Market Leading. Resource Constrained.
A world leading medical device manufacturer was seeking to reconfigure existing manufacturing capacity to enable the introduction of a new complex product line at one of its facilities. The company chose Creganna-Tactx Medical as its partner for the transfer of manufacturing lines for a range of Class II & Class III devices in which the company is the product segment market leader. Creganna-Tactx Medical dedicated a 20 person team to the project who transferred and revalidated 40 products in a 9 month timeframe. The product lines now run at a steady >1million unit per annum capacity at Creganna-Tactx Medical. Unit cost reductions of up to 10% and yield improvements of 5% – 10% were realized during the transfer process.
Newly Approved Product. How to Scale?
An emerging medical device company had just received approval for a novel Class II Electrophysiology device which incorporated multiple technologies. The company turned to Creganna-Tactx Medical to create a scalable and robust manufacturing process for its product while also transferring capacity to enable dual-site manufacture of the product in anticipation of an extensive market launch. Over a 6 month timeframe - ahead of schedule and 10% under budget – the product was brought to full production capacity with gains of 170% in output.
A world first.
A leading surgical device company was seeking to gain first-mover advantage in an emerging less-invasive surgical field. The company faced a “first to market” race; however it was internally constrained as its development teams were fully engaged in fulfilling an existing product development pipeline. The company sought the assistance of Creganna-Tactx Medical to manage and accelerate the product development pipeline for this novel product. In 15 months, Creganna-Tactx Medical brought the project from initial concept development to First in Human trials, at which the first successful surgical procedure in the US using this advanced clinical technique was performed. Creganna-Tactx Medical continues to partner with the company as it establishes its product strategy.
Start-up Company. Successful sale.
A European based medical technology start-up, established by a team of seasoned industry entrepreneurs and backed by VC investors, approached Creganna-Tactx Medical to support the development of a catheter based delivery device for a specialist coronary application. In 6 months, the Creganna-Tactx Medical team had delivered a series of iterative prototypes and clinical lots of the product and supported the company through the CE approval process. The company subsequently sold to a leading global medical device company who today continue the design and manufacturing partnership with Creganna-Tactx Medical for this product.
Funding Milestone Achieved.
A new US based medical device company retained Creganna-Tactx Medical to assist at the earliest stages of its formation. The company was seeking Series A financing but identified that in an increasingly difficult financial environment it would require some further development of its product concept. The company invested seed capital to retain the services of a Creganna-Tactx Medical design team over a 4 week period in which Voice of Customer, Proof of Concept and short run Prototyping was achieved. These early stage development supports assisted the company in securing finance. Creganna-Tactx Medical continues to work with the company to bring its product to market.
Next Generation Device. Better Performance.
A company was seeking an outsourcing partner for the development of the next generation of its Class II specialty coronary catheter. The company choose Creganna-Tactx Medical for the project which included product redesign to improve performance and design for manufacturability to achieve a consistent & repeatable product manufacturing process and thereby smooth the transition from development to commercial manufacture. The project was executed by Creganna-Tactx Medical from design concept to submission for FDA 510k approval in 20 months, was transferred to manufacturing and ramped for commercial volume. Overall, the device was greatly improved from a performance perspective enabling the customer to retain and win market share in its segment.