A preferred choice of next-gen business leaders to take key business decisions.
Gain insights with Industry specific success stories, case studies, videos and whitepapers for Sage Solutions
Get a comprehensive understanding on how to leverage maximum return and potential for ERP Software
Become the best medical device manufacturing business in the industry with Sage X3.
The medical device manufacturing industry is one of the most competitive and challenging industries in the world. About a decade ago, this industry saw significant adoption of software and technology that emphasized considerably on simplicity and design. Today, the speed has increased dramatically, and new processes and efficient devices play a substantial role in improving the manufacturing process, upgrading inventory management, enhancing the supply chain, and building cost-efficient products.Â
Here are few significant challenges that the medical device manufacturing industry is facing in India:
India imports about 75% of medical device equipment.
These devices are manufactured in other countries and have a high chance of failing in India due to the difference in the environment.Â
Also, materials management is another critical issue as most companies don’t make adequate adjustments to store and maintain such devices in appropriate conditions.
The two critical factors contributing to the broken Indian healthcare infrastructure are insufficient supplies and poor working conditions of medical devices.Â
According to a survey by WHO in 2004, 64% of the diagnostic services were distributed only across five cities. As a result, researchers failed to get pan-India feedback.
Moreover, people don’t often answer government surveys correctly, which doesn’t allow proper information collection and dissemination.
The academic-industry relationship in India isn’t robust. For example, a 2007 WIPO document shows that most Indian universities conduct very few research-related projects.Â
Further, the report suggests that consultancies play a significant role in collaborations but mostly prefer small-scale projects.
A similar study found that Indian universities lack sufficient knowledge of IPRs, leading to a low rate of inventions.
There is a long list of national and international institutions that donate money for research activities in India, including Melinda and Gates Foundation, ICMR, PATH, UGC, DRDO, Foundation for Innovative New Diagnostics, and many more. But the amount is meager.Â
According to a report by Singh and Abrol, in 2014, the Indian diagnostic research sector received less than 2% of the total annual funding for R&D for diseases. The medical device industry requires the best quality tools and affordable devices that help perform high-quality research.
CDSCO is the national regulatory authority for medical device manufacturing in the country. The Import-Export policy regulates the import of all medical devices, including heart valves, orthopedic implants, and cardiac stents in India.
Most medical devices are imported from the US, EU, Australia, Japan, and Canada, but a small yet significant percentage fail to operate in the Indian climate.Â
Moreover, complicated custom clearance processes and high import duties levied by regulatory agencies make it challenging for medical devices to enter the country.
Medical device manufacturing is one of the highly regulated industries in India. Success in this industry depends on building a robust supply chain, strict adherence to regulatory compliance, time-to-market, and highly efficient quality control.
A medical device ERP software provides the features mentioned above in a single package. It allows you to design and manufacture products that meet the highest quality standards and emerge as a competitive player in the industry.
Here are few questions you must brainstorm with your team to decide whether you require an ERP or not.
1. Do paper-based tracking systems waste a lot of time?
2. Are you able to cost-effectively manage compliance-related issues?
3. Do you have software that manages electronic signatures and document control?
4. Do you have a quality management system that ensures each medical device adheres to a predefined set of quality standards?
5. Do you have autonomous software that monitors all business processes ranging from financial management and the entire supply chain to inventory control and shop floor control?
6. Do you have advanced features like lot and serial tracking?
7. How do you interact with vendors, suppliers, and distributors?
Medical device manufacturers must tackle several challenges, such as ensuring regulatory compliance by drug administration bodies, deploying cutting-edge manufacturing processes, and purchasing essential raw materials on time.
Closely controlled processes allow you to manufacture superior quality products that meet the highest quality standards. Sage X3 is one of the best manufacturing ERP software that helps medical device manufacturers to run closely controlled processes for managing five significant areas: Manufacture, Design, Maintenance, Distribution, and Service.
Here are 5 critical challenges that Sage X3 ERP helps medical device manufacturers to resolve:
a. Monitor exception alerts and work in progress in real-time to resolve bottlenecks faster.
b. Cut operational costs through scheduling and advanced capacity planning tools.
c. Eliminate errors by ensuring quality standards compliance such as ISO 9001 and ISO 13485.
d. Eliminate errors that arise due to quality issues by identifying trends and patterns.
a. Prevent the use of discrepant material by placing stock codes, bins, and lots.
b. Improve order fulfillment and reduce forecasting errors by optimizing inventory levels.
c. Manage the exchange of materials brought from the supplier.
d. Accelerate the purchasing process by automatically generating and delivering RFQ to prospective suppliers.
a. Estimate labor costs and profitability of the project beforehand.
b. Generate factory and purchase orders instantly.
c. Streamline the order-taking process and automatically generate a customer-specific configuration of the product.
India is the 4th biggest medical device manufacturer in Asia and is a part of the top 20 markets in the world. Statistics show that this industry was pegged at USD 5.2 billion in 2020 and is expected to reach USD 50 billion by 2025. Although 80% of the current sales are met through imports, it provides a solid impetus to indigenous medical device companies to produce products for global consumption and home markets alike.Â
The coronavirus pandemic came as a wake-up call for medical device manufacturers. For example, only 20 medical device manufacturers were manufacturing 62 lakh PPE kits before 2020. But today, there are 140 PPE kit manufacturers with an annual capacity of 25.55 crores. Similarly, swab manufacturers have gone up from 0 to 5, mask manufacturers from 30 to 108, RT PCR kit manufacturers from 0 to 8, and ventilator manufacturers from 8 to 17.
The medical devices industry is proliferating at 37% CAGR and is expected to swell to USD 50 billion by 2025. Thanks to the country’s burgeoning middle class and reliance on cutting-edge technology, this dream will be realized soon.
Indian companies must adhere to the following three-pronged strategy to become competitive in the future:
a. Companies must invest in building and implementing cutting-edge technology, integrating intelligence tools for better operability, and reinventing traditional business models.
b. Monitor the challenges presented by new entrants and new markets and adapt and reposition to face them.
c. Brainstorming how the position of medical device manufacturers will change in the value chain of the future. It will help them decide which model to adhere to — B2C, B2B, one-stop shops, or a combination of them.
Sage X3 is the best ERP solution for medical device manufacturers because of numerous reasons. For example, it allows you to maintain strict quality assurance requirements, FDA compliances and those set by other institutions worldwide, maintain excellent relationships with multiple subcontractors, adhere to short product lifecycles, and meet every other challenging demand of this industry.
Here are few benefits that Sage X3 software will provide you to excel in the medical device industry.
Medical device manufacturing is one of the highly regulated industries where minor quality issues can lead to disastrous consequences. Sage X3 allows companies to adhere to quality standards compliance such as ISO 13485 to ensure that each medical device conforms to predefined operational tolerances, a particular set of desired characteristics, and provides expected results.
Sage is a leading provider of ERP systems for the medical device industry. The built-in CRM module provides complete visibility of orders and returns, maintains and upgrades service contracts, manages warranty claims, and ensures customer satisfaction.
Sage X3 ERP system allows medical device companies to minimize the risks of a product recall through its lot traceability features. They can retrieve the entire archive of historical transactions over several years that helps during the auditing process.
Software medical device manufacturing software — Sage X3 records all historical details, such as patient benefits, material costs, supply chain activities, quality issues, and long-term results.
Sage X3 provides companies a competitive advantage to meet customer expectations by fulfilling orders on time. Medical device manufacturers access real-time dashboards that provide enhanced visibility and full traceability into manufacturing processes, financial management, materials management, sales orders & purchase orders, regulatory requirements, and supply chain. They also learn about the external market’s exact requirements that provide a competitive edge and significantly improve time-to-market.