Articles

When working with a contract manufacturer to create a component or assembly that your company will depend on, it is critically important to align on the deliverables, expectations, and timeline. A single misstep in the process or a misunderstanding of design intent can create delays or quality issues that derail a major project. How can you prevent these challenges and avoid the pitfalls? Lead with quality.

Machining in the orthopedic industry is a highly advanced process, with high-precision CNC machines, lasers, new materials, surface-finishing technologies, inspection systems, and sophisticated software. These technologies are essential for creating the orthopedic implants, devices, and instruments we depend on.

Business is on the rise among orthopedic device manufacturers, especially for joint replacements and increased funding for R&D, with many new devices in development. Additional inventory is also needed to support an increase in post-pandemic elective surgeries and the migration of these procedures to ambulatory surgical centers (ASC).

Employees represent the heart of any organization on multiple levels. Typically, employee salaries and benefits represent one of, if not the single largest, cost of any business. Yet, once employees enter the doors, companies often begin to move to the next issue on their priority list. However, successful employee engagement is a never-ending opportunity to build a stronger company.

Consider the role your employees play in the following:
● Product quality and industry knowledge
● Client satisfaction and service
● Visible external brand representation

These are all essential components that drive the differentiation between you and your competitors….

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…