Means Engineering, Inc.

Product development engineering in medical, industrial, semiconductor equipment & military with a standard of excellence in form, function and design.


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(760) 931-9452 | info@meanseng.com
5927 Geiger Court, Carlsbad, CA 92008-7305

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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.

 

 

Filed Under: About Us Tagged With: carlsbad contract manufacturer, carlsbad contract manufacturing, CM, contract manufacturer, contract manufacturing, electronics assembly, internet of things, iot, medical device assembly

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.

 

Filed Under: About Us Tagged With: carlsbad contract manufacturer, carlsbad contract manufacturing, CM, contract manufacturer, contract manufacturing, ISO 13485, medical, medical devices, medical industry

Creating High Quality Medical Devices

August 14, 2020 By meiadmin

Medical devices help ensure quality of life for people around the globe. Used for a variety of diagnostic and treatment purposes, these devices play an important role in safeguarding the well-being of our increasingly health conscious population. Thanks to medical devices, diseases get caught earlier, improving outcomes and decreasing the cost of healthcare for millions of Americans.

Medical Devices Must Meet Strict Regulatory Requirements

When it comes to medical device creation, it’s crucial that organizations follow strict guidelines to ensure the production of high quality and reliable products. Regardless of intended use, medical devices face some of the toughest regulatory guidelines of any industry. It is up to developers and innovators to understand these regulations and ensure compliance when designing and producing devices for the medical industry.

In the United States, medical devices are regulated by the Food and Drug Administration (FDA) and the Centers for Devices and Radiological Health (CDRH). Based on associated risk, medical devices receive a Class I, Class II, or Class III classification. While Class I devices carry the lowest associated risk, Class III devices have the highest. The level of regulatory control depends on device classification.

Outsourcing Medical Device Design & Production

Companies looking to enter the medical device industry often find it difficult and confusing to understand the different CFR’s associated with the design, development, labeling, and production of medical devices. This is enough to keep many organizations out of the medical device industry altogether. However, this probably isn’t the best choice. The medical device and diagnostic industry is worth over $300 billion.

Organizations looking to produce high quality medical devices could benefit significantly from partnering with a trusted medical contract manufacturing service provider. Outsourcing to an ISO 13485 certified contract manufacturer ensures the production of high quality devices that meet strict regulatory compliance requirements. But this is just one piece of the puzzle. Organizations must also look for a partner that’s easy to work with and understands the importance of treating their staff and partners with the respect and attention they deserve.

Southern California Medical Device Contract Manufacturer

Means Engineering works directly with each of our valued customers to help develop a solution that exceeds their expectations in regards to both quality and care. Our vertically integrated approach makes it possible for partners to maintain control and monitor every step of the manufacturing process. By handling everything in-house, Means Engineering provides increased visibility and simplified supply chain coordination.

If you’re considering venturing into the medical device industry, or you require assistance with your existing medical device design and/or production, we encourage you to contact us to see why we’re the Southern California contract manufacturer of choice. We look forward to hearing from you.

 

Filed Under: About Us Tagged With: carlsbad contract manufacturer, CM, contract manufacturer, ISO 13485, medical device contract manufacturer, medical device creation, medical device design, medical device manufacturer, medical devices

Building Trust in Your Brand

August 7, 2020 By meiadmin

Every company wants to be successful. This is true for both start-ups and large corporations. Without consumer trust, your company simply won’t do very well. This is especially true for companies in competitive industries like electronics.

Consumers have high expectations when it comes to the quality, functionality, and reliability of new products. Companies looking to produce new products need to ensure they meet consumer expectations. Without proper testing and quality controls, organizations can lose a lot of business and develop a bad reputation. It’s important that organizations do all they can to ensure the quality and reliability of every product produced.

Outsourcing Reduces Costs and Time to Market

Partnering with an experienced contract manufacturer can help organizations bring new products to market faster. This may be especially beneficial for companies in the electronics industry. Technology changes at a rapid pace, and companies often find it difficult to keep up.

Unfortunately, by the time most companies finish designing, producing, and testing new electronic devices in-house, consumers have already moved on to the next best thing. Working with an experienced contract manufacturer could give these organizations the upper hand. The right CM has the tools, technology, people, and experience needed to keep up with changing consumer demands.

Expanding Into New Markets

Companies responsible for the production of electronic devices often worry about moving into new markets. The rules and regulations of certain industries like medical, aerospace, and defense prevent many companies from expanding. What many of these organizations do not realize is that partnering with a qualified contract manufacturer can allow them to meet industry standards, making it possible to grow their business and significantly increase their revenue opportunities.

Access to Raw Materials

Companies often find it difficult to access the raw materials needed to produce products in-house. This can cause delays in the time it takes to bring new products to market. Because of their experience, contract manufacturers typically have good relationships with raw material suppliers. This helps ensure they have everything they need to produce products on time and on budget.

Means Engineering offers a variety of contract manufacturing services to businesses of all shapes and sizes. Please contact us for information.

Filed Under: About Us Tagged With: carlsbad contract manufacturer, carlsbad contract manufacturing, CM, contract manufacturer, contract manufacturing, electronics manufacturing, southern california contract manufacturer

Choosing an Electronic Contract Manufacturer for Medical Device Creation

July 31, 2020 By meiadmin

Creating devices for the medical industry requires extensive experience and knowledge of industry requirements. Medical devices are highly regulated for both quality and reliability. This is important, as many people rely on the safety and efficiency of medical devices. Perhaps more than any other industry, OEMs planning to produce products for the medical industry should partner with an experienced electronic contract manufacturer.

In addition to understanding how to comply with government regulations, an experienced ECM should meet the following requirements. This can help ensure a successful and mutually beneficial partnership.

Experienced Technical and Managerial Team

The more experienced the electronic contract manufacturer is, the more likely they can help when problems arise. ECMs with experience producing a wide range of devices can often locate problems and suggest viable solutions based on findings from previous projects. In addition to solving problems that arise during production, experienced ECMs can assist with design-for-manufacture review, saving OEMs a considerable amount of time and money on assembly.

Well Maintained Equipment

It’s not enough for an ECM to have quality equipment. They need to properly maintain it to ensure continuous and reliable operation. Calibration of machines and tools should take place at regular intervals.

Proper maintenance not only helps ensure on-time delivery of high quality products, it also allows the ECM to achieve the right tolerance. This is especially important as the medical device industry has stringent tolerance requirements.

Ability to Adjust to Meet Customer Changes

Needs and requirements can change. This is why it’s so important that OEMs select an agile, flexible, and highly responsive ECM to work with.

ISO 13485 Quality Management System

The international standard for a quality management system for the medical device industry, ISO 13485 is designed to be used throughout the entire lifecycle of the medical device. Using ISO 13485, organizations can develop a quality management system that ensures the quality of finished products and the effectiveness of manufacturing processes.

Means Engineering offers electronic manufacturing services for the medical device industry. Our extensive experience and quality management system allows our team to manage risk effectively and bring safe and effective products to market.

Filed Under: About Us Tagged With: carlsbad contract manufacturer, carlsbad contract manufacturing, CM, contract manufacturer, contract manufacturing, ISO 13485, medical devices, medical industry, southern california contract manufacturer

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ABOUT US

MEI features depth of experience in medical, industrial, semiconductor equipment and military products. All product development efforts start with a unique set of requirements, yet we deliver results that share a common standard of excellence in form, function and design.

Our turn-key capabilities provide smart, simple solutions to cumbersome outsourcing issues, and provide our clients with an intelligent route from concept to market.

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