ISO 9001 Archives - Means Engineering, Inc.

Medical Device Creation – Ensuring a Successful Contract Manufacturing Relationship

November 20, 2020 By cscheafer

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 cscheafer

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.

Ensuring Business Continuity During Uncertain Times

September 18, 2020 By cscheafer

Many OEMs struggle to achieve redundancy in their supply chain while keeping costs low. Unfortunately, redundancy can cost organizations a lot of time, money, and resources. Focusing on redundancy distracts teams from other important tasks, often delaying important development milestones.

Dealing with the Unexpected

Unexpected events can cause major problems for business continuity. This became apparent in recent months as the COVID-19 pandemic prevented OEMs and other businesses in the manufacturing industry from accessing the components needed to produce products and continue business as normal. In addition to pandemics, other events like fires, floods, and natural disasters can impact an organization’s ability to fulfill orders. The only way to mitigate the risks of these kinds of events is to develop a business continuity plan and partner with a contract manufacturer (CM) that offers redundant sourcing and manufacturing capabilities.

Unfortunately, many contract manufacturers have reduced or halted production during the global health emergency. This has caused major supply chain issues, impacting OEMs and numerous businesses around the world. For organizations supplying devices to the medical or defense industry, supply chain issues could mean the difference between life and death.

Outsourcing Helps Protect OEMs from Supply Chain Problems

When the unexpected occurs, organizations need a partner they can trust to help them continue business as normal. The right contract manufacturer helps organizations continue producing high quality products while making necessary repairs or moving their facility to a new location. When utilized on a regular basis, a contract manufacturer can offer assistance year round to help fulfill periods of high demand and help organizations as they grow and expand into new markets.

Outsourcing makes it possible for teams to focus on other important aspects of their business. This increases the chance of growth and success and gives businesses a competitive edge even during natural disasters and other events that impact the ability for most businesses to succeed.

U.S. Based Contract Manufacturing Services

From design to production and testing, Mean Engineering, Inc. offers a wide range of contract manufacturing services. Our team has years of experience working with a variety of industries.

In order to ensure continuous production and uninterrupted support for the companies that depend on us, Means Engineering has implemented a COVID-19 response plan. Aimed at preventing the spread of disease and keeping our staff safe, our response plan has become an important part of everything we do.

Please contact us to learn how Means Engineering can fit in your business continuity plan.

Industry Certifications – Why They’re Important

June 26, 2020 By cscheafer

You have many things to consider when choosing an electronics contract manufacturer. Although you’ll probably spend some time negotiating price and other important aspects of your contract, electronic manufacturing certifications should remain non-negotiable. These important industry certifications ensure the CM you work with meets rigorous quality expectations as required by the industries they serve. Without proper certification, the CM simply cannot guarantee quality or that the product produced meets industry-specific regulatory compliance standards.

General Certification – ISO 9001

The International Organization for Standardization (ISO) 9001 certificate shows that the contract manufacturer has implemented and maintained a quality management system. This certification is internationally accepted and proves that the CM consistently meets customer requirements and continues to strive to improve product quality.

Medical Device Industry Certification – ISO 13485

ISO 13485 is required for a CM to design and/or produce devices for the medical industry. This important certification ensures the CM has effectively implemented and maintained its quality management system. It also ensures the CM implements certain controls and protocols to ensure product safety.

I order to achieve ISO 13485 certifications, contract manufacturers must meet specific requirements for testing, inspection, and product traceability.

Aerospace Industry Certification – AS9100

Aviation Space (AS) 9100 certification encompasses all requirements for ISO 9000 as well as additional aerospace industry-specific quality and safety standards. In order to receive AS9100 certification, a CM must display an emphasis on risk management, adopt proven production processes, and pass an AS9100 audit.

Final Thoughts

When selecting a CM, it never hurts to ask to see their certification documents. CMs that have taken the time to obtain industry-specific certification are generally happy to provide this information on request. If the CM tells you otherwise, or fails to provide the appropriate documentation, it’s probably best to take your business elsewhere.

Means Engineering offers contract manufacturing services to organizations across a wide range of industries. We are proud to hold several industry-specific certifications including ISO 9001, ISO1 3485, and AS9100. Please contact us for more information about our contract manufacturing services.

Avoid These Common Mistakes When Outsourcing

June 19, 2020 By cscheafer

For organizations that produce or manufacture products, outsourcing provides numerous benefits. In addition to reducing costs and time to market, outsourcing part or all of production can significantly increase the quality of products produced. However, it’s extremely important that organizations make an informed decision when choosing to outsource.

Although most organizations see positive outcomes from outsourcing, selecting the wrong contract manufacturer can cause significant problems. This is especially true for OEMs producing electronic devices that rely on the correct assembly and testing of several complex components.

Organizations considering outsourcing will want to avoid the following common mistakes when working with a contract manufacturer:

Choosing the First CM on the List

The CM you choose can have a major impact on the quality and functionality of your finished product. It’s extremely important that OEMs take their time to interview several different CMs before selecting one to work with. OEMs might find it helpful to create a list of their needs and requirements, including any regulatory standards the finished product must comply with. These needs should be discussed in detail during the interview process.

Failing to Discuss Project Objectives

Maintaining good lines of communication ensures the success of the contract manufacturing relationship. Unfortunately, OEMs often fail to make the project objectives clear to their CM. This can lead to problems with the finished product. It’s crucial that OEMs provide clear instructions regarding project plans, specs, colors, and materials.

Not Putting Enough Trust in Their CM

Outsourcing requires a certain level of trust on the part of the OEM. In order to complete the project, OEMs must hand over project plans and blueprints. Occasionally, the CM may make recommendations to improve the quality or reduce the cost of production.

Choosing the CM With the Lowest Rates

Every business wants to reduce costs. However, choosing a CM with the lowest rates could end up costing OEMs more money in the long run. Low prices typically do not equate to high quality. If it sounds too good to be true, it probably is.

Means Engineering offers contract manufacturing services for organizations and OEMs. Our team has years of experience producing parts and components for multiple industries including medical, aerospace, and defense. Please contact us for information about our services.