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.

In order for ProengineerPortal to effectively approach a medical device process development problem or create a new product industrial design, we must first define the task at hand. This first step in the new product development process is completed in order to create a product specification document, which is critical to the initial planning phase in developing a new product. This document details all of the features and benefits of the product development design. Often we begin by trying to define the problem to be solved and then we design a new product development plan. In listing the requirements for the proposed product engineering design plan, we try to think of it in terms of attributes, not solutions. There are cases where the design needs to solve a specific problem or the company wants to create a new product for sale. The task may be to broaden the product line or replace a dated product in order to enhance the position of the company in the marketplace. Often, however, we have a specific problem that needs to be solved in the product development phase. In order to come up with an effective solution, we must first understand the problem, the known constraints, and even the potential markets for this product, if they have not been predetermined.

This is why the specification document is often developed as the first step in the new product development design process. Although we must try to correctly define this problem, we must also be very careful not to try and solve the problem immediately at this stage because it might interfere with the new product development initial planning phase. Initially, we need to try and define the problems by listing the constraints and requirements for the system. In other words, by trying to list the attributes of the problem and not the potential solutions themselves, we are far more likely to come up with a creative approach to the problem and avoid getting stuck with solutions that eliminate the possibility of unique and exciting new design approaches.

Finally some level of basic research may be needed into either the problem or the technology available. Medical device manufacturing requires state of the art current technology as well as new innovations so research and development is critical at this phase. The new product development information serves to set the course for following design phases. 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. Also a good product specification will result in better product design, clear task goals, and a greater likelihood of working within a scheduled timeframe and budgetary constraints.

B. Design Concept

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. Typically, ProengineerPortal will list the possible solutions as they are suggested. This may include making basic preliminary design sketches based on new product development research. It is important to note that, at this point in the process, a good designer tries to be as non critical of the ideas as possible. Later in the process, we try to eliminate the inadequate or inappropriate ideas and focus on one or more critical concepts which should definitely be pursued.

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. At this point, we try to pinpoint a medical product design focus in order to pursue a concrete medical device process development action plan.

C. Design

At this point, the sketches and ideas are going to become three dimensional models, or medical prototypes. In addition, we provide detailed drawings of the medical devise design prototypes. Also, an analysis will probably be done to determine the appropriate sizes for the applied loads. Forces acting on our medical 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 medical device design feasible. Depending on the application, at this point, it may be necessary to incorporate some corporate knowledge that has been developed over the years for similar medical manufacturing products in this market segment. We should understand, at this point, that this analysis in not final and that this is going to be an ongoing process as our medical device design is created, tested, and likely redesigned.

D. First Phase is Complete

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. The medical device process development is critical at this stage. This next phase, the feasibility phase, will focus on the technical problems and the development of a medical prototype whereas the initial phase focuses more on theoretical analyses and working on an initial new product development plan.