In today's technologically advancing market, medical device research
and development has to happen quickly and effectively in order to
fully capitalize on market opportunity. Product development requires a
series of integrated phases which are the beginnings of the product life cycle.


Phase I - Conceptual Design

Product discovery is the beginning of the product life cycle. First,
we need to recognize an opportunity for a new engineering device, consider
the market and visualize a competitive advantage.
Phase two of the medical device contract
manufacturing process focuses on the
technological product risks and how these
risks will be overcome. The third phase of medical device engineering
design encompasses multiple testing procedures
which include the following categories: feasibility,
functionality, durability, and ultimately the
consumer. The engineering product development process
of the beta medical prototype begins with a beta test plan.
After the engineering product development process
and a successful pre-production run is complete,
full-scale manufacturing of the medical device can
proceed. At this point, the medical engineering
device is expected to penetrate the market aggressively,
so customer feedback and support are critical. There
has to be timely follow-up and design enhancements
related to critical issues. This may lead to design
enhancements later on. Creating conceptual product designs typically
includes a fair amount of what is called brainstorming.
This process in which designers toss around possible
ideas, whether they are practical, irrational, or,
in some cases, simply illogical, is a way of broadening
the scope of the problem and opening up the possibility
of creative problem-solving methods. The brainstorming
phase is critical because the creativity involved can
lead to more dynamic and innovative product designs.
Once we have done some of this brainstorming, either
individually or often in groups, frequently called
creativity sessions, we then try to define the solution
in more manageable and applicable formats. At this point,
we start evaluating product design ideas, picking the
best attributes, if appropriate, and putting together
one or more concepts to pursue in new product development.
Also, we may create some sketches or detailed descriptions
of the problem, and possibly even start a review of
whether the idea may be patentable. Initially, we need to try and define the problems by
listing the constraints and requirements for the system.
This document details all of the features and benefits of
the product design. The specification document is
beneficial in keeping the product development on the
intended course, which will ultimately lead to a
successful medical device prototype design.
At this point, the sketches and ideas are going to become
three dimensional models. In addition, we provide detailed
drawings of the design prototypes. Also, an analysis will
probably be done to determine the appropriate sizes for the
applied loads. Forces acting on our device design, including
the potential weight of the design, may require a deflection
analysis along with calculation of stresses and other necessary
analyses in order to help make the preliminary device design
feasible. The first phase of new product development within the product life
cycle is completed once the concept approval meeting has been held.
At this point, the product design team and client signs and approves
the specifications as well as product design concept documents.
This initial phase of the medical device design is critical because
it sets-up the next phase of the new product development for success. Early in the design stage ProengineerPortal uses computer-aided
engineering (CAE) analysis and simulation tools. By using these
simulation tools, the products reliability dramatically increases,
this also leads to a shorter time to build and test a physical
Prototype Verification of concept medical prototypes is
more often a simply constructed prototype model.
This reveals only the features that are in
question and proves their capability. The primary
objective of a verification of concept prototype
model is to help develop a medical device prototype
which is going to be ready for medical device
contract manufacturing The overall goal of the alpha medical prototype
design is to create a functioning prototype that
meets all of the medical device design specifications.
Upon successful completion of the alpha medical prototype
testing, an evaluation meeting is held to assess the
results of the testing and to determine where changes
are necessary. These changes will be built-in to the beta
medical prototype design, which would be the next step in
the product development The medical device product development and design phase
requires a series of beta units to be designed and manufactured.
Chances are that, as we go through the design process and create
medical device design prototypes, we will discover certain features
that need to be changed or improved. We may now need to go back,
after creating our alpha medical device design prototype and possibly
do some more feasibility testing, and make additional modifications
to the product design. After the completion of the beta medical device testing,
the product device transitions to preproduction. The purpose
of preproduction is to changeover the prototyping efforts to
medical device manufacturing standard level production. All
beta unit documentation is then converted to production level
standards.

Manufacturing and tooling methods are studied to ensure good
manufacturing practices are utilized.

A. Verification of Concept Prototype

Phase two of the medical device contract manufacturing process focuses on the technological product risks and how these risks will be overcome. It may be necessary to test the capability of a medical prototype design concept before further deliberation is given to it. In this situation, a verification of concept prototype is built. After the development of the prototype, a prototype approval meeting is planned. Verification of concept medical prototypes is more often a simply constructed prototype model. This reveals only the features that are in question and proves their capability. The primary objective of a verification of concept prototype model is to help develop a medical device prototype which is going to be ready for medical device contract manufacturing.

Initially, the verification of concept prototypes may be scale models, as in the case of some large products, or models made of other more easily formed materials. Sometimes a verification of concept prototype may include only certain features of our medical prototype design. They may also be created so that we can perform some feasibility testing on our conceptual design, if it is a relatively new and unique idea. Often, with the development of verification of concept medical prototypes, it is not practical to have them created out of the same material that will be used for the final product. For instance, machined steel may be utilized for a verification of concept medical prototype instead of casting. Cast plastic may be utilized as opposed to injection-molded pieces, or other methods that lend themselves to lower-cost verification of concept medical prototyping. The development of prototypes in many industries is even a specialized field for technicians because prototype cost can be significant in the overall research and development process.

B. Alpha Prototype

During the medical device contract manufacturing process, once the verification of concept for medical prototype design is approved, the alpha prototype test plan is to be written. This test proposal is generated prior to the design of the alpha prototype. This written alpha medical prototype test plan document ensures that the required operation of the unit is accounted for and explains in detail the testing requirements that the alpha medical prototype must meet. After authorization of the alpha test plan, the alpha prototype is designed and detailed to meet the design specifications. The overall goal of the alpha medical prototype design is to create a functioning prototype that meets all of the medical device design specifications. Realistically, final production tooling is not accessible at this juncture, so rapid prototyping procedures are usually utilized. ProengineerPortal uses several different prototyping procedures to rapidly produce plastic part designs and injection molding designs without the necessity for costly tooling or industrial design services. Upon successful completion of the alpha medical prototype testing, an evaluation meeting is held to assess the results of the testing and to determine where changes are necessary. These changes will be built-in to the beta medical prototype design, which would be the next step in the product development.