Practice and Reflection on Roles in the Development of New Molecular Diagnostic Pipeline Medical Products
Domestic Team - Name/Student ID
I. Introduction
1. Course Background and Project Significance
The molecular diagnostics industry is witnessing prominent technological trends such as automation, high throughput, and the growing demand for POCT (Point-of-Care Testing). It also boasts substantial market potential in areas like infectious disease detection and early cancer screening.
The development of new products in this field holds significant value in enhancing medical efficiency, including shortening detection time and reducing human errors.
2. Personal Motivation and Goals for Participation
Drawing on my professional background, my core goals in participating in this project include improving technical implementation capabilities and gaining experience in cross-functional collaboration.
II. Team Roles and Division of Labor
1. Personal Role Positioning
I served as a member of the R&D team, with the core responsibility of optimizing the sample pre-processing module in the technical roadmap.
2. Team Collaboration Mode
The team adopted an architecture where the CEO oversaw the overall work, and 4 functional managers were assigned specific tasks. The communication mechanisms included weekly meetings and the use of cross-departmental collaboration tools.
There were multiple collaboration scenarios with other roles. For instance, I worked with the marketing manager to identify the needs of target users.
III. Specific Work Content and Contributions
1. Task Execution Details
- Participation in Technical Route:
I was involved in technical decisions, such as advocating for the adoption of microfluidic chip technology to replace traditional PCR.
I solved specific problems, like optimizing the sample loading speed, reducing the processing time from 15 minutes to 8 minutes.
2. Achievements and Quantitative Indicators
Quantifiable achievements included completing 3 iterations of technical prototypes and participating in demand interviews covering 5 potential customers.
IV. Experience, Lessons and Improvement Suggestions
1. Successful Experience
The effectiveness of cross-functional collaboration was evident, such as the R&D and marketing teams jointly defining the core functions of the product.
The application of tools and methods, like using SWOT analysis to clarify the competitive strategy, played a positive role.
2. Main Challenges and Reflections
There were technical difficulties, for example, the control of sample cross-contamination failed to meet expectations.
Communication barriers existed, such as the problem of translating R&D terminology into marketing language.
3. Improvement Suggestions
For process optimization, it is suggested to add “technology-market” biweekly joint meetings.
In terms of skill improvement, there is a need to strengthen the learning of clinical regulatory knowledge.
V. Application and Migration of Roadmap Method
1. Roadmap Practice in the Project
The technical roadmap included phased goals: proof of concept → prototype development → clinical trials → registration and approval.
The market roadmap set time nodes for user education → cooperation with pilot hospitals → large-scale promotion.
2. Application in Personal Work
I used the roadmap to decompose personal tasks. For example, “algorithm optimization” was broken down into three stages: data collection → model training → clinical verification.
3. Migration Plan for Future Work Scenarios
I plan to apply roadmap thinking to career development, such as setting milestones in technical project management.
I also have a continuous learning plan, such as supplementing medical regulatory knowledge to support product registration.
VI. Conclusion
The project has brought me improvements in technical capabilities, team collaboration, and industry cognition.
The future of molecular diagnostic product development is promising, with trends like AI integration and home testing on the horizon.