Top Medical Device Consulting Companies

List of Top Medical Device Consulting Companies

Healthcare Tech Outlook
6 min readJul 6, 2021

Medical equipment manufacturing is opening new doors for expansion while addressing several medical professional needs across the world. This year’s medical device industry trends reflect the relentless pace of transformation, change, and growth impacting nearly every aspect of the industry. Whether it’s the growing specialization in sustainability, the continued growth of products, the increase of ingestible devices, or regulatory changes, medical device makers are gearing up to navigate a dizzying array of opportunities and challenges facing the industry.

With an increase in the number of chronic diseases, an aging global population, gastrointestinal disorders, carcinoma diagnoses globally, and therefore the shift toward preventative strategies in healthcare to tackle disease progression, ingestible medical devices is witnessing an eternal growth trajectory. At the same time, there’s also a surge in VR-based medical equipment immediately, resulting in a rise within the industry’s investment in reformed versions of VR devices to fuel further growth.

According to several other market reports, the inflow for revenue for medical devices in 2020 will cross the previous year’s numbers. Alongside, the FDA has recently uncovered a faster pathway for the approval of medical devices and has been working to solidify their compliance strategies.

At this juncture, there’s a significant kind of medical device manufacturing service/consulting companies entering the landscape with a collection of advanced and insightful offerings. MedTech Outlook has compiled this edition to assist the medical device manufacturing fraternity in strengthening its infrastructure and simultaneously enabling growth. The list comprises prominent consulting companies within the industry that solve medical device manufacturing challenges. Besides, the magazine also includes insights from thought leaders within the sector on the industry trends, best practices, recent innovations, and their advice for aspiring CIOs and CXOs.

Top Medical Device Consulting Companies

Globizz Corporation

A consulting firm that marries knowledge of the medical device market and corporate culture in the US, the latest FDA regulations, and the clients’ unique needs to help Japanese medical device companies thrive in the US market

Hull Associates

Hull Associates offers strategic market access and reimbursement consulting to enable pharmaceutical, medical device, and diagnostics organizations develop targeted strategies for their products such that they are recognized by payment systems and readily adopted by healthcare providers. Hull Associates has served over 350 companies across all disease areas, and among 22 major global markets. Since its inception, Hull Associates has worked on almost every major innovative device produced in the medical industry, such as the percutaneous heart valves, robotic surgical systems, and the latest in vitro diagnostics

Ingenarious Consultants

Assists medical device manufacturing startups with every phase of their product development process. The company adopts a unique, phased approach to structure the product development process in a financially viable manner. It starts with the close integration of Ingenarious’ team with that of the clients’ to understand their vision and requirements. There upon, the company works to identify the most crucial needs in materializing their ideas and vision. With this phased approach, the company offers startups end-to-end visibility about the scope of product development while reducing the risks in making financial and business decisions. Furthermore, in several instances, Ingenarious has even gone the extra mile supporting startups in applying for grants to raise capital for product development.

Irwin & Associates

Irwin & Associates specializes in diverse areas, such as project management, quality system creation, user documentation, quality engineering, verification & validation, risk management, design control, R&D to production transfers, process development, biocompatibility, and microbiology/sterilization validation and more. The team assists the company in setting up a document control system, a training program, a quality manual, and the appropriate procedures required to get them off the ground to conduct their initial studies and launch their products. For larger organizations, Irwin & Associates provides design control, process development, project management, regulatory, and technical writing to propel their projects forward.

JALEX Medical

JALEX Medical offers product development, design engineering, regulatory affairs, and quality management solutions along with the expertise of its biomedical engineers to support clients in the medical device industry through every stage of the development process.. The company provides step-by-step directives to startups to take their product from ideation to fruition. It works on the process of 3D CAD modeling, finalizing the materials and the manufacturing process, and then prototyping the product for client approval. It further works on the verification and validation process, after which it helps clients acquire clearance on their products to go to market. JALEX Medical works as an extension of the clients’ engineering and regulatory department while supporting them throughout the roll-out process

Lachman Consultants

Lachman Consultants provides expert compliance, regulatory affairs, and technical consulting services for the pharmaceutical and allied health industries around the world

Paladin Medical®, Inc.

Paladin Medical®, Inc. offers expertise based on over 40 years of experience in the medical device industry to help products comply with FDA regulations and enter the U.S. market with the least difficulty. The company specializes in a full range of medical product regulatory, clinical, and technical contract services for FDA and international premarket applications as well as support to regulatory compliance for the medical device regulations. Paladin Medical®, Inc. stays on the cutting edge of both biomedical engineering of new medical products and the regulatory science that goes with getting those products to the marketplace. The company typically caters to start-up device manufacturers or the established companies with emerging new technologies

RJR Consulting, Inc

RJR Consulting helps its clients expand their global geographical presence. It does so by providing them regulatory supportand assisting them in developing a new market in the targeted country, without the need for them to set up an office locally.

Strategy Inc.

Strategy Inc. delivers investment and market strategy due diligence for changing the standard of care medical technology. Founded in 2000, a team of proven medical device and healthcare market research experts combine in-depth primary research findings with traditional and innovative analytical tools to provide the probability of successful commercialization. Entities with a platform technology where prioritization of the indication for use with the highest probability to succeed with the maximum return is a specialty. Globally focused, 46% of business is international, providing services to foreign entities seeking to US launch their technology. Clients include emerging companies, financiers and enterprise companies with technologies in all stages of product lifecycle


Covance Inc., the drug development business of LabCorp®, is the world’s most comprehensive drug development company, dedicated to advancing healthcare and delivering Solutions Made Real®. Our unique perspectives, built from decades of scientific expertise and precision delivery of the largest volume of drug development data in the world, along with our innovative technology solutions, help our clients identify new approaches and anticipate tomorrow’s challenges as they evolve. Together with our clients, Covance transforms today’s healthcare challenges into tomorrow’s solutions. We also offer laboratory testing services to the chemical/agrochemical industries and are a market leader in toxicology services, central laboratory services, discovery services and a top global provider of Phase III clinical trial management services



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