U.S. Medical Device Outsourcing Market Size, Share & Trends Report

U.S. Medical Device Outsourcing Market Size, Share & Trends Analysis Report By Services (Quality Assurance, Contract Manufacturing), By Application (Cardiology, Diagnostic Imaging, IVD), By Class, And Segment Forecasts, 2023 - 2030

  • Report ID: 978-1-68038-600-4
  • Number of Pages: 240
  • Format: Electronic (PDF)
  • Historical Range: 2018 - 2021
  • Industry: Healthcare

Research Methodology

A three-pronged approach was followed for deducing the U.S. medical device outsourcing market estimates and forecasts. The process has three steps: information procurement, analysis, and validation. The whole process is cyclical, and steps repeat until the estimates are validated. The three steps are explained in detail below:

Information procurement: Information procurement is one of the most extensive and important stages in our research process, and quality data is critical for accurate analysis. We followed a multi-channel data collection process for U.S. medical device outsourcing market to gather the most reliable and current information possible.

  • We buy access to paid databases such as Hoover’s and Factiva for company financials, industry information, white papers, industry journals, SME journals, and more.
  • We tap into Grand View’s proprietary database of data points and insights from active and archived monitoring and reporting.
  • We conduct primary research with industry experts through questionnaires and one-on-one phone interviews.
  • We pull from reliable secondary sources such as white papers and government statistics, published by organizations like WHO, NGOs, World Bank, etc., Key Opinion Leaders (KoL) publications, company filings, investor documents, and more.
  • We purchase and review investor analyst reports, broker reports, academic commentary, government quotes, and wealth management publications for insightful third-party perspectives.

Analysis: We mine the data collected to establish baselines for forecasting, identify trends and opportunities, gain insight into consumer demographics and drivers, and so much more. We utilized different methods of U.S. medical device outsourcing market data depending on the type of information we’re trying to uncover in our research.

  • Market Research Efforts: Bottom-up Approach for estimating and forecasting demand size and opportunity, top-down Approach for new product forecasting and penetration, and combined approach of both Bottom-up and Top-down for full coverage analysis.

  • Value-Chain-Based Sizing & Forecasting: Supply-side estimates for understanding potential revenue through competitive benchmarking, forecasting, and penetration modeling.

  • Demand-side estimates for identifying parent and ancillary markets, segment modeling, and heuristic forecasting.

  • Qualitative Functional Deployment (QFD) Modelling for market share assessment.

Market formulation and validation: We mine the data collected to establish baselines for forecasting, identify trends and opportunities, gain insight into consumer demographics and drivers, and so much more. We utilize different methods of data analysis depending on the type of information we’re trying to uncover in our research.

  • Market Formulation: This step involves the finalization of market numbers. This step on an internal level is designed to manage outputs from the Data Analysis step.

  • Data Normalization: The final market estimates and forecasts are then aligned and sent to industry experts, in-panel quality control managers for validation.

  • This step also entails the finalization of the report scope and data representation pattern.

  • Validation: The process entails multiple levels of validation. All these steps run in parallel, and the study is forwarded for publishing only if all three levels render validated results.

U.S. Medical Device Outsourcing Market Categorization:

The U.S. medical device outsourcing market was categorized into three segments, namely services (Quality Assurance, Regulatory Consulting Services, Product Design And Development Services, Product Testing & Sterilization Services, Product Implementation Services, Product Upgrade Services, Product Maintenance Services, Contract Manufacturing), application (Cardiology, Diagnostic imaging, Orthopedic, IVD, Ophthalmic, General And Plastic Surgery, Drug Delivery, Dental, Endoscopy, Diabetes Care), and class (Class I, Class II, Class III).

Segment Market Methodology:

The U.S. medical device outsourcing market was segmented into services, application, and class. The demand at a segment level was deduced using a funnel method. Concepts like the TAM, SAM, SOM, etc., were put into practice to understand the demand. We at GVR deploy three methods to deduce market estimates and determine forecasts. These methods are explained below:

Market research approaches: Bottom-up

  • Demand estimation of each product across countries/regions summed up to from the total market.

  • Variable analysis for demand forecast.

  • Demand estimation via analyzing paid database, and company financials either via annual reports or paid database.

  • Primary interviews for data revalidation and insight collection.

Market research approaches: Top-down

  • Used extensively for new product forecasting or analyzing penetration levels.

  • Tool used invoice product flow and penetration models Use of regression multi-variant analysis for forecasting Involves extensive use of paid and public databases.

  • Primary interviews and vendor-based primary research for variable impact analysis.

Market research approaches: Combined

  • This is the most common method. We apply concepts from both the top-down and bottom-up approaches to arrive at a viable conclusion.

Regional Market Methodology:

The U.S. medical device outsourcing market was analyzed at a regional level.

All three above-mentioned market research methodologies were applied to arrive at regional-level conclusions. The regions were then summed up to form the global market.

U.S. medical device outsourcing market companies & financials:

The U.S. medical device outsourcing market was analyzed via companies operating in the sector. Analyzing these companies and cross-referencing them to the demand equation helped us validate our assumptions and conclusions. Key market players analyzed include:

  • INTEGER HOLDINGS CORPORATION - Integer Holdings Corporation is a prominent outsourcing manufacturer specializing in the production of medical devices for various fields, such as cardiac, vascular, neuromodulation, and portable medical products. The company also manufactures batteries utilized in non-medical sectors, including military, environmental, and energy markets. Notably, in 2014, Lake Region Medical acquired Accellent, further strengthening its position in the industry. The following year, Greatbatch, Inc. acquired Lake Region Medical, solidifying its status as one of the largest outsourced manufacturers of medical devices. Finally, in 2016, the merger of Greatbatch and Lake Region Medical resulted in the establishment of Integer Holdings Corporation.

  • AVAIL MEDICAL PRODUCTS, INC. - Avail Medical operates as a service provider for outsourced product development. Their medical device outsourcing services include product design, process development, prototyping, and metrology testing. The company specializes in the production of single-use medical devices utilized in operating rooms. In 2008, Flex Ltd, a prominent player in the contract manufacturing market across various industries, acquired Avail Medical. Since the acquisition, Avail Medical has been operating under the trade name "Flexmedical Disposables".

  • ACTIVE IMPLANTS - Active Implants specializes in creating orthopedic solutions that replicate the natural biomechanics of the muscular system. The company's primary focus is to offer clinical validation services for their investigational product, known as "NUsurface," which is an artificial knee meniscus. Additionally, Active Implants manufactures medical cups utilized in joint replacement surgeries, which are distributed internationally through different partners. The company has established offices in the Netherlands to cater to the European market. Furthermore, Active Implants has a well-equipped research and development facility in Israel with highly trained researchers and material experts.

  • OMNICA CORPORATION - Omnica Corporation, a privately owned design and engineering firm, offers comprehensive services for the advancement of medical products. Situated in Los Angeles, their facility spans 25,000 square feet and is equipped with state-of-the-art technology, enabling them to create a wide range of medical devices. Their clientele comprises startups, medium-sized enterprises, and large corporations operating in the medical devices market, both domestically in the United States and internationally.

  • TELEFLEX INCORPORATED - Teleflex Incorporated serves as the parent company for Teleflex Medical OEM, a company specializing in medical device outsourcing. Teleflex Medical OEM offers various services, including product concept development, prototyping, and manufacturing. With six manufacturing sites throughout the United States, the company boasts a highly skilled workforce, advanced manufacturing technology, and vertically integrated capabilities, all contributing to efficient project delivery for clients. Teleflex Medical OEM's expertise lies in producing various medical products, including catheters, medical conductors, wires, sutures, and micro-diameter medical tubing.

  • KINETIC CLIMAX INC. - Kinetic Climax, Inc. is a subsidiary of Dynacast, a company that specializes in the production of components using multi-slide die-casting technology. In 2014, Dynacast acquired Kinetic Climax to enhance the parent company's position in the metal injection molding industry. With a global presence, Dynacast operates 22 production facilities in 16 countries.

  • CANTEL MEDICAL CORP. - Cantel Medical specializes in providing infection prevention services and products within the healthcare industry. The company operates across various sectors, including dialysis, endoscopy, healthcare disposables, and water purification & filtration. These segments are managed by three Cantel Companies—Medivators, Crosstex International, and Mar Cor Purification. Cantel offers detergents, disinfectants, medical reprocessing systems, and other materials in the endoscopy segment. The water purification & filtration segment focuses on separation and filtration products, sterilization, decontamination, and water purification services. Within the dialysis segments, Cantel provides sterilants, disinfectants, medical device processing systems, and materials for renal dialysis. The healthcare disposable segments encompass infection prevention & control products as well as single-use products. Cantel Medical has a global presence in the Americas, Asia, Europe, and Australia.

Value chain-based sizing & forecasting

Supply Side Estimates

  • Company revenue estimation via referring to annual reports, investor presentations, and Hoover’s.

  • Segment revenue determination via variable analysis and penetration modeling.

  • Competitive benchmarking to identify market leaders and their collective revenue shares.

  • Forecasting via analyzing commercialization rates, pipelines, market initiatives, distribution networks, etc.

Demand side estimates

  • Identifying parent markets and ancillary markets

  • Segment penetration analysis to obtain pertinent

  • revenue/volume

  • Heuristic forecasting with the help of subject matter experts

  • Forecasting via variable analysis

U.S. Medical Device Outsourcing Market Report Objectives:

  • Understanding market dynamics (in terms of drivers, restraints, & opportunities) in the countries.

  • Understanding trends & variables in the individual countries & their impact on growth and using analytical tools to provide high-level insights into the market dynamics and the associated growth pattern.

  • Understanding market estimates and forecasts (with the base year as 2022, historic information from 2018 to 2021, and forecast from 2023 to 2030). Regional estimates & forecasts for each category are available and are summed up to form the global market estimates.

U.S. Medical Device Outsourcing Market Report Assumptions:

  • The report provides market value for the base year 2022 and a yearly forecast till 2030 in terms of revenue/volume or both. The market for each of the segment outlooks has been provided on region & country basis for the above-mentioned forecast period.

  • The key industry dynamics, major technological trends, and application markets are evaluated to understand their impact on the demand for the forecast period. The growth rates were estimated using correlation, regression, and time-series analysis.

  • We have used the bottom-up approach for market sizing, analyzing key regional markets, dynamics, & trends for various products and end-users. The total market has been estimated by integrating the country markets.

  • All market estimates and forecasts have been validated through primary interviews with the key industry participants.

  • Inflation has not been accounted for to estimate and forecast the market.

  • Numbers may not add up due to rounding off.

  • Europe consists of EU-8, Central & Eastern Europe, along with the Commonwealth of Independent States (CIS).

  • Asia Pacific includes South Asia, East Asia, Southeast Asia, and Oceania (Australia & New Zealand).

  • Latin America includes Central American countries and the South American continent

  • Middle East includes Western Asia (as assigned by the UN Statistics Division) and the African continent.

Primary Research

GVR strives to procure the latest and unique information for reports directly from industry experts, which gives it a competitive edge. Quality is of utmost importance to us, therefore every year we focus on increasing our experts’ panel. Primary interviews are one of the critical steps in identifying recent market trends and scenarios. This process enables us to justify and validate our market estimates and forecasts to our clients. With more than 8,000 reports in our database, we have connected with some key opinion leaders across various domains, including healthcare, technology, consumer goods, and the chemical sector. Our process starts with identifying the right platform for a particular type of report, i.e., emails, LinkedIn, seminars, or telephonic conversation, as every report is unique and requires a differentiated approach.

We send out questionnaires to different experts from various regions/ countries, which is dependent on the following factors:

  • Report/Market scope: If the market study is global, we send questionnaires to industry experts across various regions, including North America, Europe, Asia Pacific, Latin America, and MEA.

  • Market Penetration: If the market is driven by technological advancements, population density, disease prevalence, or other factors, we identify experts and send out questionnaires based on region or country dominance.

The time to start receiving responses from industry experts varies based on how niche or well-penetrated the market is. Our reports include a detailed chapter on the KoL opinion section, which helps our clients understand the perspective of experts already in the market space.

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