Growing 3D Printing
3D Printing in healthcare faces several challenges, from a supply chain spanning the globe to finding secure ways to share sensitive data and regulating a rapidly changing industry.
Context & Challenges
3D Printing is expected to rise to a value of $2.32 billion by 2020, with a CAGR of 26.2% during the forecast period. Growing demand for personalized healthcare solutions is driving the industry, with the technology allowing for entirely customized treatment. Further, it provides precise and more efficient solutions as well as compensates for the growing dearth of organs for transplants.
For 3D printing to sustain its growth and meet its potential, it must overcome several challenges. To meet custom orders in a timely manner, all around the world, it must surpass geographic and production limitations and be able to respond to data from multiple sources accurately and in real-time. This will impose an additional concern of security, as requests and producers will need to be verified, and sensitive data will need to be protected.
Additionally, as 3D printing begins to increase distribution and provide products to hospitals and patients, it will need to clear higher regulatory hurdles. For example, 3D printers have been called upon during COVID-19 to print nasal swabs for testing kits, and many cannot do so simply because they do not have the FDA clearance to do so. To achieve FDA clearance involves presenting huge amounts of data and can be a compliance nightmare.
For the FDA to regulate the industry is a challenge in itself. Last December, the agency issued guidance on 3D Printing, referred to as additive manufacturing, covering device design, testing of products for function and durability, quality systems requirements and what to include in premarket submissions. This is only a preliminary set of thoughts, as the industry is expected to dramatically evolve, for example including nontraditional manufacturers like hospitals in the future.
Given that there is currently little standardization in the industry, the FDA must constantly keep up with a changing landscape on multiple fronts. If they do not succeed in properly regulating the industry, the effects could be dire. For example if companies print nasal swabs that are not up to standard, then COVID-19 patients could receive false negative results, leading them to think they don’t need to quarantine and further spreading disease.
3D printing has the potential to be life-saving if it grows as it could. However, if unregulated, improper products could have detrimental effects on patients.
- Traditional 3D Printers
Traditional 3D printers are subject to a host of challenges, from compliance with regulation to scaling to meet demand and a global supply chain.
- Non-Traditional Manufacturers e.g., Hospitals
Hospitals and other healthcare institutions are moving away from the practice of outsourcing 3D printers and towards internal printing facilities. However, they face reimbursement and regulatory challenges which hinder cost-effectiveness.
- The FDA
The FDA is scrambling to keep up with the rapidly changing 3D space, and to understand and regulate it. Part of the challenge here, beyond lack of standardization is disorganized data, and a complex and untraceable supply chain.
The Good News
STRATO provides the necessary technological foundation for 3D printing to succeed.
- STRATO’s distributed ledger stores all data in one place
- STRATO’s automation builds a record of verified data in real-time
- STRATO’s peer-to-peer network authenticates data and communicates it seamlessly
- STRATO’s smart contracts ensure providers and consumers conduct secure and efficient transactions
- Maintain a record of access, update in real-time to ensure data owner control and traceability
- Spin private chains to immediately and securely provide access to data to new permissioned parties, controlling who accesses what data through encryption
- Allow data owners to monetize data by requiring fees for access by certain parties
- Integrate genetic data with existing systems through STRATO’s scalability and single ledger
Any STRATO insurance solution leverages STRATO’s enterprise grade features
- RESTful APIs for direct connection of IoT devices such as provider’s iPads to the blockchain network
- Identity Management, OAuth and SSO capabilities for simplified IoT authorization and user login
- Privacy via private chains to keep sensitive data private and control who sees what data
- Enterprise Data Modeling for integration into existing data systems, and to ensure genetic data is meaningful and actionable