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Healthcare manufacturing has been booming in recent years. In fact, the global medical device industry is expected to rise from $471 billion in 2020 to $623 billion by 2026, with a 5% annual CAGR growth.

This growth is driven by increasing public and government funding and lessened restrictions on some devices. However, the pandemic, rising inflation, and overall economic uncertainty have created a snowball effect across multiple business sectors. 

Specifically, the healthcare and medical devices industries face a range of major threats and obstacles. These issues include everything from supply chain shocks and regulatory compliance tracking to customization roadblocks and outdated technology. The way to overcome supply chain challenges lies in implementing ERP medical device manufacturing software, such as NetSuite for healthcare.   

Common Healthcare Supply Chain Challenges

Medical devices, biotech, pharma, and similar healthcare industries have struggled with various barriers to their supply chains. The resulting shortage of materials, components, and parts is primarily caused by capacity reduction, demand surge, and coordination failure.  

The most common barriers revolve around four main supply chain challenges:  

Supply Chain Shocks

The pandemic pushed medical device manufacturers into a supply chain crisis that shocked the system. Supply chain shocks are sudden and unexpected events (e.g., pandemics, cyberattacks, etc.) that cause dramatic fluctuations in supply and demand. Manufacturers are now challenged with a high demand for equipment and supplies amid parts and raw materials disruptions and bottlenecks, as well as labor shortages.  

According to a McKinsey Global Institute (MGI) report, supply chain shocks that last longer than a month reoccur every 3.7 years. In addition, within a ten-year period, these frequently occurring shocks can cause companies to lose a significant portion of their one-year earnings. On average, medical device companies lose 37.9% of revenues and pharmaceuticals lose 24%.  

Regulatory Compliance Tracking

The medical device industry is highly regulated for safety, effectiveness, quality, and security. As such, manufacturers must maintain compliance throughout their entire processes, from purchasing and receiving to design and production to testing and storage. However, components that move through supply chains can be tricky to track when they aren’t considered end products.  

To combat this, the U.S. Food and Drug Administration (FDA) makes it mandatory that all items contain a unique device identifier (UDI). UDIs are submitted and stored in the Global Unique Device Identification Database (GUDID). That way, medical devices can be tracked from the manufacturers all the way to the patients assigned to use them. But this also puts added pressure on medical device companies. 

Customization Roadblocks

Customization has become the name of the game in many sectors. 3D printing technology has drastically changed the way manufacturers produce medical devices. They can now create 3D-printed medical devices specially built to suit consumers’ individual needs and expectations. This approach offers opportunities to produce on-demand products using a wide range of materials that are more flexible, cost-effective, and faster to prototype.  

3D-printed medical devices include orthopedic implants, surgical instruments, dental crowns, prosthetics, medical phantoms, and many others. Bioprinting, a type of 3D printing that involves placing living cells into shapes to form tissues and organs, already exists for simple organs (e.g., bladders). In the future, biotech companies will be able to create more complex organs for transplantation.  

The downside to creating custom parts is that it can slow down supply chains. In addition, FDA regulations for 3D-printed medical devices are complex to navigate. This makes the widespread distribution of highly personalized healthcare products another major challenge.  

Outdated Technology

While the medical device industry forges forward with groundbreaking innovations, some companies are still stuck in the past. Manual systems and processes lack efficiency and sustainability, which are must-haves, especially as consumers and businesses face periods of uncertainty. Unfortunately, concerns over the added expense, effort, and regulations are holding back many manufacturers.   

Digital transformation is at the forefront for those desiring to meet changing consumer demand and maintain a competitive advantage. The value of digital technology could reach $3 trillion by 2030 as healthcare organizations realize a 10-20% savings in efficiency.  

Green Business Systems (GBS) is a medical device ERP solutions service provider that helps companies streamline business functions and get products to market faster. 

Overcoming Supply Chain Challenges

Finding ways to overcome issues impacting healthcare supply chains is an enormous challenge in itself. Following are four approaches manufacturers can take to get back on track and stay on track. The key lies in using ERP technology.  

Implement Modern Technology

Business leaders must understand the importance of staying current with technology. This applies to all business processes, from manufacturing and distribution to operations and accounting. Newly implemented or upgraded systems should allow for greater transparency and traceability throughout the manufacturing process. As a result, products can be tracked to identify supply disruptions or respond to adverse events.  

ERP for medical device manufacturers, pharma, and biotech is the ideal way to ensure all business functions work seamlessly together. It allows for real-time snapshots of the supply chain and communication with suppliers and customers. This helps companies minimize the effects of shocks and disruptions in the supply chain.  

Take Advantage of Predictive Analytics

he medical device industry is highly regulated for safety, effectiveness, quality, and security. As such, manufacturers must maintain compliance throughout their entire processes, from purchasing and receiving to design and production to testing and storage. However, components that move through supply chains can be tricky to track when they aren’t considered end products.  

To combat this, the U.S. Food and Drug Administration (FDA) makes it mandatory that all items contain a unique device identifier (UDI). UDIs are submitted and stored in the Global Unique Device Identification Database (GUDID). That way, medical devices can be tracked from the manufacturers all the way to the patients assigned to use them. But this also puts added pressure on medical device companies. 

Use Data to Improve Processes

In addition to predictive analytics, data can be leveraged to streamline entire business functions. Use data to improve the manufacturing process, which greatly influences product quality. Supply chain segmentation helps streamline product flow by matching them with optimal conditions for production and distribution. Lastly, operation assessments can be performed to increase operational efficiency and prevent maintenance issues.  

ERP systems provide the capability to manage all processes and conduct assessments. For healthcare organizations, this helps ensure the smooth, efficient production of high-quality products.  

Diversify Supplier Lists

In finance, the golden rule is never to put all your eggs in one basket. The same holds for vendors and suppliers of components and parts needed to manufacture medical devices. Relying on a single supplier puts the manufacturers at a greater risk. That third-party vendor could end up with issues related to shortages, quality, and even compliance. Instead, generate a list of partners and consider local niche organizations.  

Managing a diverse set of suppliers using a medical device ERP system reduces this potential risk. This is essential for companies like pharma contract manufacturing organizations (CMOs) and contracts development and manufacturing organizations (CDMOs).  

As a NetSuite cloud services partner, GBS can offer customized ERP solutions to transform and optimize your business for increased efficiency and reduced costs. 

Features and Benefits of ERP

Many can reap the rewards of implementing modern technology into their business processes. More specifically, ERP offers many valuable features and benefits for medical device manufacturers, biotech companies, pharma companies, and CMOs/CDMOs 

Healthcare ERP Software Key Features

Global business management capability to manage subsidiaries and third-party contracts.  

Manufacturing resource planning to streamline manufacturing and enhance supply chain management.  

Financial and accounting that integrate with sales and service workflows and provide real-time production tracking.  

Budgeting and forecasting to provide integrated budgeting and planning applications.  

Customer relations for a 360-degree view of current contacts and easy-to-use communication channels.  

Healthcare ERP Software Benefits   

Eliminates the need for outsourcing, reducing the risk of compliance and safety issues that can lead to many lives lost, lawsuits, and fines.   

Provides better communication between contract partners and a better compliance record.   

Improves accuracy and output, so safe pharmaceuticals reach consumers more quickly.  

Resilient medical product supply chains are designed to prevent shortages that compromise public health and safety. They’re characterized by a level of awareness that includes transparency, communication, and analytics. In turn, businesses must implement measures to mitigate, prepare for, and respond to adverse events that affect supply chains. ERP for medical device manufacturers, NetSuite for healthcare, in particular, is an invaluable tool for managing the supply chain.  

Get Started with Implementing ERP Solutions

The post-pandemic era leaves many organizations scrambling to adapt to the unexpected change in supply and demand. The urgency of an unprecedented time has led to the need for more third-party contractors. As healthcare organizations face unique supply chain challenges, they must also maintain the highest quality, safety, and compliance levels. Companies that offer pharmaceutical, biotech, and medical device products can’t afford to take legal and financial risks associated with a complicated and nuanced industry. That’s where healthcare ERP software comes in.   

At GBS, we help healthcare businesses run as smoothly as possible. Our custom ERP software solution, NetSuite for healthcare, is designed for biotech, pharma, medical device manufacturers, and other healthcare organizations. As industry experts, we can help you navigate complex regulatory requirements and streamline processes for optimal safety and compliance. To learn more about our healthcare ERP software, contact us today.