In mid-August 2023, a rating of 10 leading world companies specializing in the production of orthopedic medical devices was announced. The list is based on the annual revenue indicators of vendors.

It is noted that the global industry of orthopedic solutions and systems is recovering from the recession provoked by the COVID-19 pandemic. GlobalData analysts believe that new generations of orthopedic robots equipped with artificial intelligence and machine learning will further improve clinical outcomes. Some market participants such as Stryker and Zimmer Biomet are betting on innovation by developing new products and services based on their surgical robotic systems, surgical planning tools and digital medical instruments.

Ranking of 10 leading global companies specializing in the production of orthopedic medical devices has been announced

According to the resource MassDevice, the Tor-10 of the world's largest manufacturers of orthopedic medical devices was formed on the basis of official data obtained from the financial statements of the companies themselves. The rating indicates the size of annual revenue and its change in relation to the previous financial year:

1. Stryker - $18.4 billion (+ 7.8%);

2. Johnson & Johnson DePuy Synthes - - $8.6 billion (0%);

3. Zimmer Biomet - $6.9 billion (+ 1.6%);

4. Medtronic (cranial and spinal technologies) - $4.5 billion (0%);

5. Smith + Nephew (orthopedics and sports medicine) - $3.6 billion (0%);

6. Enovis - $1.6 billion (+ 10.0%);

7. NuVasive - $1.2 billion (+ 6%);

8. Globus Medical - $1 billion (+ 6.8%);

9. Orthofix (merged with SeaSpine) - $698 million (+ 6.5%);

10. ZimVie (spinal business) - $450 million (-16.8%).

It is also noted that as of mid-August 2023, NuVasive and Globus Medical are in the process of merging. It is planned to complete the corresponding procedure by the end of the third quarter of 2023.^[1]

The market size of medical equipment protection systems is estimated at $6.57 billion

On October 10, 2022, ResearchAndMarkets analysts published a study according to which the global medical device safety market will amount to $6.57 billion in 2022 and is expected to reach $9.85 billion by 2027 with a growth rate of 8.43%. Read more here.

2020

5 trends in medical technology to be expected in 2020

In mid-January 2020, the MedTech Dive portal published an article listing five trends in the field of medical technology that should be expected in 2020.

Uncertain future of ethylene oxide sterilization

In February 2020, the Environmental Protection Agency is preparing to publish new restrictions for commercial ethylene oxide-based sterilizers. It is not yet clear how the government intends to protect the public from carcinogenic gas while maintaining access to a critical sterilization method that is used to process more than half of all U.S. medical devices. A 2019 advisory committee meeting noted that shutting down just one or two commercial sterilizers could be disastrous for the medical device supply chain.

MedTech Dive published an article listing five trends in medical technology that should be expected in 2020

The industry hopes the agency will unveil proposals that would modernize pollution control technology without abandoning sterilizer services.

Refunds are a priority

Reimbursement of funds is a priority area of the trade lobby in 2020. Medical device manufacturers have long lamented the so-called "death valley," which runs between obtaining permission to sell medical equipment and real reimbursement.

However, the medical equipment industry could benefit on another front with insurance companies planning to create a program to speed up beneficiaries' access to disruptive technologies that "could potentially improve treatment outcomes and quality of care."

Stricter Medical Equipment Regulations

In 2012 European Commission , she proposed to modernize the supervision of medical equipment, and in 2017 parliament voted to adopt the Equipment Regulation medical. Now there is growing concern among manufacturers about stricter standards, which will take effect as early as May 26, 2020. In addition to the new requirements for the equipment itself, they are worried about the standards of after-sales service, which will also require more return.

Medical device manufacturers have long lamented the so-called "death valley" that runs between getting permission to sell medical equipment and making real refunds

Breakthrough Device Program

This program allows developers of highly effective devices for the diagnosis and treatment of "life-threatening or irreversible diseases/conditions" to request special status for this equipment, which will allow manufacturers to work more closely and timely with regulators in the course of pre-sales activities.

According to a representative of regulatory authorities, the number of devices that received the status of "breakthrough" under the program in 2019 reached 136. In addition, manufacturers have an additional incentive to participate in the program: a new way of reimbursement, which will allow developers to receive compensation without complying with a number of other requirements.

A wave of changes in senior management

Some major manufacturers of medical equipment will change their leaders by the end of the year. Whether these changes (in a number of companies - for the first time in decades) will significantly affect the conclusion of individual transactions or the overall strategy of companies by the end of 2020 is still unknown.

Perhaps the most notable change was the change in management of Abbott, which will receive a new CEO and new CFO in March 2020. Retiring chief executive Miles White has run the company since 1998. BD with Medtronic will also have new CEOs - these changes are scheduled for late January and April 2020, respectively.^[2]

2019

Ranking of Medical Equipment Market Leaders

At the end of January 2021, the ProClinical portal published a rating of the largest manufacturers of medical devices. Experts took the volume of sales of companies in 2019 as the basis of their report.

10. Cardinal Health - $15.4 billion

The American company Cardinal Health offers pharmaceuticals, other medical products and services. In fiscal 2020, the company's revenue in the medical segment decreased slightly, while year-on-year growth decreased by 1% due to the adverse effects of the pandemic.

9. Becton Dickinson & Company - $17,3 млрд

Beckton Dickinson & Company (BD) is an American company that manufactures and markets medical devices, instrumentation systems and reagents. BD's medical division grew by 8% thanks to research and development of new drugs.

Medtronic, Johnson & Johnson, Thermo Fisher Scientific - Medical Equipment Market Leaders

8. Siemens Healthineers - $19bn

Siemens Healthineers, headquartered in Germany, is the medical arm of the Siemens conglomerate working in automation and electrical engineering. Siemens Healthineers plans to upgrade the range and expand production in all three major segments: imaging, diagnostic and advanced therapy devices.

7. Fresenius Medical Care - $19 billion

The German Fresenius is a leading provider of dialysis products and services with more than 300,000 employees in more than 100 countries. The acquisition and implementation of the home system dialysis NxStage significantly increased the company's performance, and the stable Fresenius business model helped the company develop even amid the pandemic. COVID-19

6. Philips - $19 billion

Philips is a multi-disciplinary technology company. Philips' medical division is responsible for 42% of the company's global revenue and consists of three main areas: diagnosis and treatment, patient care and personal health. Philips has unveiled a strategic plan to further accelerate growth through geographic expansion, innovative technology adoption, organic investment and partnerships.

ProClinical: Ranking of Medical Equipment Market Leaders

5. GE Healthcare - $19.9 billion

GE Healthcare is widely known for its imaging, ultrasound and medical care solutions. The company's healthcare sales are growing on the strength of its Life Care Solutions division. GE Healthcare has also conducted a number of deals to enter the market for 3D printing, surgical robotics and virtual care.

4. Abbott - $20 billion

The American corporation Abbot supplies medical devices and products to more than 160 countries. The company has 107,000 employees worldwide and is widely known for creating revolutionary products in the areas of diagnostics, medical equipment, nutrition and branded generics.

3. Thermo Fisher Scientific - $25,5 млрд

The American company Thermo Fisher Scientific deals with the problems of medical diagnostics and consists of four main segments: solutions for biomedical sciences, analytical devices, specialized diagnostics and laboratory services.

2. Johnson & Johnson - $26 billion

Johnson & Johnson manufactures a wide range of products used in orthopaedics, surgery, interventional medicine, and eye health. The company plans to improve its portfolio of innovative technologies by absorbing other companies and creating strategic partnerships.

1. Medtronic - $28.9 billion

Medtronic remains the largest medical device manufacturer in the world. This company employs more than 90,000 employees in 150 countries and still optimizes new medical technologies, is engaged in research work and is taking over emerging markets.^[3]

Reviews of medical equipment increased by 50%

In 2019, the Food and Drug Administration (FDA) conducted 48 recalls of medical equipment, up 50% from a year earlier. This is evidenced by the data of the MD + DI&QMED portal.

The exact reason for this increase is unclear, but the trend is clear: medical devices are increasingly being recalled due to defective software. So, in 2019, Stericycle Expert Solutions reported that it was the problems with software that became the main reason for the recall of medical equipment from the market.

FDA Medical Equipment Recall 2016-2019

As we increasingly rely on AI and data collection, software is becoming an increasingly significant element of medical devices, while increasing their vulnerability, "explained Stericycle employee Chris Harvey. - It often turns out that the software used to control the medical device acts against expectations. In addition, we cannot be sure of their safety at all - manufacturers have only recently paid attention to the protection of medical devices from cyber threats.

In 2019, due to software problems, a number of devices recalled companies such as Medtronic, Zimmer Biomet, Brainlab, Hamilton Medical, Fresenius Kabi and Smiths Medical.

The most serious of the last cases in 2019 was the recall of incubators for infants made by GE - due to a production marriage, babies fell out of cuvez (a device with automatic oxygen supply and maintaining the optimal temperature in which a premature or sick newborn is placed) and were hospitalized with such severe injuries as skull fractures, hemorrhage and brain edema. In total, six reports of traumatic brain injuries were received, no deaths were reported.

Another major issue that led to the recall involved the Medfusion 4000 syringe pump manufactured by Smiths Medical. Due to software problems, the devices stopped sending low battery alarms, which led to an unplanned interruption of therapy.^[4]

3 top trends in the medical equipment market

In early December 2019, analysts KPMG presented an overview of major trends that will affect the medical device industry in 2020.

1. Impact of the latest technologies on clinical research

Large technology companies have already realized the value and growth potential of the healthcare and medical equipment sector and therefore invest significantly in its development. By blurring the boundaries between retail and information technology, giants such as Google, Apple, Facebook and Amazon are emerging as key players in the medical industry and clinical research. These companies use the latest developments - cloud storage, wearable technology and artificial intelligence - and thereby change people's understanding of medical equipment and how it can be used.

KPMG presented an overview of the main trends that will affect the field of medical devices in 2020

Already 64% of life sciences companies have switched or are switching to cloud technologies and are beginning to actively use big data analysis. And as more personal, health-related wearable devices enter the market, so does the volume of incoming data that opens up opportunities for new clinical research.

2. Impact of Regulations on Clinical Trials

The new European Rules on the Use of Medical Devices (MDR) and the Rules on the Use of Medical Devices for In Vitro Diagnostics (IVDR) will replace the current Directive on Medical Devices in 2020-2022. All new devices will have to comply with new regulations, otherwise they will not be able to enter the European market. Medical device manufacturers have already taken care to certify their products in accordance with the new rules.

The new regulation is intended to ensure a more transparent relationship between regulators, manufacturers and customers, while improving the results of diagnosis and treatment. MDR/IVDRs will include a number of changes relating directly to medical equipment manufacturers, including tightening requirements for the safety and functionality of medical devices. Manufacturers need to implement a systematic approach to continuously collect and analyze clinical data relating to medical devices for subsequent safety monitoring. A brief analysis of these data will be transmitted to the European Medical Device Database (EUDAMED).

Impact of Regulations on Clinical Trials

3. Clinical Trial Dossier Reference Model

Although the Clinical Trial Dossier (CSR) reference model was presented as a possible way to control clinical trial documentation, this model has come to be used in a much broader context.

The DCI reference model not only verifies the quality of data in a consistent standardized format, but also allows the collection and analysis of all data during clinical trials. The CSR reference model not only supports data integrity, but also simplifies cross-referencing and focuses on data activities. These include collecting data at key stages, ensuring quality control, and notifying users of missing data.

Now the creation of databases in accordance with the generally recognized reference model is considered an advanced approach to working with medical documentation, including regarding medical equipment. This is partly due to standardized nomenclature, as such a model has become one of the simplest and most effective resources for medical practitioners. A recent survey found that 85% of industry respondents use the DCI reference model or consider using it in the future.^[5]

7 Top Medtech Trends

In early August 2019, reviewers of Medical Design and Outsourcing, which covers the situation in the medical device market, presented a list of trends that are observed in this market in 2019.

1. Every major medical tech company wants its own robot

Intuitive Surgical remains the dominant manufacturer of robotic surgical technology. But other big companies come into play, especially developers of orthopedic surgery technologies like Stryker Corporation, DePuy Synthes, Zimmer Biomet and Smith & Nephew, which have already launched or are preparing to launch their own robotic surgeons.

Leading positions in the global medical device market are occupied by countries with developed, highly competitive economies, with high innovation potential

The leading Intuitive Surgical earlier in 2019 released the da Vinci SP system for single-port laparoscopy with combined instrumentation in a one-inch tube that contains a flexible laparoscope and three instruments for performing the operation.

2. US-China trade war hits medic makers

USA Donald Trump The President said that the United States will introduce new duties of 10% on goods China worth $300 billion from September 1, 2019. The trade war is taking a heavy toll on large medical device companies, many of which have facilities China in or supply equipment components to East Asian partners. However, in July 2019, the United States exempted several categories of medical devices from 25% duties, including surgical, radiotherapy and dental devices, which somewhat facilitated the position of manufacturers.

3. Shortage of sterilization sites

Regulatory authorities continue to combat the consequences of the use of ethylene oxide (EO), used to sterilize disposable medical devices. It turned out that excessive emissions of a carcinogenic sterilizer harm the environment and the health of the local population, so several sterilization sites were closed. These actions led to a crisis among manufacturers of medical equipment, which immediately began to search for alternatives and methods to reduce EO emissions.

4. Curtailing powers FDA

FDAScience magazine reports that the FDA's consumer protection capabilities have been severely curtailed under the Trump administration. It is reported that the distribution of warning letters is reduced by a third, and the distribution of warnings to manufacturers of medical devices - by two thirds.

5. FDA under fire

The FDA also made a number of statements and proposed a transformation plan in response to harsh public criticism. In 2018, Netflix documentary The Bleeding Edge and The Implant Files series of the International Consortium of Investigative Journalists, which showcased patient injuries caused by faulty devices, blew up the public. The FDA announced plans to reorganize its centers and permit practices to improve control of materials and finished products.

Reviewers of Medical Design and Outsourcing, which covers the situation in the medical device market, presented a list of trends that are observed in this market in 2019

6. Mergers and Acquisitions

Among medical device manufacturers, merger and acquisition deals continue, although not all of them are breaking records in scale. Companies are adopting new technologies and looking for new opportunities as they seek to compete in the booming healthcare market.

7. Initial public offering is back in business

The most prominent cases of initial stock offerings include Livongo Health, a digital healthcare platform for managing chronic diseases that raised $355 million when it went public, and TransMedics, a manufacturer of transplantable organ transportation systems that raised nearly $105 million during its IPO.^[6]

The largest producers according to Forbes

In mid-May 2019, Forbes magazine published a list of the world's largest manufacturers of medical devices as part of the Forbes Global 2000 rating. It is compiled on the basis of the aggregate estimate of revenue, profit, assets and market value of companies.

The largest manufacturer of medical equipment and consumables for him is named, the Johnson & Johnson market capitalization of which by mid-May 2019 amounted to $366.2 billion. The second place was taken Medtronic with a result of $113 billion, and the top three was closed (Stryker $67.3 billion).

The largest manufacturers of medical equipment. Sorting by Market Capitalization Size, Forbes Data

If we take all medical companies, then here Medtronic is named the leader of Forbes Global 2000. Following are Thermo Fisher Scientific and HCA Healthcare. Medtronic and Thermo Fisher Scientific are focused on growing businesses in emerging markets, while HCA Healthcare, which is among the largest operators of the hospital network, is focusing on increasing the number of clinics in the US and UK, observers said.

Medtronic is ranked 150th in the list of the world's largest companies. The company leads the way in sales of heart treatment and maintenance equipment, insulin pumps and products for spinal diseases.

Medtronic's vast portfolio has the advantage that growing product cycles offset other declining cycles, says Morningstar analyst Debbie Wang.

But it does not do without problems. Medtronic is in the news on a battery problem in implantable pacemakers. Eliminating production defects and recalling devices is expensive for the vendor.

Medtronic HQ

Thermo Fisher Scientific by May 2019 leads the production of research and laboratory equipment, chemical reagents and clinical drugs. The company, which ranked 222nd in the Forbes Global 2000 overall ranking, has more than 350 thousand customers among pharmaceutical and biotechnology firms, hospitals and clinical diagnostic laboratories, universities, research institutes and organizations involved in environmental protection, production quality and product control.

Thermo Fisher Scientific has made strides in mass spectrometry and has made acquisitions totaling more than $30 billion since 2010. The last by May 2019 was the purchase of the manufacturer of viral vectors for gene therapy Brammer Bio for $1.7 billion. Brammer Bio operates in a niche market that is growing at about 25% per year. Thermo Fisher's revenue in 2018 amounted to $24.4 billion, net profit - $2.9 billion, and market capitalization reached $104 billion by May 2019.

Among the ten largest medical companies in the world were also: Fresenius (No. 4 in the field of health care, No. 258 in the entire Forbes Global 2000 rating); Becton Dickinson (No. 5 in Health, No. 355 in General), Stryker (No. 6 in Health, No. 366 in General), Boston Scientific (No. 8 in Health, No. 557 in General), and Baxter International (No. 9 in Health, No. 617 in General).

For the first time, EssilorLuxottica entered the top 10, which ranked 7th among the largest medical companies and 383rd in the overall ranking.

The Forbes publication says that the largest medical companies are increasing revenues amid an increase in the number of elderly people and growing demand for medical products and services from middle-income people. According to Deloitte forecasts, global health spending will grow by 5.4% per year and rise to $10 trillion by 2022 against $7.7 trillion in 2017.^[7]

2018

Top 20 largest manufacturers of medical equipment

In September 2019, Medical Design & Outsourcing presented a new edition of the ranking of the world's largest manufacturers of medical devices. According to journalists, consolidation continues in the market, as a result of which small players become part of large companies, and the latter expand their business. In 2018, the first hundred manufacturers of medical equipment earned a total of $397.5 billion, which is 3.5% more than a year ago.

Medical Design & Outsourcing introduced a new edition of the ranking of the world's largest manufacturers of medical devices

1. Medtronic

Medtronic remains the leader in the medical device market, which in 2018 raised about $30.56 billion or $339,522 per employee. The company's research and development costs reached $2.33 billion.

2. Johnson & Johnson

Johnson & Johnson, with revenue of $27 billion and R&D costs of $1.76 billion in 2018, strengthened its position in the market for robotic surgeons thanks to acquisitions.

3. Philips

In 2018, sales Philips exceeded 18.12 billion euros, and R&D expenses - $2 billion, income per employee - $276,661. In 2017, the company was in fourth place in the list of the largest manufacturers of medical equipment, and a year later it rose by one position.

4. GE Healthcare

GE Healthcare moved from 5th to 4th in the ranking with annual revenue of $19.78 billion.

5. Fresenius

Sales Fresenius in 2018 amounted to $19.55 billion, R&D expenses - $158.3 million, income per employee - $173,566. Compared to 2017 the German , the company dropped two positions in the ranking.

6. Siemens Healthineers

Siemens Healthineers ended 2018 with a turnover of 13.43 billion euros and spent about $1.51 billion on R&D.

7. Cardinal Health

In 2018, Cardinal Health received $15.63 billion in revenue or 315,818, if you take it per employee.

8. Danaher

Danaher retained 8th place in the ranking of the largest manufacturers of medical equipment in 2018, earning $15.57 billion.

9. Stryker

Stryker climbed from 10th to 9th on the list, recording annual revenue of $13.6 billion or $377,778 per full-time employee.

10. EssilorLuxottica

EssilorLuxottica, with a turnover of 10.8 billion euros, is in 10th place in the rating.

Medtronic took 1st place in the top of the largest manufacturers of medical equipment

11. Abbott

Abbott became the 11th largest producer of medical equipment in 2018, up from 14th the year before. The company's revenue reached $11.4 billion.

12. Baxter

Baxter's revenue for the year was $11.13 billion, compared to $222,540 per employee.

13. Owens & Minor

Owens & Minor has a high annual revenue per employee of $578,748. Sales from the company in 2018 were equal to $9.84 billion.

14. Boston Scientific

Boston Scientific's revenue in 2018 is $9.82 billion, and its ratio to one employee is $306,969.

15. Henry Schein

Henry Schein dropped from 9th to 15th in the ranking, earning $9.4 billion or $522,222 per employee for the year. 2018 will be remembered by the company as the year it bought the manufacturer of equipment for caring for wounded North American Rescue and separated its $5 billion veterinary business.

16. Becton, Dickinson

Becton, Dickinson retained the 16th line of the rating with revenue at $8.62 billion.

17. B. Braun

B. Braun's revenue in 2018 reached $8.16 billion, and revenue per employee - $128,050.

18. Zimmer Biomet

Zimmer Biomet finished 2018 with sales of $7.93 billion and R&D expenses of $391.7 million.

19. Alcon

In 2019, Alcon registered revenue of $7.15 billion, which allowed the company to remain in 19th place in the list of the world's largest manufacturers of medical devices.

20. 3M

3M in 2018 had revenue exceeding $6 billion. The company remained on the 20th line of the list.^[8]

Five problems in the production of medical equipment

In January 2018, research firm Infiniti Research named five major challenges facing medical device manufacturers.

1. Product Quality Assurance

Medical device manufacturers must guarantee the high quality of the devices so that regulators release the products to market. Manufacturers know that recalling a device from sale negatively affects the reputation of the brand and the total profit of the company. Thus, ensuring the proper safety and reliability of the equipment provided is very important to maintain the company's competitiveness in the market.

2. Compliance state and support

Medical device manufacturers must ensure that safety standards and product compliance are met, including government standards that may differ from country to country. In addition, one of the main challenges for medical device manufacturers is obtaining government support in the form of research and development subsidies, rapid approval from regulators, tax and financial support, and the provision of tax incentives.

3. Localization of medical devices

Local manufacturers of medical devices are known to be more successful compared to international counterparts. Perhaps this is because local producers value a personalised approach that addresses local needs and considers local constraints.

4. Integration of network control systems with devices and data protection

Network device management, which is highly valued in the innovation market, is still a technical catch for manufacturers. The main problem is the collection, protection and management of a huge amount of confidential data stored on cloud servers.

5. Product Development Cost

As a result of the above problems, overcoming the growing cost of product development as a whole comes to the fore. In addition to meeting regulatory standards, health officials always estimate the price of a new device.^[9]

2017: Forecast from EvaluateMedTech for 2022

In October 2017, EvaluateMedTech made a forecast according to which in 2022 the global sales of medical equipment will amount to $522 billion with an average annual growth rate (CAGR) of 5.1%. By comparison, the CAGR for the global drug market is 5.2%.

Among manufacturers of medical equipment in 2022, according to the forecast, the US-Irish company Medtronic will remain the undisputed leader with a projected sales volume of $37.7 billion.

The largest market segment in 2022 will be diagnostic test equipment with sales of $70 billion. According to the forecast, Roche will remain the largest supplier in this segment with sales of $12.8 billion in 2022.

2016: Medtronic is the market leader

At the end of 2016, according to EvaluateMedTech, Medtronic became the largest medical tech company in the world with sales of almost $30 billion. Abbott, who absorbed St Jude, advanced to second, beating Johnson & Johnson.

2013: Top 10 leaders by sales volume

Thanks to health care reform in the United States, consumer priorities in health care began to change faster, and government pressure on manufacturers of medical equipment increased - now they are forced to prove that their products meet the requirements to contain or reduce costs.

Another factor limiting the entry of new medical and diagnostic equipment into the markets was the tightening of the procedure for obtaining insurance coverage in 2013. Not surprisingly, the reduction in insurance payments reduces the potential for companies to make a profit. In addition, the volume of new medical equipment approved by the FDA has decreased.

To increase sales amid the difficult economic situation in the United States and Europe, many companies are forced to resort to measures to reduce costs and optimize their operations. While the number of mergers/acquisitions has decreased across the industry as a whole, large manufacturers have continued to actively work with an eye to diversifying the product portfolio, investing for the long term and growing sales volumes that cannot be achieved with the existing range.

Some companies showed an increase in sales, despite all the restrictions. Thus, Covidien and Abbott allocated pharmaceutical divisions and focused on medical equipment and medical devices.

Data on sales volumes of companies in the top 10 relate exclusively to medical equipment. For conglomerates such as Siemens and Johnson & Johnson, the indicators of the divisions specializing in these products are separately displayed. As for General Electric, it reports on the indicators of the GE HealthCare division as a whole, and the data on medical equipment were calculated by experts.

</strong></p>

№	Company	Sales volume, billion dollars
№	Company	2013	2012
1.	Johnson & Johnson	28,5	27,4
2.	Siemens	17,9	17,7
3.	Medtronic	17,0	16,6
4.	Roche	11,3	11,0
5.	Covidien	10,2	9,9
6.	Abbott	9,9	9,6
7.	General Electric	9,8	9,8
8.	Philips Healthcare	9,4	9,6
9.	Stryker	9,0	8,7
10.	Boston Scientific	7,1	7,3

Source: EvaluateMedTech

Notes

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