DIFFERENT CONTRACT MANUFACTURING: RESPONSIVE. TRANSPARENT. CREATIVE.

Contract Manufacturing

Our medical equipment contract manufacturing services, certified to ISO 13485:2016, tackle two distinct challenges with manufacturing electromechanical medical devices: quality-controlled, low-volume product and open, accurate pricing models.

We are a contract manufacturing partner that helps you accelerate with ingenuity, speed and flexibility that allows for demand volatility as your product sales grow.

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CASE STUDY

How Blur helped Polarean through the entire manufacturing process.

Learn how Blur Product Development helped Polarean manufacture a revolutionary product to change the game for lung disease.


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Our Contract Manufacturing Services Include

Some contract manufacturers have their clients create all the manufacturing documentation and then manually enter that information into their own systems. At Blur contract manufacturing, we don’t waste time reformatting your paperwork into our system for the sake of aesthetics. We work with you to make sure the critical items are addressed and our documentation packet is complete so we can build a compliant product.

Don’t have all of your documentation ready for rapid manufacturing? No problem! We love to work with clients to create the necessary documentation. Our fluid change control process prevents us from being the bottleneck, and our “flex” lines allow us to bring on new partners rapidly rather than placing them on a calendar that is weeks out based on schedule.

Our quality management system is ISO 13485:2016 compliant, meaning our contract manufacturing site builds and services medical devices that meet customer expectations and applicable regulatory standards.

Click here to see our certification.

Blur’s contract manufacturing site is compliant with 21 CFR Part 820. Why does this matter? Well, this means we are certified to build Class I (low-risk), Class II (medium-risk), and Class III (high-risk) medical devices. We can safely build medical devices that fall anywhere on the risk spectrum.

Our team has also supported clients with Pre Market Approval FDA audits, a more stringent path to getting medical device clearance by the FDA.

Medical equipment manufacturing is a highly regulated field that requires specialized knowledge of national and international standards, supply chains, and best practices to succeed.

At Blur contract manufacturing, we have deep knowledge of industry standards and a breadth of experience manufacturing medical devices in many different categories including ophthalmology, ultrasound, neurostimulation, microfluidics, robotics, and more. The majority of our manufacturing is in the medical device industry, though we also have experience with EPA regulated and cosmetic products.

Blur contract manufacturing specializes in electrical mechanical devices, also known as capital equipment. Capital equipment is any medical device that is not disposable, is meant to last for a predetermined amount of time, and brings in capital.

Capital equipment often has a disposable element that goes with it which generates the majority of the income. For example, electric toothbrushes (capital equipment), if cared for properly, will last for years while the bristle head (disposable) should be replaced every few months.

Blur contract manufacturing is a strong partner for anyone looking for an electrical mechanical device manufacturer that partners with a disposable.

The supply chain market is unpredictable and has many ebbs and flows; these ebbs and flows can significantly impact medical device manufacturing if not taken into account. Our contract manufacturing site stays on top of the supply chain market by completing a supply chain analysis on all of the parts in a build (the BOM) to understand what parts are at risk for long leads and prices surges. We then use that information to plan current and future builds, meet expected price-points, and hit deadlines.

Part of understanding the manufacturing risk associated with a medical device is determining precisely how it could fail on the manufacturing line, also known as a manufacturing risk assessment. Using a process called Process Failure Mode Effect Analyses, or pFMEAs, we analyze the potential root causes of manufacturing failures in your medical device and implement preventative measures to ensure successful builds. This process is an essential step in preventing failures that are attributed to the manufacturing assembly process; the more issues you know about up front, the more you can prevent.

Manufacturing risk assessments also point out areas where you can remove human error and reduce risk. The two primary ways we achieve this are by implementing assembly fixtures and test fixtures. Assembly fixtures are custom solutions that make the manufacturing process more efficient and aid in reducing risk, such as a fixture that aligns two difficult parts for gluing. Test fixtures are custom solutions that make specific tests autonomous so they can run without the intervention of manufacturing engineers. Creating a detailed manufacturing risk assessment will help identify which parts of the manufacturing process could benefit from assembly fixtures or test fixtures.

Blur contract manufacturing provides full open-book pricing; this means you can see where the Cost of Goods is coming from in your medical device build. No more reading between the lines on a quote, you can see the exact price breakdown line-by-line in an easy-to-read spreadsheet.

We realize that cost doesn’t just matter in the big picture, it also matters in the nitty gritty price per unit. Our team performs time studies to show you what phases of manufacturing are contributing the bulk of our labor. Once we see the bottlenecks in production, we work with you to come up with creative solutions that improve efficiency and decrease labor costs. We work faster and your costs decrease; it’s a win win!

Blur contract manufacturing has an in-house certified ISO-7 cleanroom that we use during manufacturing or testing when the medical device needs to be in a controlled environment. Clean room manufacturing differs from standard medical device manufacturing in that it is done in a highly controlled environment. The amount of particulate in the air is controlled by HEPA filters and monitored continuously; ISO-7 cleanrooms have 60 air changes per hour and less than 2,930 particles/meter^3 greater or equal to 5 microns.

Having a clean room at our manufacturing site means we can complete many tasks in-house that would otherwise have to be sent out to a third party.

We love coming up with creative solutions to manufacturing problems and utilize test fixtures and assembly fixtures frequently at our contract manufacturing site. We provide solutions for incoming inspection test fixtures, final test fixtures, in-process assembly fixtures, and everything in between. Developing test and assembly fixtures allows for more reliability and improves throughput; the result of those efforts is a consistent build that can scale with you.

It’s the thing no one likes and everyone needs: documentation. We are passionate about helping you create documents and processes that work with you, not against you.

Blur contract manufacturing is here to help you with a full Device Master Record (DMR). Whether it’s scrubbing BOMs or reverse engineering products to create assembly instructions, we’ll work with you through the documentation you need.

Verification and validation of medical devices should reflect the final manufacturing process. At Blur, we reduce doubt and risk during your FDA process by building products for verification and validation at our contract manufacturing facility. We use the same manufacturing processes as we would in the final product, ensuring your product is built in a GMP environment.

Using devices built in a dedicated manufacturing facility for testing provides confidence in the final results. It also allows you to find areas for improvement in the manufacturing process before going to final production, making sure you’re ready to hit the ground selling once your medical device gets FDA approval.

At Blur contract manufacturing, we run regular time studies by bench and analyze speeds to ensure that we have a balanced line and improve the product build efficiency.

Service is an important part of the lifecycle of any manufactured device. At our contract manufacturing site, we provide service inventory management and keep parts to provide service to your customers. We can ship parts to your field service team so they can provide support to your customers, or our in-house service technicians can complete depot repairs at our manufacturing site and ship them back to you or your clients.

Need a warehouse to store your medical device parts or finished goods? No problem! Blur contract manufacturing has dedicated storage areas for client products. We also partner with a local warehouse in Durham, NC to store larger materials off-site and coordinate deliveries as needed.

Pre-Production Devices

If you’re not commercially ready and need controlled product for testing, Blur contract manufacturing is a great fit! We work with you and your team to build V&V test units, which allows for early manufacturing feedback.

Innovation & Flexibility

Our ISO 13485 quality system is designed with flexibility and efficiency in mind. Our creative transfer to manufacturing team offers innovative ideas, integrity, and openness in pricing with the goal of commercial success.

Scaling for Commercialization

We are able to build any size BOM, from 30 pieces to 1000 pieces, from small devices to devices the size of an MRI machine. We offer Manufacturing, Distribution, and Service, making us a one-stop shop.

MAKING THE TRANSITION

Transfer to Manufacturing

During the transfer to manufacturing process, we'll work with you to see where you are with your Device Master Record and work through any existing gaps in documentation. We'll also assess whether we need in-process assembly or test fixtures to assist with a more robust and efficient assembly process.

Contract Manufacturing Medical Device
SMALL RUN MANUFACTURING

Pilot Build

Our two steps to a successful pilot build? First, we build quality-controlled, low-volume product for testing and clinical use, with the flexibility and costs that larger manufacturers cannot achieve. Second, we take those learnings and apply our creativity, hustle, and open costing models to full-scale production manufacturing. The result is a product that has the lowest possible COGS and a thorough understanding of the supply chain, capacities, and procedures needed to make your product ramp a success.

EXPANDING YOUR PRODUCT

Manufacturing Scale Up

Ready for full-scale manufacturing? Blur contract manufacturing is the perfect partner to grow with you. We start with you on your small volume production runs and scale with you to your hockey stick future forecasts.

Contract Manufacturing
Electro-mechanical Medical Contract Manufacturing
EFFECTIVE MAINTENANCE

Ongoing Service

For many companies, service is an afterthought. Everyone is ready for their first sale, but they forget to plan for maintenance and service for their electrical/mechanical device. We're here to consult with you on service and provide our expertise as a Depot Service provider.

We're here to help

SHORT RUN MEDICAL DEVICE MANUFACTURING?

We know it’s tough to get manufacturers interested in small quantities. Whether it’s for V&V, clinical, or a pilot run, short run manufacturing is critical to the success of your company. It needs to be fast, fluid, and cost-effective. Through the manufacturing process, you’ll improve your design, understand and document your process, and fully understand your COGS.

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