Medical Technologies

Move More Reliable Medical Devices To Market in Less Time

SES uses a proven alternative to the traditional build-test-modify-repeat model for developing medical devices that can reduce time-to-market by as much as 25%.
Its a common frustration for device developers: a prototype product is available quickly, but it may be months or even years before that device can be sold. SES offers a faster approach.
Hours oF EFFort Standard Effort Rate

SES Effort Rate projEct timElinE

Focused Early Effort SES applies a great deal of effort early in the design process to thoroughly understand device function, manufacturing, cost and reliability. This understanding is developed through detailed evaluation of the design using predictive analysis, testing to determine baseline behavior, and careful materials characterization and selection. By discovering and resolving problems early, surprises are avoided and later stages of the process go faster and more smoothly. Combined with expertise and experience, this flexibility is what many clients consider our companys most valuable asset.

Flexible, Multi-Disciplinary Stafng SES has the staffing depth to deploy engineers with specialized expertise when and where their skills are needed. This includes experts in the areas of mechanics, plastic and metal materials, fluidics, thermal science, testing, product/process reliability, and many manufacturing processes. These experts are brought onto the project team when they are needed in the development process and shift off of the team once their expertise is no longer necessary.

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ConcEpt PhasE

P r E l i m i n a ry D E s i g n P h a s E

DEtail DEsign PhasE 1 & 2

TransFEr to Production

The traditional approach evaluates what is needed and too quickly settles on a concept to meet those needs. This typically results in a compromise in the design that doesnt provide maximum performance in any aspect of the design.

Key elements of a design are Form, Fit and Function. The traditional approach focuses on the form and fit of the components as required for the concept, often neglecting function.

The traditional approach starts with testing a functional prototype, then revising the concept based on prototype performance. Another prototype is then produced from the revised design and again undergoes testing. Consequences of this approach are: (1) it can be difficult to converge on a final design, (2) the final design is just good enough, and (3) the scale up to production can present previously unobserved problems.

Using the traditional build and test approach, transfer to production can be difficult and time consuming. This approach is not conducive to arriving at a product that is easy to manufacture.

SES PROCESS

STANDARD PROCESS

SES Tr ansFEr to Production

SpEciFIc ation

SES concEpt phasE

S E S P r E l i m i n a ry D E s i g n P h a s E

SES dEtailEd dEsigN phasE

Many projects begin with a loosely defined specification of what the final product might be. Starting with a loose specification is risky and can be very wasteful. Designing to a target that is not required will add needless cost and complexity. If an actual requirement is missed from the initial specification, the whole concept may need to be scrapped and the team sent back to the drawing board. The SES approach includes spending additional time and effort before the concept phase to review, revise, and clarify the specification. The result of this effort is to provide a specification that matches what is truly required to create a good product, with no extraneous items nor missing requirements. This ultimately saves development cost and reduces the risk of rework during the projects.

The SES approach takes additional time in the concept phase to establish actionable requirements and measure baseline performance data. Several concepts are developed and evaluated using engineering first principles and simple tests to assess feasibility. Prior to the down-select activity, these concepts are further evaluated for their anticipated reliability, manufact uring complexity, and cost. The result of taking this additional time up-front is invariably a better, more manufacturable concept.
Additional SES Design Phases Characterization

In order to build a higher level of understanding, SES considers multiple concepts in the Preliminary Design phase before selecting a preferred approach. For each concept we will typically (1) create virtual models to predict performance and identify key functional characteristics, (2) evaluate manufacturability, (3) estimate sensitivity to tolerances and (4) test simplified bread-board models to verify our analysis. The result is higher confidence that the product will perform as expected, and a significantly shortened transfer to production.

The SES approach avoids build and test iterations. SES uses findings from the preliminary design to converge on a detailed design. This design is optimized with respect to the key performance characteristics and planned manufacturing methods. The creation and testing of prototypes is merely for confirmation of predicted performance. Testing is generally successful and additional design or rework is minimal.

The SES process leverages the fact that we have incorporated good manufacturing practices from the very beginning, and throughout the design process. Because all design approaches have been reviewed by the manufacturing groups, there are no surprises and no major rework. With SES, early optimization of manufacturability facilitates a smooth and routine transfer to production.

The SES approach takes additional time to establish actionable requirements and measure baseline performance data.
Preliminary Feasibility & Analysis
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Can it be manufactured? Will it meet operational expectations within the materials limits? Does it fall within cost parameters?

About Stress Engineering Services

Established in 1972, SES is an employee owned company. We have had a dedicated medical technologies practice since 1995, focusing on device development, diagnostics, robotics, instruments, disposables and reliability. Our staff is experienced in a diverse range of engineering disciplines including mechanical, biomedical, manufacturing, electrical, metallurgical, materials, theoretical and applied mechanics. Over 80% of SES engineers hold advanced degrees, most are licensed P.E.s and the average engineer has more than 15 years experience over a broad range of industries.

What Clients are saying about SES

[SES engineers] helped take our design and within a week, improved it to help save millions in production costs. I would highly recommend the Stress Engineering staff. engineering manager Our company has a long history of working with SES, and we continue to be impressed with their ability to adapt to our needs. We estimate their efforts saved us 3 months on an overall 12 month schedule from concept to release, but more importantly the design was fully optimized before tool release and the development phase was extremely efficient. vice president of engineering & product development

For a Faster Approach to Developing More Reliable Medical Devices Call SES Today at 513-336-6701
ON THE WEB AT MEDICAL.STRESS.COM
CINCINNATI HOUSTON NEW ORLEANS BATON ROUGE C ALGARY

2012 Stress Engineering Services, Inc.

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