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.
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)
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?