Life Sciences Orthopedic Devices

Benefits

Achieve system validation with qualified cloud infrastructure

Integrate quality directly into core business processes

Improve supply chain governance and visibility

Establish consistent global processes

Control transaction costs, pricing and reconciliations in group buying scenarios

QAD offers a unique solution for orthopedic device manufacturers including a world-class, full-featured ERP that delivers the agility needed to adapt to changing business and regulatory requirements. QAD Cloud ERP Life Sciences Edition is at the core of QAD’s orthopedic device solution that provides manufacturers full control of manufacturing processes while remaining compliant with global Good Manufacturing Practice (GMP) regulations.

Orthopedic Device Manufacturer Value Chain

Key features of the solution include material traceability, demand planning, supply chain execution, quality management and global financials. These and other capabilities help orthopedic device manufacturers control risk while improving operations that align with business strategy.

Reduce manual process costs and errors by 50% by automating complaint management and quality-related processes.

Increase inventory turns, reducing inventory by 10-25% by using sophisticated forecasting methods and detecting demand forecast changes as they happen.

Improve DIFOT through better supply chain insight and accurate tracking of in-process inventory.

QAD Orthopedic Device Solution Overview

The orthopedic devices manufacturing industry has experienced strong growth in recent years due to changes in patient demographics. Aging populations, the prevalence of orthopedic diseases, increasing rates of obesity and the overall surge in active lifestyles all contribute to greater demand for implantable orthopedic devices. Surgeries have become less invasive with shorter recovery times supported by emerging technologies like robot-assisted procedures and 3D printed devices. Physicians have become more adept at diagnosis and treatment, resulting in an overall improvement in patient outcomes and trust.

To take advantage of the growth, however, orthopedic device manufacturers face constant pressure to innovate. Hospitals and physicians no longer view orthopedic manufacturers as device providers but rather solutions providers. Healthcare providers expect manufacturers to provide a variety of kitting and solutions options that shorten surgery times, increase operating room efficiency and improve patient outcomes — many of which are tied to reimbursement. Manufacturers often work directly with physicians to devise comprehensive surgical solutions to complex clinical problems.

In addition, regulators around the world have increased their focus on patient safety. New standards like ISO 13485:2016 and regulations like Unique Device Identification (UDI) require manufacturers to invest in expensive systems and make operational changes that deliver no chargeable patient benefit.

While the orthopedic device industry outlook remains healthy and capable device manufacturers have a promising future, challenges remain. The following are critical business and manufacturing processes addressed by QAD’s world-class solution that helps orthopedic device manufacturers successfully address their challenges and sustain growth.

QAD QMS (Quality Management System)

Item Level Serialization

QAD TAM (Trade Activity Management)

QAD Automation Solutions — Data Collection and Label Printing

Regulatory Compliance

QAD DSCP (Demand and Supply Chain Planning)

Lot Traceability

QAD EAM (Enterprise Asset Management)

QAD BI (Business Intelligence)

An overview of the first three critical processes follows. For information about the other processes, please visit QAD.com.

QAD QMS (Quality Management System)

QAD QMS (Quality Management System) offers advanced capabilities and supports improvements in key medical device metrics by helping device manufacturers integrate related process data, automate required business processes and comply with global GMP regulations. 

QAD QMS 

QAD Automation Solutions – Data Collection and Label Printing

Increased regulatory scrutiny is creating compliance challenges for device manufacturers. ISO 13485:2016, the new standard for medical device quality systems, and regulations like Unique Device Identification (UDI) are placing greater emphasis on supply chain governance and material traceability.

Serialization capability combined with QAD Automation Solutions, which provides label printing and data collection capabilities, allows greater visibility and processes transactions more quickly and accurately. In addition, QAD’s UDI solution automates the aggregation of required UDI attribute data from sources across the enterprise and maintains a single and secure system of record for regulatory submissions. The solution enforces access control, preserves data integrity and manages changes throughout the product lifecycle and provides serialization and data collection for inventory tracking, as well as enhanced label printing services for the creation of regulatory compliant labels.

Serialized Inventory Browse with Label Printing

QAD TAM (Trade Activity Management)

Orthopedic device manufacturers often have significant challenges managing EDI transactions and reconciliations. Large wholesalers and distributors transact a huge amount of data with manufacturers that require reconciliation. Group purchasing organization (GPO) contracts are dynamic and intricate. Other related challenges include constantly changing prices, contract terms and complex chargebacks. Many manufacturers use manual processes and rely on spreadsheets to manage this complexity that often results in significant loss of revenue due to short payment, double payment and incorrect contract terms. QAD TAM (Trade Activity Management) automates this complex transactional environment, reducing errors, lowering costs and adding efficiencies.

Trade Contract Activity Center

For more information on how the QAD Orthopedic Device solution can help your company, please contact QAD at +1-805-566-6100 or email info@qad.com.