316 Product Development

What 316 Product Development does

316 Product Development is a privately held, Indianapolis-based engineering services firm that provides end-to-end product development for clients in regulated and complex industries. Founded in 2013 and operating with a small core team of roughly six professionals, the company runs a six-phase lifecycle methodology spanning Understand, Ideation, Proof of Concept, Develop, Launch, and Sustaining. Its primary client segment is medical device companies, with additional engagements in aerospace and defense, industrial manufacturing, and consumer products. Notable past work includes the vacuum-assisted breast biopsy device program (linked to a customer exit valued at $250 million), implantable venous valve IP, and projects for enterprise customers including Hologic (ATEC/Celero), Ford, Fiat, Augmenix, NuvoMed, and Sensocon.

The service catalog is organized into modular capabilities covering mechanical and electrical/software engineering, industrial design, rapid prototyping (SLA, FDM, SLS, CNC, RTV castings), medical device development with regulatory and biocompatibility expertise, intellectual property strategy, systems engineering, manufacturing engineering, and user-centered research and human factors. The firm holds patents on implantable venous valve technology and vacuum-assisted breast biopsy devices, demonstrating principal-level technical authorship in regulated product categories. The business model is project-based professional services, with custom quotations per engagement and direct sales motion targeted at enterprise clients.

Go-to-market is purely direct, with no channel intermediaries, and marketing relies on website portfolio content, project case studies, and team profiles rather than paid or outbound demand generation. The company serves a domestic U.S. market concentrated in the Midwest, with no disclosed international operations or outside funding, and is led by founder Jake F (President, Engineer, Project Manager), Brady W (CFO/Strategic Planner and former CEO/CFO), and a team spanning mechanical engineering, business development, automation, and digital marketing. Community partnerships with Hope Center Indy and Yeshua Society reflect the firm's local community involvement rather than commercial activity.

Name

316 Product Development

Legal name

316 Product Development

Website

https://316productdevelopment.com

Company type

Private

Founded year

2017

Operating status

Operating

Headcount range

1–10 employees

Short description

316 Product Development is an Indianapolis-based engineering services firm that delivers end-to-end product development across medical devices, aerospace, industrial, and consumer sectors, with particular depth in regulated medical device development, prototyping, and commercialization support for enterprise clients.

Ownership category

akta.pro rank

Headquarters

HQ city

Indianapolis

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. Product Development Services: Fee-for-service product development consulting spanning engineering, design, prototyping, and manufacturing support. Services are project-based and typically scoped per engagement.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

316 Product Development is a professional services firm that delivers end-to-end product development through six phases: Understand, Ideation, Proof of Concept, Develop, Launch, and Sustaining. The company provides mechanical, electrical/software, and industrial design engineering, rapid prototyping, medical device development with regulatory compliance, systems engineering, manufacturing engineering, intellectual property strategy, and human factors research for enterprise clients across medical devices, aerospace, industrial, and consumer products.

Product overview

316 Product Development is a services firm, not a single product company. The company provides comprehensive product development services organized around six core phases: Understand, Ideation, Proof of Concept, Develop, Launch, and Sustaining. These services span multiple specialized modules including Electrical and Software Engineering, Mechanical Engineering, Medical Device Development, Industrial Design, Rapid Prototyping, Intellectual Property, Systems Engineering, Manufacturing Engineering, and User Centered Research/Human Factors. The company works across diverse industries including medical devices, aerospace, automotive, and consumer products, supporting clients from initial concept through production launch and ongoing sustaining engineering.

Differentiator

Problem solved

Functional benefit

Products and services

• Product Development Services

Quantifiable outcome

• Led development that resulted in $250 million company acquisition
• +4 more outcomes

Named customers9 records

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Two partnerships are on record, tiered minor.

• Hope Center IndyminorStrategic or Co-development PartnerCommunity partnership with Hope Center Indy. Hope Center's mission is to be a Christ-centered program to help develop the personal and professional lives of women who have been rescued from human trafficking in order for them to re-enter society with the confidence, health, and technical skills needed to succeed. 316 PD is proud to partner with this organization.
• Yeshua SocietyminorStrategic or Co-development PartnerLong-time partnership with Yeshua Society including serving meals, hosting youth bible studies, building repairs, and providing Chromebooks for the Yeshua Society Christian School. The Yeshua Society is a Christian community with a Christ-centered compassion ministry that serves and develops avenues of escape primarily for people impacted by physical, emotional, academic, financial and spiritual poverty.

Scale indicators5 records

Recent moves5 records

Expansion highlights4 records

Direct peers

• Smart Design: Smart Design is a strategic design and product development consultancy offering industrial design, mechanical engineering, and user research across consumer, medical, and industrial markets. Comparable to 316 PD in its cross-disciplinary product development approach and vertical diversification.
• Farm (EPAM): Farm is a product development and engineering services firm (now part of EPAM Continuum) specializing in mechanical engineering, industrial design, and software development for medical and consumer products. Directly comparable in its full-lifecycle product development offering and regulated industry expertise.
• StarFish Medical: StarFish Medical is a medical device design, development, and contract manufacturing services firm serving startups through large OEMs. Directly comparable in its regulated product development lifecycle offering and medical device specialization.
• BlackHägen Design: BlackHägen Design is a medical device design and development firm specializing in user research, industrial design, and mechanical engineering for regulated medical products. Directly comparable to 316 PD's medical device focus, human factors capabilities, and FDA submission expertise.
• Nectar Product Design: Nectar Product Design is a product development firm offering industrial design, mechanical engineering, and prototyping services. Comparable to 316 PD in its boutique-scale product development model and cross-industry client base.
• HS Design: HS Design is a medical product design and development firm specializing in human factors engineering, industrial design, and mechanical engineering for medical devices. Directly comparable to 316 PD's combination of human factors, industrial design, and medical device regulatory expertise.
• Ximedica: Ximedica is a medical device design and development firm with deep regulatory and quality systems expertise spanning concept through manufacturing. Directly comparable to 316 PD's medical device development practice, with a similar focus on FDA-regulated product development and design controls.
• Worrell: Worrell is a product design and development firm offering industrial design, mechanical engineering, and product strategy services across medical devices, consumer, and industrial markets. Directly comparable to 316 PD in its full-lifecycle product development offering and cross-vertical client base, though typically larger in scale.
• Bresslergroup: Bresslergroup is a product development consultancy specializing in research, industrial design, and engineering for medical, consumer, and commercial products. Directly comparable to 316 PD in its regulated medical device expertise and human-centered design approach.

Emerging players

• GCMI (Global Center for Medical Innovation): GCMI is a medical device innovation center offering design, prototyping, regulatory, and clinical research services to medical device developers. Comparable to 316 PD in its medical device development focus and regulatory support capabilities, though structured as a non-profit innovation center.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights7 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 316 Product Development