Concise Engineering

What Concise Engineering does

Concise Engineering is a privately held, founder-led medical device Contract Development and Manufacturing Organization (CDMO) headquartered in Clearwater, Florida. The firm provides end-to-end engineering and regulatory services across nine service disciplines — Program & Project Management, Risk Management, Regulatory/Quality (RA/QA), Systems Engineering, Usability Engineering, Mechanical Engineering, Electrical Engineering, Software Engineering, Software Quality, and Electrical Product Safety — spanning the full product lifecycle from concept through FDA submission and manufacturing transfer. Its portfolio includes 13+ disclosed medical device projects across orthopedics, electrosurgery, arthroscopy, hydrosurgery, wound therapy, automated external defibrillators (AEDs), surgical handpieces, dental/orthodontic devices, sports medicine, light-therapy wearables, bionic pancreas systems, and ECG telemetry, with multiple programs achieving 510(k) clearance and at least one FDA Warning Letter remediation (Renasys NPWT) returned to market. The firm maintains ISO 13485:2016-compliant QMS templates reviewed by Notified Bodies and FDA, and operates an international strategic partner network for in-country Authorized Representative services across the US, Australia, New Zealand, Germany, India, the UK, Latin America, and Asia.

The business operates on a fee-for-service, project-based professional services model with quote-based engagements and no publicly disclosed pricing tiers. Go-to-market is sales-led and content-driven: a 'Get in Touch' website CTA, Justin Bushko's direct booking link, and personal LinkedIn outreach are supplemented by the MedTechMan blog and MedTech Insider newsletter (24+ articles) as top-of-funnel demand generation targeting medical device entrepreneurs. Customer segments span both MedTech startups (KynderMed, Light Therapy Startup, AED startup, Bionic Pancreas client) and mid-to-large medical device enterprises and multinationals (Conmed, TouchPoint Medical, UK-based NPWT and Versajet multinationals). President Justin Bushko is the named engagement lead across the testimonial base, creating founder-key-person dependency. Revenue is not disclosed; with 1-10 employees and individual programs exceeding $2 million per year, the firm is estimated to operate in the $1M-$5M annual revenue band, supported by organic growth with no institutional funding, no subsidiaries, and no disclosed M&A.

Name

Concise Engineering

Legal name

Concise Engineering, Inc.

Website

https://concise-engineering.com

Company type

Private

Founded year

2003

Operating status

Operating

Headcount range

1–10 employees

Short description

Concise Engineering is a Clearwater, Florida-based medical device CDMO providing end-to-end engineering and regulatory services across nine disciplines. President Justin Bushko and a small team serve startups and multinationals through 510(k), De Novo, and PMA pathways.

Ownership category

akta.pro rank

Headquarters

HQ city

Clearwater

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Engineering Services: Concise Engineering provides fee-for-service engineering and consulting work across the full medical device development lifecycle, from concept through regulatory submission and manufacturing transfer. Revenue is generated through project-based professional services engagements.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels5 records

Core offering

Concise Engineering is a medical device Contract Development and Manufacturing Organization (CDMO) that provides end-to-end engineering services spanning concept, design, regulatory submission, and manufacturing transfer. The firm delivers ten engineering service disciplines — Program & Project Management, Risk Management, Regulatory/Quality, Systems Engineering, Usability, Mechanical, Electrical, Software Engineering, Software Quality, and Electrical Product Safety — to medical device companies from startups to multinationals across orthopedics, surgical, implant, electromechanical, and wearable device categories.

Product overview

Concise Engineering is a medical device Contract Development and Manufacturing Organization (CDMO) providing comprehensive engineering services across the full product lifecycle. The company offers a portfolio of 12 medical device development projects (Arthroscopy Pump, Hydrosurgery/Versajet, Arthroscopy Console, Negative Pressure Wound Therapy/Renasys, AED, Surgical Handpieces, Electrosurgical Device, Dental Appliance, Sports Medicine, Light Therapy Devices, Bionic Pancreas, and ECG Telemetry) and 9 engineering service disciplines (Program & Project Management, Risk Management, Regulatory/Quality, Systems Engineering, Usability Engineering, Mechanical Engineering, Electrical Engineering, Software Engineering, Software Quality, and Electrical Product Safety). The company operates as a services firm rather than a product manufacturer, supporting clients from concept through FDA clearance and manufacturing.

Differentiator

Problem solved

Functional benefit

Brands

• MedTechMan: A comprehensive resource for medical technology innovation, featuring articles, design insights, engineering expertise, and development tips for MedTech entrepreneurs. Run by Justin Bushko, President at Concise Engineering.

Products and services

• Program & Project Management Project and program management services with over 20 years of experience managing multi-million-dollar medical device programs, supporting clients from concept through regulatory submission and manufacturing transfer.
• Risk Management Risk management services including SOP development, documentation, DFMEA processes, and ISO 14971-aligned risk analysis for 510(k), PMA, and software compliance projects.
• Regulatory/Quality (RA/QA) Regulatory strategy and quality assurance covering pre-submission meetings, 510(k), De Novo, PMA, IDE, CE Technical File, and ISO 13485:2016-compliant QMS implementation for medical device clients.
• Systems Engineering Systems engineering and architecture services including requirements development, architecture design, and traceability mapping from system requirements to verification and validation activities for medical devices.
• Usability Engineering Usability engineering services following IEC 62366-1 requirements for FDA compliance, including home-use device testing with lay-person validation for medical device programs.
• Mechanical Engineering Mechanical engineering services including industrial design, human factors, 3D CAD modeling, rapid prototyping via FDM and SLA 3D printing, injection molding support, and manufacturing test fixtures for medical device development.
• Electrical Engineering Electrical engineering services covering component selection, schematic capture, board layout, and prototype production with microcontrollers, analog/digital systems, and communication protocols for medical device hardware.
• Software Engineering Software and firmware development for embedded systems and cloud platforms following IEC 62304-compliant processes, supporting C/C++, C#, Python, and Java for medical device software.
• Software Quality Software quality services delivering IEC 62304-compliant documentation including requirements specifications, detailed design, test plans, protocols, and reports for 510(k) and PMA medical device submissions.
• Electrical Product Safety Electrical product safety testing and certification support including pre-screening, formal testing per IEC 60601-1, EMC testing, and risk management table preparation for medical electrical equipment.

Quantifiable outcome

• 1/3 time-and-cost savings reported by an Arthroscopy Pump client compared to hiring a new in-house team.
• +5 more outcomes

Named customers17 records

Segments4 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

One partnership is on record.

• International Regulatory NetworkcoreStrategic or Co-development PartnerConcise Engineering maintains an expansive network of strategic partners with international offices in the US, Australia, New Zealand, Germany, India, the UK, Latin America, and Asia. This network allows the company to function as an in-country Authorized Representative and supports international regulatory submissions including CE Technical Files and submissions to multiple global regulatory bodies.

Scale indicators13 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• StarFish Medical: Canadian medical device product development firm offering end-to-end design, engineering, regulatory, and manufacturing transfer services — closely comparable in service model and boutique positioning to Concise Engineering.
• MindFlow Design: Medical device and life sciences product development firm offering concept, engineering, and design services to startups and OEMs — a small, focused peer in the medical device engineering services space.
• Meddux: Medical device development and contract manufacturing firm covering concept, design, regulatory, and production for complex interventional and surgical devices — directly comparable in CDMO service scope.
• Bresslergroup: Boutique medical device and consumer health product development consultancy spanning industrial design, mechanical/electrical engineering, and regulatory support — a close direct peer in size and full-lifecycle service model.
• Kablooe Design: Small medical device product development and design consultancy providing human factors, mechanical design, and regulatory support — comparable boutique competitor in the medical device design services market.

Broad incumbents

• Tegra Medical: Medical device contract manufacturer specializing in precision metal and plastic components, finished devices, and assembly — an established CDMO with similar end markets but a manufacturing-heavy model.
• Phillips-Medisize: Large-scale medical device CDMO (Molex-owned) providing drug delivery, diagnostic, and medtech design, development, and manufacturing at global scale — broader incumbent with overlapping but much larger capabilities.
• Confluent Medical Technologies: Medical device CDMO focused on nitinol, polymers, and engineered components for interventional and surgical applications — a broader incumbent serving overlapping device categories (cardiovascular, surgical) as Concise's portfolio.
• Flex Medical: Global electronics and medical device contract manufacturer offering design, engineering, and manufacturing services across a wide healthcare portfolio — a broad incumbent with overlapping medical device capabilities.
• Jabil Healthcare: Global manufacturing services company with a large healthcare and medical device CDMO business spanning design services, tooling, and high-volume manufacturing — a major incumbent competitor with significantly greater scale.

Market position

Strengths5 records

Weaknesses5 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/concise-engineering-inc-

Compliance5 records

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 Concise Engineering