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SERVICES

DESIGN/DEVELOPMENT

SUCCESS STORIES

Success Story 1

Body Contouring Line Development and Transfer
Liposuction, Microinjection and Cannula Accessories

The Challenge

Primo Medical Group was tasked with production transfer of an entire Body Contouring Line from a client's vendor at a small, outdated fabrication shop to our ISO-certified manufacturing facility in under six months from receipt of drawings. The timeline was critical to avoid backorder situations for the client. The line consisted of over 300 products with 1,000 prints, and required an overhaul of manufacturing methods, fixtures and procedures, process validations and risk documents.

The Solution

To avoid product backorder situations, Primo Medical Group developed a working schedule collaboratively with the client by prioritizing products based on inventory levels. Working from this schedule, we pulled the 1,000+ prints into our electronic document control system and prepared Quality Inspection Plans and Manufacturing Routings, allowing internet web portal access and approval ability for our client at every step in the process.

The as-received status of the prints required rework of a large portion of the drawings by the Primo Medical design group, after which our manufacturing engineers developed the assembly fixtures and manufacturing processes for all 300+ products, including:

  • TIG Welding
  • Induction Brazing
  • Torch Brazing
  • Flaring
  • Precision Tip Turning
  • Laser Engraving
  • Press Fits
  • Bonding
  • Packaging/Labeling

Primo Medical group developed the pFMEA for the line and prepared and executed against a Master Validation Plan to validate all of the manufacturing processes.

The Result

Primo Medical Group successfully transferred the line without creating a backorder situation within the timeframe set by the client, and since has been producing all products in the line with stellar approval ratings.

Primo Medical Group won the client's External Supplier of the Year Award in 2014 as a result of our continued excellence in supplying them with high quality product on or before schedule.

The client's continued trust in Primo Medical Group's design and manufacturing services led to the award of several contracts for the redesign of their microinjection line to reduce the tortuosity of the reinjection pathway and to prevent cell lysing while improving operating room surgical product recognition and differentiation.

 

Success Story 2

Surgical Device Development and Transfer Stapler,
Vessel Sealer and Radio Frequency (RF) Generator

The Challenge

A start-up company engaged Primo Medical Group to assist in the development, cost-reduction, verification and validation activities for a suite of miniaturized surgical devices. Primo Medical Group was also tasked with developing manufacturing fixtures and processes as well as the turn-key supply chain, including manufacturing, assembly, packaging, warehousing and distribution.

This project presented several unique challenges, including:

  • Miniaturized devices required tight tolerances, a specialized supply chain and precision assembly processes.
  • Starting Cost of Goods Sold (COGS) were unacceptable.
  • Transfer of design control authority from a previous design vendor to Primo Medical Group.
  • Geographic separation between client, previous designers and Primo Medical Group.

 

The Solution

Primo Medical Group established an in-house team of engineering, quality and purchasing professionals led by a dedicated Program Manager who served as a single point of contact and liaison for the customer and design firm. This approach allowed for transparency and improved communication with the client as well as the harmonious relations necessary for transferring design control from the previous design firm, even though both were geographically remote. We set up an internal office for our client as their “home away from home”, with a regular, alternating visit schedule to maximize face time at our facility and their offices. This also fostered the relationship and close communications. Primo Medical Group redesigned elements of the staple delivery and trigger functionality as well as the aesthetics of the device. We performed stack-up analyses to identify and correct pre-existing design tolerance issues and sourced alternative coatings to improve device function and to strengthen the supply chain.

Design for Manufacturability (DFM) and supply chain efforts were initiated early to keep vendors current with the latest designs in real time while reducing costs through DFM and supplier order optimization. We also qualified components through first article inspection and risk-based quality inspection plans. Primo Medical Group developed manufacturing procedures and a Process Failure Modes and Effects Analysis (PFMEA), as well as a Master Validation Plan (MVP) to validate the suite of manufacturing processes required to address the complexity of the devices, including:

  • Laser Welding
  • EtO Sterilization
  • Ultrasonic Welding
  • Bonding
  • Precision coatings
  • Laser Engraving
  • Precision Machining
  • Precision Assembly
  • Electronics Assembly and Test
  • Machining
  • Packaging and Labeling
  • Functional Testing

Additionally, Primo Medical Group is applying Lean Six-Sigma principles through our Operational Excellence (Op-Ex) program to refine internal processes.

The Result

Primo Medical Group smoothly transferred design control from the previous design firm to our team.
We improved functionality, aesthetics, reliability and assembly through design changes and fixed pre-existing tolerance stack-up issues. We developed and refined manufacturing processes, resulting in cost reductions of over 20% on one product alone.
Primo Medical Group set up a dedicated, comprehensive cost reduction effort targeting materials, processes, design and supply chain. This process is continually reviewed and implemented once a cost reduction is identified. Based on the strength of our work our client awarded additional work on the development and design verification of a series of next generation devices and new product developments to augment their product lines.

 

Success Story 3

Women's Health Line Development and Transfer Fluidic cassette with self-contained pumping, heating and level sensing systems

The Challenge

Primo Medical Group was selected to move the partially developed manufacturing line from a world class medical device company's own facility and install it in our Class 7 clean room. With over 40 components, 60 assembly steps and 10 testing procedures the goal was to refine the production line including fixture improvement, process validation, pilot build and full release to manufacturing.

Post-transfer the customer required that the pilot line assembly and testing processes be reduced from a cycle time of 50 minutes down to 32 minutes.

The Solution

Primo Medical Group assigned an engineering group including an Engineering Project Manager to work in close collaboration with the client to commission the line on time and within budget despite scope changes, engineering challenges and supply chain issues.

The line included the following assembly and testing processes:

  • Ultrasonic welding
  • Bonding
  • Precision Assembly
  • Leak Testing
  • Electronics Assembly and Test
  • Hi-Pot Testing
  • Packaging/Labeling

Primo Medical Group became an extension of the customer's project team and produced deliverables in both the customer's and our own ISO compliant quality systems. Weekly project meetings were conducted, many with the customer on-site.

The monumental task of reducing cycle time to 32 minutes was accomplished through Primo Medical Group's in-house Lean Manufacturing practitioners that applied the appropriate Lean Manufacturing methods. Initially, a single piece flow work cell was developed by taking the complex assembly that was performed by one operator and breaking it into 5 time-balanced assembly stations. By using 5S work place organization techniques and simplification of the assembly steps, the cycle times began to drop and the 32 minute goal was achieved ahead of schedule.

The Result

Not only was the production line fully validated and commissioned, but Primo Medical Group was able to ramp up production from 7,000 units the first year to 30,000 units in year two with complete supply chain continuity and a stellar quality record. With over 125,000 devices produced, the line continues to steadily operate and provides our client with high-quality, trouble-free products. Primo Medical Group is responsible for all sustaining engineering for the product line and has maintained the same PM throughout the entire successful process.

 

Success Story 4

Steerable Introducer with dual steering
Design of a device to deliver catheters & other devices

The Challenge

The customer had developed a steerable introducer prototype designed to access hard-to-reach locations in the vasculature and contracted Primo Medical Group to complete the design, perform validation and transfer the complex product into production including regulatory submittal and commercialization.

Challenges included:

  • Unique design that tested current manufacturing methods.
  • Small components and narrow catheter diameters challenged the methods of construction and the physical strength of materials.
  • The cost of the product had to be reduced for commercial viability.
  • The customer lacked sufficient quality and document control systems.
  • After release of the first configuration, product line extensions would be required to achieve well-rounded product families.

The Solution

Primo Medical Group established a dedicated, multi-disciplined project team to tackle the design and manufacturability issues. Working closely with the customer, a detailed project plan including all design control elements as well as ISO testing and validation activities was constructed in order to map the path to commercialization. Extensive engineering studies and Design for Manufacturability (DFM) techniques were applied to solve this complex challenge.

Primo Medical Group redesigned the steerage, liner and drive mechanisms while creating manufacturing processes for the varied-durometer catheter shaft and tip segments. A detailed assembly process was developed to produce repeatable shafts that met ISO requirements for sheath and hemostasis valve leakage, joint separation, radio opacity, surface finish, dilator/hub strength and guidewire strength.

The Result

Through sound engineering and sheer persistence the product was launched as planned and multiple product line extensions were released. One of the successful product line extensions was executed for another company in order to improve their process for precisely implanting a device into the apex of the left ventricle. Primo Medical Group has continued to partner with the customer and is now an active owner of this product providing technical, quality and distribution support.

 

Success Story 5

Liposuction Cannula and Single Use Cartridge
Design of a Single Piece, Reusable, Pressurized-Stream Cannula

The Challenge

The customer had developed a two piece design for a reusable cannula that delivered a pressured, pulsed, stream of heated saline for a new liposuction technique that allows fat removal without damage to blood vessels or nerve fibers. The heated saline was supplied by a cartridge installed in a control console outside of the sterile field. Primo Medical Group was asked to redesign the product for regulatory submittal and commercialization.

Challenges included:

  • The product was extremely expensive and required extensive DFM
  • The cannula and handle were difficult to sterilize in an autoclave
  • The handle assembly was oversized and uncomfortable, and heated/ vibrated excessively
  • The cartridge was bulky and had a poor commercial appearance
  • Redesign needed to maintain the functional requirements established  in clinical trials
  • The customer lacked quality and document control systems

The Solution

First, Primo Medical Group developed a program schedule to meet the client’s needs and shared timelines on a weekly basis. Project organization was critical for this start-up client as their management resources were limited. Primo Medical Group’s document and quality control systems provided complete services for design history files, device master records and device history records to serve as the client’s quality system.

We designed and tested a new single-piece cannula system featuring a silicone, overmolded handle for surgeon comfort and protection from vibration and heat. Primo Medical Group worked closely with the vendor to develop an overmold that bonds durably and can withstand multiple autoclave cycles.

Primo Medical Group also designed the metal hub for high pressure hose and vacuum line attachment. This design maintained the original performance but reduced materials and assembly costs. We also designed the accompanying dual-lumen cannulae in a family of sizes that allows for simple cleaning.

We redesigned the cartridge system, replacing all of the internal tube flow paths with flow channels incorporated in the bag design itself, greatly reducing cost and simplifying final assembly of the cartridge. This minimized the sterile packaging and allowed for ease of assembly.

The Result

  • A cannula design that surgeons find easy and comfortable to work with
  • Cannula durability that has far exceeded the original requirements
  • The ability to easily change cannulae during procedures as desired
  • Smooth delivery of product to customers as an integrated branch from  client to end user
  • Very successful FDA audit of Primo Medical Group’s Design  Control documents

 

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DESIGN SERVICES

  • Product Conceptualization and Design Input Requirements Generation
  • Design/Manufacturing Engineering
  • 3D Solid Modeling
  • 2D Detailing
  • Finite Element Analysis (FEA)
  • Rapid Prototyping
  • Verification Testing and Protocol
  • Development/Execution
  • Design Control

DEVELOPMENT SERVICES

  • Design and Process Failure Modes and Effects Analysis (dFMEA/pFMEA)
  • Primary and Secondary Packaging Development
  • Simulated Distribution Testing
  • Accelerated Aging
  • Sterilization Validation
  • Process Development
  • Automated Test Fixturing
  • Standard Operating Procedures
  • Work Instructions
  • Inspection Plans
  • Device Master Records
  • Process Validations
  • Tooling and Fixture Design/Development
  • First Article Inspections