Ed Dougherty, Dentons

Developing an mHealth Technology? Answer These Questions First

By Maria Fontanazza
1 Comment
Ed Dougherty, Dentons

Tips from industry peers who are going through the process.

The mHealth technology landscape is a crowded place in which early planning is critical to success. With seemingly endless opportunities, establishing priorities while ensuring that current and potential investors are satisfied can be a complex process. Last week industry experts gathered at a MedTech Intelligence conference to discuss the challenges facing mHealth and how device manufacturers should work together to navigate the market. During an interactive session, Ed Dougherty, principal in Dentons’ global healthcare practice, asked attendees what questions companies should make sure they answer, especially those “starry-eyed” entrepreneurs, as they embark on developing an mHealth technology.

mHealthdatafunctionality_risk
Infographic courtesy of Tüv Süd

The following are questions (not necessarily in any order) that device manufacturers should be asking:

  • Have you contacted FDA yet? Talk to the agency from the start to get their guidance and opinions as early as possible
  • Define the product’s market—who will be using the technology and where?
  • What country do you want to pursue first? (Note: This can be a negotiation exercise with your marketing team)
  • Ed Dougherty, Dentons
    Ed Dougherty, principal at Dentons, asks device manufacturers for advice in developing mHealth technologies

    Where will the data live? Privacy laws differ from country to country, so where information is stored can have a large impact

  • Where do you sit in the regulatory landscape: What is your strategy and what are the biggest risks?
  • Does the information that your product will generate have value? And, is it actionable? In an age of data overload, physicians don’t want information that doesn’t lead to an action they can take
  • How will your product integrate into the healthcare system? For example, creating separate websites for products introduces challenges, because doctors don’t want to log into multiple sites
  • Is there IP surrounding the product? Is the IP landscape crowded?
  • What are the IT risks? What elements could make or break the technology?
  • What hardware and software barriers might the platform introduce?
  • Through what platform is the information accessible (i.e., Android, iOS, etc.)?
  • What information needs to be protected, and how does device security affect easy of use and accessibility?
  • Is the technology scalable and commercially viable?

What advice would you give to fellow device manufacturers that are developing mHealth technologies?

About The Author

Maria Fontanazza, MedTech Intelligence

Comments

  1. Eric Cunningham

    Hi Maria;

    Thank You, you have prepared a very relevant list of questions whether the device is a smart phone or a more traditional, but web enabled, med device. The two items our team had to do some extra work on were:

    – Where will the data live? Privacy laws differ from country to country, so where information is stored can have a large impact
    – How will your product integrate into the healthcare system? For example, creating separate websites for products introduces challenges, because doctors don’t want to log into multiple sites

    We were uploading data from EU and US and then eventually a broader global area. We found we had to pay attention to encryption, HIPPA and data privacy from the core of our system hard drive out to the subtle differences of data transfer concerns in the EU once the data was “in the cloud”. Unfortunately, our launch coincided with the hack of Angela Merkel’s cell phone by NSA, so some of of EU partners were extra “testy.”

    We also had many reviews to try and hammer out the best data sharing, web access structure for our users, but also one that would serve the interests of the corporations marketing goals long term.

    Regards;
    Ericc

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