Stern Ariel Dora
Harvard Business School, Morgan Hall 433, Boston, MA 02163.
J Public Econ. 2017 Jan;145:181-200. doi: 10.1016/j.jpubeco.2016.11.010. Epub 2016 Nov 23.
This paper explores how the regulatory approval process affects innovation incentives in medical technologies. Prior studies have found early mover regulatory advantages for drugs. I find the opposite for medical devices, where pioneer entrants spend 34 percent (7.2 months) longer than follow-on entrants in regulatory approval. Back-of-the- envelope calculations suggest that the cost of a delay of this length is upwards of 7 percent of the total cost of bringing a new high-risk device to market. Considering potential explanations, I find that approval times are largely unrelated to technological novelty, but are meaningfully reduced by the publication of objective regulatory guidelines. Finally, I consider how the regulatory process affects small firms' market entry patterns and find that small firms are less likely to be pioneers in new device markets, a fact consistent with relatively higher costs of doing so for more financially constrained firms.
本文探讨了监管审批流程如何影响医疗技术领域的创新激励。先前的研究发现，药物在监管方面具有先行者优势。而我发现医疗设备的情况恰恰相反，在监管审批过程中，先驱进入者比后续进入者要多花费34%（7.2个月）的时间。粗略计算表明，如此时长的延迟成本超过了将一种新型高风险设备推向市场总成本的7%。在考虑各种可能的解释后，我发现审批时间在很大程度上与技术新颖性无关，但客观监管指南的发布能显著缩短审批时间。最后，我考察了监管流程如何影响小公司的市场进入模式，发现小公司在新设备市场成为先驱的可能性较小，这一事实与资金相对紧张的公司这样做成本相对较高相一致。
