carlsbad contract manufacturer Archives - Page 4 of 30

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.

Manufacturing During COVID-19 – Keeping Staff Safe

September 11, 2020 By meiadmin

The COVID-19 public health emergency has forced businesses around the globe to reconsider the ways they handle daily tasks and operations. For businesses in the manufacturing industry, leaders have had to implement important safety measures while preparing for increased uncertainty and long-lasting changes to the work environment.

Unlike a lot of other industries, manufacturing requires heavy equipment, machinery, adequate space, and often a controlled environment. This makes working from home extremely difficult.

In order to continue operations and ensure the organizations we support can continue to thrive in a struggling economy, Means Engineering has developed a COVID-19 response plan to ensure the safety and continued well-being of our employees.

At Mean Engineering, the health and safety of our staff has always been our top priority. We have been able to stay open during the public health emergency by implementing proper safety procedures. We also developed a COVID-19 task force. The main focus of this task force is to ensure the continuous safety and well-being of our employees.

In addition to implementing CDC recommended cleaning and sanitation practices, our COVID-19 task force monitors employee health, and implements additional safety measures as recommended by leading authorities.

Preventing the Spread of Disease Takes a Team Effort

At Means Engineering, our people don’t just help organizations create new products, they bring years of industry expertise and insight to the table. They offer viable solutions to a wide range of design and production development issues. Our people truly are what sets Means Engineering apart.

Our COVID-19 plan and task force were developed following Means Engineering’s core values. These values play an important role in every decision we make.

Passion – At the center of everything we do
Integrity– We hold ourselves to high standards and honor the commitments we make. We strive to embody integrity in all our processes, decisions, and interactions
Innovation– Innovation is in our DNA as a company. We are constantly developing and supporting new methods and ideas to build products
Quality– We are dedicated to quality and always strive to produce products that meet or exceed quality standards.
Ethics– We believe in doing what’s right for the customer, right for our employees, and right for the world

Every month, Means Engineering hosts company-sponsored events. These events allow us to unwind and connect as a team. We believe this is where innovation begins. Unfortunately, during the COVID-19 pandemic, we’ve had to put these events on hold. However, we continue to show our appreciation to our staff through food trucks, cookies, and by providing them with plenty of Means Engineering merchandise.

Although life looks a little different now, we plan to continue to grow and adjust as a team. We believe this will strengthen our ability to exceed our customers’ expectations for both quality and service.

Please contact us for more information about our contract manufacturing services and the steps we’re taking to keep our staff safe.

How the Internet of Things is Changing Healthcare

September 4, 2020 By meiadmin

Outcomes-based healthcare is quickly becoming the new norm. In fact, organizations that do not embrace outcomes-based health plans will soon fall behind their competition. A recent study conducted by Avalere Health, a leading healthcare consulting plan, found that outcomes-based contract discussions are up 25% among leading health plans.

For healthcare providers, making the switch from a traditional capital expenditure model to a usage-based system makes sense. This model allows providers to charge more competitively for services. However, for medical device manufacturers, this model represents a major shift from the way things have always been done. As more providers adopt an outcomes-based system, medical device manufacturers can no longer base their designs, development, and marketing on big-ticket equipment sales.

Another change, providers now expect medical devices to include embedded software and connectivity. An important feature, this enables patient health data collection and transmission to providers and healthcare networks. This is extremely important to the outcomes-driven model. Connected devices enable providers to view patient data in real-time, increasing diagnostic capabilities and improving outcomes for patients. The medical devices of today need to include numerous features and capabilities.

IoT Medical Devices Allow for Faster Diagnosis and Better Outcomes

The Internet of Things (IoT) allows providers to remotely monitor patients. This reduces downtime and increases the predictive maintenance efficiency of medical devices. By adding a variety of sensors, manufacturers allow medical devices to capture a wide range of data. This could provide a much more complete picture of patient health. Through machine learning and AI, devices and/or providers can react in real-time to changes to a patient’s condition or health.

Making Medical Devices Smart

While most medical device manufacturers understand the importance of making medical devices “smart”, many don’t have the tools, technology, or people to produce medical devices for rapidly evolving needs. Unfortunately, medical device manufacturers that cannot keep up with advancing technology will soon find it difficult to attract new customers or maintain existing accounts. The shift to IoT is evolving quickly and recent predictions show that healthcare related IoT will top $135 billion by 2025.

Organizations unsure of how to embed software and connectivity into medical devices could benefit from outsourcing to a competent and experienced medical device contract manufacturer. Means Engineering has years of experience and understands the complex and changing needs of the medical device industry. We have ISO 13485 certification and our team is dedicated to exceeding customer expectations for both quality and service.

When you work with Means Engineering, we work directly with your organization to ensure you fully understand every step of the process. Our services are scalable, ensuring a right-sized approach for each project. Following our core values: passion, integrity, innovation, and ethics, our team works together to complete projects on-time and on-budget.

Please contact us for more information about our services.

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.

The Importance of Clean Rooms in Medical Device Creation

August 21, 2020 By meiadmin

When producing medical devices, medical device manufacturers must maintain a clean environment. This is important, as any bacteria or microorganisms can create a safety concern for patients. It’s also crucial that medical device manufacturers ensure that air pollutants don’t gather on small components, impacting their ability to function as desired. In order to keep medical devices free from contaminants, medical device manufacturers must assemble these products in a controlled environment. Using a cleanroom for medical device assembly ensures bacteria and pollutants do not impact the functionality or safety of medical devices.

Ensuring Compliance with Federal Regulations Regarding Medical Device Creation

Companies responsible for the creation of devices for the medical industry must meet strict regulations regarding the design, production, and labeling of medical devices. Regardless of the type of device and its classification with the FDA, medical device manufacturers must ensure adequate cleanliness throughout the entire manufacturing process.

The International Organization for Standardization (ISO) sets the standard for quality for the medical device industry. Companies that receive ISO 13485 certification have proven they have the tools and capabilities to ensure optimal cleanliness and contamination controls when producing medical devices.

What is a Cleanroom?

A cleanroom is a special room, typically inside a manufacturing facility with special filtration used to remove contaminants like dust, airborne microbes, and aerosol particles. Manufacturers often use cleanrooms to produce electronics, pharmaceuticals, and medical devices. In addition to cleanliness and contamination control, cleanrooms also control temperature, air flow, and humidity all of which can impact the quality of finished products.

Do You Need a Cleanroom?

Organizations often wonder whether they need their own cleanroom. For organizations creating medical devices, a cleanroom is important to ensure the quality and safety of finished products. However, finding the space and funding for a cleanroom could create a challenge. Many small and mid-size companies often struggle to justify the cost of implementing cleanroom operations into their facility. It takes a lot of people and training to ensure the safe and proper production of these important devices.

Companies can benefit from outsourcing medical device production to an ISO 13485 certified contract manufacturer like Means Engineering. Our team has years of experience and understands how to design and produce a wide range of medical devices. We offer state of the art cleanroom assembly to ensure optimal cleanliness and quality.

Right Sized Contract Manufacturing Services

When you work with Means Engineering, we work directly with you to develop a customized solution. Unlike larger contract manufacturing firms, we offer a personalized approach. No matter how big or small your project, our team stays in communication throughout the entire process.

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