Welcome to Part Two of our blog series on medical device manufacturing. If you missed our first blog, "Build Quality Medical Devices Simply," access it here.
In the medical device manufacturing sector, it's no longer sufficient to manufacture a top-of-the-line product.
Manufacturers of medical devices and diagnostics are faced with overwhelming challenges to bring the appropriate products to market at the proper time and with the highest possible quality.
They're also responsible for knowing where that product is on its complex journey so they can recall it asap should a manufacturing defect be identified.
However, the majority of manufacturers find the process of managing their medical device inventory to be one that is not only difficult but also time-consuming, labor-intensive, and expensive. Many manufacturers still rely on inefficient and outmoded systems to track and manage inventory and an army of sales reps to store and deliver valuable products in time for surgeries.
According to a report by McKinsey, supply chain expenses account for more than 40% of the total cost of medical devices.
In the current climate of the healthcare industry, these expenses are increasing due to cost pressures, a resource utilization crunch, and regulatory compliance. Because of this, the manufacturer of medical devices and their customers (hospitals and clinics) have an additional obligation to manage their field inventory assets effectively while minimizing the risk of adversely affecting patient outcomes.
Medical Device Tracking is not a competitive 'nice-to-have' – it's a legal mandate
The "last-mile "problem in the supply chain is common in the healthcare industry. The field inventory may end up in the car trunks of sales representatives, on hospital shelves as a consignment inventory (pay-as-you-use model), or in transit between hospitals and clinics.
And that's why medical device tracking matters.
According to the Food and Drug Administration (FDA), medical device tracking aims to ensure that manufacturers of specific devices establish tracking systems that will enable them to locate devices promptly in commercial distribution.
These tracking systems ensure that device tracking can serve its purpose. When a manufacturer receives an order from the FDA to implement a tracking system for a specific device, the manufacturer must track the device from the point of manufacturing through the distribution chain.
When medical devices pose significant dangers to a person's health, the FDA may request that tracking information facilitates notifications and recalls.
A ‘day-in-the-life’ of the Medical Device Manufacturer
It would be an understatement to say that the market for medical equipment is encountering difficulties due to the current state of the economy.
Daily revenue and profitability challenges include regulatory compliance, stringent quality control requirements, the complexity of modern medical equipment, and the ever-increasing research and development costs.
These issues all need to be faced and addressed to be successful.
The challenges posed by the pandemic have now accelerated the adoption of ERP technologies for device tracking and management at the manufacturing level.
In response, medical device manufacturers and health systems are moving from proof of concept to full-scale implementations of these technologies.
Even when sold through distributors, medical device manufacturers are still responsible for tracking devices from the source to the hospital, doctor, and patient recipients.
Suppose you manufacture spinal cord replacement parts, a pacemaker, or any other medical device.
In that case, you need complete visibility to notify recipients as quickly as possible in the event of a recall. It's one of the many stringent compliance requirements that device manufacturers must meet.
Compliance is not only something expected by the government in an industry that is so heavily regulated, but it is also something that customers demand in this industry.
You have to comply with regulations on two different levels: the local and the international level.
The good news?
With a robust ERP for Medical Device Manufacturers that enables you to automate your compliance processes for the industry- and location-specific regulations, you will realize many benefits: avoid warnings, recalls, the potential for litigation, steep regulatory fines, and dissatisfied customers.
You have access to the audit trails, allowing you to conduct investigations and find solutions to non-conformance issues more quickly, helping you to meet the requirements of the regulations.
Helps Maintain a Higher Standard of Quality
Your goal is to ensure that the products you sell customers are of the highest quality. The standards for the product's quality are at the center of the regulatory framework developed for this economy sector.
Unfortunately, if you can't see all of the components that go into making up an experience, you won't be able to judge or control that experience's quality accurately.
ERP software grants you the visibility you require to ensure the quality of your product at every stage, from the engineering phase to the submission phase to the production phase to the order fulfillment and delivery phase.
Keeps Better Track of Things
ERP software designed for manufacturers of medical devices provides support for traceability in many different ways, including the following:
Paperless tracking saves time and money while lowering the likelihood of making mistakes.
Keeping track of each lot and serial number
Genealogy of component products in serial order to fulfill the requirements of both customers and the industry
Product Documentation
Control of revisions and changes
Electronic signature
Keeping track of the movement of components and materials
A comprehensive record of the device's history
Increases Sales and Efforts to Satisfy Customers
Additionally, you can integrate your Customer Relationship Management software into the ERP system for manufacturing medical devices.
It allows you to provide better service to your customers by improving the visibility of your sales pipeline and the management of opportunities.
When tracking the production process and all the materials and parts required, you will have the visibility and knowledge necessary to streamline your pipeline and reduce its associated costs.
Streamlines Your Methods of Research and Product Development
One of the most important considerations when considering whether or not to launch a new product is typically the amount of money spent on research and development.
You will also be able to control the design and release processes and manage the authorizations required by your engineers when you use an ERP for Medical Device Manufacturers.
ERP software also enables you to keep tabs on and analyze those costs.
Conclusion
Enterprise resource planning (ERP) software for the manufacturing of medical devices gives you the lens to see the whole picture of your manufacturing processes, allowing you to make informed decisions that lead to increased profits and productivity.
The manufacturing of medical devices is a complex industry burdened with regulations and expenses; however, the ERP software you use, developed specifically for the requirements of your industry, can help streamline the various aspects of the process.
A robust ERP solution can simplify your processes and provide you with a clear path forward, with increased visibility, traceability, and quality control.
Ready to improve your medical device tracking?
Contact Turnkey Technologies – your solution for successful technology implementations.
Microsoft's solutions have been developed from the ground up with business needs, regulatory compliance, and data protection in mind. The Turnkey expert team can quickly update and improve your business management software, allowing you to comply with regulations easily. To learn more, please visit our industry page.
If you missed our Part One blog, "Build Quality Medical Devices Simply," please access it here.
ABOUT THE AUTHOR: Turnkey Technologies has empowered B2B, mid-sized, and enterprise organizations to optimize their data and processes to achieve more, in less time, with less expense, for over 27 years. As a Microsoft Gold Partner, we turn our magic using Microsoft technologies, our singular focus. We support Microsoft Dynamics 365 Business Central, Finance & Operations, CRM, and more with a dedicated and trained professional team in all things Microsoft. www.turnkeytec.com
