The medical device industry represents huge opportunities – especially in the United States. The U.S. alone does a trade of $140 billion in medical devices, about 40% of the worldwide total.
The problem: Regulatory requirements for medical device machining present unique pitfalls.
It’s no surprise that the medical device industry practically stands alone in terms of complexity of its regulatory landscape. Patients turn to medical devices during challenging times in life and deserve the assurance they are getting the highest quality.
However, that raises the question how innovative enterprises – especially smaller ones – can overcome this barrier to entry while delivering the excellence the public expects.
For many companies, automation is one answer to the challenges of medical device machining.
Automation Standardizes Quality Management in Medical Device Machining
Most medical device concerns spend a great deal of time, money, and energy managing their manufacturing operations. A single oversight can prove disastrous.
At the same time, manufacturers need to relentlessly pursue continuous improvement to drive down costs and ramp up throughput.
Across the world, top experts in manufacturing have worked hard to produce effective international standards for medical devices. These complex standards must be executed correctly every single time. Automation accelerates and streamlines that process.
Fully-automated systems can help even small, experimental companies fulfill their goals. Full compliance and excellent quality don’t have to be in conflict with the desire for a lean and cost-effective operation.
ISO Standards are Essential for Automated Medical Device Machining that Works
Automation systems and fixtures must be developed with the needs of the medical device industry in mind. Ideally, this means working with enterprises familiar with globally-recognized manufacturing quality standards.
The International Organization for Standardization (ISO) is the main developer of those standards. In particular, ISO 9001:2015 is a quality management certification leading manufacturing enterprises can aspire to. ISO 13485 is also pertinent for medical device machining in particular.
To foster customer confidence and regulator trust, automation with an ISO-compliant perspective is crucial. It means you can deliver on the highest standards without constantly reinventing the wheel.
To find out more, contact Nexus Automation.