airflow-assisted packaging.
It’s not uncommon for people to ask the basic question of, “What is a clean room?” In the case of Laser light, our clean room is a contained space designed to reduce particulate contamination and control other environmental parameters such as temperature, humidity and pressure. A key component is the High Efficiency Particulate Air (HEPA) filters that push air down and trap micron-sized particles (and larger) that have the potential to damage a part or cause part failure when in use.
Laser Light also has best practices in place for personnel to maintain a clean manufacturing environment, including extensive training in contamination control. These skilled professionals enter and exit the cleanroom – which should be obtained via a clean room rental if one is not readily available to you – through air showers and/or gowning rooms, and they must wear special clothing designed to trap contaminants that are naturally generated by skin and the body.
Because Laser Light manufactures highly complex and sensitive parts used in everything from electronics to medical devices implanted into the human body, we maintain the highest standards to maintain cleanliness. The positive outcomes include micromachined parts free of contamination and function as designed in real world environments.