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Industry Landscape
The orthopedic device manufacturing industry is currently experiencing steady growth, driven by an aging population, increasing demand for minimally invasive surgeries, and technological advancements in implant materials and designs. Companies are focusing on innovation, regulatory compliance, and efficient supply chain management to maintain competitiveness. Personalized implants, robotic-assisted surgery, and 3D printing are key trends shaping the future of the industry. Strategic partnerships and acquisitions are also prevalent as companies seek to expand their product portfolios and market reach.
Total Assets Under Management (AUM)
Market Size in United States
~USD 55 Billion
(5.2% CAGR)
- Aging Population driving demand.
- Technological Advancements in implants.
- Increasing Surgical Procedures.
Total Addressable Market
55 Billion USD
Market Growth Stage
Pace of Market Growth
Emerging Technologies
3D Printing/Additive Manufacturing
The use of additive manufacturing allows for the creation of customized implants and surgical tools, improving patient outcomes and surgical precision.
Robotic-Assisted Surgery
Robotic-assisted surgery enhances precision, reduces invasiveness, and improves recovery times, driving demand for compatible orthopedic devices.
Personalized Implants
Personalized implants tailored to individual patient anatomy improve fit, function, and longevity, leading to better clinical results.
Impactful Policy Frameworks
FDA Quality System Regulation (21 CFR Part 820)
The FDA's Quality System Regulation (21 CFR Part 820) outlines current good manufacturing practice (CGMP) requirements for medical device manufacturers, covering aspects such as design, manufacturing, testing, and record-keeping.
Compliance with the FDA's quality system regulation ensures Arcamed maintains high manufacturing standards, which is critical for securing contracts with orthopedic OEMs.
ISO 10993-1:2018 - Biological evaluation of medical devices
ISO 10993-1:2018 specifies the requirements for biological evaluation of medical devices, ensuring that materials used are safe and biocompatible for their intended use.
Adhering to these standards ensures the biocompatibility and safety of materials used in surgical cases and trays, mitigating risks and liabilities for Arcamed.
FDA Unique Device Identification (UDI) System
The FDA's UDI System requires medical devices to be marked with a unique device identifier to improve traceability, post-market surveillance, and adverse event reporting.
Complying with Unique Device Identification (UDI) requirements ensures traceability and accountability of Arcamed's products, facilitating better supply chain management and regulatory compliance.
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