Software Tools Help Medical Device Makers Navigate Changing Global Regulatory Landscape

The medical device industry has benefited greatly from the growing availability of financial and enterprise resource planning (ERP) software over the years. But is has suffered from a noticeable lack of software resources aimed at providing business intelligence and decision support, according to Peter von Dyck, CEO of e-Zassi  (Fernandina Beach, FL). Responding to this unmet need in the marketplace, e-Zassi has developed proprietary software tools that help outline a clear regulatory pathway for medical product design and development and partnered with Qmed.com to increase accessibility to the medical device community.

"Design and development have typically focused more on performance and efficacy and been less dependent  on regulatory aspects of the product, but those days are over," von Dyck says. "We now have to design and develop products with global regulatory classifications in mind, especially since the initial clinical studies and commercial entry point may be outside the United States. This has required that those involved in the earliest phases of product design and development [increasingly] take into consideration the regulatory and reimbursement  aspects of a product or you risk having a product that is not commercially viable."

Developed to accommodate these changing market needs, e-Zassi's Web-based tools are designed to promote efficiency, accelerate product development, and foster collaboration within the medical device sector. Providing in-depth insight into a product's global regulatory pathway, e-Zassi's InnoVision assessment software, for example, generates detailed product analysis based on information provided by the user. The resulting report helps predict both U.S. and EU regulatory classifications and identify end-user call patterns. It also identifies reimbursement and manufacturing burdens, as well as other critical market requirements, to help medical device developers make more-informed product development and commercialization decisions.

Touting the motto 'open innovation with IP protection,' e-Zassi also enables fast, secure online collaboration between medical device innovators and funding sources or OEMs. While fears of over disclosure have historically hindered online collaboration within the medical device industry, e-Zassi's InnoVision software allows the conversion of confidential material to nonconfidential information that can be readily shared earlier in the development phase between all parties, according to von Dyck.

Offered as part of the purchased InnoVision software or as a simplified, standalone tool free to Qmed users is the company's FDA Calculator. Supplying FDA classification and product codes, the tool is designed to assist foreign medical device companies with navigating the complex U.S. regulatory and reimbursement environment. "With all the reforms and uncertainty, the United States has become one of the most complicated markets to enter," von Dyck notes. "Companies located outside of the United States need to quickly understand where they stand in terms of entering the U.S. marketplace--which regulatory classification they need to be a part of and which clinical endpoints they need to satisfy. Without this kind of data, their ability to enter the marketplace will be hindered and it will take much more time and money to do."

The regulatory calculator also proves useful to U.S.-based companies operating in the current controversial regulatory climate, von Dyck comments. "Because FDA is under reform, it's [often] very difficult to understand what's going to happen," he says. "Having an FDA tool that provides decision support during this healthcare reform really allows U.S. designers and developers to embed that regulatory element into their design today on new products they intend to launch in the coming months or years."

Essentially, von Dyck notes, e-Zassi's tools have the potential to expedite the product development process for all potential stakeholders in a project. Inventors or entrepreneurs can put the information obtained via the software to use in raising capital, for example, while more-mature companies can employ the tools to more-accurately forecast launch dates and development requirements for new products they have in the pipeline. "And for the venture funds and very large companies, they can use the InnoVision tool for more-rapid due diligence purposes to screen and assess new product opportunities submitted from outside parties," von Dyck says. "They can do much more with much less time and effort and also without confidentiality agreements needing to be in place because all the content is nonconfidential." -Shana Leonard