High-level R&D milestones
Milestones: key events corresponding to retirement of risks.
- Proof-of-concept: scientific & technical feasibility
- First effective bench model prototype
- First effective tissue testing prototype
- First effective prototype in acute animal models
- First effective & safe prototype in chronic animal models
- First effective & safe prototype in humans
- Pre-production device in manufacturing feasibility
- Production device in scalable manufacturing
Anticipate and prioritize technical challenges
- Functional blocks of the device
- Break down of different disciplines
- Critical questions of all the functional blocks
- Which challenges have not been solved?
- Which is most difficult to address?
- Involve individuals from all the engineering fields
- Look-out for unexpected problem
Initial R&D Plan
R&D Personnel
Types, skill sets and number of engineers: time, cost & difficulties of challenges
Hiring engineers/consultants on a contract basis:
(1) Gaining access to expensive, specialized expertise
(2) Responding to temporary or short-term peaks in workload
(3) Bringing a fresh perspective to the resolution of challenging problems
(4) Without having to hire and then lay off dedicated resources
Cautious
(1) Work differently from in-house staff and require different incentives
(2) May not exercise the same urgency as dedicated, full-time employees
(3) Confidentiality and IP issues
(4) Incomplete knowledge transfer and documentation
Engineering resources
- Investments in facilities, equipments and other resources
- Acquisition matches the availability of R&D personnel. Both are fully and efficiently utilized
- In-house or outsource decisions affect the level of funding required
- Lead time & lab space requirements of the milestones
Test methods
- Iteratively assess various designs in order to create a effective and safe solution
- Validate & verify the solution meets key user requirement and technical specification as part of quality system
- Testing and development methods influence the company’s R&D culture and strategy
- Nonclinical: idea communication, bench testing, simulated use testing, tissue testing
- Preclinical: acute animal testing, human cadaver testing, chronic animal testing
- Clinical: live human testing
Overall timeline
- Time: a driver of both value and risk given its connection to consumption of capital and resources
- Key inputs: personnel required, engineering resources employed, testing to prove effectiveness and safety, documentation of user requirements, technical designs, experimental reports, verification and validation testing.
- Length of R&D: simple disposable < complex disposable < passive implantable < active implantable < combination product < biologic < standard pharmaceutical < biopharmaceutical
