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.
During the PRODUCT DEVELOPMENT phase of NPI, our ProSuite services encompass:
- project management
- design history file (DHF) and technical file development
- general safety & performance requirements
- design specification development
- risk analysis and management
- usability/human factors
- design verification & validation (V&V)
- contract sterilization validation (EO, gamma, e-beam, x-ray, steam)
- packaging design and validation
- contract biocompatibility validation
- performance verification and validation
- contract electrical safety and performance testing
- usability validation
- and more
During the MANUFACTURING TRANSFER phase of NPI, our ProSuite services encompass:
- DFX evaluation (design for manufacturability, assembly, and testing
- component receiving inspection
- visual inspection system
- first article inspection
- custom manual inspection
- device master record (DMR) development
- label design and in-house printing
- UDI application and implementation
- part definition and specifications
- manufacturing process instructions
- quality inspection procedures
- device / lot history records
- equipment files and processes
- IQ, OQ, PQ, PPQ
- gauge R&R studies
- calibration and preventative maintenance
- packaging
- Tyvek pouch, standard & custom
- tray, standard & custom
- poly bags, standard & custom
- scale up to automated assembly
- 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.
Prospect’s ProSuite PRODUCTION services encompass:
- turnkey contract manufacturing
- diagnostic, pharmaceutical, and surgical instrument kitting
- manufacturing environmental controls
- temperature and humidity monitored production areas
- ISO class 7 and 8 clean rooms
- electrostatic discharge
- component receiving inspection
- visual inspection system
- first article system
- packaging
- custom and standard pouch sealing
- custom and standard tray sealing
- hand assembly
- IPC certified soldering
- cable crimping
- cable harness assembly
- custom inline and final testing
- circuit boards programming and testing
- ultrasonic and radar sensor testing
- laser alignment
- supply chain management
- supply chain risk assessment
- integrated ERP system
- inventory storage and managment
- and more
Fulfillment Services
Speedy turn times matter. We respond to today’s “need it now” mentality with fulfillment services that provide a fast and convenient way to deliver to your devices to customers. You can place production orders and distribution requests 24/7 through customizable online portal. Additionally, your dedicated customer service team will provide real-time updates on production status, quality assurance, and fulfillment logistics. We want your medical device in the hands of those who’ll benefit from it as quickly as you do.
ProSuite FULFILLMENT services encompass:
- customizable order portal
- global fulfillment
- rate shopping
- real-time tracking
- cold chain logistics
À La Carte Services
At PLS we understand that sometimes folks just need help with a particular step in the development process. Our à la carte option lets you lean on Prospect’s extensive industry knowledge on an as-needed basis to keep your product moving forward.
Our à la carte services include:
PRODUCT DEVELOPMENT PHASE:
- contract sterilization validation (EO, gamma, e-beam, x-ray, steam)
- contract biocompatibility validation
- QMS implementation and monitoring
- DHF remediation
- technical file remediation
- packaging design and validation
- CE mark / 510(k) support and development
- contract design and prototyping
- proof of concept and feasibility testing
- wet lab services (animal and cadaver testing)
MANUFACTURING TRANSFER PHASE:
- DFX evaluation (design for manufacturability, assembly, and testing)
- component specification development
- supplier research and selection
- custom machined jigs and fixtures
- custom semi-automated equipment
PRODUCTION PHASE:
- DFX evaluation (design for manufacturability, assembly, and testing)
- component specification development
- supplier research and selection
- custom machined jigs and fixtures
- custom semi-automated equipment