Frequently asked questions
Here are some quick answers about how we work, who we partner with, and what to expect when reaching out to iO Life Science.
About iO Life Science
What is iO Life Science?
iO Life Science is a virtual MedTech incubator that partners with innovators to de-risk, accelerate, and execute product development; from idea through clinical and manufacturing readiness. We pair hands-on engineering with funding and commercialization expertise.
How is iO different from a traditional design firm or accelerator?
We operate a shared-risk, partnership model: we align incentives, contribute execution capacity, and help increase investor confidence as programs mature rather than acting as a fee-for-service vendor alone.
Do you also invest?
Yes. Through iO Life Ventures, we support select programs with capital and resources, helping teams progress from ideation to commercialization. Visit iO Life Ventures website->
Focus Areas and Capabilities
Which product categories do you support?
- Drug delivery (autoinjectors, ocular/IVT, high-viscosity, connected dosing)
- Diagnostics (connected point-of-care, home monitoring, image-guided
- Implantable (materials, biocompatibility, sterilization, packaging)
- Connected devices (mobile apps, BLE/cloud, cybersecurity, data standards)
- Surgical devices (mechanisms, HF for OR/ASC, reprocessing/IFUs)
What functions does iO bring to a program?
Systems/ME/EE/SW engineering; human factors/URRA; industrial design; ISO 14971 risk management; IEC 62366-1 usability; IEC 62304 software lifecycle; ISO 13485 QMS/DHF buildout; verification/validation planning; supplier/OEM sourcing; manufacturing transfer; and early market access/VAC dossier support.
Do you support patient-specific / additive manufacturing?
Yes, end-to-end: device rulesets, print orientation/control plans, post-processing, sterilization strategy, labeling, and hospital workflows.
Engagement Model
When is the right time to engage iO?
Anywhere from concept/feasibility to design transfer. We commonly enter at pre-seed/seed or Series A/B to compress time-to-evidence for fundraising and clinical adoption.
How do you structure work?
A tailored mix of milestone-based sprints (requirements → prototype → V&V) with shared-risk terms and, where appropriate, participation from iO Life Ventures.
Who owns the IP?
Your company owns program IP. iO contributes know-how and may receive equity or milestone economics depending on scope. (We’ll define this clearly in the MSA/SOW.)
Regulatory, Quality & Clinical
Which regulatory pathways do you support?
510(k), De Novo, PMA (US) and EU MDR—plus regional registrations. We build risk files, usability evidence, software documentation, and verification matrices to support submissions and clinical evaluation.
What quality system do you use?
We operate to ISO 13485 principles and create DHF/DMR/DHR structures that scale with your company’s QMS as you grow.
Do you help set up clinical pilots?
Yes. We design pre-clinical and clinical-evaluation plans with KOLs, align endpoints with value propositions, and prepare site packs (IFU, training, risk controls, records).
Connected Devices & Data
Can you handle digital health and data privacy?
Yes. We design BLE/mobile/cloud architectures with threat modeling and cybersecurity risk management, support interoperability (e.g., FHIR/HL7), and help teams prepare documentation for regulators and hospital IT/security reviews.
What about hospital adoption and VAC processes?
We craft VAC-ready evidence and dossiers—linking clinical benefits, risk controls, workflow impact, and economic rationale—to accelerate evaluation and adoption pathways.
Manufacturing & Scale
How do you ensure designs are manufacturable?
We practice DFM/DFA early, collaborate with tier-1 component suppliers/CMOs, and define tooling, tolerances, incoming QC, and validation (DQ/IQ/OQ/PQ) so the design can scale without re-work.
Can you support additive and conventional manufacturing in one plan?
Yes. We often start with rapid/bridge tooling or AM to hit clinical timelines, while locking a long-run architecture (injection molding, machining, extrusion, assembly automation) with current suppliers.
Do you help with supplier selection and audits?
We shortlist suppliers, align on CTQs/specs, support process validation, and set up quality agreements and traceability (materials, sterilization, packaging, labeling).
Can you integrate with our internal team or other vendors?
Yes. We routinely integrate with internal R&D, regulatory, contract manufacturers, and CROs; we can also lead the program as the virtual core team.
What results should we expect?
Typical milestones include moving from concept to verification-ready prototypes, successful formative/summative usability, supplier alignment for manufacturing readiness, and evidence packages that support funding, regulatory presubs, and early site interest.
Funding & Outcomes
How do you help with fundraising?
Beyond prototyping, we provide time-to-evidence roadmaps, cost/COGS models, risk burndown plans, and investor-ready artifacts (clinical value story, tech dossier). iO Life Ventures may co-invest or help syndicate.
What results should we expect?
Typical milestones include moving from concept to verification-ready prototypes, successful formative/summative usability, supplier alignment for manufacturing readiness, and evidence packages that support funding, regulatory presubs, and early site interest.
Logistics & Timelines
How fast can we get to a live demo or clinical-evaluation unit?
Program-dependent. Many teams reach alpha in ~6–12 weeks and beta/pilot units in ~12–20 weeks when requirements are crisp and suppliers are engaged early. (We’ll provide a detailed Gantt and gating criteria.)
Can you integrate with our internal team or other vendors?
Yes. We routinely integrate with internal R&D, regulatory, contract manufacturers, and CROs; we can also lead the program as the virtual core team.
Pricing & Terms
How do you price projects?
Milestone-based SOWs with transparent budgets. Some programs include equity or success economics to align incentives. (We’ll fit to stage and risk profile.)
Do you offer fixed-fee packages?
For well-bounded scopes (e.g., formative HF study, electromechanical alpha build), yes. Larger programs use a hybrid to preserve flexibility while protecting timelines.
Getting Started
What materials should we bring to a first call?
A concise brief (problem, users, claims), any clinical/market insights, target indications/claims, known constraints, and a timeline/funding context. We will propose a Risk-to-Evidence plan and early technical experiments.
Do you sign NDAs?
Absolutely. We’re comfortable executing your mutual NDA prior to deep-dive discussions.
How do we contact you?
Use the contact form on the iO Life Science Contact Page; we’ll respond and propose next steps.
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