DIFFERENT MANUFACTURING. RESPONSIVE. TRANSPARENT. CREATIVE.
Contract Manufacturing
Our medical equipment 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 manufacturing partner that helps you accelerate with the ingenuity, speed and flexibility that allows for demand volatility as your product sales grow.
Watch a quick intro to our manufacturing
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.
Our Services Include
Some contract manufacturers have their clients create all the manufacturing documentation. That contract manufacturer then takes that information and reenters it into their own format. At Blur, we don’t recreate things for sake of it being in the “Blur” format. We work with you to make sure the critical items are addressed and that we have a documentation packet so we can build a compliant product too.
Sometimes, teams won’t have all of this documentation upfront, and we are happy to help create the manufacturing documentation with you. Our fluid change control process prevents us from being the bottleneck, and our “flex” lines allow us to bring on new clients rapidly rather than placing them on a calendar that is weeks out based on schedule.
Blur is certified to ISO 13485.
Blur builds Class I, II and III medical devices and has supported clients with PMA FDA audits.
The majority of Blur’s manufacturing is in the medical device industry. Though EPA regulated products and cosmetic products are also in their capabilities.
Blur specializes in electrical mechanical device (capital equipment). We are a strong partner for anyone looking for a capital equipment manufacturer to go along with a disposable.
The supply chain market is one with many ebbs and flows and is unpredictable. Blur is on top of the supply chain market by completing an analysis on BOMs to understand what parts are at risk for long leads and price surges.
pFMEAs are essential in preventing failures that are attributed to the manufacturing assembly process. This also aids in identifying assembly fixtures and test fixtures to aid in reducing risk.
Blur provides full open-book pricing, and the ability to see exactly where the Cost of Goods is coming from.
Additionally, Blur performs time studies to show clients where the bulk of their labor is coming from. This allows Blur and the client to improve these areas to decrease labor costs.
Blur has a Class 7 cleanroom.
When it comes to fixtures, we provide solutions for anything from incoming inspection test fixtures to in-process test fixtures, final test fixtures, and in-process assembly fixtures. This capability allows for more reliability and to improve throughput. The result is a consistent build that can scale.
Blur is here to help our clients with a full DMR (Device Master Record). Be it scrubbing BOMs, or reverse engineering products to create assembly instructions, we work with our clients through the documentation they need.
Verification and validation of products should reflect the manufacturing process. At Blur, we reduce doubt and risk during your FDA process by building products for verification to ensure that you know your product was built in the manufacturing GMP environment.
At Blur, 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 Blur, we provide service inventory management and keep parts to provide service to your customers. We can even ship parts to your field service team so they can provide support to your customers. We can also provide depot repairs at Blur and ship them back to you or your clients.
We are able to house all your finished goods and parts for building devices and we’re able to distribute them to your end user.
Pre-Production Devices
If you’re not commercially ready and need a controlled product for testing, Blur is a great fit! We work with you and your team to build V&V test units. This allows for early manufacturing feedback.
Innovation & Flexibility
Our ISO 13485 quality system is designed with flexibility and efficiency in mind. Our creative transfer 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
We work with our partners to see where they are with their Device Master Record, and work through any existing gaps. As part of the manufacturing transfer, we assess any potential in-process assembly or test fixtures that may assist with a more robust and efficient assembly process.


PILOT PROJECTS
Pilot Build Run
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 we 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 the product ramp a success.
EXPANDING YOUR PRODUCT
Manufacturing Scale Up
Ready for full-scale manufacturing? Blur 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.


EFFECTIVE MAINTENANCE
On-going Service
For a lot of companies, Service is an afterthought. Everyone is ready for their first sale, but forgets to think about the fact that anything electrical/mechanical will need service at some point. We are here to help consult with you on Service as well as be 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 process, you’ll improve your design, understand and document your process, and fully understand your COGS.