Adaptable Manufacturing Requirements
The medical device industry is constantly evolving, which means changes can take place seemingly overnight. If you’re working with a third-party manufacturing company, will they be able to make the necessary adjustments when needed with a quick recovery and turn-around time?
Regulatory Controls Can Be Revised
Regardless of which country you’ll be selling your products in, it’s imperative that they meet the standards of that country’s regulatory guidelines. These requirements are extremely stringent because of the very nature of medical devices, which will be used by and for individuals in a variety of treatment situations. Any deviation from these regulatory controls will mean that entire batches or runs of a product can be recalled or removed from the market, costing you thousands or even millions of dollars and eroding your company’s reputation with both doctors and patients. Working with a manufacturer that is familiar with the guidelines of numerous countries’ governmental restrictions and requirements will minimize your loss, particularly when a new rule is put into place or an old one revised.
Working with a manufacturer that can quickly revise a process or re-engineer the current design will save you both time and money and allow you to bring the revised product to market more quickly. It’s also critical that they be able to quickly trace parts and withstand third party audits to ensure compliance.
Industry Advances Can Mean New Medical Device Manufacturing Techniques
Medical device manufacturing has to keep up with all advances in the industry. Whether your contract manufacturer is crafting catheters or producing parts for a complex pump, they need to be able to keep up with the latest developments in design and engineering. That means continuing education of their engineering and production teams as well as the ability to update systems and equipment throughout the production cycle. The evolution of new techniques shouldn’t slow down a manufacturer or keep your product from the market because they don’t have the resources to produce a satisfactory medical device in accordance with the latest developments in the industry.
Budget Considerations
Wildly fluctuating prices on everything from resins to adhesives can affect the cost of medical device manufacturing. In some cases, you may have to go back to the drawing board and rethink the choice of materials, the manufacturing schedule or your timeline to market. Working with an experienced medical device manufacturing company can mean the difference between a product that turns a healthy profit and one that it simply isn’t feasible to bring to market due to cost restrictions. Working with a company experienced in finding the best price for locally sourced materials and adept at negotiating with reliable, seasoned suppliers will help keep costs low and quality high. An in-house team of designers and engineers can also by improving the design and improve lead time to keep costs contained.
When you’re ready to outsource your medical device manufacturing, be sure to work with a company that can hurdle any of the above challenges so that last-minute changes don’t blindside them and derail your own profits.