The Medical Device Innovation Consortium (MDIC) joins manufacturers and organizations across the country in celebrating Manufacturing Day 2021. MDIC and its members recognize that manufacturing innovation is a critical part of the total product life cycle for medical devices and directly impacts patient access to innovative, safe, and effective medical technologies.

MDIC today released its white paper The Road to Advanced Manufacturing in the Medical Device Industry. Regulatory complexity, specifically the need to design products in compliance with global regulatory agencies such as FDA, is a key driver of innovation in the medical device industry and has significant impacts for the regulatory process. The white paper illustrates how a digitalization roadmap can guide a medical device company in its journey to digitally transform its product design and manufacturing practices to leverage advanced manufacturing technologies. It is the first MDIC resource focused specifically on manufacturing challenges and opportunities.

The white paper covers the following topics:

• What is advanced manufacturing?
• Medical device industry drivers
• Advanced manufacturing enabling technology
• Digital threads
• Current adoption of advanced manufacturing techniques
• Current state of the medical device industry
• Survey results and analysis
• The path forward

“While MDIC operates in the pre-competitive space, we recognize that we can play a key role in supporting innovation across the medical device industry and we are excited to add advanced manufacturing as one of our key focus areas,” said Pamela Goldberg, MDIC President and CEO. “In the last two years we have seen how critical it is for our nation to be able to rapidly innovate, regulate, and manufacture transformational medical technologies.”

“With ever-increasing complexity in a globalized industry, and the need to respond to post-pandemic changes in manufacturing strategies and supply chains, we believe now is the time to digitally transform design and manufacturing to accelerate innovation, leveraging established technologies and practices from MD&D industry leaders and other more mature industries,” said James B. Thompson, Sr. Director of Medical Device & Pharmaceutical Industry Strategy, Siemens Digital Industries Software. “Using a concept we call Digital Threads, this white paper helps guide firms to benchmark, select and structure a roadmap aligned with their company’s business and technical priorities.”

Later this year, MDIC will host a webinar on this white paper and advanced manufacturing in the medical device industry. Sign up here to be notified when more details are available.

About the Medical Device Innovation Consortium

Founded in 2012, the Medical Device Innovation Consortium (MDIC) focuses on advancing medical device regulatory science throughout the total product lifecycle. MDIC’s mission is to leverage its unique position as the only public-private partnership of its kind to transform health care into human care. Collaborating with our partners to advance science, we enable transformational medical technology to shape the world we want to live in and make that world possible by shortening the path from innovation to safety to access. For more information, visit http://www.mdic.org.

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