For medtech founders and CDMOs
You bring the expertise.We accelerate your program.
Connect your evidence, guide development, and put a costed plan behind your next milestone.
Software + expert review
For Founders
Throughline connects your research, designs, and test results into a structured program, so you can lead development and bring partners along.
Book an intro callShare your research, designs, and program goals. We connect the evidence into a strategic assessment and clear priorities.
Strategic assessment · Program dashboardGive your development partners source-linked risks and requirements. Review the analysis together and focus your team on the next milestone.
Preliminary Hazard Analysis · Design Requirements MatrixAlign your business plan and financial model with development milestones, so you can bring partners and investors along.
Business plan · Five-year P&LYour expertise guides the decisions. We connect the evidence and prepare the analysis.
For CDMOs
Throughline turns client source files into a structured program your team can evaluate, scope, and develop. Spend less time assembling the picture and more time applying your expertise.
Book an intro callBring your client’s source files and development brief. We structure the program and surface the questions your team needs to scope the work.
Strategic assessment · Open questions and prioritiesStart with source-linked hazards, requirements, and test evidence. Your specialists review and refine the analysis before putting it to work.
Preliminary Hazard Analysis · Design Requirements MatrixConnect the proposed scope to milestones and resource needs. Help your client plan the next funded stage of development.
Development milestones · Resource and financial assumptionsYour team leads the technical review. Throughline supports your engineering judgment and existing quality processes.
Throughline accelerated Coaptis, a founder-led Class III structural heart device program, from inception through a provisional patent filing and an NIH grant submission in seven months.
“As a solo medtech founder, Throughline became my team. I was able to go from inception to NIH submission in seven months. Now I can share these tools and help accelerate other founders.”
Throughline connected source evidence, risk analysis, requirements, and business planning to support development, IP, and funding preparation across the program.
Design sketches, engineering insight, and the thinking behind your device.
The concept is ready for a scoped feasibility phase.
Your research. Your designs. Your test results.
Set priorities. Coordinate development. Plan the investment.
Connected by evidence
Throughline connects one test result to your assessment, risk analysis, requirements, and dashboard. Build on each finding across the program.
The fixation mechanism cleared the initial bench gate under the proposed release sequence.
Proceed to scoped feasibility and carry the fixation range as a controlled input.Rationale: carries the proposed PHA control into design.
Put your evidence to work
Connect risk controls to requirements, requirements to development milestones, and milestones to the capital you need.
Set your next priorities with a source-linked review of development, market, regulatory, and financing decisions.
Illustrative · Fictional transcatheter program · Rev 0.3STRATEGIC ASSESSMENT
Decision brief for founder and development partner review
The concept is ready for a scoped feasibility phase. The next quote should remain conditional on fixation-range evidence, the intended-use statement, and confirmation of the verification environment.
Turn risk analysis into development decisions. Connect hazards, harms, and proposed controls to the evidence behind them.
Illustrative · 18 hazards · 11 open controls| ID | Procedure step | Hazard | Sequence of events | Hazardous situation | Potential harm | Proposed control | Evidence |
|---|---|---|---|---|---|---|---|
| R-014 | Deploy implant | Mechanical energy | Fixation is not confirmed before release | Device migrates during use | Reintervention | Positive fixation feedback and retention verification | SRC-014 |
| R-021 | Select component | Use error | Incorrect size is prepared | Component does not seat as intended | Tissue injury | Keyed interface, size marking, and setup check | SRC-008 |
| R-026 | Withdraw system | Mechanical energy | Delivery element catches during withdrawal | Unexpected force is applied | Vessel trauma | Withdrawal envelope and simulated-use test | OPEN |
Carry your design intent into clear requirements. Link user needs and risk controls to verification methods and source evidence.
Illustrative · selected trace · UR-004 to DV-009| Type | ID | Requirement | Rationale | Linked risk | Verification method | Source | Status |
|---|---|---|---|---|---|---|---|
| User | UR-004 | The user needs stable placement during the intended use period. | Prevents unintended movement after release. | R-014 | Use validation input | SRC-014 | Reviewed |
| Functional | FR-011 | The system shall confirm fixation before release. | Carries the proposed PHA control into design. | R-014 | Simulated use | SRC-014 | Reviewed |
| System | SR-018 | The fixation indicator shall remain visible throughout deployment. | Allows confirmation before the release step. | R-014 | Inspection + bench test | SRC-022 | Draft |
Keep your team focused on the next milestone. Bring priorities, owners, runway, and capital needs into one view.
Illustrative · base scenario · September reviewTarget · December 2026
At current hiring plan
Base planning case
Fictional examples shown. Delivered files are editable Word, Excel, and PDF documents.
Give your team the clarity and capacity to move faster.
Book an intro call