Your medical device company could change the world, if only you could get organized. Your company is in Iowa, your manufacturer is in China, your animal testing lab is in Denmark, and your chief scientists live in India. Sometimes it seems like one team has no idea what another is working on. Meanwhile, your investors in New York want a status update. The Internet offers great networking opportunities, allowing emerging companies to connect with potential collaborators worldwide. However, poor communication can make it difficult to coordinate the product development process and reach critical milestones. With your team scattered throughout the world, how do you bring everyone together?
Scott Hampton, chief strategist at the Medical Device Development Group (MDDG), is a firm advocate of online collaboration. The Atlanta-based group helps emerging device companies take their products from concept to commercialization. An important component of the organization’s strategy is a web-based, interactive project management portal. The client, contractors and other project participants are put into the same communications portal, so the client can see on a minute-by-minute basis what everyone is working on. Hampton concedes that the system experiences the same hiccups that any other digital portal does—the occasional crash, backup issue, or Internet outage. But at the end of the day, Hampton says, this transparent, no-barriers approach takes huge business risks off the table for investors.
Suneel Arora, patent attorney at Minneapolis law firm Schwegman, Lundberg and Woessner, believes that a collaborative portal can be extremely useful from a legal standpoint. At an emerging device company, one person may handle the regulatory side of things, while another person handles the patent process. These two sides have differing goals and may even be at odds. In shooting for a shortened approval pathway, the regulatory side will point out that their new product is equivalent to an existing product in terms of safety and efficacy. Meanwhile, in order to protect the company’s intellectual property, the patent side will try to prove that their product is unique. Sometimes, particularly in a big company, these two sides don’t always talk. Issues may occur if a company makes inconsistent statements to the FDA and the patent office. Having a portal can facilitate communication between the two sides. If the regulatory person discloses certain proprietary art, the patent person can be made aware of that and can ensure the company has met its legal obligations to disclose the same thing to the U.S. trademark office. Arora believes that this kind of online collaboration offers real opportunities to tie together disparate functions within the device development process.
Arora warns that although there are opportunities for improving IP protection by promoting collaboration, there are also risks involved. Any sort of collaboration creates a risk of public disclosure where none should exist. Most devices undergo testing in Europe before they’re brought into the U.S., and European IP laws are much more draconian than U.S. rules. In Europe, inventors need to file their patent application before they start disclosing their invention to the general public. Any kind of Internet-based product disclosure has to be limited to people who have signed confidentiality agreements. Otherwise, the company must wait until the patent application has been filed.
It’s safe to say that the Internet, even in its earliest stages, has changed the medical device development process in both small and large ways. The Internet has made the transfer of large files easier, allowing device makers to send CAD files across the country to a manufacturer who can make the parts. Emails make communication instantaneous and leave a digital paper trail that is conducive to record-keeping. Web-based portals such as Basecamp and Goplan make it easier for project participants to collaborate. “Consulting is dead,” says Hampton. “Enabled collaboration is huge.”
Has your team used a collaborative portal before? How did it work for you? Feel free to share your story in comments.