In the rush to get a new idea for a medical device from the concept stage to market, companies that are new to the industry often make a lot of very serious mistakes. Sometimes these serious mistakes result in a slight delay in the project, but in other cases, they can result in delays, budget overruns and frustration for investors that leads to lost opportunities and possible life-saving technology that is never developed.
The biggest mistakes often come with choosing medical device contract manufacturing companies to complete specific components or parts for the device. These contracting manufacturing companies can be extremely helpful to the project if they are experienced, professional and focused on quality control, but they can create havoc if they are not.
To avoid the most common mistakes new companies make in choosing contract manufacturing companies in the medical device industry, take a close look at the list below.
Choosing by Price
Selecting a medical device contract manufacturing company by the price they quote for the project is perhaps the biggest mistake a new company in the medical device field will make.
Each component of a medical device has to meet rigorous standards for production and has to have materials that are traceable. All processes used have to be recorded and documented and all variations noted. Additionally, all regulations must be met for each component from a plastic valve to a stainless steel fastener in the device.
Low price bids are typically from companies that are not familiar with the medical device prototype development requirements. A low quote should result in an extensive review of the company before determining if they are the quality service you want to use.
No Past Experience
There are many quality shops out there that have excellent reputations and do fantastic work. However, if they are not experienced in medical device contract manufacturing, it will be a very steep learning curve for the company.
As mentioned above, there is considerable documentation, recording, testing and validating of all processes used in the production of the various components. By using a company with this experience and a focus on medical device prototype and production development, there is already a complete understanding of their role in the scope of the project.
This simplifies the oversight and the management required by your team. It allows you to focus in on the overall design while the contract manufacturing companies can complete their work to the standards and requirements that are necessary based on the specific type of medical device.
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