Avania, a leading, global medical technology contract research organization (CRO), today announced its acquisition of HULL ASSOCIATES LLC and Ironstone Product Development (IPD) with a view toward addressing MedTech’s emerging priorities in regulatory and reimbursement and building scale to offer thoughtful strategies and differentiated project delivery for all product categories.
With Full Suite of Customizable Solutions, Avania is Taking
Industry Lead in Offering Targeted, Actionable Strategies for Medical Devices and Diagnostics in All Major Global Markets
Avania, a leading, global medical
technology contract research organization (CRO), today announced its
acquisition of HULL ASSOCIATES LLC and Ironstone Product Development (IPD) with a view toward addressing MedTech’s emerging priorities in
regulatory and reimbursement and building scale to offer thoughtful strategies
and differentiated project delivery for all product categories.
Headquartered in Boston,
Massachusetts, HULL ASSOCIATES LLC is a leading strategic market access and
reimbursement consultancy firm specialized in achieving market access for
medical device, diagnostic, and specialty pharma products in all major global
markets, including United States, Europe, Latin America, Japan, India, and
China. HULL ASSOCIATES LLC has in-country experts who are specialized in market
access, offering both technical knowledge and relationships to achieve results.
The core focus areas for the business include strategic services such as market
access & reimbursement assessments; evidence planning; data analytics &
health economics; pricing analysis; assessment & validation of clinical
trial designs; as well as in-country post-launch services to support coverage,
coding, and payment in all the global markets.
Founded by Joel Ironstone in 2013
and headquartered in Toronto, Canada, IPD has been focused on assisting clients
with all aspects of medical and health product development and
commercialization which directly aligns with Avania’s vision. The core focus areas
for the business are early product development, quality, and strategic
regulatory with projects in the areas of medical robotics and surgical
navigation, AI/machine learning, imaging, respiratory devices, IVDs, and
wearables. This acquisition will strengthen Avania’s position in these product
categories, further advancing Avania’s leadership in this space.
The combined organization offers
unmatched high-touch strategic and operational expertise that uniquely drive
results for medical device innovators and emerging original equipment
manufacturers (OEMs).
“The addition of HULL ASSOCIATES
and IPD furthers our vision of becoming a trusted global partner for the
MedTech community, advancing innovations from bench to bedside, improving
patient outcomes globally,” said Sapna Hornyak, president and CEO of Avania, “and will provide us with enhanced
capabilities to bring comprehensive, highly customized solutions to every
partnership as we continue to lead the MedTech CRO segment as a preferred life
cycle partner.”
Avania customers will benefit from
an expanded roster of subject matter experts in the global pre-clinical,
clinical (in vitro diagnostics, artificial intelligence/machine learning, and
software as medical device), regulatory, and market access consulting space.
About Avania
Avania is a leading,
global full-service contract research organization focused on the management of
clinical studies for medical devices, IVDs, biologics, and device-drug
combination products internationally. Avania supports products from the
first-in-human phase through the post-market phase with the same customized
approach. When you need to advance your medical technology, it takes Avania.
Avania’s vision is to be your trusted global partner in the evolution of your
medical technology from innovation to commercialization to improving patient
health and well-being.
About HULL ASSOCIATES LLC
Founded in 2007, HULL ASSOCIATES
LLC offers strategic market access and reimbursement consulting to medical
device and diagnostic clients in all major global markets. Services include
market access & reimbursement assessments; evidence planning; data
analytics & health economics; pricing analysis; assessment & validation
of clinical trial design and in-country reimbursement strategy and support. The
team of in-country experts are specialized in market access with both the
technical knowledge and relationships to achieve results.
About Ironstone Product
Development (IPD)
Ironstone Product Development (IPD)
is an ISO 13485:2016 certified medical device development company. IPD assists
clients with all aspects of medical and health product development and
commercialization. IPD’s background includes extensive work in engineering,
clinical utility and regulatory strategy enabling the team to understand the
details of how a product works both technically and clinically while clearly
communicating this to regulatory bodies.