Your platform is proven.Your product isn't, yet.
Turning a proven platform into the right product for your patients and your business is the next journey. We've been through that journey with the regulators, four times over.
4 FDA clearances. 4 CE marks. 6 INDs. 1 NDA submitted.
20 years hands-on in drug-delivery devices and combination products. Mor Tsabar, founder, led the device at NeuroDerm and systems engineering at Medingo and Roche, and supported the regulatory submissions.
Pick the platform the drug needs, not the one you already know.
Most delivery platforms are chosen by habit, or by whoever called first. We run an independent search against four requirements and tell you which platforms fit, which almost fit, and what the gap would cost.
Clinical
Viscosity, volume, dose, frequency, route. Does the device deliver what the drug needs, every time?
Users
Elderly, pediatric, lay caregivers. Can the person who will use it train themselves and get it right?
Business
Unit cost, supply risk, licensing terms, time to market. What the platform costs you beyond the invoice.
Scouting
Existing platforms and emerging ones, with no vendor behind the recommendation.
One recommendation, with the trade-offs written down.
System architecture and user studies, from the first platform screen to the design inputs.
The journey goes far beyond the device.
An existing platform gives you a head start. These six areas shape the product around it.
Product strategy
Who it is for, what it must do, and what you will claim.
Development
Systems engineering, mechanics, electronics and software, built to the design controls you already run.
Patient experience
Usability and self-training, validated with the people who will use it.
Quality and regulatory
Risk files, design history and submissions that hold up in review.
Manufacturing
Design for assembly and a supply chain that survives component end-of-life.
Lifecycle support
Post-market changes, updates and complaints handled without a redesign.
Deficiency letter? Hold letter? RFI? Call us.
A deficiency letter is not a verdict on your design. Most of the time it's a question about your evidence: how you tested, what you documented, how you explained it.
We prepare the response, fix the risk file and the design history, and keep your design. We reframe the evidence, run only the testing that's needed, and protect your timeline and your commercial plan.
Sometimes the fastest path is dropping a claim or simplifying a use case. We tell you when.
Regulatory affairs and quality assurance
Ship the update. Keep the clearance.
Your device now runs on code you don't fully control: open-source libraries, third-party drivers, cloud dependencies. FDA expects you to manage that.
We build the update strategy that holds up under review: third-party software components, cybersecurity, and change classification. The goal is to replace technician visits and device swaps with updates you can ship.
We've designed the update and connectivity architecture for an ICU device and a connected insulin pump.
Software lifecycle, system architecture and regulatory affairs
Buying or backing a device company? Know what you're buying.
Technical due diligence for investors and acquirers: architecture, regulatory path, design history, supply risk, and the technical debt that surfaces after closing.
Inside your QMS, inside your repositories.
We follow your SOPs and work in your environment, with no black box.
Support that fits the stage of your product, not a mandatory process.
What we do: quality assurance, regulatory affairs, product development, software lifecycle, user studies, system architecture and technical due diligence.
Tell us where you are in the journey.
A name, an email and a few lines are enough to start. Your message goes straight to the founder.
Prefer email or phone?
tsabar@4ms.tech
+972 52 689 6894