The first time any company works with a design service in any industry is always a steep learning curve. By choosing the right design service, a company with an idea for a new or innovative medical device can find a solid, dependable partner that can assist with or complete the design process as well as continue on to prototyping and production.
There are specific factors that a new Original Equipment Manufacturer should look for in medical device design companies. Choosing the right service starts with due diligence on the service as well as understanding what you need and what services they can provide.
Check For Certifications
In the medical device field, looking for the ISO 13485 certification is a must. Additionally, make sure the medical device design service is FDA registered to continue on with prototyping and production.
There is considerable documentation that is required for verification processes for approvals for medical devices. Working with an experienced company can make this much easier.
Ensure Confidentiality on the Project
It will be important to have a written contractual agreement with the medical device design service about confidentiality throughout the design and production phase of the project. Top companies will include this as a standard part of the services they offer.
Involve the Design Team Early in the Process
With medical devices, involving the specialized outsourced design team as early as possible in the process is the most cost-effective. The engineers on the team are very knowledgeable about regulations and requirements and can prevent the in-house team from spending weeks or months on a design that doesn’t meet standards.
Ideally, working with the design team that specializes in medical devices will be a collaborative effort. Look for a service that has a top reputation in this type of collaborative work with the in-house team.