Week 1 HW: Principles and Practices
First, describe a biological engineering application or tool you want to develop and why. This could be inspired by an idea for your HTGAA class project and/or something for which you are already doing in your research, or something you are just curious about.
Biosensing Tattoo Patches
I will explore the development of ‘e-tattoo’ or microneedle patches with biomedical and environmental sensing capabilities.
I believe embedding diagnostic devices in an at home low resource application and interpretation formats is an application where we can utilize synthetic biology to create an accessible tool to further democratise advanced healthcare and diagnostics.
It is an application of high potential but also high technical complexity. I am aware there are many technical hurdles, both biological and mechanical, that I hope to address more fully with the guidance of this course.
I have a few primary PoCs in mind just now but are very subject to change depending on the application impact and biomarker suitability after further research.
| Application | Target | Function | Biomarker | Technical Complexity Prediction Score (0-10) | Impact Potential |
|---|---|---|---|---|---|
| Cancer recurrence monitoring | Prostate cancer recurrence | Wearer can monitor for Prostate cancer markers at home- rather than hospital check ups | PSA1 | 5 - simple biomarker but general circuit and device complexity challenges | Medium |
| Metastasis Monitoring | General cancer metastasis | Wearer can monitor for metastasis markers at home – rather than hospital check ups | OPN | 5 - simple biomarker but general circuit and device complexity challenges | High |
| Exposure / Infection Monitoring | Tuberculosis | Wearer can continuously monitor for TB infection in high risk environments- such as for healthcare workers low resource environments or natural disasters | TB RNA | 7-potential biomarker complexity challenges & sensitivity challenges and general circuit and device complexity challenges | High |
| Disease Monitoring and management | Multiple Sclerosis (MS) | Wearer can self-monitor and adjust care for MS relapses | Serum neurofilament light chain (sNfL) | 8 biomarker complexity challenges & sensitivity challenges & general circuit and device complexity challenges | Medium |
**Related Papers
Next, describe one or more governance/policy goals related to ensuring that this application or tool contributes to an “ethical” future, like ensuring non-malfeasance (preventing harm).
Governance
Core governance for development and deployment could be establishing thorugh core guiding principles that align with the aspirations of aiding autonomous democratized healthcare for general good and particularly in low resource contexts
1)Ethics First Development · Beneficial Use only - only developed to meet medical illness or healthcare need
· Consensual Use Only applied to consenting populations (not without clear consent e.g drug detection in incarcerated populations)
2)Accessibility · Support economic democracy- Generate and deploy applications in a manner that at least 50% of the deployment is affordable and accessible to low resource users. · Support all users- ease of adoption, use and interpretation by the end user is a continuous core design principle.
3)Safety · User safety- ensure use of the device will cause no harm, immediate or lasting to the user
· Containment Safety - Ensure the components of the device have suitable biological and component containment measures to prevent integration or harm beyond the device, to any living system plant or animal.
3. Next, describe at least three different potential governance “actions” by considering the four aspects below (Purpose, Design, Assumptions, Risks of Failure & “Success”).
| Aspect | Overview | Considerations | Opportunities | Stakeholders | Proposed Actions |
|---|---|---|---|---|---|
| Purpose | The purpose of the device is to provide simpler health autonomy to users | Healthcare providers may not be incentivised or receptive to increasing patient autonomy. | Can reduce healthcare technician burden of running routine testing | · Users (patients) · Healthcare providers · Insurance Providers · Regulators | Make client satisfaction and minimised time ‘in-clinic’ as metrics of success for healthcare providers. |
| Design | As a healthcare device it will likely require approval by regulatory bodies such as FDA/MHRA would need buy in by large medical care groups ( e.g providers) | Regulatory bodies are struggling to define between cell therapies and ‘living diagnostics’ and therefore set appropriate regulatory expectations | Can provide a watershed case for effective regulation of living diagnostics | · Regulators · Users (patients) · Healthcare providers · Insurance Providers · General Public | Collation action with subject experts and regulatory bodies to establish a dedicated taskforce to tackle areas of confusion. |
| Assumptions | The current design brief assumes the device has suitable biomarker targets & can be suitably manufactured | The PoC detection circuit designs may require many cycles of iteration | Can set precedent of acceptable thresholds of accuracy & sensitivity for such devices | · Regulators · Creators · Funders | Creators choose well researched markers, seek input from field experts, design quick PoCs in biological contexts |
| Risks | · The device may not be reliable · Device may be harmful when broken or misused · The device may not be robust enough for home use. · Selected biomarkers may not be specific enough. · Device may not be economically viable · Device may be used for forced monitoring | There are many layers of risks using biologically active device ‘in the wild’ , a possible electrical device in a liquid system, Creating diagnostics for Non-expert users | Can identify and address risks early and become a model for considerate, purposeful and responsible synthetic biology application | · Regulators · Users (patients) · Healthcare providers · Insurance Providers · General Public | Biocontainment measures Electrical containment measures Maintain guiding values for responsible applications |
4. Next, score (from 1-3 with, 1 as the best, or n/a) each of your governance actions against your rubric of policy goals:
| Does the option: | Option 1 | Option 2 | Option 3 |
|---|---|---|---|
| Enhance Biosecurity | |||
| • By preventing incidents | X | ||
| • By helping respond | X | ||
| Foster Lab Safety | |||
| • By preventing incident | X | ||
| • By helping respond | X | ||
| Protect the environment | |||
| • By preventing incidents | X | ||
| • By helping respond | X | ||
| Other considerations | |||
| • Minimizing costs and burdens to stakeholders | X | ||
| • Feasibility? | X | ||
| • Not impede research | N/A | ||
| • Promote constructive applications | X |
5. Last, drawing upon this scoring, describe which governance option, or combination of options, you would prioritize, and why. Outline any trade-offs you considered as well as assumptions and uncertainties.
Firstly, prioritize the solid design in line with the guiding principles as this would affect the fundamental elements of the device and so prevent downstream risks. This may mean more time and resources in the design phase to factor in all considerations and seek input. I believe this would ultimately save costs in the long term; there may be instance to consider the trade-off value of actioning progress of a single promising but low impact PoC application or simpler device design to clear the path for future applications.
Second priority would be establishing regulatory clarity and acceptance with regulatory bodies such as the FDA and MHRA. This regulatory acceptance would be a major point of uncertainty and guidance on what is needed for regulatory approval as this often a fundamental step for effective development and widespread acceptance and deployment of new technologies for health-related applications.