In2Being
In2Being is a Saline, Michigan-based medical device consulting firm founded in 2010 that helps medical device startups, inventors, universities, and established companies develop products from concept through FDA clearance, offering engineering design, prototyping, and regulatory services.
- Company typePrivate
- Founded2010
- HeadquartersSaline, United States
- Headcount1–10
- GTM typeB2B
- OfferingServices
What In2Being does
In2Being, LLC is a Saline, Michigan-based medical device consulting and product development firm founded in 2010 by Managing Director Gene Parunak and co-founder Aaron Kehrer (Director of Product Development). The company provides full-service support across the medical device development lifecycle — from napkin-sketch concepts through mechanical, electrical, and software design, in-house prototyping, FDA regulatory submissions (510(k), PMA, De Novo, Pre-Sub), quality systems implementation under QSR/GLP standards, and manufacturing readiness — for medical device startups, inventors, university research teams, established manufacturers, and non-medical companies entering the medtech space. Since inception, the firm states it has served over 175 clients and developed dozens of first-in-human prototypes, with a documented track record spanning cardiovascular, surgical, diagnostic, tinnitus-treatment, autotransfusion, phototherapy, and microfluidic device categories.
The firm's underlying capabilities rest on a multidisciplinary engineering bench with specialized heritage in microfluidics and diagnostics drawn from staff who were early employees at HandyLab (acquired by Becton-Dickinson for $275 million) and Accuri Cytometers (acquired by BD in 2011). In2Being has built a portfolio of ancillary community assets that function as both brand-building and lead-generation infrastructure: PathSurveyor, a free FDA classification research tool; MedTech Crossroads, a weekly YouTube-based educational webinar series; and Pitch Party, a quarterly pitch competition awarding $2,500 to selected US-based MedTech startups. The firm also maintains a regional Michigan MedTech Database mapping local investors, mentors, manufacturers, and service providers.
In2Being operates a sales-led, professional services business model generating revenue through quote-based consulting engagements scoped to project requirements. Its go-to-market combines direct outreach, referral introductions, and content-led community engagement through webinars, downloadable resources, and industry events (including MEDICA and Xavier-MedCon). The company is privately held, founder-owned, and has not raised external capital; it operates with 1-10 employees from a single Saline, Michigan headquarters. Geographic market focus is described as the U.S. Midwest, though client engagements have produced products marketed internationally (e.g., Sisu Global Health's Hemafuse autotransfusion device in the U.S. and Ukraine).
In2Being firmographics
Firmographics- Name
- In2Being
- Legal name
- in2being, LLC
- Website
- https://in2being.com
- Company type
- Private
- Founded year
- 2010
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- In2Being is a Saline, Michigan-based medical device consulting firm founded in 2010 that helps medical device startups, inventors, universities, and established companies develop products from concept through FDA clearance, offering engineering design, prototyping, and regulatory services.
- Ownership category
- akta.pro rank
In2Being industry classification
Industry- Product category
- Medical Device Regulatory Consulting
- NAICS
- Scientific Research and Development Services (5417), Research and Development in the Physical, Engineering, and Life Sciences (54171)
- SIC
- Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Quality Engineering & Risk Management (ICH Q9/Q10, validation, change control) (HLAGAKAL)
- akta.pro secondary industry
- Third-Party/Outsourced Quality & Responsible Person Services (EU QP/RP, US Agent) (HLAGAKAO)
Keywords
Where In2Being is headquartered
LocationHeadquarters
- HQ city
- Saline
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
In2Being business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Technology or R&D, Marketing or Sales, Operations
Revenue model
- Medical Device Development Consulting: Full-service consulting engagements providing medical device development support including design, prototyping, regulatory guidance, and manufacturing readiness. Services span the entire product lifecycle from concept to FDA clearance.
- Regulatory Consulting Services: Expert guidance through FDA regulatory pathways including 510(k) submissions, De Novo requests, FDA pre-submission meetings, and quality systems development. Helps clients navigate complex regulatory requirements and prepare successful submissions.
- Prototyping and Design Services: Mechanical, electrical, and software design and prototyping services for medical devices. Creates working prototypes for clinical trials, proof of concept demonstrations, and manufacturing preparation.
Go-to-market motion1 record
Distribution channels3 records
Marketing channels7 records
In2Being product offering
Product offeringCore offering
In2Being is a full-service medical device development consultancy that supports inventors, startups, and established companies from concept through FDA clearance. The firm provides integrated services spanning engineering design (mechanical, electrical, software), in-house prototyping, FDA regulatory pathway navigation (510(k), PMA, De Novo, Pre-Submission), quality systems implementation, intellectual property development, and project/vendor management for manufacturing readiness.
Product overview
In2Being is a full-service medical device development consultancy that helps inventors, startups, and established companies navigate the medical device development process from concept through FDA clearance. Founded in 2010, the company offers integrated services spanning regulatory strategy (including 510(k), PMA, and De Novo pathways), mechanical/electrical/software design, prototyping, quality systems compliance, intellectual property development, and project management. The company maintains a proprietary case study database across multiple medical device categories including cardiovascular, diagnostic, surgical, and therapeutic devices. In2Being also operates free educational resources including the MedTech Crossroads webinar series and PathSurveyor FDA classification tool, and runs a quarterly Pitch Party program for MedTech startups.
Differentiator
Problem solved
Functional benefit
Brands
- MedTech Crossroads: A free weekly YouTube webinar series hosted by in2being covering FDA news, regulatory education, and startup support including pitch competitions.
- Pitch Party
Products and services
- Medical Device Development Consulting End-to-end medical device development service covering engineering, design, prototyping, and regulatory guidance from concept through FDA clearance. Targeted at medical device startups, inventors, and established companies.
- Regulatory Clearance Services Guidance through FDA regulatory pathways including 510(k) submissions, Premarket Approval (PMA), De Novo requests, and FDA pre-submission meetings. Designed for medical device companies seeking expert regulatory strategy.
- Prototyping Services Mechanical, electrical, and software design and prototyping services that transform device concepts into functional prototypes for clinical trials and proof-of-concept demonstrations. For medical device startups and research teams.
- Quality Systems and Design Controls Implementation of FDA Quality System Regulation (QSR) compliance, design controls, verification and validation testing following FDA good laboratory practices (GLPs). For medical device companies requiring GMP compliance.
- Intellectual Property Development Assistance with patent applications, intellectual property protection, and startup formation for medical device commercialization. Targeted at inventors and early-stage medical technology companies.
- Project and Vendor Management
Quantifiable outcome
- Over 175 clients served and dozens of first-in-human prototypes fielded since 2010
- +5 more outcomes
Companies that use In2Being
Customer profileNamed customers8 records
Segments4 records
Ideal customer profiles3 records
In2Being technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
In2Being partnerships and signals
Strategic signalScale indicators5 records
Recent moves5 records
Expansion highlights5 records
In2Being competitors and assessment
Company assessmentRegional players
- RND Group: RND Group is a Midwest-based medical device design and development consultancy providing engineering, prototyping, and regulatory support. It overlaps with in2being in services and regional footprint, particularly within Michigan's medtech ecosystem.
Broad incumbents
- Battelle: Battelle is a large applied science and technology organization with a significant medical device practice spanning engineering, regulatory affairs, and clinical research. Comparable in regulatory and development expertise but at substantially larger scale and with broader scientific capabilities.
- Cambridge Consultants: Cambridge Consultants is a global product development and technology consultancy with a deep medtech practice spanning device design, prototyping, and regulatory strategy. Comparable to in2being in concept-to-clearance support but with much larger scale and international reach.
- Veranex (formerly Xenter, MedStar): Veranex is a larger, well-capitalized medtech services platform offering design, engineering, regulatory, clinical, and market access services. It competes with in2being for full-service device development engagements but at greater scale and with broader service breadth.
Direct peers
- Validant: Validant is a regulatory consulting firm specializing in FDA and international medical device and pharmaceutical submissions. It overlaps with in2being's regulatory pathway navigation, quality systems, and submission services, though at larger scale.
- StarFish Medical: StarFish Medical is a full-service medical device design, development, and contract manufacturing firm. Like in2being, it serves startups through to established medtech companies with end-to-end product development and regulatory support.
- MED Institute: MED Institute is a contract research and medical device development organization focused on regulatory, testing, and clinical study support for device manufacturers. Overlaps with in2being's FDA pathway and quality systems services.
- Ximedica: Ximedica provides end-to-end medical device design, development, and manufacturing services. Its full-service model from concept through FDA clearance directly mirrors in2being's offerings for medtech innovators.
- FDA Quality and Regulatory Consultants (FDAQRC): FDAQRC is a regulatory and quality consulting firm serving medical device and combination product companies with FDA submission, QSR, and design control support. Directly comparable to in2being's regulatory consulting and quality systems services.
Emerging players
- Greenlight Guru: Greenlight Guru provides eQMS (electronic quality management system) software purpose-built for medical device companies. It is an indirect competitor/complement to in2being's quality systems implementation services, offering software tooling in the same FDA QSR space.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
In2Being social profiles
Digital presenceIn2Being financial estimates
Financial estimateRevenue estimate
Valuation estimate
In2Being leadership team
Management profileNumber of profiles
Profiles4 records
In2Being funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
In2Being M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about In2Being
What does In2Being do?
In2Being is a full-service medical device development consultancy that supports inventors, startups, and established companies from concept through FDA clearance. The firm provides integrated services spanning engineering design (mechanical, electrical, software), in-house prototyping, FDA regulatory pathway navigation (510(k), PMA, De Novo, Pre-Submission), quality systems implementation, intellectual property development, and project/vendor management for manufacturing readiness.
Is In2Being a public or private company?
In2Being is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was In2Being founded?
In2Being was founded in 2010. It employs 1 to 10 people.
Where is In2Being based?
In2Being is headquartered in Saline, United States, in the North America region.
How does In2Being make money?
Three revenue lines are on record. Medical Device Development Consulting is the primary driver. The others are regulatory Consulting Services and prototyping and Design Services.
Who are In2Being's main competitors?
RND Group is listed as a regional player. Broad incumbents are Battelle, Cambridge Consultants and Veranex (formerly Xenter, MedStar). Direct peers are Validant, StarFish Medical, MED Institute, Ximedica and FDA Quality and Regulatory Consultants (FDAQRC). Greenlight Guru is listed as an emerging player.
Does In2Being have an API?
No public API is recorded for In2Being.
What industry is In2Being in?
In2Being's product category is Medical Device Regulatory Consulting. Its primary akta.pro industry code is HLAGAKAL, Quality Engineering & Risk Management (ICH Q9/Q10, validation, change control), with a secondary code of HLAGAKAO, Third-Party/Outsourced Quality & Responsible Person Services (EU QP/RP, US Agent). Its NAICS code is 5417 and its SIC code is 8731.