Is your acceptance criteria optimized? Are all your metrics resolved?
We can help with DIS!
With a well-formed and comprehensive DIS, you will stay on track with what your vision REALLY is.
Our Team will transform your concepts or user needs into a set of measurable product metrics; to determine technical feasibility.
We also provide outside and objective perspectives and offer advice or guidance OR we can complete a full DIS review.
Generating a DIS is an active process and overlaps with other stages of product development.
According to the FDA, your DIS must be testable, measurable, unambiguous, and traceable — we will see to it that your DIS excels in all these elements!
The Koven DIS Commitment:
Use for planning, budgeting, communicating with potential partners and investors, and more!
By applying the Koven DIS process for one of our clients, we greatly reduced their cost to manufacture by weighting market inputs and cost acceptability.
Our capabilities include:
- User needs assessment
- Translating user needs into metrics
- Product benchmarking
- Risk assessments
- Usability engineering
- Expertise in medical standards compliance