Is your garage ready to replace the pharmacy?
How the government can be a key partner to innovation in the 21st century
Congress wasn't happy on September 21st when they grilled Mylan CEO Heather Bresch on why her company had raised the price of the EpiPen by over 500% in recent years. For many, the thought of allergy patients unable to afford access to life-saving medicine due to the price hike was outrageous. But for a community of DIY-hackers, it was a call to action.
On September 19th, ahead of Ms. Bresch's testimony on the Capitol Hill, the Four Thieves Vinegar Collective released a video detailing how an EpiPen can be made at home for under $30. Their device, cleverly called an EpiPencil, consisted of a syringe filled with epinephrine (the active compound used to treat severe allergic reactions) that was slipped into an over-the-counter auto-injector originally intended for insulin. All the components can be purchased either online or at a local pharmacy. In addition to their EpiPencil, the group also has plans for a DIY lab bench they call a "micro apothecary" which would allow users to synthesize prohibitively expensive or hard-to-obtain drugs. Currently they have instructions for Daraprim, a drug used to treat malaria and toxoplasmosis which currently costs over $750 (see "pharma bro" scandal), and with many others in the works. Although health experts have cautioned against the use of DIY solutions citing risks of incorrect dosage, reliability, and sterility, it is important that we do not lose sight of the unique opportunities in personalized medicine.
The idea of taking readily available parts and tools to create a unique widget is at the core of the DIY Maker Movement. This movement encompasses a variety of communities, including electronics, carpentry, food, clothing, mechanics, and health. Perhaps one its greatest success stories is the online marketplace ETSY. Started in 2005 for a small group of crafters in New York City, Etsy now serves over 60 million users selling everything from handcrafted bags to custom made ham radios, it is valued at over $3.5 billion. The growth of the Maker Movement has also led to the development of over 480 Makerspaces across North America, which are souped-up community garages where users can get access to training, tools, and work spaces for the price of a gym membership. Importantly, many in Congress and the White House see the Maker Movement as a way to create new businesses, jobs and, ultimately, a way to stimulate the economy.
Similarly, the medical field has seen a surge of groups and individuals demonstrating the same DIY attitude. Groups like quantified self (QS), for instance, are encouraging members to use various sensors (some commercial, some made at home) to monitor everything from sleeping patterns to blood glucose levels as a way to better understand their own bodies. A group at MIT has designed medical tools to be used like "erector sets" so that medical professionals can create customized solutions. Currently, the MIT team is collaborating with several medical centers to create health-focused maker spaces, called MakerNurse centers, that will train medical professions to use these tools to accelerate the innovation of new medical devices. Grand challenges like those from the Gates foundation and the XPRIZE foundation have also been essential in focusing the global community towards key challenges. These challenges have shown to be very effective R&D funding multipliers. For example, the first $10 million XPRIZE generated over $100 million in investment from 26 teams. The current XPRIZE Tricorder, challenge, which aims to create a palm-sized device that can monitor and diagnose 24 health conditions (à la Star Trek), has already raised over $100 million from just three teams of its 10 finalists (see here and here).
With such a vibrant community it is not surprising that an alternative to the EpiPen was developed so quickly. While there are legitimate safety concerns around using a DIY medical device, let’s not throw out the baby with the bath water. DIY solutions are often the catalyst for new start-ups and can even motivate larger entities to work on an issue by buying down risk or revealing a new market. Government should also play a central role in helping these new ideas access the market in a safe and rapid manner. To be fair, agencies like the Food and Drug administration (FDA) have created a suite of programs to speed up the process of approving new therapies. Processes like priority review, breakthrough therapy, accelerated approval, and fast track are aimed at expediting the development and review of new drugs based on factors like demonstrating improved efficacy or treating unmet medical needs.
Even with these programs, the growth of new pharmaceuticals has been constant for the past decade. Instead, it is the medical devices and technologies that have really taken off as shown in the graph below of health-related patents filed at the European Patent Office (EPO). Yes, these are European patents but let’s remember that the biggest players in this field are multinationals with names familiar to many American households like Philips (1st), Johnson & Johnson (2nd), Medtronic (3rd), Boston Scientific (6th), and Abbot (8th).
What’s clear is that there is a large demand for medical technologies, a large portion of which are personal medical devices. Innovative friendly ecosystem, such as through public-private partnerships, will be essential to the continued growth of this sector. Local governments, for instance, could use tax incentives to increase the use of old or abandoned facilities for workforce training centers. Furthermore, these centers could subsidize membership for individuals returning to the workforce (e.g. veterans, long-term unemployed) or disadvantaged individuals (e.g. homeless or low-income) who might want to start their own business or learn new skillsets. To help these new businesses grow, a voucher system could be put in place that allows small businesses to “buy” expertise and use advanced tools at research institutions. But beyond material support, federal agencies can also assist startups in navigating the regulatory process. Finally, the federal government could develop a national tech transfer strategy that facilitates the transfer of publicly funded intellectual property (IP) and expand programs that provides support for start-ups to commercialize government IP.
The American innovation community is an eclectic cast of characters such as designers, scientists, artists, engineers, DIY-hackers, and even the government itself. As an innovation partner, the government should do what it can to clear barriers and encourage collaboration, in order to facilitate the rapid introduction of safe and affordable products to the market.
Image: taken from PeakPX.
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