May 25, 2023

The Top 6 Challenges Medical Device OEMs Face and How Outsourcing Can Help

The universe of medical device contract manufacturing can be extremely difficult to manage. Medical device manufacturing is a highly complicated and complex field for obvious reasons — your business must adhere to numerous laws, regulations, and safety standards. Unfortunately, all of these regulations can drive up the price of medical device manufacturing. These rising costs can chew up profits and slow the time it takes to get your medical devices to the market. 

Let's take a broad look at the complexities your medical manufacturing firm may face while trying to get your device from creation to market. We also discuss how Sanbor Medical can help you manage these complexities. 

1. Manufacturing and Technological Expertise

There is perhaps no area of manufacturing more complicated than that of medical devices. This sector demands expertise and knowledge of dozens of types of manufacturing. In addition, it requires that your business has the medical and technological expertise necessary to ensure that you can safely build products used in healthcare settings for a wide range of uses in the diagnosis, treatment, monitoring, and support of various medical conditions.

Furthermore, expertise in one area of medical manufacturing doesn't mean expertise in another. There are vast differences across the manufacturing of multiple medical devices. These differences can force you to find different partners while appropriately managing a medical manufacturing process. 

At Sanbor Medical, our thirty-plus years in this field have enabled us to work with various manufacturers, vendors, countries, and more. As a result, we can assist your business in making crucial business and labor decisions. We can guide you throughout the process, sharing the expertise we have learned during our decades in this industry. 

2. Controlling Cost and Managing Resources

Your manufacturing business unquestionably feels the pressures brought by inflation. These issues are particularly challenging for multi-component medical devices, increasing costs for all component parts and forcing you to lose a competitive price advantage. Furthermore, managing an ever-changing supply chain can be extremely difficult. Fortunately, many of the issues related to the COVID-19 pandemic have diminished. However, various challenges remain in the form of financial pressures, inflation, and geopolitical considerations. These issues can make it extremely difficult to control costs and source raw materials.

At Sanbor Medical, we offer various potential services that can help you mitigate these concerns. For example, we work with suppliers worldwide to ensure that you have access to the materials and products you need. Our global manufacturing footprint allows us to provide competitive services and pricing through global sourcing and consolidated purchasing power. This enables you to leverage economies of scale to access the goods you need at the best price. We customize solutions based on your needs, in any of our manufacturing facilities, including the United States or a lower cost country.

3. Quality Control Challenges

Nothing is more important to a medical device manufacturer than quality control. You have financial, economic, and moral obligations to always produce the best product possible. In this highly litigious era, creating medical goods that meet the highest quality standards isn't an option, it's a must. You need rigorous manufacturing processes, quality control checks, and regular testing. This ensures you create the devices your customers expect. 

Sanbor Medical is an FDA-registered company. We are also ISO certified and have regularly passed audits from the FDA and routinely pass rigorous audits by leading top 30 global medical device companies. We can manage any quality control concerns and meet your highest standards. 

4. Developing Necessary Flexibility

In these turbulent times, quality isn't enough — you also need flexibility. Your manufacturing processes must be ready to scale up or down at a moment's notice. You must be prepared to respond to COVID-19 flare-ups, manage labor shortages, and pivot to different versions of products. As such, you need a partner with a global presence and access to multiple material and labor sources. Any manufacturing partner must have the expertise to coordinate processes that may take place across the globe.

Sanbor Medical understands these challenges and can use our decades of experience to benefit your manufacturing. Our global reach and years in the field allow us to anticipate challenges and help our clients develop the flexibility to manage any challenge. 

5. Regulatory Compliance

One of the most challenging aspects of medical device contract manufacturing is the complexity of regulations. You will have to meet a series of complicated and constantly shifting regulations. You will also be forced to manage a changing regulatory landscape that may shift as a result of numerous factors, including:

  • Changing administrations in the countries where you are manufacturing or selling your device.
  • Different interpretations of regulations depend on who is regulating or the specific political climate of the moment.
  • Temporary waivers may be granted to regulations based on broader economic or medical concerns. 

Although Sanbor Medical doesn't offer these services directly, our experience helping companies navigate complex regulatory systems allows us to offer support on regulatory compliance. We can work with you to identify businesses and outside firms that can provide these types of solutions.

6. Trust and Confidence

If your customer doesn't trust you, and if the end-user of one of your goods doesn't have confidence in its accuracy, you damage your long-term reputation and ultimately lose business. Regarding medical contract manufacturing, trust is the only currency that truly matters. Sanbor Medical's average customer has been with us for more than fifteen years, and there's a reason for that— they trust us. We operate at the highest levels of quality, share our expertise, and help you create products that can improve and save lives. In this regard, we become a true extension of your team, helping you achieve your business goals. 

The Sanbor Medical Difference

We've been in the medical contract manufacturing business for more than thirty years and fully understand the deep complexities of this area. We can assist the entire process of contract manufacturing medical devices and help you achieve your business goals. Connect with a team member at Sanbor Medical today and learn how we can help you achieve your manufacturing and cost-reduction goals.

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