Integration of our kit into society
We consider integration of our device into existing healthcare systems and current infrastructure a key challenge, and therefore a fundamental aspect of our applied design considerations.
Dialogue with Juan Solano and Alfons Van Woerkom of The Global Fund
We contacted Juan Solano and Alfons Van Woerkom of The Global Fund, an international financing organisation which has worked to fund several large-scale projects in the fight against HIV/AIDS, TB and malaria. They introduced us to the concept of market and financial analyses, in order to outline opportunities for a new diagnostic to come to market and to optimise its implementation. We reviewed a set of key points:
- Existing diagnostics on the market
- Information on the size of the market
- Regulatory framework of the country
- Well documented details of the unit cost
- Well documented details of the phases of production
- Delivery aspects (materials, transaction costs, depreciation)
This will allow an optimal pricing strategy to be determined at the level of the product and its users. Furthermore, it provides recommendations to potential investors regarding the product’s investment feasibility.
For costing of our kit we were aided by contact with David Sprent, an expert in International Supply Chain, and Juan Solano and Alfons Van Woerkom of the Global Fund. They helped us with costing, but also with the considerations that have to be taken into account when importing products into Latin America. We used Bolivia as a case study, and imagined what the situation would look like if the country were to adopt our kit wholesale, testing all 163,000 babies born every year. The kit would be manufactured in the UK and then transported to Bolivia, as according to Export.gov as of 2014 there was no local production of pharmaceuticals.
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|Component||Cost Per Kit ($)||Source|
|Bivalirudin||0.007||Cost (Selleckchem) (Modelling told us we needed 50uM)|
|Sodim Citrate||1.23^10-9||Amount Cost (Sigma Aldrich)|
|Calcium||0.00311||Amount Cost (Sigma Aldrich)|
|Tissue Factor||8.78*10^-9||Amount Cost (abcam)|
|Capillary Tube||0.074||Cost (Sigma Aldrich)|
|Injection Molding of Kit||0.685||Cost (CustomPartNet)|
|Cardboard Box (70x30x50mm)||0.1||ABCPackaging|
|Microsafe Pipette||0.075||Cost (Safe-Tec)|
|Printed Instructions||0.03||Cost (Pharmaceutical Printers)|
|TetR||8.25*10^-5||Cost (MyBioSource) (Modelling told us we needed 100nM)|
|Cell Lysate for DNA Reaction||0.9||Pardee et al. (2016)|
|DNAse 1 Inhibitor||0.007||Choi et al. (2005) Cost was assumed same as bivalirudin|
This was hard to estimate, given the unknowns in our kit, but we assumed we would ask a third-party to assemble the kit and this would lead to costs of around $0.25 per/kit.
We decided that with a minimum shelf life of around a year for our test it would be pertinent to send kits once a quarter to Bolivia, otherwise we risked them expiring before being used. With a 50x30x70mm box for our kit around 8,000 can fit on a europallet after taking into account further packaging for the pallet. This means we'd be sending 5 pallets/per quarter, and we estimated that this would cost around $12,000 per shipment to get from the factory in the UK to hospitals in Bolivia. This equates to around $0.30 per kit.
Bolivia imposes a 13% tax on pharmaceutical imports into the country.
Totalling up all these costs, and then adding 25%, as was suggested to us by those we contacted, brings the total cost of our kit to around $3.59, which is significantly less than the current other options on the market.
Dialogue with HeLEX
Consultation throughout with relevant stakeholders, including the Centre for Health, Law and Emerging Technologies (HeLEX) and Piers Millet, has brought some important difficulties to our attention. Key issues raised from our dialogue include:
- Dual-use technology in synthetic biology
- Management of data gathered from our device
- Transnational boundaries and international collaboration
You can read more about social, economic and political factors affecting our project on our Silver Human Practices page
Whilst some of these issues (e.g. dual-use) may not immediately appear applicable to a diagnostic device, biosafety and biosecurity should be considered by any groups developing new technologies using synthetic biology. A component of our Education and Public Engagement activities therefore involved approaching some of these issues in order to foster a ‘culture of responsibility’ - you can read more about our activities here.
We discussed how optimal integration of our device partly requires established guidelines to fill in gaps which may exist in current regulation. Using Bolivia as a case-study, we have produced a policy brief which summarises some of these findings, and proposes a flowchart showing our proposed optimal diagnostics strategy for Chagas disease.
Figure 5: A flowchart showing the optimal diagnostic strategy for congenital chagas disease using a rapid protease detecting kit.
One concern raised by our dialogue with HeLEX included the importance of public engagement in addressing the awareness of Chagas disease. A public health campaign rolled out in regions of Latin America with the implementation of our kit could circumvent future issues surrounding consent and knowledge of the risks associated with Chagas. Most importantly, this would need to be translated to local languages, including Spanish, to increase access of information to local stakeholders. To this end, we have produced a draft example of a public health poster which is concise and easy to read.
Figure 6: A draft public health poster for Chagas disease, translated into Spanish
Future Vision for our Kit
We approached Professor Matt Higgins at the University of Oxford, an expert on Trypanosoma brucei to learn more about the detection of trypanosomes within the human host. The insight he provided into other pathogens inspired us to improve the potential of our project being used as a platform technology, by swapping the input and outputs as required.
Having spoken to Dr Piers Millett, a Senior Research Fellow at the Future of Humanity Institute, we discussed the concept of platform technologies and how this could be applied to our project. Having a platform provides a good way of fast tracking future developments because the platform will already have met regulatory approval, therefore allowing the device to be more rapidly adapted for other diseases.
As our kit is modular, it will be able to be easily and cheaply adapted to diagnose different diseases; the cost of changing the disease is then only the input block, not also the output block. Our vision for the future is that a streamlined manufacturing process can be established which allows a rapid development of new diagnostic modules as people characterise specific proteases which are biomarkers for disease.
Pardee, K., Green, A. A., Takahashi, M. K., Braff, D., Lambert, G., Lee, J. W., … Collins, J. J. 2016 Rapid, Low-Cost Detection of Zika Virus Using Programmable Biomolecular Components. Cell, 165(5), 1255–1266. http://doi.org/10.1016/j.cell.2016.04.059.