Contract Manufacturing Solutions
The medical device life cycle is far from linear.
Outsource your contract manufacturing needs to PLS and reap the benefits of our experience. We’ve got the knowledge and ability to develop, manufacture, and bring to market complex, innovative medical devices. From the initial prototype stage to scale up production, and anywhere in between, Prospect is equipped and ready to work together to take your device wherever you want it to go.
Supply Chain Management
Trust PLS to make sure the job is done right. Managing your supply chain is a critical to meeting price, timeline and market demand in the manufacturing process. We have proven organizational systems and relationships in place to manage all the moving pieces and bring you the best possible cost savings solutions.
At Prospect, we work to maintain traceability, improve lead times, and be cost effective at every stage. This includes:
- supplier selection — identification, capability assessment, and auditing
- supplier management — relationship building, supplier approval, and performance tracking
- enterprise resource planning — inventory, manufacturing, and distribution tracking
- procurement — research, competitive bidding, and traceability
- risk management — supplier alternatives, backup suppliers, and safety stock
At PLS, we take care of the details, so you don’t have to give a second thought to things like inventory warehousing, physical production, packaging, or fulfillment. We will also work with you to develop robust manufacturing processes and training programs to facilitate a reliable, easily validated, and transferable process as your business grows and scales up.
Quality Systems Management
We’re committed to measuring, managing and improving both process and product. Regulatory compliance is an obvious priority in the medical device industry. After all, the products we’re making can have real and lasting effects on patients’ lives. At PLS, we implement state of the art quality systems management standards and practices to proactively manage the process of manufacturing your product at every stage of development and production. Which results in improving the ultimate quality of the delivered product.
To ensure FDA and international compliance, we maintain certification for ISO 13485 – medical devices (quality management systems), and audit for compliance to both ISO 14971 – application of risk management to medical devices and USA 21 CFR Part 820 – Quality System Regulation. We are also FDA registered as a contract manufacturer.
We maintain critical quality controls and ensure good manufacturing practices (GMP) compliance along the way with:
- periodic internal audits
- development and/or remediation of DHFs (design history files), technical files and DMRs (device master records)
- USA FDA 510(k) development and submission
- CE mark development and audit preparation
- inventory, purchasing and receiving ERP solutions
At Prospect, we believe it’s equally important to focus on both process and product. Because quality and compliance aren’t mutually exclusive.
Every product manufactured at PLS has a dedicated project manager. It’s part of our shared commitment to your success. And it allows us to keep budget, timeline, costs, and product performance on track. We provide timely progress reports and regularly conduct meetings to keep you apprised of the status of milestones, critical decisions and action items – by phone as well as in person – to ensure everyone is on the same page and no details are overlooked. As the development and production processes progress, you can rest assured we’re maintaining focus on every aspect of your project.
Our Westminster facility is designed for collaboration and flexiblity. Prospect’s manufacturing space features ISO Class 7 cleanroom space, a configurable manufacturing layout and dedicated electromechanical production area, as well as environmentally controlled inventory storage and warehousing areas. An open office floor plan and multiple private conference rooms make great environments for our engineering team to interact and share ideas and solutions with one another. And, the view of Colorado’s beautiful Flatirons to the west isn’t bad either.
Need a place to work yourself? Prospect’s offices, affordable manufacturing suites, and wet/dry lab space are available for discounted rent on a daily, weekly or monthly basis to provide you with flexible, cost effective ways to bring your ideas to market. It’s another way for us to be good partners.
Partnerships and Grant Support
Doing our part to make a difference in the industry. As a proud Colorado company, PLS is happy to support our clients with applications for the state’s Early Stage Capital and Retention (ESCR) grant. We’ve got experience and success with supporting the application process and can work with you to create proposals and letters of support demonstrating appropriate model refinement, market introduction, and commercial activity. We also have a track record of similarly supporting NIH and NSF SBIR grant proposal applications.
Our state has some of the best scientific minds around. At Prospect, we foster close relationships with the engineering departments at Colorado School of Mines, University of Colorado Boulder, and Colorado State University. From mentorship to interning opportunities to taking on the projects of new grads with production and manufacturing of their concepts, PLS has a happy history of forging local relationships.