Lowell regularly contributes to and is sought out for inclusion in industry articles about medical device manufacturing. Find the latest news and information below.
As an OEM, your goals include:
● Getting in market quickly
● Constant quality
● Reasonable cost and value
● No surprises
Without an industry standard, OEMs often depend heavily on the guidance of their manufacturing partner. With a wide range of approaches, customers may feel that they have to choose between cost and effectively managing risk.
With a less comprehensive inspection process, are you creating an inherent risk of variation or failure?
A more involved process such as complete 100 percent inspection adds time which can impact the bottom line….
The idea of reducing inspection costs is a face-off between two different priorities.
Priority one is budget. OEMs look for ways to reduce production costs where possible, and inspection is a seemingly good area because it can be significant portion of a production budget…
Manually dimensioning drawings can be a better option when working with a contract manufacturer.
Timelines are a top concern in orthopedic device contract manufacturing for both the company making the product and the OEM seeking to avoid time-to-market delays…
Lessons learned in robot-tending coordinate measuring machines (CMMs) translate well to a self-correcting multi-tasking machining process.
Stocked with an array of multi-spindle, multi-axis and otherwise multifunctional metalcutting equipment, Lowell Inc. is worth a visit for anyone interested in machining medical devices…
Shifting to automated data analysis for process qualification activities can improve the effort for manufacturers and their customers in several ways.
Lowell’s manufacturing team needed to start making a customer’s part on a new machine. The newer mill/turn machine was automated and would save a lot of machining time versus the original milling machine, but it required reprogramming the part.
First article inspection (FAI) is a necessary step to ensure a manufacturing process will create a medical device that works as designed and meets requirements. It is a near-to-100-percent inspection of the first part that comes off a machine. The data and measurements gathered from FAI become part of the medical device file, which is required for FDA submissions and ISO 13485.
The FAI also builds confidence in the manufacturing process. Once it is submitted and approved, it’s assumed the same process will be in place for every part produced after that.
From a contract manufacturer’s perspective, a smooth FAI is important to its OEM customer’s satisfaction…
Medical industry technologies are evolving to serve more surgical and patient needs. People are living longer, with higher expectations for staying active as they age. Surgeons want better devices, instruments, and tools to help them achieve these goals—which in most cases requires state-of-the-art manufacturing and tight-tolerance machining.
Machining continues to advance to meet the challenges of making smaller and more complex devices, sometimes from newer, harder-to-machine materials…
As product development shifts from engineering to production, manufacturers take the lead on delivering parts that meet the engineer’s design intent and are on time and budget.
While not always visible to the customer, one way manufacturers can meet these expectations is through automated machining processes. Automation opens new ways to create a more consistent part at the point of manufacturing…
Profile tolerancing offers an array of benefits for device inspection over the more commonly used linear plus/minus dimensioning.
In this competitive environment where speed to market is vital, the design and prototyping phase of any project carries more importance than ever before. Companies that can collaboratively work with suppliers from the onset and communicate throughout the project will have a better chance of being successful.
We spoke with five suppliers with expertise in design and development to get their perspective on design and prototyping in the orthopedic industry…