Our Work  | Portfolio  | About Us  | Contact Us  | Corporate Site
ISO 13485:2016 & ISO 9001:2015 Certified

        Medical Technologies

        Device Development

        Whether developing a low volume piece of capital equipment or a high volume disposable product, Stress Engineering Services (SES) incorporates crucial steps for a robust product development process.  SES has a tightly integrated team of experts, unique lab and testing capabilities, and insights into how to avoid problems as a result of seeing hundreds of product failures.  The expertise that SES brings to the table fulfills regulatory requirements and leads to safe, reliable and widely accepted products. 

        SES’s Device Development Steps:

        a. Requirements – Crucial to the end product, the first step in any effective product design is defining the requirements in an efficient and thoughtful manner.  At SES, we gather input from key stakeholders, which is synthesized to form a set of specific, actionable and numerically quantifiable requirements that are formally documented. SES believes that obtaining the correct requirements in the beginning sets the foundation for product development success.

        b. Concept Development – Whether making enhancements to an existing product or defining an entirely new product category, the consideration of diverse product concepts is essential in creating a revolutionary product.  At SES, we thoroughly and thoughtfully consider our customers, and through application research and technology explorations, we explore a multitude of concepts.  Brainstorming sessions are held with persons having diverse backgrounds and technical expertise.  The synergy of these experiences brings forth unique product concepts.  SES then performs ranking and risk assessment to prioritize concepts and identify a single effective lead.  There are significant time and cost savings by ruling out concepts that are fundamentally flawed early in the process.

        c. Industrial Design – At SES, Industrial Design is more than fine art. Critical design thinking goes into every product from the concept phase to the finished product.  The unique synergy of industrial design with rigorous engineering allows us to come up with innovative solutions that are informed by real world constraints and achievable in mass production.

        d. Human Factors / Ergonomics – Key to the success of any product is end user acceptance.  Products that are intuitive, comfortable, and consistently effective are the most highly accepted by customers.  They result in greater customer safety, more positive customer outcomes and market success.

        e. Engineering Design – The engineering design phase is where concepts are transformed from ideas into producible products.  Key technical challenges are identified and technical solutions are pursued.  Activities at this stage involve understanding the core physics that determine the system responses, performing analysis of the design and verifying that the manufacturing process capabilities match production volume requirements.

        f. Analysis – The ability to identify design problems early in the process is key to saving development time and money.  SES has the expertise to determine which analysis technique to employ and the correct application of the simulation tools.  Simulation tools allow us to analyze a broad range of design needs, including: mechanical integrity, fluid flow, thermal effects, system dynamics and manufacturing process simulation.

        g. Prototype – The creation of a prototype is an indispensable aspect of the product development process, enabling real-life, hands-on evaluations of product concepts. The cost of prototyping often puts unnecessary strain on a project’s budget.  However, SES’s unique practice of analyzing designs early in the product development process often eliminates multiple rounds of prototyping.  Not only is this a significant cost savings, but it can also reduce time to market.  At SES, prototypes are used largely as confirmation tools rather than discovery tools.

        h. Performance Verification – SES is equipped with a state-of-the-art test lab that specializes in the development of custom testing apparatuses and affords our engineers the ability to conduct necessary product assurance testing that follows all FDA guidelines for product performance.

        i. Statistical analysis – SES believes that a robust design must be manufacturable in a repeatable manner and with minimal waste.  Design for manufacture is key to achieving this.  We have decades of expertise in manufacturing process capabilities and the statistical tools to analyze and optimize for the most effective final design. Dimensional tolerance analysis checks insure the design will result in a final product that is able to be consistently produced to meet product requirements.  Additionally, our knowledge of the statistical analysis tools allows us to properly design our testing methods and quality plans.  Once test measurements are available, the statistical analysis is performed and proper conclusions drawn.

        Device Development

        Device Development

        Device Development