What Our Mechanical Engineering Team Considers
When Implementing a Medical Product Design Development Project

First, our customer relationship commences with ongoing communication with our mechanical engineering team throughout the medical product design, development, and validation process. This type of customer service leads us to better understand our client's needs so that our design firm can adapt to each medical device design situation. When working with the customer cooperatively, the probability of the product development meeting specific medical product design specifications increases. Product design is critical to ensuring our client's requirements are fully defined and good manufacturing practices are implemented. ProengineerPortal’s project management team will plan, organize, direct, monitor and control the medical product design, development and manufacturing processes so that our customers medical device will be successful and target the market thus maximizing market share.

1. PLAN AND DIRECT PRODUCT IMPROVEMENT

ProengineerPortal's project management team will collaborate with the mechanical engineering team and client to determine optimum time to develop, manufacture, and market each medical device taking into consideration maximization of quality and time while decreasing labor and production costs. The primary objective is to maximize market penetration and profitability by bringing a new medical device to market at the right time, in the right place, and at the right price, thus gaining a competitive market advantage. This can only be done with the right amount of TEAMWORK by all parties involved in the processes of the product life cycle.

2. PRODUCT DEVELOPMENT TEAM INVOLVEMENT

ProengineerPortal’s early active involvement with our client's team, such as marketing executives, program supervisors, production manufacturing engineers, materials engineers, test engineers, quality engineers, and product support staff is critical to success. This involvement provides a multi-functional viewpoint and facilitates a successful medical product design and manufacturing process by decreasing design iterations and production assembly critical problem issues. In addition, collaboration improves communication and harmonization among team members. By collaborating with our client’s, our mechanical engineering team can improve the chances of a triumphant medical product design, process development, and validation. In addition, collaboration helps with staying on schedule as well as within the allotted budget.

3. DIRECT ENGINEERING COSTS FROM THE BEGINNING

From the beginning, ProengineerPortal focuses on affordability and life cycle expenses. Our mechanical engineering team involves all departments when receiving input in the decision-making process. This helps to develop their commitment and dedication from the beginning. This type of feedback from all company employees helps us to set-up target expenses and helps to control them. We also use FEA computerized software tools to project product life cycle costs and consider these cost projections as a critical part of the decision-making process. This strategy helps to proactively control costs and maximize the bottom line.

4. INVOLVE SUPPLIERS

Suppliers know their manufactured product’s technology, function, and process constraints best. Our mechanical engineering team utilizes their knowledge during product innovation and development in order to optimize medical product design specifications. We maintain longevity with our suppliers and have open-lines of communication so that we can obtain suggestions for modifications from them. The result of this communication helps us to generate more efficient products while minimizing costs.

5. DEVELOPMENT OF ROBUST DESIGNS

To avoid repeating past mistakes, we conduct formal medical product design reviews to assure all design issues and risks have been appropriately addressed. Our mechanical engineers use standard quality engineering design and dependability strategies such as failure mode and effects analysis (FMEA) tools to help us provide a more efficient and effective way to comprehend the role and interaction of product and procedure parameters. This provides us with performance and quality characteristics which lead to robust product designs and improved reliability.

6. INTEGRATE COMPUTER AIDED DESIGN (CAD) AND COMPUTER AIDED ENGINEERING (CAE) TOOLS

CAD is the use of information technology to support our mechanical engineers with tasks such as analysis, simulation, medical product design and manufacture, planning, diagnosis, and repair. CAE tools are being used; for example, to analyze the durability and performance of components and parts assemblies. Integration of CAD tools generates the ability to create a digital product model, facilitates capture, analysis, and enhancement of product and process design information in a time sensitive manner. Integration of CAE tools facilitates process design and designation with fewer flaws, more accuracy, and a decrease in lead-time to medical manufacturing. Attributes-based solids modeling, electronic design frameworks and ideally strategies such as standard for exchange of product data (STEP) help to facilitate the downstream understanding, analysis and use of this product information. These strategies, when intelligently and cost effectively utilized, can lead to a more strategically focused development process and project organization.

Medical Product Design

7. SIMULATE PRODUCT PERFORMANCE AND MANUFACTURING PROCESSES ELECTRONICALLY

The solid modeling strategy in conjunction with variation analysis and interference checking enables the capability of an electronic full-scale model or replication. Analysis and simulation tools like FEA, thermal analysis and software simulation can be used to produce, develop, and improve both medical product and process designs inexpensively. Our mechanical engineers use these tools early in the medical product design process to generate a more complete design and to reduce the number of time-consuming changes to medical product design, testing, and iterations in prototype development.

8. IMPROVEMENT IN THE MEDICAL PRODUCT DESIGN PROCESS ON A CONTINUOUS BASIS

Our mechanical engineering project management team creates a medical product design process that eliminates non-value-added scenarios. Our mechanical engineers question why changes are expedited and how they could be expedited better, on an on-going basis. The management team makes product quality the main criterion for decisions in medical product design. Continued use of technical tools, design strategies, and other formal strategies are critical throughout the medical product design process. These strategies improve the medical product design process. We also use benchmarking as an objective source for analyzing and comparing our management process to other companies and recognizing areas for improvement. By analyzing variances in our outcomes versus our benchmarks, we are able to improve product quality thus increasing the bottom line.

Mechanical Engineering