Medical device manufacturing is subject to different standards compared to other equipment manufacturers. The reason is simply due to the health risks a poorly functioning device can cause. As such, medical device manufacturers face a unique set of challenges as they work to create new state-of-the-art devices.
Luckily, most common challenges have fairly straightforward solutions. This article will provide an overview of 7 common medical device manufacturing challenges and the steps you can take to mitigate them.
7 Common Challenges in The Medical Device Manufacturing Industry & What You Can Do About Them
1. Regulatory Compliance
Navigating regulatory requirements is a very common challenge, especially for manufacturers who export products to the international medical device market. Even those who stay domestic are often faced with constantly evolving standards and requirements.
To handle this, always check for updates from organizations like the FDA and EMA. Also, having a team focused only on compliance can help make sure your devices meet all the rules before they’re sold. This team can also check on a country’s compliance standards before you expand your reach to that area.
For your reference, here is a quick overview of the compliance standards you need to follow based on the region you intend to sell to. Please do further research on these standards for more specific regulations. This table is simply a guide to show you what to research. Please also note that this is not an exhaustive list.
| North America | |
| USA | FDA |
| Canada | Health Canada |
| South & Central America | |
| Mexico | COFEPRIS |
| Brazil | ANVISA |
| Argentina | ANMAT |
| Colombia | INVIMA |
| Peru | DIGEMID |
| Europe | |
| All EU Countries | CE Marking, MDR, EMA |
| United Kingdom | MHRA, UKCA Marking, CE Marking |
| Germany | BfArM |
| Spain | AEMPS |
| France | ANSM |
| Italy | AIFA |
| Norway | NoMA |
| Sweden | Läkemedelsverket |
| Denmark | DKMA |
| Finland | Fimea |
| Russia | Roszdravnadzor |
| Middle East & Africa | |
| Saudi Arabia | SFDA |
| UAE | MOH |
| Egypt | EDA |
| Kenya | PPB |
| Tanzania | TFDA |
| Uganda | NDA |
| South Africa | SAHPRA |
| Asia-Pacific | |
| Australia | TGA |
| Japan | JPAL |
| South Korea | KFDA |
| China | NMPA |
| India | CDSCO |
| Singapore | HSA |
| Philippines | FDA |
| Thailand | FDA |
| Malaysia | MDA |
Please also note that ISO standards must be followed in all countries.
2. Quality Control
It should be no surprise that medical equipment must be held to high quality standards. The challenge lies in maintaining consistency across all production batches. Different events may occur and different people may be involved in each production batch. However, the final product must follow the same quality standards.
Implementing a robust quality management system (QMS) can help address this challenge effectively. Regular training for your staff on the importance of quality control and the latest techniques in quality assurance can significantly reduce the risk of device defects.
Ensure that quality control is integrated into your manufacturing processes. Being proactive about QA is much easier than needing to backtrack to fix missed issues later.
3. Supply Chain Disruptions
Supply chain disruptions can stall product development and delay product delivery. Medical technology often needs specific material, so losing access to needed products can leave manufacturers stuck. While supply chain issues aren’t anyone’s fault, there are things you can do to lessen the impact.
Diversify your supplier base as much as possible to avoid over-reliance on a single source. Supply chain management software can help you gain better visibility and control over your logistics operations.
Having this visibility allows your team to anticipate potential disruptions and mitigate possible issues in real-time. Even if you don’t invest in such software, finding another way to gain this visibility is highly beneficial.
4. Technological Advancements Mid-Production
Another challenge that medical device manufacturers may encounter is technological advancements emerging mid-production. Research, development, and manufacturing all take time. It’s not unheard of for new technological advancements or requirements to appear midway through production. In this event, your team may have to pivot to meet these new standards or use new technologies to stay competitive.
Plan for agile processes before you begin your project. Doing so will prepare your team to quickly pivot if necessary without causing substantial disruptions to your project timeline. This practice is also good for any other unexpected events, like a supply chain disruption.
5. Intellectual Property Protection
Protecting your intellectual property (IP) is crucial in any competitive industry. The medical device industry is no exception to this and IP theft can happen with medical devices. Fortunately, protecting your IP is relatively simple.
To protect your IP, get patents for your devices and make everyone who works on your project sign confidentiality agreements. Regularly review your IP strategy to ensure all potential vulnerabilities are covered.
| For More Insights on Medical Device Manufacturing, Read Our Blog |
6. Market Penetration
Entering new markets and standing out can be challenging because of some compliance standards, tough competition, and customer loyalty to well-known brands. Conduct thorough market research to understand the needs and preferences of your target demographic.
Consult healthcare practitioners and potential patients to better understand their needs. Cross-reference these findings with what your competitors are doing. Then, tailor your design, development, and marketing strategies based on these insights.
7. Medical Device Cybersecurity
As medical devices get more connected, cybersecurity risks increase. Many compliance regulations are implementing additional standards to mitigate this risk. However, it’s important to validate the cybersecurity of your device for more reasons than simply meeting compliance.
Medical device cybersecurity is also a crucial component of protecting healthcare systems. Typically, when a hacker compromises a medical device, it’s to access the connected data system, not the device itself.
Knowing this, device manufacturers must integrate cybersecurity checks into their process that account for this risk. Follow all relevant cybersecurity compliance standards, and ensure that compromised software is neither a risk to the patient or the connected system if the compliance standards you follow don’t sufficiently account for this risk.
Overcome These Challenges & Keep Up With The Biggest Medical Device Companies
With the right manufacturing partner, it becomes even easier to overcome these challenges. Furthermore, choosing the right partner can help you go far beyond the bare minimum so you can compete in the same market as some of the top medical device companies.
Vantage MedTech can help you get there. We collaborate with manufacturers of all sizes to bring innovative products to market through our New Product Introduction (NPI) strategy.
This approach minimizes common challenges from development to production. Leveraging decades of experience, we navigate the product life cycle to help you avoid delays and reduce costs.
Reach out to us today if you need our assistance.
