ISO 13485 Archives - Means Engineering, Inc.

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.

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.

Please contact us for information about our contract manufacturing services.

Ensuring Business Continuity During Uncertain Times

September 18, 2020 By meiadmin

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.

The Importance of ISO 13485 Certification

August 28, 2020 By meiadmin

Organizations responsible for the design and production of medical devices need to understand the strict standards and requirements of government officials. Used for a wide range of applications, medical devices may mean the difference between life and death for those that rely on them. In the United States, medical devices are regulated by the FDA and organizations must receive ISO 13485 certification prior to their design or assembly.

About ISO 13485

ISO 13485:2016 aligns with ISO 9001:2008. It’s important to note that this version of ISO 9001 does not include the same Annex L of the 2015 version. ISO 13485 includes several safety requirements to ensure the quality and reliability of devices created for the medical industry.

Although several countries have their own set of regulations regarding medical device design and creation, ISO 13485 is the main Quality Management System (QMS) standard for medical devices. While organizations in the United States must meet both ISO 13485 and FDA requirements, the FDA plans to eventually harmonize the two.

Despite what many people believe, ISO 13485 is aimed at ensuring high quality products. It is not a standard for products. Instead, ISO 13485 is a process based standard. When followed, these processes ensure a quality end product.

Organizations or businesses receive ISO certification. Individual people cannot become certified in ISO 13485. However, one person in an organization can receive certification as an ISO 13485 Certified Lead Auditor.

Becoming ISO 13485 Certified

Organizations wishing to become ISO 13485 certified must meet strict requirements. This is necessary to ensure the organization fully understands the processes required to create high quality medical devices. Organizations must take all necessary steps to implement an ISO 13485 quality management system. They must then undergo an audit by a Certification Body (CB). If the organization passes the audit, they receive ISO 13485 certification for three years. They must get re-certified after the initial three-year period.

ISO Certified Medical Device Manufacturer

Means Engineering has the people, equipment, and technology needed to produce high quality medical devices. In addition to ensuring the proper practices and standards within our organization, we have taken the steps necessary to become ISO 13485 certified. This puts us in the best possible position to help with the design and production of a wide range of products.

When you work with Means Engineering, you gain access to the knowledge and experience of our highly qualified team. We work directly with our clients to ensure adequate communication throughout the entire process. Please contact us to learn more about our contract manufacturing services for the medical industry.