Cutting Through the Confusion: Top 7 Questions to Ask a Medical Device Outsourcing Company
Inquiries to Ponder Prior to Engaging a Medical Device Contract Manufacturing Organization
Designing and manufacturing a medical device is a complex task, even for seasoned professionals. With the added pressure of meeting regulatory requirements, it's easy to slip up and face costly delays or compliance issues. This is where a trusted, reliable medical device outsourcing company comes into play. But before you entrust them with your project, it's crucial to do your homework. Here are seven critical questions to ask potential partners to ensure you're getting the best possible service.
1. Do they boast expertise spanning the entire product lifecycle?
It's essential that your outsourcing partner possesses a rich background in medical device development, encompassing everything from concept generation to project completion. A comprehensive, well-rounded team should handle aspects like systems, software, electronics, mechanics, quality assurance, and compliance with the relevant regulations.
2. Are they well-versed in regulatory and manufacturing compliance?
Getting your medical device through the regulatory approval process without snags can be a substantial undertaking. Partnering with a firm that is knowledgeable about regulatory compliance and manufacturing best practices will help ensure you cruise through this stage, achieving first-time approval and expediting time-to-market.
3. Are they ISO 13485-certified?
ISO 13485 is an internationally recognized quality standard for medical device design, development, production, and sales. To earn this certification, a company must demonstrate the ability to consistently meet customer and regulatory requirements. Having an ISO 13485-certified partner ensures your Quality Management System will uphold your product's safety and effectiveness while streamlining the auditing process.
4. How extensive is their project portfolio?
Take a good look at their track record. Have they been in the game for a while or are they fresh to the scene? Do they boast a multitude of project successes, or a more modest number? Check how many clients they've worked with and ensure they're an appropriate fit for your company's stage in the product development lifecycle. In the intricate world of medical device design and development, experience counts.
5. Is their team based entirely in the United States?
Though it might not be top of mind initially, the location of your outsourcing partner matters. Even if they're headquartered in the US, if their team is scattered worldwide, this could lead to project setbacks due to coordination challenges across time zones. Working with a 100% U.S.-based partner helps set the stage for a smoother market entry.
6. Are they an innovator in the field?
In today's competitive medical device market, innovation is vital. Seek a partner that's known for delivering cutting-edge medical device design, development, and engineering, embracing customized and unique solutions rather than a one-size-fits-all approach.
7. Are they proficient in both verification and validation processes?
While these two elements of the medical device testing process may appear similar, they serve distinct purposes. Verification determines whether the product was built correctly, while validation ensures the right product was built. Ensuring your outsourcing partner is skilled in both key aspects can help you successfully navigate the essential controls in the development lifecycle.
Choosing the right medical device outsourcing partner is a substantial decision that can significantly impact the success of your product. By asking the right questions, you'll be well-positioned to find a partner who will help you create a product that aligns with your organization's strategic objectives, supports your revenue goals, and safeguards your brand's reputation.
At Sterling Medical Devices, we have over two decades of experience delivering medical device design innovation. We take on the entire development process, designing products that prioritize user needs, while simultaneously making smart design choices based on our extensive knowledge of product development. Connect with us here and let's discuss your next project!
Key Insights:
In addition to the top seven questions mentioned, consider asking about the following aspects to further evaluate a potential medical device outsourcing company:
- What certifications and registrations do they hold (e.g., FDA registration, EU MDR compliance, etc.)?
- Can they provide evidence of a strong regulatory compliance track record, including a history of audits and regulatory inspections?
- How do they keep current with the latest industry trends and updates in regulations and technologies?
- What project management methodology do they employ, and how do they maintain communication and updates throughout the project?
- What measures do they take to protect intellectual property?
- Can they accommodate changes in volume or design iterations as needed?
Familiarizing yourself with these topics will help you choose an outsourcing partner who excels in regulatory compliance, innovation, and project management.
- Are they not only knowledgeable in medical device design and development but also well-versed in the latest advancements in health-and-wellness, fitness-and-exercise, and medical science, ensuring their designs align with current medical-conditions and relevant discoveries?
- During product development, do they prioritize quality management by utilizing science-backed practices, enhancing the quality of the medical devices they produce?
- Are they actively involved in medtech industries, contributing to the design and creation of medical devices that cater to various fields like diagnostics, imaging, and rehabilitation, bolstering the overall medical industry?
- In collaboration with their clients, do they take a comprehensive approach to regulatory compliance, advocating for adherence to industry standards like ISO 13485 and seeking certification to demonstrate their unwavering commitment to product safety and effectiveness?
- Do they have a robust knowledge of global medical device regulations, including the US FDA's guidelines and the EU MDR, allowing them to guide clients through the complex regulatory approval process efficiently and without errors?
- In addition to skillfully managing verification and validation processes, do they also have expertise in other key areas of medical device manufacturing, such as software development, electronics engineering, and manufacturing best practices?
- Are they proactive in protecting the intellectual property of their clients, establishing contracts with appropriate safeguards, and signing non-disclosure agreements to ensure the confidentiality of all project discussions and documents?
