Product Development, Product Design, Prototypes and Florida Invention Design Experts and Orange County California

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FAQs on Shortages of Surgical Masks and Gowns by the FDA

Is there a shortage of gowns? Surgical masks?

KN95 Mask From China
KN95 Mask From China

The Below Surgical Masks and Gowns Information was found 4-15-20 on the FDA.gov website web page.
The FDA is aware that as the COVID-19 outbreak continues to expand globally, the supply chain for these devices will continue to be stressed if demand exceeds available supplies. We have received information from healthcare organizations that some distributors may have placed certain types of personal protective equipment (PPE) on allocation, basing the quantity available to the healthcare organization on previous usage, not projected use. Increased use may exceed the available supply of PPE, resulting in shortages at some healthcare organizations.

The FDA recommends conservation strategies for use by healthcare organizations and personnel—categorized for a range of clinical needs and supply levels—intended to assist healthcare organizations in determining conservation procedures during this time period. The FDA’s recommendations are intended to augment, and not intended to replace, specific controls and procedures developed by health care organizations, the Centers for Disease Control and Prevention (CDC), or CDC’s Healthcare Infection Control Practices Advisory Committee (HICPAC) to aid in infection prevention and control.

Can respirators approved under standards used in other countries, such as KN95, be used in the US during the COVID-19 pandemic?

Face Shield from China
Face Shield from China

Yes. The FDA is working diligently to mitigate any potential shortages in the supply chain and taking action to assure health care personnel on the front lines have sufficient supplies of respiratory protective devices. The FDA concluded, based on the totality of scientific evidence available, that certain imported respirators that are not NIOSH-approved are appropriate to protect the public health or safety.

On March 24, 2020, the FDA issued an Emergency Use Authorization (EUA) for importing non-NIOSH-approved N95 respirators. Under this EUA, among other criteria, the FDA accepts marketing authorization from Australia, Brazil, Europe, Japan, Korea, and Mexico who have similar standards to NIOSH. The FDA did not list KN95 respirators in this EUA because of concerns about fraudulent products listed as KN95s. On April 3, 2020, in response to continued respirator shortages, the FDA issued a new EUA for non-NIOSH-approved N95 respirators made in China, which makes KN95 respirators eligible for authorization if certain criteria are met, including evidence demonstrating that the respirator meets certain standards.

The FDA also issued guidance outlining a policy to help expand the availability of general use face masks for the general public and respirators for health care professionals during this pandemic. The guidance applies to KN95 respirators as well. It explains that for the duration of the pandemic, when FDA-cleared or NIOSH-approved N95 respirators are not available, the FDA generally would not object to the importation and use of respirators without an EUA, including KN95 respirators. Although not required, if a KN95 respirator does not have an EUA, the FDA encourages importers to take the appropriate steps to verify the product’s authenticity prior to importing.

The FDA has adjusted its import screening to further expedite imports of legitimate products and is continually monitoring its import systems to prevent and mitigate any potential issues. The FDA is ready and available to engage with importers to minimize disruptions during the importing process.
END FROM FDA
More from the FDA at FDA web page: CLICK HERE

Anthony, President
772-777-2241,
Product Development Experts, Inc.
Please feel free to contact us with your face mask and PPE – Personal Protection Equipment questions.
(Edit)

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What is Product and Invention Research and Testing

Product research and testing before you begin your product or service development is critical and after you develop your invention, you need to conduct thorough product research and testing to find out:
Product Research: why product research
1) What does your product invention or service provide or perform better than current products?
2) What similar products and patents are on the market?
3) Which are the best ways to develop, design and manufacture?

Product Testing:why product testing
1) Does your product or service work – perform as intended?
2) What is the best price to maximize sales volume and profits?
3) Which are the best distribution channels and advertising vehicles?

This is product research and testing, and it is a vital step of new product invention development. Through every stage of your product development process you should conduct product research and testing, which will help you identify product issues and help avoid costly mistakes while making important product improvements.

The initial product research will help you evaluate your idea for a new product and service and see if there is a need for it and what it is that your potential customers are looking for. If your product or service already exists, product research will tell you whether the available options on the market are meeting the needs and expectations of existing customers. This way you can learn what you can do differently, to meet the needs and expectations but also to exceed and outdo the competition.
quality-invention-product-research-and-product-testing
New product design and development is more often than not a crucial factor in the survival of a company. In an industry that is changing fast, firms must continually revise their design and range of products. This is necessary due to continuous technology change and development as well as the changing needs of customers and competition. Without an R&D program, a firm must rely on strategic product testing and product research alliances and networks.

A message from the president/owner:

I’m here to assist inventors, companies and organizations with all their Product and Invention Testing and Research needs.

Thanks for taking the time to view this Product or Invention Testing and Research blog web page.
I look forward to hearing from you,

Anthony,
Product Development, Product Invention Testing and Research Experts

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What is Product Design for Manufacturing

Manufacturers and 3d printers will request a STP, STEP or IGS, IGES or STL file 3d product design drawings for 3d prototype or for designing molds or for pricing manufactured parts for production of your invention.

Is your new product or invention ready for manufacture?
Product Design for Manufacturing

The Product Design Items you need before you contact a manufacturer;

1) Invention Concept
2) 3D Modeling CAD Design
3) Working product proof of function – a prototype
4) STEP file or IGS file CAD design drawings for manufacturing

If you have the above product or invention design items completed then we are able to help set you up with one of our manufacturers to obtain production cost pricing. If you need assistance with the above listed items we provide product design services which will provide you with the needed manufacturing requirements.

Please keep in mind that the product design file formats stated above are usually the most popular and will work for almost all product design requirements but there are exceptions. Always check with a product design professional in regards to your specific product design project.

A message from Anthony the president/owner:

I’m here to assist and service inventors, companies and organizations with all their Product Design and Prototype needs.

Anthony, Chief Product Designer

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Manufacturing In China (help tips and steps)

Manufacture or production help tips and steps when followed properly will help avoid future major manufacturing headaches and help speed up the manufacturing of your invention or developed part.
“Based on our experience dealing with Chinese manufacturers, I have outlined below a quick list of what to do and what not to do questions – answers regarding the beginning steps to manufacturing in China.

China Manufacturing Steps and Answers

Q – Is your new product or invention ready for manufacture?
A – Your product 1) design, 2) prototype and 3) manufacturing drawings should be in place before you contact a manufacturer;
1) DESIGN – concept
2) PROTOTYPE – working product proof of function
3) MANUFACTURING 3D CAD DRAWINGS – STEP file and IGS file CAD design drawings

If you have the above product or invention items completed then we are able to set you up with one of our manufacturers to obtain production cost pricing. If you need assistance with the above listed items we provide services which will provide you with the needed manufacturing requirements.

Q – Manufacturers in China are abundant but how do you find a Chinese manufacturer factory that is trustworthy and easy to communicate with?
A – Find a USA Manufacturing Consultant or Product Development Company that has a track record with a U.S. client base of inventors and product designers?

manufacturing-in-china
Manufacturing In China

Manufacturing product deposits and down payments for product production can be negotiated with manufacturers, particularly when it comes to payment terms. For example a deposit of 50 percent on your molds is enough to show a factory you’re serious and encourage them to send a sample of your product for your inspection.
Always try and promote a positive sales vision of the future by letting your enthusiasm and entrepreneurial spirit shine through to your production source. This will let your manufacturer know that you’re a serious U.S. partner. A Chinese manufacturer will be more eager to partner with you, even if you’re just starting off very small, if you can demonstrate that you have a professional and positive vision beyond just one order.

Just because your last manufacturing shipment was great doesn’t mean you can relax. Always explicitly demand perfect quality with each subsequent shipment. Don’t become complacent or allow your manufacturer to start cutting corners.

Manufacturing in China can reduce your product cost per unit.

A message from the president and a owner of Product Development Experts:

We are here to provide product manufacturing services to inventors, companies and organizations interested in having their product manufactured in China.

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Invention Idea or New Product Need Documentation “step one of invention process”

invention idea
Write down everything you can think of that relates to your invention, from what it is and how it works.

Inventors – you’ve probably heard about the “poor man’s patent” – writing your idea down and mailing it to yourself in a sealed envelope so you have dated proof of your invention’s conception. This is unreliable and unlikely to hold up in court. As of the date of this post the new patent law requires that whoever files a patent first is the owner. You should always consult with a professional patent attorney.

If you need to work with other people or companies before filing a patent always try to have the person or company you are dealing with sign a Non Disclosure Agreement form or contract (we have a link to one at near the bottom of the our home page.

Inventions – you should have a rough sketch or drawing of your invention made as soon as possible and include approximate dimensions. This will help when you need to work with a product design company for a 3d CAD design which will be needed for the prototype and manufacturing process and for your patent attorney.
Invention New Idea Patent
Inventors, many times, will first file a “Provisional Patent” with the United States Patent and Trademark Office. A provisional patent gives an inventor a one year grace period at a lower cost than a full long term (non-provisional) Utility or Design patent.

If you need to work with other people or companies before filing a patent always try to have the person or company you are dealing with sign a Non Disclosure form or contract.

A message from Anthony the president/owner:

I’m here to assist and service inventors, companies and organizations with all their invention ideas with design, Prototypes, manufacturing drawings and manufacturing.