BILTHOVEN, Netherlan--(뉴스와이어)--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.

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