Medical device manufacturing start-ups need to clear daunting product development and regulatory approval hurdles. Find out how partnering with the right contract manufacturer enables your team to focus on design and compliance while producing quality products for your customers.
People around the world are living longer, medical researchers are developing innovative treatments, and healthcare funding is increasing globally. As baby boomers age, however, the geriatric population is swelling, causing an increased prevalence in chronic diseases associated with the elderly.
All of these factors combined are creating a surge in the medical device industry, which will continue to expand in 2023.
These trends have attracted a growing number of start-up companies to the medical device manufacturing space. Industry watchers point to lean product development as a vital success factor for new firms in this sector.
The development cycle for a new medical device typically takes between three and seven years. So, anything that can improve a start-up company’s focus on product design to expedite that timeline is essential for success .
In addition to product design tasks, it’s equally vital to navigate the regulatory approval process effectively. Particularly with Class I, II, and III medical devices, you need qualified staff available to support and accurately document device claims in regulatory submissions.
To avoid confusion and delay, it’s important that these staff can provide ongoing support to answer questions, support reviews, and share additional information as needed. Preparing amendments and change reports also requires prompt attention to keep the approval process moving smoothly.
At the same time, stringent regulatory requirements make strict quality assurance essential to medical device production. Entrepreneurs in this field need to keep design staff focused on product development and regulatory compliance while ensuring that production teams meet exacting specifications.
A growing number of medical device manufacturing start-ups are turning to contract manufacturing to resolve this dilemma. Internal teams focus on research, product design, and compliance, while a trusted partner takes on the role of producing finished products that meet or exceed specifications.
Making this arrangement work requires start-ups to track down dependable contract manufacturers with the values, technology, and skills to meet their needs. Partner facilities require the necessary regulatory approvals and licenses to produce the medical device.
China is the world’s second-largest medical device market. It’s the country where most medical device start-ups find the trusted and capable manufacturing partners they need. The lion’s share of the digital components that people across the globe use every day continue to flow from Chinese contract manufacturing facilities.
Despite isolated reports that pandemic lockdowns and supply chain delays lure manufacturers elsewhere, China’s medical devices market is growing by roughly 20% annually. China’s government is determined to establish and maintain world-class biomedical and high-end medical device manufacturing facilities, both for the domestic market and export.
Choosing the right contract manufacturer an ocean away can be a daunting task for start-up companies. There are several criteria to keep in mind as part of the search process.
Quality and compliance are the top considerations. It’s essential to ensure your partner has the governmental and ISO certifications required to produce the product. Their documentation procedures for device history records, calibration procedures, and testing must be rigorous.
The next key criterion is finding the right manufacturing experience and expertise. Your partner’s real-world manufacturing experience should reduce design time and trial and error, providing key insights that allow you to create product designs that are optimized for manufacturing. With 40 years of real-world manufacturing experience and our Design For Manufacturing (DFM) process, we can help you tailor your product so that it is made with industry best practices.
Your partner should also have a range of well-integrated testing solutions in place. They should provide your start-up with an end-to-end testing strategy for each product and component.
In these days of frustrating supply chain headaches, you need to investigate how your partner manages its raw material suppliers. With China’s competitive labour rates, materials and procurement costs often make up the bulk of manufacturing costs. Plus, as we’ve all learned the hard way, reliable supply lines are the key to meeting time-to-market goals
Working with Kingstec, you'd be tapping into 4 decades of manufacturing experience and knowledge, ensuring you bring a well-designed, high-quality product to market, in the shortest amount of time and in the most cost-effective manner possible.
Western medical device start-ups are increasingly leveraging the technological and manufacturing experience of Chinese contract manufacturing. And while China’s facilities offer huge advantages, there are some potential obstacles to be aware of. Kingstec has worked with China’s leading facilities for over 40 years and can help your business navigate this marketplace, acting as an extension of your engineering, design, and logistics departments.
Call us today to learn how your business can partner with China’s cost-efficient, highly adaptable contract manufacturers to produce your neurostimulation components.
