What Alacrity does

Alacrity is a private MedTech-focused professional services firm founded in 2006 and headquartered in Santa Clara, California. The firm provides integrated design, engineering, regulatory, and manufacturing support exclusively to medical device innovators developing Class II and Class III devices, and since founding has contributed to more than 62 such device programs spanning neuromodulation, cardiovascular, endoscopic, orthopedic, drug-delivery, and diagnostic categories.

The service portfolio is anchored by Design for Manufacturability (DFM) and extends across Design Development (mechanical, electrical, catheter, optical, RF, human factors, industrial design, systems, and manufacturing engineering), Design Verification, Quality & Regulatory services (FDA CFR 820, European MDR, 510(k), De Novo, IDE, PMA, CE marking, CAPA remediation), Pilot Manufacturing, Contract Manufacturer Management, Product Strategy, and Technical Program Management. These offerings are delivered as a coordinated bundle rather than discrete modules, positioning Alacrity as a single-vendor alternative to the multi-firm stacks typically required for Class II/III development.

The firm operates a sales-led, project-based B2B model with direct client engagement and founder-led outreach. It is privately held by founder and CEO Steve Woodard with no outside investors, and pricing is quote-based per engagement. Geographic reach is limited to a single California office, with no disclosed international presence.

Name

Alacrity

Legal name

Alacrity, Inc.

Website

https://alacrity.com

Company type

Private

Founded year

2006

Operating status

Operating

Headcount range

11–50 employees

Short description

Alacrity is a Santa Clara-based MedTech services firm that delivers integrated design, engineering, regulatory, and pilot manufacturing support to medical device innovators developing Class II and Class III devices. Founded in 2006, it has contributed to 62+ device programs under founder-CEO Steve Woodard.

Ownership category

akta.pro rank

Headquarters

HQ city

Campbell

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Professional Services - Design & Engineering: Project-based design and engineering services for MedTech device development including Design for Manufacturability, design development, design verification, and technical program management
2. Pilot Manufacturing & Contract Manufacturing Management: Pilot manufacturing services and management of contract manufacturers for medical device production
3. Quality & Regulatory Consulting: Regulatory strategy, submission preparation (510(k), De Novo, IDE, PMA), QMS support, audit preparation, and compliance services

Go-to-market motion1 record

Distribution channels1 record

Marketing channels2 records

Core offering

Alacrity is a MedTech-focused professional services firm that delivers Design for Manufacturability, design development, design verification, pilot manufacturing, contract manufacturer management, product strategy, technical program management, and quality and regulatory services exclusively for medical device innovators developing Class II and Class III devices.

Product overview

Alacrity is a MedTech-focused services company offering a comprehensive suite of design, engineering, and regulatory services exclusively for medical device innovators. Founded in 2006 and based in Santa Clara, CA, the company has helped advance over 62 Class II and Class III medical devices. The core offering is a services-based model organized around Design for Manufacturability, Design Development (spanning mechanical, electrical, catheter, optical, RF, and industrial engineering), Design Verification, Quality & Regulatory Services (including FDA and CE mark submissions), Pilot Manufacturing, Contract Manufacturer Management, Product Strategy, and Technical Program Management. These services are delivered as an integrated portfolio rather than as discrete product modules, supporting medical innovators from concept through commercialization.

Differentiator

Problem solved

Functional benefit

Products and services

• Design for Manufacturability
• Design Development
• Design Verification
• Quality and Regulatory Services
• Pilot Manufacturing
• Contract Manufacturer Management
• Product Strategy
• Technical Program Management

Segments1 record

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Scale indicators2 records

Recent moves3 records

Expansion highlights2 records

Direct peers

• Cambridge Consultants: Product development and engineering consultancy (part of Capgemini Engineering) with deep medical device practice spanning design, human factors, and regulatory strategy. Highly comparable to Alacrity on the integrated engineering and product development front.
• StarFish Medical: Canadian MedTech-focused design, engineering, and manufacturing services firm serving medical device innovators across Class II and III programs. Closest direct analog to Alacrity, with a comparable integrated services model, similar niche positioning, and a track record across multiple device categories.
• Boston Engineering: Product development engineering firm with a MedTech practice spanning mechanical, electrical, software, and regulatory support for medical device innovators. Comparable to Alacrity on multi-disciplinary engineering services for MedTech startups and growth-stage companies.
• Donatelle: MedTech-focused contract design and manufacturing firm in New Brighton, MN, serving device innovators across Class II and Class III programs. Overlaps directly with Alacrity on design-for-manufacturability, pilot manufacturing, and contract manufacturer management.
• Veranex: MedTech-focused product development, engineering, clinical, and regulatory services firm formed by combining Ximedica, Biorez, and other specialists. Directly comparable to Alacrity, offering an integrated design-through-regulatory services portfolio to medical device innovators.
• Invetech: Australia-based MedTech design and product development services firm with engineering, instrumentation, and manufacturing capabilities for diagnostics and medical device clients. Directly comparable to Alacrity in serving innovators across the concept-to-commercialization lifecycle.

Broad incumbents

• Tegra Medical: MedTech contract manufacturer offering design, engineering, and precision manufacturing (including complex catheter and metal components) for Class II and Class III devices. Closely overlaps with Alacrity's pilot manufacturing and Design-for-Manufacturability capabilities.
• Phillips-Medisize: Major MedTech contract design and manufacturing organization (part of Molex) providing full-lifecycle services to drug delivery, diagnostics, and medical device innovators. Broader-scale competitor to Alacrity's design and pilot manufacturing offerings.
• Jabil Healthcare: Global contract manufacturing services provider (NYSE: JBL) with a sizable healthcare and MedTech division offering design services, pilot manufacturing, and full-scale production for medical device innovators. Much larger incumbent overlapping with Alacrity's later-stage service offerings.
• Integer Holdings: Large public medical device contract design, development, and manufacturing organization (NYSE: INGR) with global footprint. Competes with Alacrity for innovator clients, particularly as programs scale beyond pilot and into full manufacturing.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

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 Alacrity