Upwards of 75% of new medical device launches fail to either make it to market or maintain an established market demand. Medical device product development is inherently risky, expensive, and complex. Furthermore, investment into a design asset by a company's resources is automatically in a state of rapidly depreciating value until the product can produce revenue. The market could change, a competitor could launch first, the design could be wrong, and the technical risk could be too high to produce a usable product.
Anyone in charge of launching a new medical device program is faced with a key resource question:
Will the design team be internal or will an outside development partner be brought in?
When the right external partner is chosen the leading medical device companies recognize value:
Access to talent and innovation is not possible with an internal team
Lower overall cost
Lower risk, by leveraging domain experts
Faster time to revenue
Greater manufacturability of designs
Here is how leading medical device companies partner with outside design teams to launch innovative new products.
Before shopping for the right partner, the following are established first:
Market pain/user needs to be understood
Initial user requirements are developed
The development budget is established and vetted
An achievable market launch timeline is agreed on by stakeholders
Technology readiness is established
Initial freedom to operate is established
An internal subject matter expert is assigned to the project
How to interface and work with an external design partner:
Establish clear intellectual property (IP) ownership and freedom to operate responsibilities
Enter the relationship with mutual trust and respect
Establish a clear statement of "scope", who is responsible for what
Agree on an achievable schedule
Use a technology de-risking approach, each successive phase should reduce technical risk
Only enter ISO 13485 design control once requirements are established, and technical risks are low
New product development projects are fraught with risks and delays. Typically those delays can be attributed to missing the key inputs listed above or a lack of suitable working parameters with an outside design partner. When done successfully, companies can leverage the resources and experience of outside design and development partners, achieving faster time to revenue. lower risk, and reduced cost.