4MS

Our Expertise

Drug Device Combination

100 years

of combined experience in the
combination products.

Injection Devices (Autoinjectors, Pen Injectors, Prefilled Syringes), Patch pumps, Infusion Pumps and Inhalers. Devices built for self-training and self-use for various populations and conditions. 4ms brings the full-stack expertise to take your combination product from concept through clearance.

When FDA response sends you back

A deficiency letter is not a verdict on your design. In most cases, it is a question about your evidence: how you tested, what you documented, and how you explained it to the reviewer.

After managing dozens of FDA responses across combination products, our most consistent finding is this: the design was right. The problem was how it was presented, tested, or positioned. We fix that - without the cost, delay, and risk of a ground-up redesign.

Medical Device Development

End-to-end product development from concept through design freeze. We lead architecture, systems engineering, HW/SW design, and regulatory-ready documentation across complex and combination products.

Software moves fast. Your update strategy needs to keep up.

Sending a technician or shipping a replacement device used to be an accepted answer. Today, modern software doesn't work that way — and neither does the regulatory landscape.

The real problem is that your device now runs on components you don't fully own or control. Open-source libraries, third-party drivers, cloud dependencies — all of them can change, break, or carry vulnerabilities. The FDA expects you to manage that. Most companies don't have a strategy that holds up under scrutiny.

We built one that does.

Our Services

Your Team, Scaled. No Barriers

Designed for the Real World, Not Just the Lab.

Specialized Experience in High-Stakes Sectors

Most firms work in a "black box"—you send a spec and hope for the best. At 4 milestones, we believe in radical transparency.

Unified Workflow: We work directly within your repositories and CAD environments to ensure a single source of truth.
Shared Compliance: We follow your existing SOPs, ensuring that every design choice fits your Quality

Most firms work in a "black box"—you send a spec and hope for the best. At 4 milestones, we believe in radical transparency.

Unified Workflow: We work directly within your repositories and CAD environments to ensure a single source of truth.
Shared Compliance: We follow your existing SOPs, ensuring that every design choice fits your Quality Management System (QMS).
Bridge the Gaps: While your team focuses on core IP and knowledge, we handle the heavy lifting of execution and technical hurdles.
Dynamic Scaling: As your project lifecycle evolves, we adjust our team composition to match your current phase without the corporate overhead.

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Specialized Experience in High-Stakes Sectors

Designed for the Real World, Not Just the Lab.

Specialized Experience in High-Stakes Sectors

We don't just "do engineering"; we understand the specific challenges of your niche:

Chronic Care & Wearables: Expertise in Diabetes and Parkinson’s disease management tools.
Connected Health: Robust architectures for drug delivery, diagnostics, and home-use devices.
Critical Compliance: Deep knowledge in Cybersecurity, Data Protection, and

We don't just "do engineering"; we understand the specific challenges of your niche:

Chronic Care & Wearables: Expertise in Diabetes and Parkinson’s disease management tools.
Connected Health: Robust architectures for drug delivery, diagnostics, and home-use devices.
Critical Compliance: Deep knowledge in Cybersecurity, Data Protection, and Human Factors (IEC 62366).
Complex Systems: Managing the intersection of Software (SaMD), Electrical Design, and UI/UX.

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Designed for the Real World, Not Just the Lab.

A product that passes V&V but fails in the field is not a success. Our senior engineers lead with a "Day 2" mindset:

Serviceability & Upgrades: We design for in-field upgrades and easy maintenance from the initial architecture phase.
User-Centric Distribution: We consider the entire journey—from packaging and shipping to how a clinician or

A product that passes V&V but fails in the field is not a success. Our senior engineers lead with a "Day 2" mindset:

Serviceability & Upgrades: We design for in-field upgrades and easy maintenance from the initial architecture phase.
User-Centric Distribution: We consider the entire journey—from packaging and shipping to how a clinician or patient actually interacts with the device.
Optimized for DFM: By integrating Design for Manufacturing early, we ensure your product isn't just "notable" but actually scalable and cost-effective.

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4 MileStones

Delivering Your Path to Market

Every Project Is Unique

We Offer Full Turnkey Development or Seamless Team Augmentation for Medical Devices.

Our Expertise

Our Services

Your Team, Scaled. No Barriers

Designed for the Real World, Not Just the Lab.

Specialized Experience in High-Stakes Sectors

Specialized Experience in High-Stakes Sectors

Designed for the Real World, Not Just the Lab.

Specialized Experience in High-Stakes Sectors

Designed for the Real World, Not Just the Lab.

Designed for the Real World, Not Just the Lab.

Designed for the Real World, Not Just the Lab.

Contact Us

Questions or Comments?

4MS

Let's Talk

Subscribe

Delivering Your Path to Market

Every Project Is Unique

We Offer Full Turnkey Development or Seamless Team Augmentation for Medical Devices.

Our Expertise

Our Services

Your Team, Scaled. No Barriers

Designed for the Real World, Not Just the Lab.

Specialized Experience in High-Stakes Sectors

Specialized Experience in High-Stakes Sectors

Designed for the Real World, Not Just the Lab.

Specialized Experience in High-Stakes Sectors

Designed for the Real World, Not Just the Lab.

Designed for the Real World, Not Just the Lab.

Designed for the Real World, Not Just the Lab.

Contact Us

Questions or Comments?

4MS

Let's Talk

Subscribe

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