Phase III Development & Design
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.
Summary of our Medical Device Engineering and Engineering Product Development Process
A. Beta Prototype
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. 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. We may have discovered, during this process that some product design features can be simplified while others are no longer feasible. There are unanticipated complications in new product development which occur periodically. At this point, we can make these modifications before we go into the next step, which is typically testing.
Testing can involve any of the following:
Feasibility Testing: is the testing of a medical device design prototype or product to determine if the principle of operation is feasible.
Conceptual Testing: is similar to feasibility testing except that it may involve only a specific engineering product development concept and can be very limited in scope.
Functionality testing: is used to determine whether a medical device design prototype or model actually performs in the manner for which it was conceived.
Durability Testing: is used to determine whether the appropriate lifetime of a machine or part of a machine can be attained during the actual product life cycle.
Consumer testing: is testing of the medical device design by potential customers which usually is comprised of compiling their opinions.
Normally Beta testing is performed by prospective clients or by trained physicians in order to gain an expectation of what actual problems might be encountered in the engineering field. When the test plan is ready for implementation, the beta medical device design prototype commences. Upon contractual authorization of the beta medical device design, manufacturing and beta medical device design testing proceeds. The medical device design beta units are tested in the field. After field testing, the results are examined and modifications are made as required by the specifications. Lastly, a final engineering product development design approval meeting is conducted. After this approval process, the unit is ready for medical device manufacturing and market introduction on a pre-production basis.
B. Pre-Production
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. Rapid prototyping of the medical device is done to verify the efficiency of the manufacturing process. This process is a critical part of the medical device process development and validation. Beta sample units produced from this rapid prototyping manufacturing process are normally released to the general market as sales samples.
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.
