Reimbursement & Regulatory
“Walnut Hill Medical has been a valuable partner helping us navigate reimbursement and regulatory. They coordinated our activities with CMS including a successful C-code application and connected us with policy representatives in medical societies. Their regulatory team efficiently wrote and submitted our successful 510(k) application for CivaSheet. They have helped our company meet key milestones. We continue to work with Walnut Hill Medical because of the professionalism and effectiveness they bring to each task.”
Susan Babcock
CivaTech Oncology
Richard Wunderlich
President, Myelotec
Grant Development
“Walnut Hill Medical provided expertise in the grant development and budgeting processes enabling Atlanta Catheter Therapies, Inc. to receive a $244,479 grant on our first application. Their knowledge of the agency and procedures provided clear directions to facilitate completing the request. Not only do I highly recommend Walnut Hill Medical for obtaining non-dilutive research funding, but we plan to engage them again for larger funding opportunities.”
Paul J. Fitzpatrick, CEO
Atlanta Catheter Therapies, Inc.
Market Access
“The Walnut Hill Medical team brought exceptional insight and clarity to an extremely diverse and complicated landscape, adding tremendous value. Top qualities: Expert, Good Value, High Integrity.”
Phil Mansour, Principal
PMC Consulting
Quality Management
“Walnut Hill Medical played a critical role in the creation of our Quality Management System. They did so in a precise and efficient manner, allowing us to meet our objective at a reasonable price. We considered a number of different firms, both big and small, but found that Walnut Hill Medical simply provided the greatest value. We are a better company because of our relationship with them.”
Vincent L. Olmo, COO
Revolutions Medical Corporation
Regulatory
“We had a great experience working with the Walnut Hill Medical team. We found the final assessment to be very thorough, and it pulled together a lot of useful information. We look forward to working together in the future when we are ready to do the pre-submission.”
Stephen Kalinsky
Augment Health
Reimbursement
“We have had the pleasure of working with the Walnut Hill Medical team and we feel so blessed to have been connected with them. They have exceeded our expectations by creating a detailed and customized reimbursement guide. They are focused on building a relationship with their clients and went above and beyond to accommodate our needs and schedules. We are thankful for the resources they provided but mostly for the relationship we continue to foster with them.”
Kaitlyn Buss, PT, DPT, CSMS
Clinical Research Expert, H Robotics
Reimbursement Strategy
“Walnut Hill Medical drafted a sound reimbursement strategy for our novel device and assisted us in the execution of that strategy every step of the way.”
John Zak, CEO
Pro2Cool TecTraum
Regulatory & FDA
“Walnut Hill Medical played an integral role in our effort to fast-track low-cost ventilators in response to a Defense Health Agency pandemic-related challenge. Their regulatory expertise in the medical device industry contributed greatly to navigating the FDA's Emergency Use Authorization process, part of a collaborative effort that was able to provide ventilators to front-line medical professionals in an unprecedented timeline.”
Leadership Team
Wright Brothers Institute
Reimbursement
“Walnut Hill Medical enabled us to understand and efficiently navigate the complexity of the CLIA reimbursement process.”
John Zack, CEO
BioChip Labs
Regulatory Expertise
“It has been a pleasure to work with the staff at Walnut Hill Medical. Their guidance, direction, and regulatory expertise has been instrumental in helping prepare us and move us forward with our application to the FDA. For anyone seeking to engage with the FDA, I would highly recommend Walnut Hill Medical. Their experience, expertise, and follow-through is exceptional and will help ensure the best possible outcome for you and your team. We could not have done it without them.”
Medical Device Innovator