Client Testimonials

Steve Goedeke, CEO of Cardionomic, Inc.

Cardionomic is a start-up pursuing a PMA for a novel heart failure therapy.  After speaking to many leaders in the Minnesota medtech community I concluded that LibraMed, and Sew-Wah specifically, was the best pathway to success.  I have not been disappointed.  Sew-Wah brings a wealth of experience to our team and a long standing, constructive relationship with the FDA.  Sew-Wah has been an excellent partner and coach as we’ve gone from a dead start through three pre-sub meetings in 9 months.  Our combined efforts have culminated in the FDA being fully supportive of our submission strategy and use of the Early Feasibility Study pathway.  I look forward to continuing to partner with Sew-Wah as we march towards our PMA.

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Tom Ressemann, CEO of Entellus Medical

With Libra Medical as our partner, I could rest at night knowing that our regulatory and clinical strategy was well defined and getting executed efficiently. Sew-Wah’s personal level of engagement in understanding our needs and the competence her team delivers is unparalleled in the industry.

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Joe Goldberger, CEO and President  of Interrad Medical, Inc.

Interrad LogoSew-Wah has been capable of overseeing the development of our regulatory submissions and our clinical studies since she started Libra Medical two years ago.  Since then, we have received FDA clearance for our first device and are completing a clinical study under her watchful eye.  There are simply very few individuals, companies or firms – anywhere, who can offer the high level of advice and support to medical device companies, in the comprehensive fashion that Sew-Wah and Libra Medical effectively can.

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Robert J. Thatcher, Executive VP Cardiovascular Systems Inc. (CSI)

Cardiovascular Systems IncLibra Medical is a part of the CSI regulatory and clinical team and has added value in many ways during the past 17 months in both Regulatory and Clinical areas. An example of the time and money they have saved us, is the work they have done with our Coronary feasibility trial. Fifty patients were recruited and enrolled in this trial at two sites in India in less than six weeks. While the speed of the enrollment is impressive, the work done in advance of choosing the India location with the FDA was the most impressive. The relationship developed over time with the FDA and the CSI / Libra Medical team enabled the India trial to be discussed and agreed to while working directly with the FDA.

In the clinical area, Libra Medical helped close out our two peripheral clinical trials, and helped develop the strategy on numerous post market studies currently under development or being implemented today. Unlike most consultants Libra Medical has never brought excuses to our teams, only results. It is not unusual to have next day turnaround on key deliverables as well as work on the weekends to get things done on time.

From a customer perspective, Libra Medical has been extremely effective interacting with our diverse customer base. They are not intimidated by our various physician specialties and are politically savvy enough to ensure clinical protocols are written to be effective without stepping on our customer toes. Our customers enjoy working with the Libra Medical team and quickly come to respect the expertise they bring to the CSI team. We look for ways to include Libra Medical in customer meetings focused on clinical trials and protocols as they always add value in these settings. They are always looking for ways to get things done in the most cost effective way possible; I have found this a very unique trait for any consultant.

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Ann Krzmarzick, Project Manager Cardiovascular Systems Inc. (CSI)

Cardiovascular Systems IncWe engaged Libra Medical in a clinical project that we did not have the bandwidth to execute in the timeframe required. Libra Medical’s work on our clinical studies is impeccable – from creating the protocol to managing the study sites. Every detail is addressed in a timely manner. They are responsive, knowledgeable and congenial colleagues. I am thankful we’ve been able to trust them and rely on them so heavily to accomplish our goals!

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Kari Cierzan, Product Manager at American Medical System, Inc.

ams_logo1Sew-Wah Tay and her team not only met our deadlines, but the quality of and and manner in which the data were gathered allowed us to speed up our launch timing and utilize the data to support the tactics and messages we planned for. The Libra Medical team was very accessible and responsive, and I would recommend working with them again.

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Jonas Runquist, VP of Regulatory and QA, Heart Leaflet Technologies (HLT)

Heart Leaflet TechnologiesHeart Leaflet Technologies, Inc. (HLT) has been working with Libra Medical since December of 2007. Libra Medical has assisted HLT in development of the HLT Quality System, and has provided assistance with some design control and risk assessment documents. In addition Libra Medical has provided assistance with the Clinical Protocol and CRF development.

HLT’s experience working with Libra has been very positive. They have consistently provided rapid turn around of projects and the quality of work has been very high. Libra has also been very responsive in addressing questions and providing guidance as needed.

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