Project Management

Each project at Interplex
Medical is assigned a Project Manager under Design Control. Within the Design Control Process there are design reviews that allow customers to be involved in the development process. The project manager is responsible for developing a project plan, maintaining a design history and communicating to customers and suppliers. The team includes design engineers, manufacturing engineers and quality engineers. The Director of Quality and Regulatory Affairs and the VP of Research and Development meet with each project manager on a weekly basis to discuss project status and design or quality issues. Customer relationships are highly valued at Interplex Medical and are important to the progress of each project.


Engineering & 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. In the conceptual stage, we are not only looking at practical solutions, we are also investigating intellectual property in these areas to make sure our anticipated solutions can be practiced.

Breadboards
& Prototypes

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

• Procedure & technology review
• Prior art & 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

Clinical & Tissue Labs

We offer 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. We also have use of the University’s human cadaver laboratory facility. We provide the necessary Institutional Animal Care and Use Committee (IACUC) protocols for clinical studies. Interplex Medical can facilitate Institutional Review Board (IRB) studies at hospitals to gather data for regulatory submission.

 

Research & Development

Taking a practical approach to research and development activities allows our customers to benefit from a systematic, problem-solving methodology. Working directly with the surgeon and customers, our up front style of working with tissue as soon as possible reduces our development cycle and assures on-target results. Unlike many engineering firms who spend much of their development time behind the monitor, Interplex Medical’s engineers not only spend time with clinicians OR, they also test 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 innovative , minimally-invasive 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) analysis, performing Design Verification and Design Validation activities, we are systematically turning ideas into sustainable and viable products.