内容来源：https://nav.al/regulatory

内容总结：

监管前沿：对话三位前沿创业者

在本次系列对话的第三部分中，Vercel创始人Guillermo Rauch、Boom Supersonic创始人Blake Scholl和Science Corp创始人Max Hodak围绕监管议题展开了深入讨论。核心观点如下：

监管的“红皇后竞赛”

Blake指出，传统监管流程严重拖慢了创新迭代速度。以飞机认证为例，仅防雷击测试就需要撰写200页合规文档，耗费数月时间。而借助RAG（检索增强生成）技术，他们现在只需几分钟就能完成这项工作。这不仅节省了时间，更关键的是降低了变更成本——修改设计不再是几个月的工作量，而是几分钟的事。这意味着企业敢于调整方案，并能用少量高创造力工程师替代大量低水平合规文档撰写者。

Max则认为，硅谷普遍将监管视为创新障碍的观点有些片面。许多监管本身是为了公共利益（如控制雾霾、让河流可游泳），问题在于人类理解和遵守这些规则的成本太高。如果能将监管流程做到“零摩擦”，这将是AI的未充分发掘的潜力。

Naval提出了一个有趣的担忧：当监管机构也开始用AI生成大量合规文件时，就会变成“智能体对智能体”的战争。而Blake认为，即便这样也比现状好——目前建筑审批等流程中，消防部门等机构仅凭道德权威就能拖延数月，而一个快速给出反馈的AI代理即使批评过头，也比当前的无尽等待要好。

Guillermo从另一个角度指出，监管其实就是“测试用例”。只要规定合理且无矛盾，它们可以作为AI智能体的有效护栏，防止企业向空中“乱丢垃圾”。

为什么医疗领域创新匮乏

Blake用开车类比当前的基建审批流程：你要先写计划、送审、等三个月回复，然后才能出发。这极其荒谬，但这就是美国物理基础设施建设的现状。他主张将监管模式从“预审批”转向“执法监督”。

Max提到，医疗领域的根本问题在于激励不对称：FDA批准十个好药没人表扬，但一个病人死亡就会被国会传唤。这种负向激励机制导致监管机构倾向于“宁缺毋滥”，最终损害的是患者利益。

Naval进一步指出，这是选民意愿的体现。美国人对风险极度厌恶，导致物理世界（医疗、基建）的创新远落后于数字领域（AI、加密）。他呼吁进行“真正的50州实验”——不同州采用不同监管和税收政策，让公民选择适合自己的创新环境。Blake补充了“创新区”概念：通过自愿加入的YIMBY区域，尝试不同规则，成功经验可以推广。

中国FDA正在超越美国

Max对比了全球监管体系：欧洲的“通知机构”系统（私人企业受政府授权进行认证）因竞争机制而更高效；而中国的CFDA（国家药监局）已批准了首个可植入脑机接口，审批速度和成本远低于美国。他指出，医疗设备成本高昂的根本问题是上市成本过高，导致无法像手机行业那样实现“更便宜→更多人购买→总支出增加→行业繁荣”的正向循环。中国通过降低上市成本，使产品价格从10万美元降至1万美元，这才是真正的去监管化。

医疗：资本主义中的共产主义特区

Naval犀利指出，美国医疗体系本质上是“资本主义社会中的小型共产主义社会”——没有真正的私人市场，价格信号失灵。他提出一个大胆设想：将个人年收入的20%设为医疗免赔额（穷人零免赔，富人数百万免赔），超出部分由政府和保险覆盖。这将迅速催生私人市场，就像牙科、眼科、整形外科那样通过消费者直接付费实现技术进步。但大多数人不愿接受这种思路。

Sid的故事：为一人定制的医学

Max分享了GitLab创始人Sid的故事：他罹患罕见癌症后，主动利用个人资源开创了自己的个性化治疗方案，最终催生了六七家生物技术公司，数十种新药用于他的治疗方案，使他远超医生预期生存期。

Guillermo感叹，这种“为一人定制”的医学需要患者在最虚弱时展现出极强的主动性，而AI应当在这方面发挥作用——让更多人能够获得知识和资源，而不仅仅是那些有钱人。

中文翻译：

监管前沿
本期为四位前沿创始人系列对话的第三部分：Guillermo Rauch（Vercel）、Blake Scholl（Boom Supersonic）与Max Hodak（Science Corp）。
亦请参阅第一部分：代币化浪费，节省时间；第二部分：氛围编码硬件；以及第四部分：自主型企业（敬请期待）。

监管红皇后赛跑
Blake：我们在监管方面发现的一件事是——它极大地降低了变革抵触，并提升了迭代效率。举例来说：假设你要认证一架飞机。你必须完成的无数事项之一，是证明它能承受雷击。测试计划的监管文档可能长达200页。传统做法是雇一个——说实话——不太聪明的工程师，他愿意坐在那里，像猴子敲键盘一样，写出200页的合规文件。这需要几个月。而且，如果你对飞机设计做了改动，那简直想哭，因为又要花两个月重做这些死板的合规文件。
我们发现可以构建一个RAG（检索增强生成）系统，基本上只需——大概几分钟——就能搞定所有这些工作。直接效果是节省大量时间。间接效果是，如果你改变飞机规格，现在只需几分钟而非几个月。所以你实际上更愿意去改变。第三层效果是，你可以淘汰那些水平一般的工程师，只用少数真正有创造力的人，他们能快速迭代，因为变革成本降低了。从某种意义上说，整个监管负担——这种严重阻碍迭代能力的东西——就消失了。

Max：这是目前AI领域一个被严重低估的故事。硅谷的共识是监管很糟糕——我们想加速，想实现这个美好的未来，想要富足与繁荣，而任何拖慢这个未来的东西都应避免。当然，我们确实监管过度了。我们已经搞得什么都建不成了。在很多地方，建造任何实体物品所需的流程简直疯狂。
但很多监管本身并不是问题。如果你真的读过这些规定——拥有没有烟雾弥漫的城市很棒。能在许多河流中游泳很棒。其中很多规定本身就是进步。问题在于，人类要理解并遵守这些规定非常困难，而且每次你和政府交换文书，都要等上好几个月。如果你能把我们学到的很多东西变得完全无摩擦，那将非常酷。我认为这是一个被低估的故事。

Naval：直到监管机构也开始向我们输出代币（指大量文件）。然后你开始收到监管机构发来的海量合规文件，这就成了智能体对智能体的战争。但至少这场战斗是公平的。

Max：这基本上就是我们现在的情况。

Blake：我其实认为那会比现在有所改进。现在最糟糕的一点是，如果你想建任何实体东西，必须先拿到建筑许可证。在证明清白之前，你是假定有罪的。我们遇到最麻烦的是消防部门，因为他们有道德光环——毕竟他们是从火场救人的人——但实际上他们做的事就是浪费你几个月的时间来刁难你的建筑设计。如果我们能用一个人工智能体来取代消防局长，快速评审你的建筑方案——即使它的反馈可能过头——也绝对比今天这种拖延要好得多。

Guillermo：当Max刚才提到这可能是件好事——即我们有这么多监管——我脑子里想的是：让智能体成功的关键，是人类或其他智能体设定好正确的测试护栏。人们对“斜杠目标”或“拉尔夫循环”之类的东西非常兴奋，也就是你告诉模型：“去做这个，这是你的退出标准。”我正在对Blake说：“去让我们所有人都能超音速飞行。你的退出标准是你已经遵守了所有这些法规。”完全存在这样一种世界：我们说监管很棒——它们就像我们的测试套件。只要通过它们不会引发矛盾，而且法规本身合理，它们就是极好的护栏。否则，我们就会直接把粗制滥造的东西送到空中。

Naval：这会变成一场红皇后竞赛。他们会用智能体，我们也会用智能体。我认为我们可能会有更好的智能体——那是好事，比起人与人对抗。但他们的周期时间、响应时间可能会变得更长。应用商店现在充斥着垃圾信息。我敢肯定专利局也是如此。这些机构会缓慢地采用AI。他们会遭到聪明企业家的DDoS攻击（分布式拒绝服务攻击），被他们用海量文件淹没。这些东西的审批时间可能会因为突然被淹没而延长。

为什么医疗领域没有创新
Blake：这创造了一个真正转变监管模式的机会。想象一下，如果我们今天像造东西一样在城市里开车。在你开车去任何地方之前，你必须先写一份计划，寄给某个监管机构，然后等待。你的计划必须详细说明：“我们将走某某路线，以这个速度行驶，使用转向灯，在每个停车标志前停车，绝不闯红灯”，等等等等。三个月后你收到反馈：“我们认为你应该走另一条街。”最终你获得批准，然后开车去某个地方。这太疯狂了——你哪儿也去不了。然而，这正是我们在美国建设实体基础设施的方式。我们应该让更多的事情基于执行来进行监督，而不是基于预先批准。

Max：我不想把自己置于太大的风险下——如果我把一个医疗设备运送给很多人，那就需要——存在未知因素。我们是负责任的，我们做了临床试验，我们报告了所有数据，但是——

Naval：Max，这就是为什么现在医疗领域创新如此之少。FDA（美国食品药品监督管理局）的审批流程是一场噩梦。事实上，过去十年硅谷科技领域最大的两个进步——AI以及之前的加密货币——它们都属于数学领域，因为那是最后一个未受监管的领域。当他们开始监管前沿模型和GPU时，这也会停止。Peter Thiel感叹在物理领域没有创新。嗯，这是因为巨大的监管障碍阻碍了它。
你总能找到一个可怕的案例——一种疫苗，或一起著名的医疗灾难——但监管无处不在，触角无处不在，而且有这么多相互矛盾的监管机构。SpaceX被起诉没有雇佣足够的——我忘了是什么——移民或难民之类的，但他们被政府另一方面的规定禁止雇佣这些人，因为他们不是公民。这不像逻辑代码，必须在同一个地方编译。这些都是遍布各处、随意制定的法规。你可能遵守了一个州的法律却违反了另一个州，违反了联邦法律，惹恼了这边这个人，而那个人选择起诉五十个人中他的一位朋友。这是任意的，是反复无常的。

Blake：而认为这让事情更安全的想法完全是神话。看看波音公司。他们认证了737 MAX，这架飞机上有一个单一的传感器，对飞机的抬头和低头姿态拥有完全的控制权。没有哪个实习生会蠢到认为这是个好主意。然而它却一路通过了认证系统。这些东西实际上并没有让我们更安全，只是让我们更慢。

Max：嗯，这里肯定存在功能障碍。我认为其中一些确实让我们更安全，比如NRC（美国核管理委员会）让我们更安全——他们的工作是确保核能安全，他们通过从七十年代起直到我认为去年才批准零座新核电站来实现这一点。如果我们永远不建任何东西，那当然是绝对安全的。
我想非常明确地说——在很多这类问题上，我是站在放松管制一边的。我同意Blake的观点，很多流程可以更高效。但我也认为，说“这只是FDA，只是这些机构的问题”有点太轻描淡写了。问题更深层。如果FDA批准了十种非常重要的药物，他们得不到任何表扬。一旦有一个病人死亡，他们就会被拖到国会面前挨训。他们有着非常负面的激励机制。现实是，这反映了美国人民的信仰。在人体研究中承担风险的认知，与我们获得新药的速度之间，存在一种权衡。

Blake：这完全是信息不对称的。如果你批准了一件坏事，你的职业生涯就完了。如果你阻止了一件好事，没人会注意到。这造成了一种不对称的放缓。我认为这是监管体系中需要解决的最重要问题。

Max：这是一个非常深层次的问题，因为这就是选民的立场。我们会对未来正在做的某些工作进行民意调查，以了解美国人民的态度。如果你逼得太紧，你可以绕开它——去Próspera（洪都拉斯的一个特别经济区），有各种方法试图加速。但如果你被视为一个不良行为者，你就会被我们所生活的社会排斥。这是你需要给出答案的问题。这比仅仅说“我们需要监管改革”要深刻得多。

我们需要一场真正的五十州实验
Naval：Max，你说到了一个深刻的问题——这就是选民、公民的立场。我们喜欢责怪政客。你在X上经常看到——人们会说：“这个政客，那个政客，别的政客。”但他们是经过多数投票选出来的。这就是人民的真实立场。那就是他们选择的整套方案。你可能不喜欢这个具体的形式，但如果你拿掉这一个，很快会有非常相似的东西取而代之，因为选民会再次把他们选回来。
在文化上，大多数人很难理解我们失去了什么，错过了什么。法国——有个法国企业家在X上感叹，GDP的57%被政府吸走了，所以你无法创建公司。但对普通法国公民来说，这并不明显。他们没注意到自己错过了什么。他们只知道他们比美国稍微穷一点。《经济学人》刚发了一篇小文章——经济学家们在三十年后终于重新成为资本主义者——谈到美国如何超越所有人，增长更快，变得更大。但他们立刻话锋一转说：“这是因为海洋，因为自然资源”——除了资本主义，什么都提到了。他们不想说那个肮脏的C开头的词，因为出于某种原因，所有这些杂志在某个时间点都变成了马克思主义者。他们无法想象或设想，如果我们当初能更自由放任一点，更开放一点，本来会是什么样子。
我很想看到真正的五十州实验。不同的法规，不同的税收结构。现在联邦税收结构和联邦法规主导一切。但想象一下，如果你得了癌症，你可以去某个小州，尝试每个人正在研制的所有药物。买者自负——你得自己做研究。这就是所谓的实验区。对无人机也一样。对飞机也一样——稍微难点，因为要飞越很多区域——但没错。

Blake：这里面有些很神奇的东西——创新区的概念。我们有一个巨大的邻避（NIMBY）问题。但如果你创建了自愿加入的迎臂（YIMBY）区，你就创造了那个实验框架。根据定义，它发生在人们同意的地方。你可以尝试不同的规则，或者没有规则，或者不同的执行方式——推定无罪直到证明有罪——然后看看实际发生什么。创新后果是什么？安全后果是什么？然后成功经验可以传播开来。

Max：回应Naval的观点，一个创新区并不能解决药物发现的问题。不久前通过了《尝试权法案》。在此之前很久，我们就有了“单一患者IND”这个途径。如果你的医生打电话给FDA说：“我想给我的病人用一种未经批准的药物”，他们批准了超过99%的这类请求。他们甚至可以通过电话批准。
问题是，要给病人用药，你仍然需要临床级别的药物。唯一拥有这种药物的实体通常是正在进行临床试验的知识产权所有者——他们正在投入数亿美元来开发这东西。如果你那位可能本来就病得很重的病人出了什么事，FDA会做出不利推断，这被视为该药物的属性，是全局性的——与你的创新区无关。所以有两个问题。一，你需要让知识产权所有者给你一些他们的药——他们不会那么做。二，你需要防止全球性的监管机构对他们给你药物后的临床试验结果产生怀疑。

Blake：在医学领域，你会怎么解决这个问题？

Max：这是内部行话。例如，必须禁止FDA对不同用户使用同一种病毒载体做出不利推断。有一些特定的方法，可以通过相对轻松的监管手段真正加速创新，只需防止这种偏执左右我们的决策。

中国的FDA正在击败我们
Guillermo：国外有什么比FDA更好的机构吗？我们用什么基准来评判这些监管机构？

Naval：所有人都遵循FDA。所有人都模仿FDA。

Max：两点补充。第一，欧洲——并不真的比FDA好，但他们有不同的体系。他们有所谓的“公告机构”——基本上是由其所在国政府授权的私营企业来认证东西。火车、飞机、医疗设备。公告机构体系在审核层面创造了稍好的激励机制，因为他们可以雇佣人员，可以发展，存在竞争。他们自身必须遵守东道国政府设定的条件，但这意味着他们的审核员数量可能比美国多出成千上万。
第二，实际上现在有一个获批的、已付费的植入式脑机接口（BCI），就在中国。中国药监局（CFDA）有自己的独立思考。他们有一个体系，我认为如果我们不小心，它可能会让我们难以招架。将药物或设备推向市场的成本要低得多。你可以直接在人体上尝试，直接在市场上尝试。
这是我花了很多时间思考的事情。二十年前，我们购买的笔记本电脑和手机少得多；每一个都贵得多。现在它们更便宜了，数量也多得多，我们买得更多，总支出增加了。这很好。高通、三星和苹果的股价大涨。大家都高兴。他们用手机和笔记本电脑产生的超额财富去购买更多的手机和笔记本电脑。
这在医疗领域不会发生。由于报销机制——存在这种企业层面的销售——我们用于购买医疗服务的资金池基本上是固定的。它并不会因为有更多能带来更好医疗结果的东西出现而增加，就像我们在技术增长型行业看到的那样。医疗支出的增长速度大致与税收收入的增长速度相同。如果AI蓬勃发展并取得重大进展，两年后我们在AI上的支出增加十倍，那可能很棒。但如果两年后我们在医疗上的支出增加十倍，那将是一场灾难。这与成为一个技术增长型行业是根本矛盾的。
医疗领域存在一个普遍问题，都与同一件事有关：将这些产品推向市场的成本太高了。这就是中国正在解决的问题。解决之道不是单一支付方或修改健康保险。而是降低成本，这样人们就可以用信用卡购买，通过融资，最坏情况下像买车一样——然后你就在交易中向他们收费。要做到这一点，我们必须降低这些产品推向市场的成本。中国正在这样做。这将使他们能够以1万美元而非10万美元的价格出售这些东西。这就是放松管制。

医疗是资本主义内部的共产主义社会
Naval：从根本上说，医疗领域没有私人市场。人们有时会做一个类比——想象一下，你不再去餐馆付钱吃饭，而是去所有餐馆，月底把所有收据和账单寄给保险公司或政府，然后他们给你报销。那么每家好餐馆门口都会排起长队。每家差餐馆都会空着。等待时间会非常糟糕。产品不会改进。你基本上是在一个更大的资本主义社会内部运行一个小型的共产主义社会。这就是我们在医疗领域做的事。

Blake：我们在道路方面也在做同样的事，这就是为什么会有交通堵塞。高速公路没有动态定价，所以它总是拥堵。

Naval：如果你想短暂地触碰一下医疗领域的“第三条轨道”，想想这个计划。告诉我它有什么问题。想象一下，你年收入的前20%就是你的医疗免赔额。如果你身无分文无家可归，那就是零。如果你很富有，那就是数百万美元。无论你年收入多少，前20%就是你的医疗免赔额。剩下的由政府和你今天的常规保险上限系统支付。
你很快就会创造一个私人市场。在牙科、整形外科以及许多选择性医疗程序中，你会形成竞争局面。你会得到改进。看看眼科领域的LASIK（激光视力矫正）。看看牙科领域的贴面、牙套和牙科手术。看看整形外科。这些领域确实在进步，因为它们是私人支付——人们用金钱投票。我们需要在常规医疗体系中做一些类似的事情。但人们会失去理智。他们甚至不想向前思考一步。“不，不，不，那穷人怎么办？”穷人没有收入。“对有些人来说20%太高了。”好吧，你可以在里面加一些免赔额。但总的来说，如果你没有一个让人们自费支付医疗费用的私人市场，你就无法得到这种反馈循环。你就无法获得这种向系统投入更多资金的能力。
现在，非常富有的人可以自愿向系统中投入资金。但价格毫无章法。费率卡毫无章法。系统不是为此设计的。如果你去购买医疗服务并想自费支付，有时他们会报出一个比保险公司支付价格高十倍的价格。

Sid的故事：N-of-1医学
Max：你听说过GitLab的Sid的故事吗？他公司IPO（首次公开募股）极为成功，随后被诊断出患有罕见癌症。他的存活时间远远超过了预后判断。他真的把主动权掌握在自己手里。他先做了前线化疗，然后有一种替代疗法可用，他试过了也没效果，医生们说：“我们对你没辙了。”从那以后，诞生了六七家公司。现在他的治疗路径上有二三十种药物。他还活着。

Guillermo：他状态很好。我前几天见过他。他基本上创建了自己的个性化医疗和治疗方案。

Max：我现在已经听过好几个这样的故事了。我非常清楚，在高端层面——如果你不需要跟保险公司打交道，你有资源，你会说：“我要用上现代科学的全套工具”——就有可能实现不可思议的结果。如果你去问你的医生：“如果我这样做会怎么样？”他们会开始大喊大叫，乱扔东西。但在高端层面，不可思议的事情是可能的。这种类型的N-of-1医学最终将成为一个非常丰富的研究来源，用于理解如何构建更具可转化性的东西。

Guillermo：这需要病人在他们最脆弱的时刻拥有巨大的主观能动性，这相当讽刺。我的一个朋友死于癌症，他最不想做的事就是研究N-of-1医学——他每周都在走向死亡。这正是AI应该大放异彩的地方，让普通人在遇到这种情况时也能知道能做什么。很疯狂的是，几乎没有人能获得这些信息，这不仅仅是钱的问题，更是知识获取的问题。

英文来源：

The Regulatory Frontier
Part 3 of our four-part discussion with three frontier founders: Guillermo Rauch (Vercel), Blake Scholl (Boom Supersonic), and Max Hodak (Science Corp).
Also see Part 1: Waste Tokens, Save Time, Part 2: Vibe Coding Hardware, and Part 4: The Autonomous Company (coming soon).
The Regulatory Red Queen Race
Blake: One of the things we’ve seen related to regulatory — it massively reduces change aversion and improves iteration. Example: let’s say you’re going to certify an airplane. One of the zillions of things you have to do is prove it can withstand a lightning strike. The regulatory documentation for the test plan stretches on for, say, 200 pages. What you would classically do is hire a — let’s be honest — not super-bright engineer who’s willing to be there, monkey at keyboard, writing 200 pages of regulatory compliance documentation. It takes a couple of months. And by the way, if you change the airplane, now you want to cry, because there’s another two months of rework of this rote compliance documentation.
What we’ve found is we can build a RAG that will enable us to basically prompt our way through all of that work in — let’s call it minutes. The first-order effect is you save a lot of time. The second-order effect is, if you change the specification of the airplane, it now takes minutes, not months. So you can actually be willing to change. And the third-order effect is you can get rid of the not-very-great engineers and have a small number of really creative ones who can iterate rapidly, because the cost of change goes down. In a certain sense, the entire regulatory burden — which really hurts the ability to iterate — drops away.
Max: This is a really undersold story in AI right now. The consensus in Silicon Valley is that regulation sucks — we want to go faster, we want to realize this amazing future, we want abundance, prosperity, and stuff that slows down that future is to be avoided. Certainly we’ve over-regulated. We’ve made it impossible to build stuff. It’s totally crazy what goes into building any physical thing in a lot of places.
But a lot of the regulations themselves are not the problem. If you’ve actually read a lot of these things — having non-smog-choked cities is great. Being able to swim in many rivers is great. A lot of these things were progress. The problem is that it’s really difficult for humans to deal with understanding and complying with this, and every time you have to exchange a letter with the government, you wait months. If you could take a lot of the things we’ve learned and make them totally frictionless, that would be pretty cool. I think that’s an under-sold story.
Naval: Until the regulator starts spewing tokens back at us. Then you start getting huge amounts of documents from the regulators that you have to comply with, and it’s agent-on-agent wars. But at least it’s a fair fight.
Max: That’s basically what we have now.
Blake: I’d actually argue that would be an improvement from where we are now. One of the terrible things right now is, if you’re going to build anything physical, you have to get a building permit. You’re guilty until proven innocent. The worst thing we’ve run into is the fire department, because they have the moral imprimatur of people pulling people out of burning buildings — and yet what they actually do is just screw with your design for buildings for months. If we could replace the fire marshal with an agent that would critique your building plan quickly — even if its feedback were overdone — it would be massively better than the delays that exist today.
Guillermo: When Max was talking about this potentially being a good thing — that we have all this regulation — my head went to: the thing that makes agents successful is humans or other agents setting up the right testing guardrails. People are really excited about slash goal, or Ralph loops, where you tell the model, “Go do this, and this is your exit criteria.” I’m telling Blake, “Go make us all supersonic. Your exit criteria is that you’ve complied with all of these regulations.” There’s totally a world where we say the regulations are great — they’re like our test suite. As long as passing them doesn’t incur contradictions, and the regulations are actually reasonable, they’re an awesome guardrail. Otherwise we’d be shipping slop directly into the air.
Naval: This is going to turn into a Red Queen’s race. They’re going to have agents, we’re going to have agents. I think we might have better agents — that’s good, as opposed to human-versus-human. But their cycle time, their response time, may get longer. The App Store is drowning in spam right now. I’m sure the patent office is drowning in spam. These agencies are going to be slow adopters of AI. They’re going to get DDoSed by clever entrepreneurs just overloading them with documents. It’s possible the approval time for this stuff may extend out as it suddenly gets flooded.
Why There’s No Innovation in Healthcare
Blake: It creates an opportunity to really shift the regulatory model. Imagine if we drove around a city the way we build things today. Before you could go anywhere, you’d have to write a plan, ship it to some regulator, and wait. Your plan would have to specify, “We’re going to take such-and-such a route, drive this speed limit, use our blinker, stop at every stop sign, never run a red light,” blah blah blah. Three months later you get a critique back: “We think you should drive on this other street.” Eventually you get approval and you go drive somewhere. It’s insane — you can never go anywhere. And yet that is absolutely the way we build physical infrastructure in this country. We should actually make more of these things enforcement-based, rather than pre-approval-based.
Max: I don’t want to be under too much — if I ship a medical device to a lot of people, there needs to be — there are unknowns. We were responsible, we did clinical trials, we reported all the data, but —
Naval: Max, this is why there’s so little innovation in medical right now. The FDA approval process is a nightmare. In fact, the two biggest advancements in tech in Silicon Valley in the last decade — AI and, before that, crypto — they’re both in the math domain, because that’s the last unregulated domain. When they start regulating frontier models and start regulating GPUs, that stops as well. Peter Thiel laments that there’s no innovation in the physical domain. Well, it’s been held back by huge regulatory barriers.
You can always find a scary case — a vaccine, or a famous medical disaster — but the regulations spread everywhere, the tentacles are everywhere, and there are all these contradictory regulatory bodies. SpaceX got sued for not having enough — I forget what — migrants or refugees or whatever, but they’re not allowed to hire them, by government regulation on the other side, because they’re not citizens. This is not like logical code that has to compile in one place. These are made-up random regulations all over the place. You might comply with one state and violate another, violate federal over here, annoy this guy over here, that guy chooses to prosecute one out of fifty people who are his friend. It’s arbitrary. It’s capricious.
Blake: And the idea that this makes things safer is a complete mythology. Watch Boeing. They certified the 737 MAX, which had a single sensor that had complete authority over the nose-up, nose-down attitude of that airplane. No intern is dumb enough to think that’s a good idea. Yet it got all the way through the certification system. This stuff doesn’t actually make us safer, it just makes us slower.
Max: Well, there’s definitely dysfunction here. I think some of this makes us safer in the sense that the NRC makes us safer — which is that their job was to make sure nuclear energy was safe, and they did this by permitting zero plants from the seventies until I think a year ago. It will be perfectly safe if we never build any of it.
I want to be really clear — I’m on the side of deregulation on a lot of this. I agree with Blake that a lot of this can be done more efficiently. But I also think it’s a little too dismissive to say, “This is just the FDA, the agencies.” The problem is deeper. If the FDA approves ten really important drugs, they don’t get any credit. One patient dies, and they get hauled before Congress and yelled at. They have very negatively-biased incentives. The reality is that this is reflective of the beliefs of the American people. There’s a trade-off between the perception of risk taken in human-subjects research, and the rate at which we get new medicines.
Blake: It’s totally asymmetric. If you approve a bad thing, your career is over. If you block a good thing, nobody notices. It creates an asymmetric slowdown. I think that is the most important problem to solve in the regulatory state.
Max: This is a very deep problem because it is where the voters are. We poll some of the stuff we’re working on in the future to understand where the American people are on it. If you push too hard, you can work around it — go to Próspera, all kinds of ways to try to go faster. But if you’re seen as being a bad actor, you’re rejected from the society we live in. That’s the thing you need an answer for. That’s deeper than just saying, “We need regulatory reform.”
We Need a True 50-State Experiment
Naval: You have a deep point there, Max — it’s where the voters, the citizens, are. We like to blame politicians. You’ll see this on X all the time — people are like, “This politician, that politician, the other politician.” They’re elected, by majority vote. This is where the people literally are. That’s the package, that’s the bundle they’ve chosen. You may not like this instantiation, but if you removed this one, something very similar would take its place, because the voters would just vote them right back in.
Culturally it’s very hard for most people to understand what we lost, what we missed. France — there’s a French entrepreneur on X lamenting that 57% of GDP gets sucked up by the government, so you can’t create companies. But to the average French citizen, that’s not visible. They don’t notice what they’re missing. They just know they’re slightly poorer than the US. The Economist just did a little piece — economists are finally coming back around to being capitalists after thirty years — on how the US is outstripping everybody, growing faster, getting bigger. But they immediately turn around and say, “It’s because of the oceans, because of natural resources” — everything but capitalism. They don’t want to say the dirty C-word, because for some reason all these magazines became Marxists at some point. They can’t envision or imagine what could have been if we had just been a little more laissez-faire, a little more open.
I would love to see a true experiment among the fifty states. Different regulations, different tax structures. Right now federal tax structure and federal regulations dominate everything. But imagine you could go to some small state if you had cancer, and you could try every drug everyone was cooking up. Caveat emptor — you’ve got to do your research. This is known as the experimental zone. Same for drones. Same for aircraft — a little harder, because you’ve got to cross a lot of areas — but yeah.
Blake: There’s something magical in there — the notion of innovation zones. We have a huge NIMBY problem. But if you create opt-in YIMBY zones, they create that experimentation framework. By definition, it happens where people are consenting. You can try different rules, or no rules, or different ways of enforcing — innocent until proven guilty — and see what actually happens. What are the innovation consequences? What are the safety consequences? Then the successes can spread.
Max: To Naval’s point, an innovation zone would not solve the problem in drug discovery. The Right to Try Act passed a little while ago. We’ve had this pathway called Single Patient IND for a lot longer than that. If your doctor calls the FDA and says, “I want to give my patient an unapproved drug,” they approve over 99% of those. They can even grant them over the phone.
The problem is that to dose a patient you still need clinical-grade drug. The only entity with that is typically the IP owner who’s in the middle of running a clinical trial — they’re investing hundreds of millions of dollars into making this thing. The FDA will draw an adverse inference if something bad happens to your patient who’s probably really sick to begin with, and that’s seen as a property of the drug, which is global — not related to your innovation zone. So there are two problems. One, you need to get the IP owner to give you some of their drug — they’re not going to do that. Two, you need to prevent the global regulator from casting doubt on what might happen with their clinical trial if they give you some.
Blake: How would you address that in medicine?
Max: This is inside baseball. The FDA has to be prohibited from drawing adverse inferences across different users of a capsid, for example. There are specific ways you could really accelerate innovation with a relatively light regulatory touch by just preventing this paranoia from driving our decisions.
China’s FDA Is Beating Ours
Guillermo: Is there anything better than the FDA out there? What are we benchmarking these regulators against?
Naval: Everyone follows the FDA. Everyone copies the FDA.
Max: Two expansions. First, Europe — not really better than the FDA, but they have a different system. They’ve got these notified bodies — basically private businesses blessed by their host governments to certify things. Trains, planes, medical devices. The notified-body system creates slightly better incentives at the review layer because they can hire people, they can grow, there’s competition. They themselves have to be compliant with conditions placed by host governments, but it means there can be many thousands more reviewers than in the US.
Second — there actually is one approved, getting-paid implantable BCI today, which is in China. The CFDA is thinking for itself. They have a system that I think is going to give us a run for our money if we’re not careful. The costs to bring a drug or device to market are just much lower. You can try things in humans and try things on market.
Here’s the thing I’ve been spending a lot of time thinking about. Twenty years ago we were buying far fewer laptops and phones; each one was much more expensive. Now they’re cheaper, there are far more of them, we buy more of them, total spending has gone up. This is great. Stock prices of Qualcomm and Samsung and Apple are way up. Everybody’s happy. They’re using the excess wealth generated by phones and laptops to buy more phones and laptops.
This doesn’t happen in healthcare. Because of the reimbursement mechanism — there’s this enterprise sale happening — the bucket of money we use to buy healthcare is basically fixed. It is not increasing as there’s more stuff producing better healthcare outcomes, the way we see in technological growth industries. The rate of spending on healthcare grows at roughly the rate of growth of tax receipts. If AI is booming and there are major advances, and two years from now we’re spending ten times as much on AI, this could be great. But if in two years we’re spending ten times as much on healthcare, this would be a catastrophe. This is fundamentally at odds with being a technological growth industry.
There’s this omni-problem in healthcare, all related to the same thing: it’s just too expensive to bring these things to market. That’s what China is getting at. The way out of this is not single-payer or some revision to health insurance. It’s to bring down the costs so that someone can buy this with a credit card, finance it, maybe like a car, worst case — and then you charge them in the transaction. To do that, we have to make it cheaper to bring these things to market. China is doing that. That will allow them to sell these things for $10,000 instead of $100,000. That is deregulation.
Healthcare Is a Communist Society Inside Capitalism
Naval: Fundamentally, there’s no private market in healthcare. The analogy people make sometimes — imagine that instead of going to restaurants and paying, you’d go to all the restaurants, and at the end of the month you’d send all the receipts and bills to your insurer or to the government, and they would reimburse you. There’d be a line outside every good restaurant. Every bad restaurant would be available. The waits would be terrible. The product wouldn’t improve. You’re basically running a small communist society inside a larger capitalist society. That’s what we’re doing in healthcare.
Blake: It’s also what we’re doing on roads, which is why we have traffic. There’s no variable pricing for getting on the highway, which is why it’s always clogged.
Naval: If you want to step on the third rail of healthcare for a moment, think about this plan. Tell me what’s wrong with it. Imagine that the first 20% of your annual income was your healthcare deductible. If you’re broke and homeless, it’s zero. If you’re rich, it’s millions of dollars. Whatever your annual income is, the first 20% is your healthcare deductible. The rest is paid by the government and the insurance system, up to the usual caps they have today.
You’d create a private market pretty quickly. In dental, plastic surgery, a lot of optional medical procedures, you’d get a competitive situation. You get improvement. Look at optometry with LASIK. Look at dental with veneers and braces and dental surgery. Look at plastic surgery. Those fields do seem to be advancing because they’re private payers — people voting with their money. We need to do some equivalent of that in the normal healthcare system. But people lose their minds. They don’t even want to think one step ahead. “No, no, no, what about the broke person?” The broke person has no income. “Twenty percent is too much for some people.” Okay, you can put some deductible in there. But generally, if you don’t have some private market where people are paying out of pocket for what are medical procedures, you’re just not going to get this feedback loop. You’re not going to get this ability to spend more money into the system.
Right now, very wealthy people can spend voluntarily into the system. But the prices aren’t anywhere. The rate cards aren’t anywhere. The system’s not designed for it. If you go shopping for medical care and you want to pay out of pocket, sometimes they’ll quote you a price that’s 10x what they charge the insurance company.
Sid’s Story: N-of-1 Medicine
Max: Have you heard Sid’s story from GitLab? He had a massively successful IPO, then was diagnosed with a rare cancer. He has lived way past the prognosis. He really took it into his own hands. He did frontline chemo, then there was one alternative available, he exhausted it, and the doctors were like, “We’ve got nothing for you.” Since then, six or seven companies have come out of it. There are now twenty or thirty drugs in his escalation ladder. He’s still alive.
Guillermo: He’s doing great. I saw him the other day. He basically created his own personalized medicine and treatment plan.
Max: There are a handful of these anecdotes I’ve heard now. It is really clear to me that at the high end — if you’re not dealing with insurance, you have the resources, you’re like, “I want the full toolbox of modern science” — outcomes are possible that are crazy. If you go ask your doctor, “What will happen if I do this?” they will start shouting and throwing things. But crazy things are possible at the high end. This type of N-of-1 medicine is going to end up being a really rich source of research for understanding how to build more translatable things.
Guillermo: It requires a ton of agency from the patient in a moment where they’re at their weakest, which is pretty ironic. My friend passed away from cancer, and the last thing he wanted to do was research N-of-1 medicine — he was dying by the week. This is where AI should really shine, and democratize what you can actually do when you find yourself in that situation. It’s kind of crazy how few people get access to this, just from a knowledge perspective, not just monetarily.