OPHTHALMIC INNOVATOR

The pathway from invention to product

The steps necessary to bring an idea to manufacture and market.

By Carl Awh, MD, Michael Korenfeld, MD, Kevin Rollins, JD, Gregg Scheller

	Gregg Scheller is an engineer/inventor with 90 patentable inventions. He has been in ophthalmology for 30 years and started four medical-device companies. He holds significant financial interest in Katalyst Surgical. His e-mail is gs@katalystsurgical.com.
	Carl C. Awh, MD, is a retina specialist with Tennessee Retina PC in Nashville, Tenn. He is a consultant to Bausch + Lomb, Katalyst Surgical, Notal Vision, Synergetics and Volk. His e-mail is carlawh@gmail.com.
	Michael Korenfeld, MD, is in private practice with Comprehensive Eye Care Ltd., of Washington, Mo. He is a consultant to Bausch + Lomb, Katalyst Surgical and Volk. His e-mail is michaelkorenfeld@hotmail.com.
	Kevin P. Rollins, JD, is a patent attorney who has represented clients ranging from independent physician inventors to Fortune 500 Companies.

“The company may be hesitant to provide the market analysis, so be prepared to insist the company defend its position.”

An inventor needs to understand the critical elements of the commercialization process to bring about a successful collaboration with a manufacturer. This installment provides an overview of that process and attempts to identify the necessary steps involved in bringing a product from invention to market.

The typical company will perform a market analysis of any proposed product before it initiates the manufacturing process. As a part of this analysis, the company will develop a product description that precisely identifies its function, use and target market. This should also include competitive information and profitability.

An inventor should ask for this information before signing any agreements with the manufacturer. A company may be hesitant to provide this information, so be prepared to insist the company defend its reluctance to share it.

STEPS IN DEVELOPMENT

Product requirements

The first step in product development is the establishment of detailed product requirements. The manufacturer should share and review them with the inventor. Marketing professionals usually prepare these requirements, that should include product functionality and usability requirements and manufacturing cost targets.

Building the prototype

After the manufacturer completes the product requirements, an engineer will design a product expected to meet them. The engineer may then build a prototype based on both the requirements to demonstrate the functionality and usability of the product. Inventors should offer to evaluate prototypes and provide feedback on early product development.

Prototypes are often built without cost considerations, such as manufacturing time and component costs. Taking a technology from prototype to a profitable product requires a substantial effort. Issues that might seem trivial, such as packaging, frequently require a significant amount of time to resolve.

Additionally, product development does not stop once the company releases the product. It is an ongoing process that monitors customer feedback and adjusts product design when necessary.

REGULATORY PROCESS

Variables that influence cost

The regulatory process can be a major hurdle and require substantial time and money. Approvals are geographic in scope, so if a company plans to sell a product in multiple countries, it will need to obtain multiple regulatory approvals. The degree of difficulty and costs can vary depending on product function and an individual country’s regulatory requirements. Most developed nations generally require more regulatory effort than developing nations.

In general, disposable products require more effort than reusable ones; drugs require more effort than medical devices; implantable devices require more effort than short-term use products; surgical machines require more effort than surgical machine accessories; and diagnostic products require more effort than therapeutic products. Finally, approvals for products similar to existing, approved devices are usually easier to obtain.

MANUFACTURE AND SALES

The manufacturing process

After a company knows how to make a product and has satisfied the regulatory requirements, it must figure out how to manufacture it at or below the costs the product requirements specified. If a third party can do that, then the company may outsource the manufacturing.

Sometimes, manufacturing in house may be required to reduce costs. In-house manufacturing means the company must manufacture or procure all the components in advance of when it expects to complete the assembly process. For new products, the company may struggle to find and keep reliable vendors for all the components. Additionally, changes in product design may require different components from different vendors. Manufacturing a new product is a significant challenge for anyone.

Sales and distribution

If a company cannot market and sell products in the quantities and regions necessary to commercialize a new technology, then all the other milestones do not matter. But if the company is ready to move onto sales, it may employ a direct sales force of employees, an indirect sales force of contractors, or a combination of the two.

Sales representatives need training on a new product, and the process can be lengthy and costly. Additionally, sales representatives are usually dispersed geographically, so training requires either a product manager to travel to each one, or have all of them travel to one location for group training. After the sales representatives are trained, they typically try to schedule product demonstrations with physicians. Positive demonstrations may lead to completed sales.

Turning an invention into a commercial product requires a significant dedication of time and resources. It is essential the inventor understands and gives consideration to each step involved. This will increase the chances of success in the endeavor. We hope this brief overview will help prepare and guide the potential inventor in the selection of a commercialization partner — the topic of our next installment. OM