and money to complete the relevant regulatory processes, and cannot simply
free-ride on the first company’s investment in clinical trials.
74 In some ways,
this gatekeeper function of the FDA partially replicates the function of the
75 To be sure, it is weaker in some ways (especially for follow-on devices proceeding through the 510(k) pathway), but in others it is
76 For instance, the FDA gatekeeping authority is automatically
enforced—companies do not need to expend resources searching for
potential patent infringers on the market, as the FDA will do it for them.
patents are less commonly available for mobile health companies, FDA
approval may be one way of partially regaining their function.
Second, FDA approval carries with it an imprimatur of safety and
effectiveness that can be highly valuable to a company.
78 Companies can
avoid publicly releasing particular types of information, including trade
secrets about how their products work, if the FDA has viewed all the relevant
information and approved the product on that basis.
79 The FDA is highly
respected by both the public and experts in the relevant fields,
80 meaning that
its approval decisions are both trusted and important to other decision makers
within the health care context.
81 If consumers have a choice between two
products—one FDA-approved, recommended by their physician and paid for
by their insurer, and another with more limited functionality and no
recommendation from a trusted intermediary—they may be inclined toward
One example of this approach is Empatica, a company developing a series
of devices that measure and monitor a range of vital signs.
flagship product, a smart watch called Embrace, was designed primarily for
74. See id. (Noting generally that every new medical technology goes through the relevant
75. See Yaniv Heled, Patents vs. Statutory Exclusivities in Biological Pharmaceuticals
— Do We Really Need Both?, 18 MICH. TELECOMM. & TECH. L. REV. 419, 449–50 (2012).
76. Id. at 430– 32 (looking at similarities and differences between the patent system and
77. Id. (discussing how the FDA doesn’t allow generic drugs to enter the market for a
period of 5 years).
78. See Device Denials, Approvals and Clearances, U.S. FOOD & DRUG ADMIN. (Apr. 7,
DeviceApprovalsandClearances/ (noting that FDA approval shows that a medical device is
safe and effective for its intended use).
79. Aaron S. Kesselheim & Michelle M. Mello, Confidentiality Laws and Secrecy in
Medical Research: Improving Public Access To Data on Drug Safety, 26–2 HEALTH AFFAIRS
483, 484–85 (2007).
82. Embrace: Monitors Seizures, Sleep and Physical Activity, EMPATICA (2017),
https://www.empatica.com/product-embrace (last visited Apr. 7, 2017).