Decentralization in Medicine

Industry application of 3D printing

Since the early 2000s, 3D printing has marched steadily from the corporate labs and academic institutions to design and manufacturing circles. It has been rising in popularity since the first “off the shelf” printer was made available in 2009.  The usage of 3D printers has gone beyond producing prototypes, they are now increasingly being applied in other spheres such as producing customizable jewelry, personalized gifts, and chocolates. However, one of the industries that are positioned to gain most out of the advances in 3D printing is medical devices and pharmaceutical industry. The technology is already finding its uses in this field for printing customized tools to facilitate research in the laboratory, tissues for research and prosthetics and dental implants. For pharmaceutical companies, an extension of these uses will be manufacture of   “Personalized medicine” and making them accessible to masses at an affordable price in a decentralized way. Customized medicine is emerging as the foremost trend in pharmaceutical development and represents attractive business opportunity for pharma companies.

 Traditional distribution model of Medicine

In a traditional model, the distribution of medicine consists of three major steps. First, medicines are manufactured in centralized facilities; Second, medicines are distributed to point of discharge; Finally, medicines are dispensed to patients through pharmacies and other medical outlets. .3D printing could change all this by eliminating the need for multiple phases of distribution and allowing for the consumer to obtain the medication in a much shorter length of time.

Decentralized distribution model of Medicine

In a decentralized model powered by 3D printing, local pharmacies, government organizations and other licensed individuals will be able to print medicines as per the unique needs of the patients. Personalized medicine presents architectural innovation for pharmaceutical companies. It requires a radical shift in thinking about how medications will be produced and distributed along with new technological capabilities to manufacture medicines in a decentralized manner. Instead of manufacturing and distributing medicines, all pharmaceutical companies need to do is share or email medical formulations to pharmacies for on-drug drug printing. These Blueprints can be easily distributed and used globally in a much faster and efficient manner. The technology works by pharmacists purchasing polymer inks pre-loaded with a drug and then printing out pills at a local dispensary.  The pill is printed layer by layer until it achieves the desired shape. In certain cases; a powder is spread in a thin layer, and then the liquid is added. The two substances bond with one another to form a single porous layer. The process is repeated as many times as necessary to build the product.

Advantages of decentralization in medicine

Now, Let’s look at some specific ways 3D printing has the potential of transforming the medicine. First, Decentralized manufacturing of medicines can be phenomenal in providing health care to the developing countries or remote areas which may be too difficult for big pharma companies to serve due to high cost or logistical challenges.  Second, decentralization can reduce “time to market” of the crucial drugs amidst the emergency, for example, China is currently fighting the health emergency caused by Coronavirus and Scientists across the world are working on formulations to contain the virus. Suppose a scientist in one part of the world finds the possible cure, all he has to do is share the blueprint of formulation with pharmacies authorized to print medicines in China, thus significantly reducing the time to reach the patients as compared to traditional channel. Third, decentralization can help fulfill the increased demand for personalized medicines. The on-demand manufacturing allows creating specific dosages as per the unique needs and profile of the patient such as age, race, gender, symptoms and medical history. This is specifically revolutionary for kid’s market segment as pills can be produced in shape, color and taste which are appealing to kids.

For Pharmaceutical companies, the decentralization of manufacturing can be instrumental in increasing revenue by reaching new geographies and selling personalized medicines of various shapes and sizes and with unique release profiles at a premium. It will also reduce cost by reducing the “time to market”, inventory and complex distribution network

Challenges of Decentralization in Medicine

It is pertinent to note that, decentralization of medicine manufacturing through 3D printing comes with its share of challenges. Firstly, Quality control can be a concern in a decentralized setting. There is a potential for abuse through the printing of illicit drugs or counterfeit medicines. Moreover, malware/ virus or a blocked nozzle could affect the printing process, ultimately producing a harmful product. The cartridge used by the physicists needs to be manufactured under good manufacturing standards. Second, decentralization also poses regulatory challenges. Manufacturing regulation and local legal requirements can be an impediment to dispensing of 3D printed medication on a larger scale, thus making the whole model financially unviable. Third, decentralization can increase the number of patent violations, thus leading to an increase in legal costs. Each authorized printer of medicine will have to negotiate a separate license with the patent holder, increasing administrative burden and reducing control for the pharmaceutical company.

Way Forward

Decentralized manufacturing of medicine will require vision, money, and time for the technology to evolve into the anticipated applications. Pharmaceutical companies need to focus not only on building technological capabilities but also on ensuring quality control, regulatory compliance, and patent protection in order to bring 3D printing of medicines to local pharmacies. This architectural innovation will sure provide a source of competitive advantage to the first mover. Using 3D tech to produce niche drugs that will be costly to manufacture through traditional manufacturing will be a good starting point.

https://www.washingtonpost.com/news/innovations/wp/2015/08/11/why-it-matters-that-the-fda-just-approved-the-first-3d-printed-drug/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4189697/

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