Electronic Devices Archives - Page 2 of 15

Recent Changes to IEC 60601-1 Impact Medical Device Manufacturers

December 4, 2020 By meiadmin

When creating devices for the medical industry, it’s crucial that manufacturers take care to ensure the quality, consistency, and reliability of every part produced. This isn’t just important for consumer satisfaction, it’s crucial for the health and safety of those that use these important devices.

Medical devices are regulated by the Food and Drug Administration (FDA). In order to prove compliance, medical device manufacturers must meet the standards for the safety and essential performance of medical electrical equipment.

The internationally recognized standard, IEC 60601, was first published in 1977. Since that time, the standard has been updated and restructured several times. The most recent update to IEC 60601-1 was published earlier this year and includes several changes and clarifications. It’s important that medical device manufacturers learn and understand these changes to ensure compliance.

The most recent amendment, A2:2019, will mark the standard for medical devices for the next few years. The next change is not expected until 2024.

Important Changes to IEC 60601-1

While some of the changes to IEC 60601-1 seem minor, they could result in previously certified devices not meeting the new requirements for compliance. It’s crucial that medical device manufacturers take some time to make themselves familiar with A2:2019.

IEC 60601-1 A2:2019, also known as Version 3.2, includes 78 changes. The most important changes are listed below.

IEC 60601-1 A2:2019 updates out-of-date references to ISO 14971 and IEC 62304
Amendment 2 includes important changes that align IEC 60950-1: A2 and IEC 62368-1 in regards to safety requirements for audio/video, information, and communications technology
A2:2019 includes error rectification and clarifications
The Amendment includes changes affecting the design and layout of medical devices
The Amendment also includes changes to standards for labelling, electrical hazards, mechanical hazards, thermal hazards, hazardous situations and fault conditions, and ME systems.

It’s important to note that these changes apply to both manufacturers and those responsible for testing medical devices and medical device components. Testers can only accept components that comply with IEC 60950-1 until December 20^th, 2020. After this date, in stock medical devices and components can no longer be used.

Medical Device Contract Manufacturing Services

Working with an experienced contract manufacturer can help ensure compliance with FDA requirements. An experienced CM has the tools, experience, and technology needed to keep up with changing regulations.

Means Engineering offers contract manufacturing services to OEMs and organizations in the medical industry. Please contact us for information about our services.

Grow Your Business with Contract Manufacturing Services

November 27, 2020 By meiadmin

Businesses today face tough competition. In addition to keeping up with technological advancements and improvements, businesses must bring new products to market faster. Organizations wishing to remain competitive need to continuously locate ways to reduce costs and production time. Businesses often find this extremely difficult, especially during periods of economic downturn.

Outsourcing enables businesses to produce products faster and at a lower price than possible with in-house production. Utilizing the help of an experienced contract manufacturer provides access to the people, equipment, and technology needed to produce a wide range of products. These individuals often have years of experience and know how to produce high quality products quickly and efficiently.

What is Contract Manufacturing?

Contract manufacturing is a form of outsourcing between a manufacturing firm and a hiring company. The hiring company contracts with the manufacturing firm to produce parts and/or complete products. Depending on the needs of the hiring company, contract manufacturers might handle many different parts of product development and production including:

Product Design
Prototyping
CNC Machining
Tooling
Production

Benefits of Contract Manufacturing

In addition to improved quality and reduced time to market, contract manufacturing services eliminate many of the costs associated with in-house production. Hiring a CM reduces the amount of capital spent on the maintenance and operating costs of equipment and machinery. It also reduces the costs associated with hiring, salaries, wages, HR, and benefits.

Perhaps the greatest benefit of outsourcing is that it provides the hiring company with access to the people, equipment, and technology needed to ensure the production of high-quality parts and products.

What Types of Businesses Hire Contract Manufacturers?

Although most people assume only large companies hire contract manufacturers, nothing could be further from the truth. Many entrepreneurs and start-ups utilize contract manufacturing to bring new products to market.

Larger companies utilize contract manufacturing to fulfill periods of high demand and to test out new markets. Hiring a CM allows organizations to discover the profitability of new products, without having to invest the time and money into producing new products in house.

California Contract Manufacturer

Means Engineering offers contract manufacturing services to businesses across a wide range of industries. Our services reduce costs and time to market. Our team understands the unique challenges faced by organizations today. We work directly with each of our clients to ensure a mutually beneficial and long lasting relationship.

Please contact us for more information about our contract manufacturing services.

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.

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.

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.