5 Challenges Faced by Medical Device OEMs – And How to Overcome Them
Designing, manufacturing, and commercializing medical devices is complex. There are many opportunities for medical device OEMs as the industry continues to go through a period of growth, but there are also risks, challenges, and pitfalls. Mitigating those risks, overcoming the challenges, and avoiding the pitfalls is crucial for success.
The challenges faced by medical device OEMs can vary depending on the type of products in question and a range of other factors. For example, while cybersecurity is a major concern and area of priority for all medical device companies, there is a significantly enhanced level of risk for companies that manufacture connected devices.
In this blog, we are going to focus on five challenges that apply to most medical device OEMs. They include:
- Regulatory compliance
- Quality
- Manufacturing expertise
- Supply chain management
- Cost management
Regulatory Compliance
Medical device OEMs must deal with an ever-changing regulatory landscape. Not only are regulators making changes to keep up with patient expectations and the latest technology innovations, but they are also modernizing processes.
There are also different requirements and interpretations in different jurisdictions, depending on where you market your products.
Staying on top of the latest regulatory developments is essential, but it is also beneficial to share the regulatory burden by working with an experienced partner. A partner with regulatory expertise, FDA-approved facilities, and regulatory-approved products will help to reduce compliance costs, risks, and complexities.
Quality
Quality is an ever-present consideration for medical device OEMs. Quality is essential for product safety and compliance reasons, and it is important for business success.
As a result, quality must be a central priority for all medical device companies, including OEMs. It is also beneficial to work with medical device product and component suppliers that have a proven quality track record.
Manufacturing Expertise
Manufacturing medical devices requires specialist expertise, equipment, and capabilities, especially when manufacturing highly complex, intricate, and often delicate components and devices.
Medical device OEMs can have the required experience and capabilities in some areas, but it is also beneficial to collaborate with specialist partners for specific components.
We can use our experience at Galt as an example. We use our extensive manufacturing expertise in our specialist areas (vascular access and interventional medical devices) to enhance and augment the manufacturing capabilities of our medical device OEM customers.
Supply Chain Management
Supply chain management in the medical device industry has always been important, but recent years have brought the issue into even sharper focus. The ability to reliably source raw materials, the availability of specialist materials and components, shipping lead times, forward planning, and supply chain visibility are some of the complexities that medical device OEMs deal with on a daily basis.
An important part of mitigating supply chain challenges in the medical device industry is to work with partners and component suppliers with the capacity and capabilities to consistently deliver on requirements.
That feature – capacity – is often overlooked in supply chain management. However, risks increase significantly if your partners and suppliers are working at maximum capacity as there is no room for error. The ability to react to unforeseen circumstances is also restricted if your component partners are working at max capacity while scaling up to meet growing demand can be unnecessarily costly and slow.
Therefore, it is important to consider capacity in your overall supply chain management equation.
Cost Management
Like supply chain management, cost management has always been important, but recent experiences with inflation have also brought this issue into even sharper focus.
Modernizing, streamlining, and automating internal processes are some of the ways medical device OEMs can reduce costs. It is also important to work with partners and suppliers that prioritize providing value to customers and who also invest in the future.
Again, we can use our experience at Galt as an example. We have recently invested in an expansion of our manufacturing capabilities in Costa Rica. This will ensure we have the available capacity to meet the demands of our OEM customers, as highlighted in the above point. It also ensures we can continue to deliver value to our customers.
Helping You Overcome Medical Device OEM Challenges
If vascular access and interventional medical devices and components are part of your product offering as an OEM, we can add value to your business at Galt. We have regulatory expertise and well-established quality systems, as well as extensive manufacturing capabilities in our specialist areas. Get in touch with a member of our team today to discuss your requirements.
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