Pressure-Tipped Heart Needle Honored as Finalist in the Medical Design Excellence Awards

Thursday, May 28, 2015 - 15:30

MDEA represent medtech industry’s premier medical device design competition

Mansfield, MA – May 29, 2015 – Proven Process Medical Devices Inc. is pleased to announce that its customer, EpiEP, has been selected as a finalist in the 2015 Annual Medical Design Excellence Awards competition for its innovative pressure-tipped heart needle. Finalists were officially announced in the May Issue of MD+DI magazine. Winners will be announced at the 2015 MDEA Ceremony held Tuesday, June 9, 2015 in conjunction with the MD&M East event at the Jacob K. Javits Convention Center in New York.

As a supplier to the finalist, Proven Process overcame the limitations of existing retractable needle design by developing a pressure-tipped heart needle – a retractable, dual lumen needle that carries a sensor, which measures pressure differentials during the puncture of the muscle structures surrounding the heart. An overmolded handle provides clearance for pass-through of a fiber optic cable and a Luer connection so that liquid can be flushed through the non-coring needle. The design process included considerations for needle length and handle configuration, pressure sensor placement and bonding to the inner tube. The 510K-approved device gives surgeons better awareness of their tools' positions and alerts them when they might risk puncturing a ventricle. Current procedures for minimally invasive access to the epicardium run the risk of puncturing the right heart ventricle up to 30% of the time during catheter and pacer lead insertion.


The MDEA is the medtech industry’s premier design competition committed to searching worldwide for the highest caliber finished medical devices, products, systems, or packaging available on the market. The awards program celebrates the achievements of the medical device manufacturers, their suppliers and the many people behind the scenes — engineers, scientists, designers, and clinicians — who are responsible for the cutting-edge products that are saving lives; improving patient healthcare; and transforming medtech one innovation at a time.

“Developing this product gave us a chance to improve surgical precision in epicardial procedures and reduce patient risks. At Proven Process, we are focused on serving our role in the medical community as a high-integrity, world-class contract developer and manufacturer of best-in-class medical devices. The results are often realized in increased patient safety, as in the case of this pressure-tipped needle developed by our client and partner, EpiEP,” said Ken Fine, Proven Process president and co-founder.

Entries are judged by an impartial panel of medtech experts. Unlike other design competitions that are merely styling contests, the MDEA jury is comprised of a balance of practicing doctors, nurses, and technicians alongside industrial designers, engineers, manufacturers, and human factors experts. MDEA jurors comprehensively review entries based on the following criteria: the ability of the product development team to overcome all challenges so the product meets its clinical objectives; innovative use of materials, components, and processes; user-related functions improving healthcare delivery and changing traditional medical attitudes or practices; features providing enhanced benefits to the patient and end-user in relation to clinical efficacy; manufacturing cost-effectiveness and profitability; and healthcare system benefits such as improved accessibility, efficacy, or safety, in addition to providing attention to a critical unmet clinical need.

The 2015 MDEA Juror Panel selected 45 exceptional finalists in 10 medical technology product

categories. Products were judged based on design and engineering innovation; function and user related innovation; patient benefits; business benefits; and overall benefit to the healthcare system.

Winners will be announced on Tuesday, June 9, 2015 at MD&M East’s main networking event — the 2015 Medical Design Excellence Awards ceremony. MD+DI will recognize the finalists and announce the Bronze, Silver, and Gold winners in each of the 10 medtech categories, as well as present the Readers’ Choice, Best-In-Show, Lifetime Achievement Awards, and more! RSVP during your MD&M East registration to reserve your ticket. Admission is FREE but donations are encouraged to benefit NCIIA’s BMEidea, a design competition for biomedical engineering university students whose winners will also be announced at the ceremony.

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