Case Studies

Case Studies

Case Study 1 – Design and development of Class II device for a leading medical device manufacturer
 

Case Study 2 – Manufacturing ramp-up for a newly approved product, early stage company
 

Case Study 3 – Design and development of a novel concept device for a start-up, venture back company
 

Case Study 4 – Design and development of a device for a new clinical field for a leading surgical device company

Case Study 1 - Design and development of Class II device for a leading medical device manufacturer

Challenge:
To design, develop and ramp to market release the next generation of a Class II device for a leading player in the Minimally Invasive (MI) medical device market. The project addressed an accessory device used in the placement and retrieval of minimally invasive devices in vivo during an MI therapy procedure.

Project Success
This project was fully managed by a Creganna Contract Design Service team. The team delivered the project from design, validation & verification, transfer-to-manufacture to volume ramp-up to market release. The device design exceeded the initial performance requirements of the customer, enabling the market release of a superior product. Manufacturing targets were also exceeded at the volume ramp phase -a target yield of 85% was required by the customer. Yields in excess of 95% were achieved. The project duration for this FDA approved product was 12 months from initial contact to market release.

Case Study 2 – Manufacturing ramp-up for a newly approved product, early stage company

Challenge:
A venture capital backed early stage company that had just received FDA approval for an advanced catheter based Class II device and required rapid ramp up to meet market demand. In conjunction to fulfilling market demand, the customer was seeking to streamline manufacturing for volume production at their existing facility and find a partner to undertake additional manufacturing to meet capacity. The customer’s key goal was to find a partner who could add value to their product rather than a contract manufacturing engagement.

Project Success:
A project management team from Creganna Contract Design was gathered to work exclusively on this customer project. The team were deployed to the customer’s current manufacturing site to understand the supply chain, manufacturing process and other requirement to produce the product. Initially, a lean manufacturing program was undertaken to introduce best practice for the existing product lines, introduce superior process methodologies and simplify the manufacturing process. Weekly output was tripled at the customer’s existing manufacturing site. Production capacity was mirrored at a Creganna facility enabling the customer to undergo a steep ramp in capacity.


Case Study 3 – Design and development of a novel concept device for a start-up, venture back company

Challenge
To design and manufacture a novel concept Class II minimally invasive catheter based device. The customer, an early stage venture backed company led by senior physicians, had developed a new product concept for vascular therapy. Initial project requirements were to conduct benchmarking and concept feasibility programs. Key to the project was the achievement of project milestones set by investors.

Project Success
Supporting the project from a starting position, the Creganna Contract Design Service team moved from concept development to First in Man Trials in four months. This impressive development timeline was achieved by working activities in parallel, frequent communication with the client and dedicating a full cross functional team to the project. Other milestones achieved by Creganna in conjunction with the client included CE mark approval and MCT. Creganna’s input to achieve key milestones contributed to investor confidence in the ability of the client company to bring a portfolio of new products to market.  
 

Case Study 4 – Design and development of a device for a new clinical field for a leading surgical device company

 
Challenge
A division of a leading medical device company wished to develop a device for an emerging clinical application. The client faced a first to market race; therefore an accelerated product development timeline was central to project success. 
 

Project Success
From initial concept development, Creganna Design Service set out to achieve First In Man trials in 15 months. 510K submissions were also supported by the team. The team developed the full product for the customer incorporating activities such as performance testing, biocompatibility testing and animal trials.
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