Client
Large Medical device product development company in UK. This company focuses on developing and then marketing products for the medical sector.

Product Description
The product is a medical consumable kit made up of a number of customised assemblies and a custom moulded plastic part. The kit is packed and sterilized using ETO sterilization.

Client Brief
The client had completed the product development cycle and was launching its marketing campaign for this particular product. It had established an initial supply solution to deliver samples. It now wanted to partner with a company who would work with them to establish the suitable supply base and then deliver a full turnkey supply solution which would cover all aspects of the supply management. The client required a capacity to be put in place to meet a level of 100K units per month for this kit.

Gentians Solutions
Gentians role was to work closely with the client, take the client brief and put in place a cost effective supply solution which met both the regulatory and quality requirements of the product.

Gentian fulfilled the brief by:

• Gentian worked closely with the client at the planning phase to understand both its com- mercial and quality requirements for this product. This involved gaining an understanding of the end market as well as the cost drivers for this product.
• Gentian took these requirements and worked with its extensive network of manufacturing options across various geographical locations. The primary areas considered suitable for this project were China, India and Mexico.
• Cost benefit analysis was performed on each option to allow Gentian to form an opinion as to the best commercial solution for the client.
• Quality Audits as well and plant evaluations were carried out to allow Gentian form an opinion in terms of suitability for the assembly sites for this product.
• Gentian put in place a one stop shop solution for its client where Gentian effectively became the supplier for this kit and took on responsibility for all Quality, manufacturing and supply chain related issues.
• Final selection involved establishing manufacturing in China managed by Gentians engi- neering and logistics team both Locally in China and Ireland
• Gentian managed initial launch in production which involved:
  • Production planning to clients forecast.
  • Tooling commission.
  • Process validation,
  • Pilot batch approval.
  • Production ramp up.
• Gentians client just places an order on Gentian and Gentian gets the product manufac- tured and delivered wherever the customer requires.

Results

• Full turnkey supply solution put in place for customer with no additional overhead required in their organisation.
• Cost effective global supply solution but client still dealing with Gentian’s program manager locally and in the same time/language zone to the client.
• All Levels of the supply chain meet regulatory requirements and are approved to ISO 13485 standard.
• Cost reduction compared to previous customer projections of 15%.
• Customers internal resources released to work other prod- ucts rather than on non core activities.

Client
Company which develops and markets its own range of consumable products to the medical and pharmacy sectors in Ireland and the UK.

Product Description
The product is a new packaging innovation used for dispensing medicine by pharmacy and healthcare professionals. The product is a customised assembly which consists of foil, cardboard and blister packaging technologies.

Client Brief
As the primary innovator of the product our client’s role was to develop the product and establish the routes to market for the product.

To compliment this our client wanted to partner with a company which would establish and deliver a cost effective, high quality and reliable manufacturing solution for the product. The cost competiveness element of this project dictated that moving the assembly portion of this product to a low cost region needed to be explored and implemented.

To this end it now wanted to partner with a company who would work with them to establish the suitable manufacturing and supply base and then deliver a full turnkey supply solution which would cover all aspects of the supply management of the assembled parts in bulk to its facility in Ireland.

The client required a capacity to be put in place to meet a level of between 1-2 Million units per year for this product.

Gentians Solutions
Gentians role was to work closely with the client, take the client brief and put in place a cost effective supply solution which met both the regulatory and quality requirements of the product.

Gentian fulfilled the brief by:

• Gentian worked closely with the client at the planning phase to understand both its commercial and quality requirements for this product. This involved gaining an understanding of the end customer as well as the cost drivers for this product.
• Gentian took these requirements and worked with its network of manufacturing options in various geographical locations. The Geographical regions considered suitable for this product were Vietnam and China.
• Cost benefit analysis was performed on each option to allow Gentian to form an opinion as to the best commercial solution for the client.
• Quality Audits as well and plant evaluations were carried out to allow Gentian form an opinion in terms of suitability for the assembly sites for this product.
• Final selection involved establishing manufacturing in China managed by Gentians engineering and logistics team both Locally in China and Ireland.
• Gentian managed initial launch in production which involved:
  • Production planning to clients forecast.
  • Tooling commission.
  • Process validation,
  • Pilot batch approval.
  • Production ramp up.
• Gentian’s customer just places an order on Gentian and Gentian delivers the assembly directly to its customer’s facility in Ireland.
• Gentian put in place a one stop shop solution for its client where Gentian effectively became the supplier for this kit and took on responsibility for all Quality, manufacturing and supply chain related issues.

Results

• Gentian’s customer achieved a reduction of 20% on its overall product cost.
• Full turnkey supply solution put in place for customer with no additional overhead required in their organisation. This eliminated to need for them to coordinate the activities of four different suppliers.
• Cost effective global supply solution but client still dealing with Gentian’s program manager locally and in the same time/language zone to the client.
• All Levels of the supply chain meet regulatory requirements and are approved to ISO 13485 standards.
• Full wrap around quality assurance service in place for their product.

Client
This customer is an established company that develops and markets its own range of surgical simulation training systems.

Client Brief
The company came to Gentian with a working prototype for a new revision of its product.

Our role was to:

• Finalise the design of the product, ensuring suitability for manufacturing
• Put in place the appropriate outsourced supply chain and manufacturing solution
• Manage the NPI process through to steady state manufacturing

Gentians Solutions
This was a comprehensive project going from the design stage straight through to full manufacturing.

Gentian fulfilled the brief by:

• Implementing a fully project-managed solution for the NPI stage of the project, taking full responsibility for all aspects of the project
• Providing full Design for Manufacturing Engineering services to ensure that the product was both manufacturable and reliable
• Supplying design for compliance services where the design was analysed and revised to ensure compliance with the UL standard for laboratory equipment
• Managing the complete compliance process on behalf of the client and coordinating all testing and approval activities
• Sourcing, auditing and qualifying the appropriate supply base for the product subassemblies, which included plastics, metal fabrication and various electronic components
• Providing a turnkey supply and configuration solution that involved supply chain management of all subassemblies with final assembly, configuration and testing performed on-site at Gentian

Gentian Skillsets Deployed

• System design engineering
• Manufacturing engineering
• Supply chain development and management
• Sourcing and procurement
• Low volume manufacturing
• Compliance engineering
• Test engineering
• Program management

Results

• New product was launched three months earlier than planned, pulling in significant revenue
• Standard product lead time was reduced from 10 weeks to 6 weeks
• Manufactured cost of product decreased by 12%
• Overhead costs to the client were lowered substantially
• Gentian’s full turnkey service released internal resources for the client
• Client inventory liability decreased by 50%

Client
This client’s chief activity is developing and marketing its own range of gas analysis instrumentation.

Client Brief

The customer was designing a new revision of an existing product line. Their aim was to modernise the product line and incorporate new features and functionality in its design.

While the client retained the development of the core technology components, they required Gentian to carry out a full system redesign. This included redevelopment of metal housing, revision of system layout for ease of maintenance and ergonomic design, and redesign of plastic front panel to incorporate user LCD interface and to enhance the overall look and feel of the system.

Gentians Solutions

Gentian liaised with the client’s R+D group to understand the functionality of their products and to learn what the key differentiating factors of the new design should be. During the project, Gentian worked closely with the client through their own development process to understand and react to any changes in the design brief and functionality of the final unit.

Gentian performed the following key tasks:

• Customer requirement capturing
• Concept development
• 3D modelling and rendering of metal and plastic concepts
• metal and plastic design
• Cost analysis for finished manufactured product
• Prototype development and build
• Design for manufacturing analysis
• Technical review sessions with client and feedback into design process
• Design debug
• Design finalisation and new product introduction to manufacturing

Gentian Skillsets Deployed

• Project management
• Product design and styling
• Plastics design
• Metal housing design
• Electronic system design
• Design for manufacturing
• Sourcing and procurement

Results

Successful design of new product which delivered:

• Enhanced user functionality
• Easier maintenance (reducing the cost and time to client during installations and servicing procedures)
• Improved aesthetics and design styling to complement client’s rebranding and new product launch
• Completion of design on time, enabling client to achieve planned revenues from new product launch
• Reduced overall cost to client for design phase of project

Client
A third-level technology spin-out company developing infection control instrument for use in hospitals.

Client Brief
Our client had developed the core technology and functional prototype for an electronic product to be used in a medical infection control application. The product involved plastic housing and core electronics, as well as touch-screen and bespoke vision systems.

The client engaged Gentian at the point where it required the product to be prepared for deployment in a critical clinical pilot scheme at one of its key customer sites. The client’s instruction to Gentian was to carry out a design review of the current revision and subsequent implementation of improvements. The aim of this exercise was to enhance the design to ensure ease of manufacturing and appropriate reliability for the duration of the pilot scheme. In addition, Gentian was to take full responsibility for the manufacturing and delivery of the systems for the pilot run.

Gentians Solutions
Gentian engaged closely with the client’s development team to deliver the following:

• Full review of hardware design and implementation of enhancements
• Electronic system design review and implementation of improvements
• Redesign of elements of internal system layout to improve reliability
• Electronic technical problem-solving support to software development during system debug and implementation of permanent solutions
• Production of systems for pilot scheme
• Test and debug of pilot systems
• Technical support to client during installation and roll-out of pilot scheme

Gentian Skillsets Deployed

• Electronic systems engineering
• Design for manufacturing
• Mechanical systems engineering
• Reliability engineering
• Compliance engineering
• Low volume engineering batch manufacturing
• Procurement and supply chain management

Results
We achieved successful deployment of systems for the duration of the pilot run. Our customer’s key project milestones were achieved:

• Delivery of systems to pilot site took place ahead of schedule
• Engineered solutions and manufacturing of units were achieved within budget
• Reliability of systems was enhanced
• Lower failure rates were achieved thanks to the improved electronic design of system
• Assembly design was improved resulting in reduced time for electronic and mechanical assembly
• Enhanced system design made the unit easier to install and reduced time spent on maintenance