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Medical Device Creation – Ensuring a Successful Contract Manufacturing Relationship

November 20, 2020 By meiadmin

Contract manufacturing enables organizations to produce products without the large expense of machinery and technology or the operating costs associated with manufacturing. While contract manufacturing offers numerous benefits to companies across a wide range of industries, there are significant benefits for the medical equipment and device segment.

Strict requirements and the need for machinery capable of creating precision-dependent products often creates a barrier for organizations wishing to enter the medical device industry. These same factors cause many OEMs to leave the market as well. Organizations could benefit from utilizing the help of an experienced medical device contract manufacturer.

Hiring a contract manufacturer allows OEMs to spend less capital, hire fewer employees, spend less time and effort on quality control, and eliminate purchasing hassles. The contract manufacturer handles procurement, production, and testing, allowing the OEM to focus on other important aspects of their business.

Organizations wishing to hire a contract manufacturer should consider it as they would any other long-term business relationship. Before selecting a CM, it’s important to gather as much information as possible.

Selecting a Contract Manufacturer

OEMs should take care to ensure they fully understand the capabilities, strengths, weaknesses, and experience of the contract manufacturer they choose. It’s highly suggested that OEMs develop a list of questions prior to contacting and interviewing each CM. It might also be beneficial for the OEM to contact some of the CM’s customers for feedback.

Process Development

After selecting a contract manufacturer, the development process begins. If this is an existing product being transferred from the OEM, all existing work instructions and raw material sources get shared with the CM at this point. During a series of “knowledge transfer” meetings, the OEM and their staff provide as much information as possible about the manufacturing process. These meetings shouldn’t just include engineers and operators, assembly workers with experience creating the part should be involved as well.

For new products, the contract manufacturer will need to develop the manufacturing process and supply chain. However, it’s still important for the OEM to provide input and knowledge as necessary.

Training & Process Qualification

Once the process is defined, operator training and qualifications begin. Regardless of the type of product, there are standards and optimum processes to adhere to. This is especially true when producing medical devices. These devices face some of the strictest quality standards.

Pilot Builds

The pilot build allows OEMs and contract manufacturers to locate areas that could benefit from improvement. This is the stage when the OEM or CM makes adjustments to the work flows and/or the work instructions.

Entering the Production Phase

Following the pilot build, the CM begins production of the product. It’s crucial that OEMs provide an accurate demand forecast at this point. This helps the CM determine raw material procurement schedules and reorder points.

Means Engineering provides contract manufacturing services for the medical device industry. Please contact us for details.

How Start-Ups & Entrepreneurs Utilize Contract Manufacturing

November 13, 2020 By meiadmin

Entrepreneurs face many challenges when starting a business. In addition to figuring out how to properly market and brand their business, they must also determine how to bring new products to market. Obtaining office space and hiring and training marketing personnel and office management takes up a significant portion of a start-up’s budget, leaving very little to produce prototypes. Unfortunately, it’s not likely that a start-up will receive funding without a tangible product that investors can see and touch.

Outsourcing makes it possible for entrepreneurs and start-ups to produce products without acquiring additional space, equipment, machinery, or people. Utilizing a contract manufacturer not only saves money, it eliminates many of the issues commonly faced by new businesses.

Creating High Quality Products

No one wants to purchase an inferior product. Manufacturers must ensure the quality and consistency of every product produced.

Contract manufacturers often have years of experience. They provide a second set of eyes for design plans. When utilized during the design phase, contract manufacturers help spot areas that could benefit from improvement. This helps avoid costly repairs and recalls, saving the organization time and money and helping ensure customer satisfaction.

Ensuring Compliance with Industry Regulations

It’s important that manufacturers remain compliant with the safety and environmental regulations of their industry. Experienced contract manufacturers, like Means Engineering, carry multiple industry certifications to ensure compliance with internationally recognized standards for both safety and quality.

Choosing a Contract Manufacturer

When selecting a contract manufacturer to work with, it’s important to locate an established organization with experience working with multiple industries. Even if the organization does not plan to move into new markets, knowing this option is available can make a big difference if anything changes in the future.

For organizations that plan to obtain their own manufacturing equipment, building a good relationship with a contract manufacturer ensures the continuous flow of products. Contract manufacturers often help businesses fulfill orders during periods of high demand.

Means Engineering provides comprehensive contract manufacturing services for businesses across a wide range of industries. Please contact us for more information about our services.

Choosing the Right Contract Manufacturer for Your Needs

November 6, 2020 By meiadmin

While several options exist, companies often wonder where to start when looking for a contract manufacturer. Making the choice to outsource is an extremely important decision. It’s crucial that organizations take the time necessary to interview several companies.

Businesses can evaluate potential partners using the following criteria.

Attitude

Above all else, it’s important to select a contract manufacturer that will go the extra mile to make sure your product launch is a success. Look for a CM that offers flexibility. Make sure the contract manufacturer is able and willing to change direction when the project requires it.

NPI Process

It’s extremely important that the contract manufacturer you choose has the experience, infrastructure, and NPI processes in place to ensure a smooth transition from prototype to volume manufacturing. During your interview, ask about their New Product Introduction (NPI) process.

Technical Expertise

When selecting a CM, it’s important to ensure they have the technical experience and skills needed to complete your project. It’s not unreasonable to ask to view examples of past projects the CM has completed with similar technical requirements.

Size

A lot of companies mistakenly believe that bigger equals better. This isn’t always the case, especially when it comes to contract manufacturing. Partnering with a large CM when you’re a small to medium-sized business could lead to problems down the line. Small to mid-size companies often feel they don’t get the attention they deserve from larger contract manufacturers. Alternatively, partnering with a very small CM could lead to problems if your needs are bigger than their facility and/or people can handle.

Location

Working with a CM that’s located in your general area makes communication and validation much easier. Meetings and project updates can take place face to face as opposed to over the phone. This increases visibility and confidence as you move into production.

Quality

Quick production time means nothing if the finished product doesn’t meet the quality standards of your organization and your customers. It’s important to look for a contract manufacturer with skilled staff and QMS certifications including ISO 9001 and AS9100.

Organizations looking to outsource part or all of their production should look for a contract manufacturer that meets all of the criteria mentioned above. Although your organization may have other requirements as well, these six areas can have a major impact on the overall success of your project.

Please contact us for information about our contract manufacturing services.

Contract Manufacturing for the Military

October 30, 2020 By meiadmin

Across the nation, contractors are seeing increasing demand for electronic devices in almost every industry. Used for numerous applications in the defense industry, the rapid expansion of high-tech military equipment and components has created high demand for electronics manufacturing.

With increasing demand, the country’s prime defense contractors often find they cannot handle the large volume of orders. These contractors turn to electronic contract manufacturers for help.

Outsourcing Allows Prime Contractors to Fulfill Large Orders

Contract manufacturers, like Means Engineering, provide a variety of turnkey manufacturing services. Outsourcing enables organizations to fulfill periods of high demand and provides access to experienced professionals and state-of-the-art equipment and technology. Utilizing the assistance of a qualified contract manufacturer saves a considerable amount of time and money over in-house production.

Military Electronics Manufacturing

Contract manufacturing of military electronics looks a lot different than contract manufacturing for other industries. Instead of producing complete products, contractors enlist the help of contract manufacturers for the production of unique components. Other services commonly outsourced include design, prototyping, assembly, fabrication, tooling, qualification testing, and procurement.

Manufacturers responsible for the creation of devices for the military must meet strict requirements for both quality and consistency. Military electronics are used for a variety of mission critical operations. When outsourcing, it’s crucial to locate an electronics manufacturer with the proper equipment, people, skills, and technology to ensure products meet exact specifications. It’s also important to ensure the contract manufacturer carries ISO 9001 certification. This certification proves the manufacturer has taken the time and effort to develop and maintain a quality management system.

Although contract manufacturers may use a number of different tools to produce components for the defense industry, contract manufacturers that utilize a 5-axis machine achieve better results. Unlike 2-3 axis machines, 5-axis machines rotate on 5 axes, enabling the creation of complex parts and components. 5-axis machining allows for tight tolerances. For orders of 10 to 10,000 pieces, these machines ensure the consistency of every piece produced.

U.S. Based Contract Manufacturer

Means Engineering provides a wide range of contract manufacturing services for the defense industry. In addition to production of complex parts and components, our experienced team has years of experience providing design, CNC machining, and testing of military electronics. Please contact us to learn more about our contract manufacturing services for the defense industry.

Outsourcing Allows OEMs to Expand Into New Markets

October 23, 2020 By meiadmin

Companies looking to expand into new markets often face difficult decisions. While most of these organizations understand the benefits of expansion and the potential for increased revenue, many simply aren’t sure how to acquire the equipment, space, and people needed to grow their business. This is especially true for OEMs and other organizations looking to produce parts or products for the medical, defense, or aerospace industries. These industries have strict requirements, and organizations must prove that they have the equipment and skills needed to meet tight tolerances and produce extremely complex devices.

Unfortunately, many organizations avoid expansion or turn down jobs because they do not have the resources needed to complete the work. This can lead to significant loss for the company. In addition to potential loss of revenue, organizations that do not expand will likely fall behind their competition in coming years. This could prove to be especially damaging now, as the world attempts to rebuild the economy. Organizations everywhere will soon be looking for ways to increase earning potential and stability. Expansion into important and essential industries like medical and defense ensures OEMs remain successful even during times of economic downturn.

Outsourcing Reduces Cost and Time to Market

Organizations wishing to expand could benefit from outsourcing part or all of their production to a qualified contract manufacturer like Means Engineering. Outsourcing provides access to experienced individuals, quality equipment and machinery, and state-of-the-art technology at a fraction of the cost of in-house production. Contract manufacturers often have years of experience working with a wide range of industries.

Carlsbad Contract Manufacturing

When you work with Means Engineering, we work directly with your organization to ensure a successful and mutually beneficial relationship. Our team has experience creating complex devices for the medical and defense industries. As an ISO 9001 and ISO 13485 certified contract manufacturer, we understand the unique requirements of these industries and work hard to ensure the quality and consistency of every part produced. Our 5-axis machine allows us to produce extremely complex parts and products.

At Means Engineering, we understand the challenges OEMs face when expanding into new markets. Our team can help you clear this hurdle and ensure the continued success of your company.