Want to understand the capabilities of your potential partner? Start with these questions.

You found the product development company at a trade show, and now you are visiting their office.  They gave you a tour and asked if you had any questions.  What should you ask?  How can you determine if this company can actually develop your project successfully?  Here are a few questions to get you started.

1. Are they generalists or specialists? Being a specialist means turning down projects that are not in your area of expertise.  This can be difficult to do.  Some companies accept a wide array of projects to ensure work for their team, but they do not develop deep skills in any one specific area.  When a product development company specializes in a particular discipline, they hire engineers with extensive experience in that one area and provide the equipment and services necessary to excel in that one area of specialization.   Your project benefits from their continued learning and your development time is reduced by their focused knowledge.

 

2. How much relevant experience do they have? While it’s unlikely that you will find a product development company that has developed a product that is identical to the one you are looking to develop (after all, you are developing a new product), ask to see examples of previous projects which feature similar functions.  For example, if you are looking to develop a microfluidic diagnostic product the company should be able to provide examples of features that are common to microfluidics such as reagent storage/delivery, sample preparation, metering, mixing, etc.  It’s important to engage a product development company with specific experience in the functional areas that will be required in your product.

3. Do they offer multiple manufacturing options? There are basically two types of product development companies: independent design and combined design and manufacturing companies.  An independent product development company will design a product that best fits your requirements and help you transfer to a contract manufacturer that has the capabilities to manufacture and assemble the product in your estimated volume.

Combined product development companies are owned by the contract manufacturer; they will always design a product that fits their internal capabilities and then keep the product in-house for manufacturer.  This limits the design options available for your product before you have even started development.  It also limits your ability to shop for the best manufacturing partner.  Instead of a limitation, they will often frame this relationship as an advantage; indicating that the close working relationship is required for seamless transfer to manufacturing.  The truth is that any experienced ISO 13485 company has procedures that ensure the successful transfer to any contract manufacturer.  While development may involve discovery and substantial challenges, transfer to manufacturing is more of an exercise that may be precisely planned and coordinated.

4. How much internal structure and support do they have? Make sure that the product development company is more than engineers in an office.  While this keeps their overhead low, without internal prototyping capabilities these companies must outsource every step of development.  This means there is no control of quality or lead time, which can result in significant delays to market.  Useful internal capabilities are: rapid prototype fabrication such as stereolithography and CNC machining, prototype molding, finite element analysis, laboratory with extensive testing capabilities and cleanroom assembly.

 

5. Are they ISO 13485 certified? A formal audited quality system is critical to a successful medical product development project.  It ensures that the project is properly developed and documented for regulatory submission.  ISO 13485 requires significant company resources and commitment to quality.   An ISO 13485 quality system provides a superior product development environment that ensures continual improvement of services.