Whether your outsourcing needs call for the design of instruments or 3D printing of an implant, you should create a list of essential questions and considerations for your supplier partner. What are their capabilities? What is their expertise? What best practices do they follow?
We asked Tecomet’s Kevin Hayes, Senior Director of New Product Development, and Chuck Hansford, Director of Advanced Material Processing, three questions about selecting an outsource partner.
What best practice can device companies implement to ensure that outsourced product development and manufacturing are on time and budget?
Hayes: Define user needs. Establish the scope of the project. Provide all of the design inputs at the beginning of the product development. We are missing this information sometimes, and it’s important to be thorough and detailed upfront.
For example, the project scope must be defined to avoid scope creep. When you’re moving down the development path and looking at a timeline, you’re looking at milestones; scope creep may affect your ability to be on time and budget.
If we have all of the information up front, we can start out of the gate. You don’t want to miss anything. As we move through product development cycle phases, we want to ensure that we’re on track, and we don’t have surprises.
What question do you wish your device company partners asked you about the product development process? Why?
Hayes: Who will own Design Control of the Device? Do you have the capability of performing Design Control, creating a Design History File and/or Technical File? This is important to establish the deliverables at the end of the project.
What’s the #1 thing device companies should consider when outsourcing the manufacture of a 3D-printed product to a partner?
Hansford: The #1 thing to consider when choosing an additive manufacturing partner is to make sure that they offer a complete package of experience. They must have additive manufacturing expertise, engineering and design capability (design to the process), systems and process validation, post-process capability and the willingness and experience to help guide the customer from concept to production.
These attributes will lead to shortened lead-times, lower cost and quality products.