Devices We Make
We take pride in improving the performance and safety of new medical devices. Our dedicated team understands that reduced costs and high manufacturability are critical factors for medical device success. Additionally, we are committed to creating solutions that get your product to market.
PLS has the experience and ability to manufacture and produce complex, innovative medical devices. Since 2016, Prospect has partnered with companies like yours to develop and manufacture:
Sterile single use devices
like surgical spine instruments, orthopedic implants, patient specific surgical guides, orthopedic laser alignment instruments, dental instruments and fluid management tubes – that meet regulatory compliance and reduce contamination risks.
Electromechanical devices
such as centrifuge systems, mobility navigation systems, and electrical stimulation devices – that incorporate semi-automated manufacturing systems, printed circuit board assembly (PCBA), precision ground wires, stents, coil components and more.
Combination products
including autoinjectors – that support various drug delivery methods, intersect the medical device and pharmaceutical industries, and support a medical breakthrough mentality.
Diagnostic kits
ranging from sterile kits to convenience kits that tests liver function and physiology – to help detect, diagnose, and treat patients and provide safer, more timely results.
NPI Services
Count on our expertise in New Product Introduction (NPI) to take your concept to market. From supporting design development with your team to developing your manufacturing process, to testing pre-production builds, to production launch, we’ll take the necessary steps to ensure your medical device is regulatory compliant, cost effective to produce, consistent and reliable, scalable, and built to your performance requirements.
At PLS, manufacturability is a key factor in the equation from day one. We start by taking the time to fully understand your vision. Then, we work with you to establish effective designs for manufacturability techniques and solutions; test and improve production methods; and develop cost effective, efficient manufacturing process instructions – all while keeping focused on your budget and schedule. By maintaining process controls, we help ensure your product meets regulatory, quality, performance, and cost requirements.
Changes happen during NPI. Especially in the early stages. We’re patient with the process – because going through different iterations is part of learning, growth, and improvement. That’s also why we have no production minimums at the NPI stage. Throughout the new product introduction process, you’ll find the PLS team is both responsive and flexible as your vision and needs evolve.
Key services we provide during the NPI process:
- device master record development
- manufacturing layout design and set up
- process failure mode effects analysis (FMEA)
- process validation plans and reports
- equipment specifications and files for calibration and preventative maintenance
- process qualification protocols and reports (IQ/OQ/PQ)
- manufacturing cost reduction analysis and fixed priced modeling
- supply chain selection, approval, and management
- gauge R&R (repeatability and reproducability) studies
- manufacturing fixture and tool design and fabrication
- and more
Key services we support your team with during the NPI process:
- design history file remediation
- product specification definition
- risk management file documentation
- usability and human factors development (engineering lab services) performance tests executed against specification
- performance V&V protocol development, execution, and reporting
- third party management of sterilization, biocompatibility and packing validations
- and more
Production Services
Let’s get your product out in the world. From early market testing to high volume production, PLS has comprehensive solutions to support your scale up path to success. Our medical device assembly capabilities include electromechanical assembly, sterile instrument assembly, and combination products as well as diagnostic kitting and PPE.
Prospect’s production space is configurable and ready to meet changing requirements as your product gains marketability and production needs grow. We can easily scale from just a few orders to high volume production. To support your growth process, we keep refining the equipment and fixture designs, in-process inspection/testing, and manufacturing process to help reduce costs and increase yields. We also streamline the fulfillment process with our online ordering system via client login.
Our packaging validation services help ensure the highest efficacy in your product’s packaging. With Prospect’s in-house capability, we can validate your packaging requirements, including bubble leak (ASTM F2096: Detecting Gross Leaks by Internal Pressurization) and peel (ASTM F88: Seal Strength for Flexible Barrier Materials) testing. At PLS, we’re committed to working with you to meet FDA and ISO11607 requirements for process validation and continued process monitoring.
You can count on PLS for:
- production and process control
- material flow, assembly flow, and ongoing time studies
- in-process inspection and testing
- equipment specifications, procurement, qualification, and maintenance
- fixture design and fabrication
- process measurement, analysis, and improvement
- production efficiency monitoring
- inventory control and management
- online ordering system
- fulfillment all over the world