The
development of a new product requires a complete multi-disciplinary team of
experts on hand at what is considered one of the most critical stages - product
design. Several experts are required in order for a company to possess a
"complete" knowledge of the whole design, development and
manufacturing process. This is especially difficult for new start-up ventures.
In today's competitive market, designing a new medical device and bringing it to
market requires a serious financial investment as well as risk. QSI, teamed up
with NASP, can play an
important role in reducing that risk, and accelerating the whole process. The
result is a more economical design to the development process.
New
medical devices are born when modem technology and accumulated industry
experience are applied to a revolutionary idea. Start-ups typically require a
large financial investment to cover immediate costs of hiring an R&D group.
The leader is often the person with the vision for a new or improved device.
However, collateral financial burdens are caused by the need for:
•
Procuring a manufacturing area;
• Environmental
controls;
• Molding equipment;
• Packaging and
labeling equipment;
• Sterilization
equipment; and
• space for
warehousing product and distribution;
Each
one of the above listed parts of a medical device company is critical, and
requires extensive written procedures to be generated, implemented and
maintained, as well as a trained professional management staff. This adds a
further threatening burden to the finances of a start-up venture.
North
American Sterilization & Packaging is a fully integrated medical device
company offering all the contract services necessary for you to bring the fruit
of your research and development to market without most of the financial risk
involved in a dedicated stand alone start-up. A strategic partnership with NASP
allows you to reduce your initial capital investment, and concentrate it on your
team of R&D experts. We provide the rest in our fully functional FDA
registered facility in Franklin, NJ. Take your idea and concentrate all your
resources on it. From the start, we involve our team of experts that will advise
you at every critical phase about issues regarding all aspects of manufacturing,
packaging and sterilization. Once your design is complete you will have been
advised so as to avoid future problems once the product goes into clinical
trials, and routine manufacturing. Knowing in advance what device and packaging
characteristics facilitate sterilization will help you get to market faster than
your competitors. And since you don't have to waste time and money in generating
extensive procedures beyond those necessary for the design phase, your start-up
is extremely streamlined and cost efficient.
Producing
your first prototype product requires nothing more than transferring your design
to our fully qualified facility. Our procedures are already in place, our
facility FDA registered and inspected, and our staff is ready to design and
validate tailored manufacturing, packaging and sterilization processes to meet
and exceed your needs. You go from the design phase right to executing your
marketing plans. We can even manage your warehousing and distribution needs.
Once you take your idea and complete the final design, you and your investors
are free from any major investments. Your risk is greatly reduced. And you have
the benefit of taking advantage of our years of experience with devices ranging
from complex trays to critical Class 3 devices.