Full Lengthen Video | Product Design & Development | Runtime 5:07 mins
Project Management
Ideation
Engineering
CAD Design
Analysis
Product Design & Development
Creativity:
Our design team can work on creative solutions while integrating design for manufacturability principles
Creativity:
Our design team can work on creative solutions while integrating design for manufacturability principles
Concept generation:
We are able to generate novel concepts – whether that is working off of only your identified need in the marketplace or off of your initial concept
Concept generation:
We are able to generate novel concepts – whether that is working off of only your identified need in the marketplace or off of your initial concept
Adaptable:
We are flexible to follow your NPD process or ours. The same applies for a quality management system.
Adaptable:
We are flexible to follow your NPD process or ours. The same applies for a quality management system.
Anatomical breadth:
We have design experience from head to toe, inside and outside of the body.
Anatomical breadth:
We have design experience from head to toe, inside and outside of the body.
Platform flexibility:
Our engineers are platform agnostic and can use any CAD software to produce models and drawings leading to rapid prototypes and, eventually, production level products. We consider production method early, whether traditional machining, additive manufacturing, injection molding, or something else.
Platform flexibility:
Our engineers are platform agnostic and can use any CAD software to produce models and drawings leading to rapid prototypes and, eventually, production level products. We consider production method early, whether traditional machining, additive manufacturing, injection molding, or something else.
More than a “design firm”:
We focus only on medical device and we integrate other disciplines (quality, regulatory, IP, manufacturing) early and effectively in the product development process
More than a “design firm”:
We focus only on medical device and we integrate other disciplines (quality, regulatory, IP, manufacturing) early and effectively in the product development process
New Product Development (NPD)
We follow a five-phased NPD process
Design Reviews at the conclusion of each phase allow for multiple Go/No-Go decision points as a means to minimize risk and refine scope
We have a strong network of manufacturers best suit prototype and production needs
We follow a five-phased NPD process
Design Reviews at the conclusion of each phase allow for multiple Go/No-Go decision points as a means to minimize risk and refine scope
We have a strong network of manufacturers best suit prototype and production needs
Go Further with Kapstone
Your device has exponentially more value the further you go along the NPD process
Potential buyers want to see more than just a concept and prototypes
De-risk your investment and take the steps to successfully sell a safe medical device
Do the proper documentation required by quality and regulatory standards
Go Further With Your Idea | Runtime 2:05 mins
Your device has exponentially more value the further you go along the NPD process
Potential buyers want to see more than just a concept and prototypes
De-risk your investment and take the steps to successfully sell a safe medical device
Do the proper documentation required by quality and regulatory standards
Go Further With Your Idea | Runtime 2:05 mins
Your IOS 10993 Guid: Understand and Safely Navigate Biocompatability Standards
Successfuly bring your device to market in a safe, cost effective way by:
- understanding the requirement of IOS 10993
- Learning which type of device are under the most scrutiny
- Gaining a better understand of the costs & time required for certain biocompatability test
- Follow one example case study
