What Sage Product Development does

Sage Product Development is a Massachusetts-based contract medical device design, development, and low-to-mid volume manufacturing firm founded in 2011 by Jeffrey Cerier, Amos Cruz, and Jonathan O'Keefe. The firm serves medical device startups and early-stage companies end-to-end — from early concept and feasibility through product development, project management, regulatory submission support, and market launch — with particular depth in flexible endoscopy, minimally invasive surgery, catheter-based devices, implants, and electro-mechanical assemblies. Its in-house capabilities include wet lab, Class 7 Clean Room manufacturing, and an FDA-registered cGMP facility under ISO 13485:2016 certification, enabling clients to transition projects from design through verification, validation, clinical builds, and commercial launch without handing off to a separate manufacturer.

Sage generates revenue through multiple streams: quote-based professional engineering and project management services, low-to-mid volume contract manufacturing including assembly and distribution support, and unit-priced component sales of proprietary laminated catheter shafts and laser-cut hypotubes in 5, 7, and 9 French sizes via its e-commerce storefront. Regulatory and quality services are delivered through a strategic partnership with AlvaMed, giving clients an integrated design-plus-regulatory package. The firm's go-to-market relies on case-study-driven content marketing targeting startup and early-stage medical device companies, supplemented by direct sales via RFQ forms and LinkedIn. Notable client outcomes include FDA 510(k) clearances and CE Marks for CarpX, the Bolt Navigation System, DiLumen Is/Ik, EsoCheck, and the LOCalizer wire-free breast tumor localization system.

Name

Sage Product Development

Legal name

Sage Product Development, Inc.

Website

https://sagepd.com

Company type

Private

Founded year

2011

Operating status

Operating

Headcount range

11–50 employees

Short description

Sage Product Development is a private Massachusetts-based medical device design, development, and low-to-mid volume manufacturing firm serving startups and early-stage companies end-to-end — from concept through FDA clearance and contract manufacturing — with specializations in catheter-based devices, flexible endoscopy, minimally invasive surgery, and implants.

Ownership category

akta.pro rank

Product category

Medical Device Design and Contract Manufacturing

NAICS

Research and Development in the Physical, Engineering, and Life Sciences (54171), Surgical and Medical Instrument Manufacturing (339112)

SIC

Surgical & Medical Instruments & Apparatus (3841), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Quality Engineering & Risk Management (ICH Q9/Q10, validation, change control) (HLAGAKAL)

Keywords

• Medical device development
• Contract manufacturing
• Minimally invasive surgery
• Flexible endoscopy devices
• FDA 510(k) submission

Headquarters

HQ city

Boxborough

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Infrastructure, Technology or R&D, Marketing or Sales

Revenue model

1. Product Development Services: Engineering and design services for medical device concept, feasibility, product development, and project management from early concept through FDA regulatory submission
2. Contract Manufacturing: Low-mid volume manufacturing for verification and validation testing, clinical studies, and market launch. Includes assembly, packaging, and logistics services for medical devices
3. Component Sales: Direct sales of engineered medical device components including laminated catheter shafts (5Fr, 7Fr, 9Fr sizes) and laser cut hypotubes through e-commerce shop
4. Regulatory Support Services: Quality and regulatory consulting services through AlvaMed partnership for FDA submissions, quality management system implementation, and clinical trial support

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels5 records

Core offering

Sage Product Development is a medical device product development firm that partners almost exclusively with medical device startups and early-stage companies to design, develop, and manufacture mechanical medical devices from concept through commercialization. Its offering spans early concept and feasibility assessment, mechanical product development (with deep expertise in flexible endoscopy, minimally invasive surgery, and catheter-based devices), project management using Earned Value Analysis, low-to-mid volume contract manufacturing in a Class 7 Clean Room / cGMP facility, and regulatory and quality support through its AlvaMed partnership. The firm also sells engineered components (laser cut hypotubes and laminated catheter shafts) directly through its e-commerce shop.

Product overview

Sage Product Development is a medical device development and manufacturing company offering end-to-end services from concept through commercialization. Their portfolio includes four core service offerings (Early Concept & Feasibility, Product Development, Project Management, and Contract Manufacturing) plus Quality & Regulatory Support through their AlvaMed partnership. They manufacture and sell medical device components including Laser Cut Hypotubes (5Fr, 7Fr, 9Fr sizes) and have developed multiple FDA-cleared medical devices for clients including CarpX (minimally invasive carpal tunnel device), Bolt Navigation System (spine surgery navigation), LOCalizer (breast tumor localization), EsoCheck (esophageal cell collection), and the DiLumen C² EIP instruments (endoscopic surgical tools). Their expertise centers on flexible endoscopy, minimally invasive surgery, and catheter-based devices.

Differentiator

Problem solved

Functional benefit

Products and services

• Early Concept & Feasibility Service evaluating device design and functionality, assessing clinical safety, and guiding necessary modifications to move the design through the product development lifecycle.
• Product Development Mechanical medical device development covering disposables, reusables, implants, and equipment, with deep expertise in flexible endoscopy, minimally invasive surgery, and catheter-based devices.
• Project Management Project planning, execution, and monitoring using Earned Value Analysis to keep projects on schedule and budget with early warning of cost or timing issues.
• Contract Manufacturing Low-to-mid volume manufacturing builds of new medical devices for verification and validation testing, clinical studies, and market launch, plus logistics and distribution support.
• Quality & Regulatory Support Integrated regulatory and quality services delivered via the AlvaMed partnership, including regulatory strategy, QMS implementation, and clinical trial support for startup and early-stage medical device companies.
• Laser Cut Hypotubes (Laminated Catheter Shafts 5Fr, 7Fr, 9Fr) Engineered medical device components with PTFE liner and Pebax jacket, offering varying flexibilities through different laser cut patterns along the shaft length. Sold directly through Sage's e-commerce shop at $580 per unit.

Quantifiable outcome

• 100+ client companies served since founding in 2011
• +2 more outcomes

Named customers6 records

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

One partnership is on record.

• AlvaMedcoreStrategic or Co-development PartnerStrategic partnership between Sage Product Development and AlvaMed to deliver integrated solutions for start-up and early-stage medical device companies. The collaboration combines Sage's product development expertise with AlvaMed's regulatory guidance for seamless navigation through regulatory pathways from concept to market launch. Services include conceptualization, design, prototyping, testing, regulatory strategy, quality management system support, clinical trial design, and post-market surveillance.

Scale indicators5 records

Recent moves5 records

Expansion highlights5 records

Direct peers

• StarFish Medical: Canadian medical device design, development, and contract manufacturing firm serving startups and OEMs. Directly comparable in offering scope (concept-to-commercialization services) and client profile (early-stage medtech).
• Veranex (formerly Ximedica): U.S. medical device design, engineering, and contract manufacturing services firm (Ximedica rebranded under Veranex). Closely aligned service portfolio including regulatory, design, and low-volume manufacturing for medtech clients.
• Meddux Development Corporation: Medical device product development and manufacturing services firm with capabilities in catheter-based devices, disposables, and implants. Directly comparable in technical focus and end-to-end development model.

Broad incumbents

• Tegra Medical: Larger medical device contract manufacturer with extensive capabilities in metal and plastic components, assembly, and finishing. Comparable on the manufacturing side of Sage's offering, with broader scale and global footprint.
• Resonetics: Medical device contract manufacturer specializing in laser micromachining, nitinol components, and catheter-based device production. Highly relevant on the catheter/hypotube manufacturing axis that Sage also serves.
• Integer Holdings: Large medical device outsource manufacturer with capabilities spanning components, subassemblies, and finished devices. Represents the high-volume scale tier that Sage's clients eventually transition to.
• Farm Design (part of Phillips-Medisize): Medical device industrial design and product development firm (now within Phillips-Medisize/Molex). Closely aligned in design-for-manufacturability and human-centered device development, but operating as part of a larger corporate parent.

Emerging players

• Nelson Labs: Medical device and life sciences testing, sterilization, and regulatory consulting services firm (now part of Sotera Health). Comparable to the regulatory/quality/validation portion of Sage's service offering through its own and acquired entities.
• MindFlow Design: U.S.-based medical device product design and engineering firm focused on industrial design, human factors, and mechanical engineering for medtech clients. Comparable niche player in the design-only segment of the value chain.

Regional players

• NEMERA: European medical device design, development, and manufacturing firm with strong presence in drug delivery, ophthalmic, and inhalation devices. Comparable in concept-to-commercialization model with focus on combination products and devices.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/sage-product-development-inc-

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Sage Product Development