medical devices Archives - Page 2 of 3 - Means Engineering, Inc.

Choosing an Electronic Contract Manufacturer for Medical Device Creation

July 31, 2020 By meiadmin

Creating devices for the medical industry requires extensive experience and knowledge of industry requirements. Medical devices are highly regulated for both quality and reliability. This is important, as many people rely on the safety and efficiency of medical devices. Perhaps more than any other industry, OEMs planning to produce products for the medical industry should partner with an experienced electronic contract manufacturer.

In addition to understanding how to comply with government regulations, an experienced ECM should meet the following requirements. This can help ensure a successful and mutually beneficial partnership.

Experienced Technical and Managerial Team

The more experienced the electronic contract manufacturer is, the more likely they can help when problems arise. ECMs with experience producing a wide range of devices can often locate problems and suggest viable solutions based on findings from previous projects. In addition to solving problems that arise during production, experienced ECMs can assist with design-for-manufacture review, saving OEMs a considerable amount of time and money on assembly.

Well Maintained Equipment

It’s not enough for an ECM to have quality equipment. They need to properly maintain it to ensure continuous and reliable operation. Calibration of machines and tools should take place at regular intervals.

Proper maintenance not only helps ensure on-time delivery of high quality products, it also allows the ECM to achieve the right tolerance. This is especially important as the medical device industry has stringent tolerance requirements.

Ability to Adjust to Meet Customer Changes

Needs and requirements can change. This is why it’s so important that OEMs select an agile, flexible, and highly responsive ECM to work with.

ISO 13485 Quality Management System

The international standard for a quality management system for the medical device industry, ISO 13485 is designed to be used throughout the entire lifecycle of the medical device. Using ISO 13485, organizations can develop a quality management system that ensures the quality of finished products and the effectiveness of manufacturing processes.

Means Engineering offers electronic manufacturing services for the medical device industry. Our extensive experience and quality management system allows our team to manage risk effectively and bring safe and effective products to market.

Getting Ahead of Component Shortages

June 12, 2020 By meiadmin

Recent events have put much of the world on hold. This includes many of the manufacturers of the components used to create a number of electronic devices and widgets. While many manufacturers have returned to business as normal, component shortages could still pose a problem as everyone scrambles to catch up. It’s important that OEMs learn how to deal with potential shortages both now and in the future.

Component shortages occur for several reasons. Before taking any steps to remedy issues with the component supply chain, organizations must first understand the factors responsible for the current shortage. OEMs can then make an informed decision about how to best handle the situation.

Purchase Components in Advance

Organizations need to make sure they have sufficient cash flow to pay for components in advance. Some components have lead times up to fifty weeks. Purchasing in advance can save organizations a lot of trouble on future projects.

Utilize Trusted Partners

Today’s markets change rapidly. Many manufacturers have begun prioritizing larger customers. It’s important to make sure your organization has the resources to fulfill large orders, especially during periods of high demand.

Understand Potential Lead Times

Certain components may have lead times up to fifty weeks. This can cause delays when bringing products to market. It’s important that OEMs learn as much as they can about potential lead times so they can better understand the types of delays they may face in the future. Armed with the right information, OEMs can provide the best options to their customers.

Transparency during the production process is important to the overall success of any project. A quality CM provides clear answers about component delays and the reasons behind them.

Forecast Component Needs

Creating a forecast of component needs ensures everyone has a clear understanding of the project requirements. This keeps everyone on the same page and ensures the CM knows what is expected and when.

Southern California CM

Means Engineering offers contract manufacturing services to OEMs and other organizations looking to increase quality and reduce time to market. Our team has years of experience and understands what works and what doesn’t when it comes to electronic component design. Please contact us for more information about our services.

Importance of Testing New Products

January 4, 2019 By meiadmin

Product testing is important for a number of reasons. Testing allows an organization to ensure the quality of new products before they go to market. It also helps locate areas that could benefit from improvement. Fixing these issues before products hit the shelf helps prevent possible loss of customers and reputation.

Types of Testing

There are several different types of testing including quality assurance, product reliability testing, and lifecycle testing. Testing typically takes place during the manufacturing phases of product development and is often focused on consumer expectations.

Products for certain industries must meet strict requirements such as products created for the medical, defense, and aerospace industries. Components in these devices must meet a much higher standard than those used in other products.

Some products require Premarket Approval (PMA) testing before being passed on to consumers. This is true for medical devices that support or sustain human life. The proper operation and quality of these devices is crucial to the prevention of illness or injury.

Outsourcing

Organizations often attempt to handle product testing in-house. Unfortunately, this can cost a considerable amount of money. In order to maintain a testing lab, organizations must acquire the appropriate space, equipment, labor, and certificates.

Organizations can benefit from outsourcing testing to a qualified contract manufacturer. A contract manufacturer assists with all parts of production, from design to testing.

Qualified Contract Manufacturer

Means Engineering provides contract manufacturing services for organizations across a wide range of industries. We provide assistance with design, production, and testing of products. Our team has years of experience and understands the unique needs of businesses creating products for industries with complex requirements.

We provide all types of testing including quality assurance, product reliability testing, and lifecycle testing. We our AS 9100 and ISO 9001 certified. This helps us ensure the quality and consistency of every product produced.

Means Engineering tests product functionality off the line. We use predetermined factors to determine the level of testing and scores each product receives. When necessary, we test individual parts as well as finished products to ensure optimal operation and functionality.

Improving Customer Satisfaction

November 23, 2018 By meiadmin

Businesses today have extremely high expectations when it comes to new products. They want more features and options than ever before. It can be difficult to keep up with demand and expectations.

It’s important that organizations consider the way their products are received. After all, your customer’s satisfaction in your products helps determine the amount of future sales, referrals, and repeat business. This is especially true for companies creating products for the aerospace, defense, and medical industries. These products must meet a number of strict requirements and expectations for quality and operation.

Quality

Quality is one of the top things that businesses consider when choosing a company to work with. New products must be extremely high quality and durable. Products created for demanding industries must withstand extreme conditions without malfunction or failure. It’s crucial that your company fully tests all products and components prior to passing them on to your customer.

Price

Although price isn’t always a determining factor, it definitely plays a part in the selection of products and devices. Organizations and Government agencies are often on tight budgets. Meeting requirements for price and quality can be challenging.

Delivery Time

In addition to budget, businesses and Government agencies must meet deadlines. If your organization promises to provide a specific product by a specific date, you need to deliver. Failure to meet your predicted deadline can lead to loss of reputation and loss of business. This can significantly affect your bottom line.

Why Use a Contract Manufacturer?

A contract manufacturer can help you improve the quality of your finished products. At Mean Engineering, our team of professionals will look over your design plans to locate areas that could benefit from improvement. This allows us to find ways to improve quality, reduce the cost of production, and reduce the time it takes to deliver your product.

Our team has years of experience working with a number of industries. We have worked with several demanding industries including aerospace, defense, and medical. Our team understands the unique challenges that come with meeting strict requirements for quality and operation. We fully test all products and components throughout production. This allows us to ensure a high quality finished product.

Contract Manufacturing for the Medical Industry

August 3, 2018 By meiadmin

The medical industry is one of the largest and fastest growing industries in the world. Every year, Americans spend billions of dollars on healthcare. Much of this money is spent on medical devices. These devices are crucial to the diagnosis, treatment, and management of a wide range of conditions and ailments.

The U.S. spends more on healthcare than any other country in the world. In fact, American consumers and healthcare professionals spent approximately $156 billion on medical devices last year. This represents an astounding 40% of the global medical device market.

Meeting Strict Requirements

As demand grows and the market expands, more and more manufacturers are looking to bring their products to market. However, creating medical devices takes a vast knowledge of the industry and its specific requirements.

Companies creating medical devices must follow strict rules and regulations. These regulations are in place to ensure the safety, quality, and accuracy of products produced. Regulations are constantly changing, and manufacturers must keep up to date with these changes in order to remain compliant.

Quality is extremely important when it comes to medical devices. Any issue that could affect performance must be identified and addressed long before it is able to cause a problem. This is why testing throughout production is so important.

Using a Contract Manufacturer

Many companies do not have the people, equipment, or technology needed to produce high quality medical devices. These companies often turn to a qualified contract manufacturer for help. A contract manufacturer produces products under the name or brand of the company that hires them.

Means Engineering Inc. has extensive experience producing products for the medical industry. We have the staff and equipment needed to produce a wide array of high quality medical devices. We provide a variety of services including design, manufacturing, and testing. We work directly with your company to ensure that medical devices are created at the lowest cost and highest quality possible.

Means Engineering is an ISO 13485 certified company. Being ISO 13485 certified ensures design and manufacturing requirements are being met with a standard approach. This helps minimize risk, reduce costs, and ensure the quality and consistency of every product produced.