The Basics of New Product Development for Emergency Care

Do you have an idea for a new emergency medical device? Do you envision your idea’s lifesaving applications but don’t know the first thing about turning your idea into reality?

As a frontline caregiver, you are in a perfect position to identify innovations that can aid the U.S. healthcare market. In fact, demand is at an all-time high for products that improve patient care, enhance healthcare workers’ productivity and reduce costs.

The first thing to ask is: Is there a market for your product?

New medical products must appeal to three customers: the user (you and your colleagues), the purchaser (a hospital, city government or other buying group) and the payer (insurance companies that reimburse purchasers for medical procedures). In addition, your product must meet FDA approval and in some cases, several other regulatory agencies must agree.

A smart inventor thoroughly analyzes the market before devoting too much time and energy to a concept. This involves talking with potential customers, observing users in typical work settings, conducting competitive research and analyzing distribution channels and pricing options.

Second, can your invention be patented?

A patent is the grant of property rights to the inventor, issued by the U.S. Patent and Trademark Office. In general, it is good for 17 years and excludes others from making, using or capitalizing on your invention in the United States.

To be patentable, an idea must be novel. That means, it never existed anywhere at any time. Start by finding out if your idea has already been patented or published in publications such as engineering or scientific journals. This is called a prior art search; your goal is to determine if your idea occurred to someone else before you. You can conduct a preliminary search of the US Patent and Trademark Office records at www.uspto.gov. If you still believe your idea is original, get verification from a registered patent attorney.

A word of caution: Beware of firms that offer to help you get your idea into the marketplace without a patent. Many inventors have paid thousands of dollars to these firms and gotten nothing for their money. In fact, many of these organizations are scams and the government has been prosecuting them for fraud.

Third, who will develop your product?

Breathing life into a concept requires engineering. What will your product look like physically? How will it work? How will it be powered? These and myriad other questions need to be answered.

You will want to contact a reputable product development firm that specializes in medical devices and engineering for FDA approval. This firm should be willing to openly and truthfully discuss your project’s technology requirements, schedule and budget.

Look for an organization that provides a safe, comfortable environment where you can confidently discuss your needs—a firm that has the right combination of technical, personal and professional skills to ensure your experience is as pleasant as it is profitable.

After the firm signs a non-disclosure agreement, they will conduct a thorough analysis of your priorities (time to market, costs), your customers’ requirements, and craft a complete definition of your product.

The firm will identify safety concerns, regulatory requirements, the type of environment in which your product will be used, human factors that may affect safety and efficiency, and the articulated and unarticulated needs of potential buyers.

The actual product design stage is when your product starts to take tangible shape. The look and feel is hammered out and functional components are identified. Soon after, the design is reviewed for manufacturability. It is verified that it functions as it was designed, and validated that it meets its intended use.

Think of the product development process as the diagnostic pathway you use with patients: examination, development of treatment, treatment, and verification that the treatment accomplished the goal.

Fourth, will the FDA approve your product to be sold in the U.S.? There are a maze of regulatory requirements in this country related to design, development, manufacture, marketing and servicing of new medical products. The FDA oversees all new medical devices, from bandages to artificial hearts, using regulations and product standards as the yardsticks that define specific requirements inventors must follow to assure product safety and to provide accurate information to health professionals and consumers.

If problems arise, the FDA can take a number of actions to protect the public health, including recalling the product, having federal marshals seize the product or even, when warranted, asking the courts to issue injunctions or prosecute you if you deliberately violate the law.

Once the applicable certifying body and regulations are identified, the product development firm you are working with should conduct a thorough assessment to determine which parts of the regulations apply to your product. This is a key milestone as cost/benefit determinations are made concerning strict regulatory adherence versus rationale—points that can significantly affect your product’s cost and development schedule, and ultimately its profitability.

Can you make any money? The U.S. Patent Office reports that less than 3% of patents ever make any money for the inventor. Yet, in sharp contrast to these statistics, many successful inventors have a virtual 100% success rate.

People will always have accidents and require emergency care. If you have a good idea, the marketplace will support it. Collaborate with an accomplished product development firm that has experience with regulatory agencies, and you could be the owner of the next big idea.