Medical Device Design / Medical Device Engineering

Clinical and Tissue Labs

Interplex Medical offers services to facilitate clinical studies in both animals and humans for the development of medical devices and implants. Interplex Medical has an affiliation with the University of Cincinnati for the use of acute and chronic studies involving animals, in addition to the use of the human cadaver laboratory facility. Interplex Medical provides the necessary Institutional Animal Care and Use Committee (IACUC) protocols for clinical studies. Interplex Medical can also facilitate Institutional Review Board (IRB) studies at hospitals to gather data for regulatory submissions.

Conceptual Design

Interplex Medical offers early stage conceptual design services from idea generation with hand sketches, non-functional ergonomic models and proof-of-principal models to functional prototypes for clinical evaluation. Within the conceptual stage, we are not only looking at practical solutions but we are also investigating intellectual property in these areas to be sure our anticipated solutions can be practiced.

Breadboards and Prototypes

Interplex Medical takes great pride in our fundamental engineering approach of being in the operating room with the surgeon and our customers to solve problems and create unique solutions. Our unique, results-based approach to problem solving consists of the following steps:

Initial disclosure of problem and suggested solution(s)

• Procedure and technologies review
• Prior art and patent review
  
• Brainstorming meeting for idea generation with multi-disciplined staff
• Concept generation
• Packaging the concept into realistic configurations
• Proof-of-concept prototypes
• Functional testing of proof-of-concept prototypes
• Design iteration(s)
• Functional prototypes
• Clinical evaluation
• Product design
• Packaging design

Research & Development

Our practical approach to research and development activities allows our customers to benefit from a systematic problem-solving methodology. By working directly with the surgeon and customers, our up-front approach of working with tissue as soon as possible reduces our development cycle and assures on-target results. Unlike many engineering firms who spend all of their development time behind the monitor, Interplex Medical’s engineers are testing their proof-of-concept models on actual tissue to get a better understanding of device to patient/user interactions.

Product Development

One of Interplex Medical’s core competencies is our knowledge and experience in the medical field; specifically, mechanical surgical devices. Our skilled staff has delivered many different types of devices which provide new, noninvasive procedures to market, thereby, improving the lives of people all over the world. We are committed to delivering practical solutions that enable our customers to bring needed technologies to market. The backbone of our product development system is the lean Design Control System that is as compliant for a Fortune 100 company as it is flexible for an inventor with an idea. Our disciplined approach to solving problems translates into faster design cycles and cost reduction. By defining our Design Inputs at the beginning of a project and implementing our Risk Analysis tools and the use of a wide variety of Design Tools such as Finite Element Analysis (FEA), Tolerance Stack-up Analysis (TS), Design for Manufacturability (DFM) analyses performing Design Verification and Design Validation activities, we are systematically turning ideas into sustainable and viable products.

Project Management

At Interplex Medical, all projects are run under Design Control and each project is assigned a Project Manager. The Project Manager is responsible for developing a project plan, communicating to the customer (as well as all suppliers) and maintaining the Design History File. This structure maintains a consistent point of contact for our customers and suppliers. Within the team are additional Design Engineers, Manufacturing Engineers and Quality Engineers. Our Director of Quality and Regulatory along with the VP of Research & Development meet with each Project Manager on a weekly basis to discuss project status, in addition to any design or quality issues. Within the Design Control Process are Design Reviews that allow our customers to be as integral to the development process as they desire to be.