Portable Ultrasound Practitioner Purchase Journey

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Portable Ultrasound Practitioner Purchase Journey: USA

The data on how licensed practitioners make purchase decisions in the portable ultrasound market, including sources of information and ways of learning about new devices, is not available. Email and professional networks are key ways in which healthcare providers learn about new devices online. The most trustworthy sources of information include peer-reviewed journals, white papers and case studies from manufacturers, and recommendations by key opinion leaders. There is no evidence that regulations are among the key factors for buying portable ultrasounds. It appears that hospitals and physicians make decisions based on performance and cost-effectiveness data due to flat or declining reimbursement rates.

Findings

Insights into the Portable Ultrasounds Market

  • There is no information on how licensed practitioners learn about new devices in the portable ultrasound market or on sources trusted for such device purchases specifically.
  • Several medical device providers and business media sites provide guides on how to choose an ultrasound machine. They include articles by Integra Medical Systems, Medical Expo, National Ultrasound, and Business News Daily.
  • There are also case studies of portable ultrasounds, including Sonosite by FujiFilm. Based on the data on the trustworthy sources of information for new medical device purchase decisions, it is likely that they are important for licensed practitioners looking to purchase a portable ultrasound device.
  • However, there is no data to confirm the above assumption.
  • In the absence of information specific to the portable ultrasound market, the research focused on providing additional insights into the medical device market.

Online Sources of Information on New Medical Devices

  • According to Penrod, a company that provides sales and marketing expertise in the healthcare industry, 50% of professionals who don't see sales representatives still take interest in digital promotions of medical devices.
  • Additionally, 80% of physicians use the Internet for professional reasons.
  • While email is the obvious choice for medical device companies to reach to licensed practitioners, it is quickly becoming overused.
  • Penrod believes that online professional networks are the places where practitioners may be the most responsive to information on new devices. They include WebMD MedSpace and LinkedIn.
  • Curtis Coulter also believes that regular social media networks are increasingly popular among healthcare practitioners. It cites research by QuantiaMD, according to which 60% of physicians think that social media improves the quality of care they provide and 24% use it daily for new medical information.
  • The company mentions that many medical device companies have already capitalized on this trend, including Medtronic, which successfully promotes itself on Facebook, YouTube, Twitter, and LinkedIn.

Trusted Information Sources

  • According to Evidera, hospitals and physicians have a system to evaluate new medical devices. They create value analysis teams (VATs) that include physicians, clinicians, and purchasing staff.
  • Those teams base their assessments on sources such as papers published in peer-reviewed journals. They are trustworthy because they provide an independent, evidence-based opinion.
  • Other sources include manufacturer's white papers, brochures, and evidence briefs, economic models that assess cost-effectiveness, and data collected through electronic medical records.
  • The Digital MedTech Survey found that physicians overwhelmingly prefer to learn about new medical devices through educational resources such as case studies.
  • Case studies are among the preferred types of educational materials. They can either serve as a source of information for physicians or for their patients. They typically include key data on the device, including "positive patient outcomes, reduce operational costs, increase productivity, lower readmission rates, increased quality of care, and staff and administrative efficiencies."
  • Additionally, Definitive Healthcare believes that medical device sales can be influenced by Key Opinion Leaders (KOLs). They are physicians that have experience and respect within the specific health network or in a particular discipline or market. If device manufacturers manage to connect with them, they can not only advise on the go-to-market strategy but also act as intermediaries between medical device companies and physicians.
  • One survey found that recommendations from KOLs are the top reason for choosing a medical device for 62% of healthcare providers.
  • While it was not a winning factor, other choices weren't connected to a particular source of information. 94% mentioned consistent outcomes, 93% - positive patient outcomes, and 88% - durability.

Regulations in the Market

  • As noted in the original research, in the US, medical devices are regulated by the Food and Drug Administration (FDA).
  • The device's class determines the regulatory pathway. According to FDA, "most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval."
  • Portable ultrasounds are considered Class II devices, which means that they require 510(k) clearance.
  • After analyzing the database of 510(k) premarket notifications, we concluded that most such devices are regulated by Part 892 (Radiology Devices) of Title 21 (Food and Drugs), Chapter I (FDA Department of Health and Human Services), Subchapter H (Medical Devices) of the Code of Federal Regulations, which was last revised in April 2020.
  • Specifically, portable ultrasound devices that have been approved recently, such as Butterfly IQ, Philips EPIQ, and FUJIFILM's Sonosite, have been regulated under section 892.1550 titled "Ultrasonic pulsed doppler imaging system."
  • Additionally, manufacturers of such products have to comply with all relevant regulations from Title 21 of the Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1000 through 1005.
  • However, it is unlikely that those regulations have a big impact on purchase decisions since "there are no federal radiation safety performance standards for diagnostic ultrasound."
  • At the same time, according to research by Evidera, the most important factor in new medical device purchases is a thorough analysis of existing data on the device's performance relative to price. It is influenced by declining or flat reimbursement rates.
  • The above issue also makes the purchase process more structured and makes hospitals and physicians collaborate closer on making purchase decisions.

Research Strategy

According to our research through healthcare, medical device, and business media, reports on ultrasound and portable ultrasound market, as well as white papers and blog articles by companies that offer such devices, the information on how licensed practitioners learn about new products in the portable ultrasound market, what sources they trust, and how they make purchases from this space is not available.

At the same time, while it is possible to find some relevant information on the medical device market in general, it is scarce and fragmented, which made it difficult to include a lot of statistics. Similarly as with portable ultrasounds, we searched industry reports, healthcar and medical device media, company white papers, and articles by medical device and marketing companies. After verifying the information provided in the original research, we found that some of the key quantitative data points are outdated and only relevant to a specific group (influencer physicians). Still, we collected all the relevant findings. When applicable, we made and explained assumptions relevant to the portable ultrasound market.

It is possible that the information is included in paid reports such as The Digital MedTech Survey.
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Portable Ultrasound Practitioner Purchase Journey: Germany

The European market for portable ultrasound machines (PUM) is expected to grow to reach $2.12 billion by 2024. Germany is a leading market within the EU for PUM and is a world leader in Medtech. The purchasing journey for PUM varies depending on the organization or individual purchasing it and for what purpose.

Learning About New Devices

  • COMPAMED and MEDICA are large trade fairs for medical suppliers and institutions. While individual practitioners are unlikely to attend these events, hospitals and large hospital groups are. In 2019, 121,000 trade visitors and more than 5,500 MEDICA exhibitors attended COMPAMED and MEDICA. In Germany, new devices for hospitals are often purchased through group purchasing organizations exterior to the hospitals, as well as through a centralized department within a hospital network.
  • Personal relationships between Medtech companies and individual buyers are essential and an often undervalued part of the buying process. This is particularly true for smaller clinics and individuals. Larger hospitals and university hospital networks form relationships with companies on a much larger scale, with one hospital often purchasing new devices on behalf of other hospitals in the network, nevertheless, forming professional relationships with suppliers is key in the purchasing of new equipment.
  • It is a legal requirement for medical practitioners in Germany to undertake continued professional development annually, with 70% of this in their specialized field. This ensures that practitioners are up-to-date with the latest research and technical developments, and with the prioritization of digital healthcare in Germany, this includes the latest Medtech. Individual practitioners and smaller clinics learn about new technology as part of this development, with practitioners in larger hospitals informing and influencing decision-makers from a clinical perspective.

Online Sources for Medical Practitioners

  • The German Medical Journal has over 800,000 visitors annually. It is a peer-reviewed journal that includes news from medical research and innovations in medical diagnostics and equipment. With respected sponsorship partners including Medtech companies and medical suppliers, the German Medical Journal is a well trusted online resource for medical practitioners.
  • The Deutsches Ärzteblatt is the most widely read medical journal in Germany, offering specific editions aimed at GP's, clinicians, and other working doctors. It is the official journal of the German Medical Association and the National Association of Statutory Health Insurance Physicians, and the only publication aimed directly at doctors in Germany. The journal covers a wide range of topics including the latest developments in medical devices, diagnostic, and research tools.
  • MedtecLive runs online and in-person conferences and trade shows for medical professionals in Germany. They have partnered with respected government bodies and companies including The Bavarian Ministry of Economic Affairs, Regional Development, and Energy. The events include lectures, seminars, and networking opportunities with leading professionals and companies. A recent event in Dusseldorf was attended by 123,000 visitors and more than 5000 exhibitors.
  • Medizinio is an online portal for medical practitioners to compare devices and gain advice on purchasing new devices. They have a section dedicated to ultrasound machines and provide offers and information on top brands within the industry.
  • The International Journal of Medical Device and Adjuvant Treatments publishes regular articles and papers about innovative devices and current research. The journal is peer-reviewed by experts in the field of study relating to each article, this ensures its credibility within the industry.
  • The World Health Organization (WHO) publishes reviews, articles, and journal entries often highlighting the latest developments and news within the health sector. As a global organization, the WHO has become a well respected and established online resource for medical news, regulations, and developments.

What Professionals Look For in Medical Devices

  • The German healthcare system is regarded as one of the best in the world, with a focus on innovation. More than 65% of German physicians see innovation as a priority in maintaining these high standards.
  • In Europe, all medical devices must have the CE marking, meaning they are certified for use in Europe, however, studies have shown many practitioners prefer products that have been evaluated and reviewed by other neutral bodies. Consumers look for GS and TUV marks to show that an electronic device has been safety tested. While these marks are not legally required they will be something practitioners are looking for.
  • As the third-largest market for medical devices in the world worth $37 billion, Germany imports fewer medical devices than other European countries with purchasers choosing devices manufactured in Germany instead.

Other Relevant Legislation

  • The context for this research in Germany is that there have been two legislative amendments put in place in recent years that highlight priorities within the medical profession. There is a focus on digital transformation with the introduction of The Special Care Contract in 2015 and the Digital Care Act (DVG) in 2019.
  • With the EU Medical Device Regulation coming into effect on May 26th, 2021 the regulatory requirements for medical devices will increase, causing practitioners to seek clarification on the compliance of new technology. Manufacturers with approved devices on the market have three years to demonstrate compliance with the new legislation.
In order to understand the purchasing journey for practitioners in Germany, we first had to understand the context. Using regional and national government sites, medical journals, and news reports we uncovered some interesting insights on the latest changes to legislation in Germany. We then attempted to find the required information through market research reports but these are paywalled. We used websites including the International Trade Administration and PR Newswire to understand the size of the market and current trends with the aim of gathering specific data related to medical devices. While some data was available, it was limited in scope and detail. We used medical journals, reports, and news sites to seek more detailed data but were unable to find this. We then widened our search to look at Europe as a whole but were not able to find specific data relating to the purchasing of portable ultrasound machines. It seems this information is not widely available. However, we expect that the information could be available from the paywalled reports we've linked to in this research. We have instead provided what information was available regarding the purchasing of new medical devices and the legislation related to this in Germany.
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Portable Ultrasound Practitioner Purchase Journey: Canada

As previously captured, Health Canada is the parent department in the Federal Canadian Government with the regulatory authority to control the purchase and sale of medical devices, including portable ultrasound devices in Canada. However, after exhaustive research, we could not find information regarding ways licensed practitioners learn, research, and purchase new medical devices specifically focused on portable ultrasounds.

Regulatory Framework /Government Requirements

  • As outlined in the earlier research findings, Canada demands compliance with ISO 13485:2003 from the manufacturers of Class II, III, and IV medical devices, including portable ultrasound devices.
  • Other sources are providing additional information regarding the regulatory framework for innovations and products in ultrasound technology.
  • Health Canada has the regulatory authority of ensuring access to safe and effective medical products by the Canadians.
  • The Food and Drugs Act (FDA) regulates imported and Canada-manufactured medical products, including medical devices sold in Canada.
  • Non-regulated health professionals in Canada can be involved in portable ultrasound devices, but they are not under provincial or federal law.
  • Canada’s non-regulated health professionals depend on professional associations such as Sonography Canada for regulation.
  • Health Canada’s Special Access Program approves the use of unlicensed medical devices in Canada.
  • Sonographers, the greatest users of ultrasound devices, are bound by the guidelines for professional ultrasound practice as advanced by the Society and College of Radiographers and British Medical Ultrasound Society.
  • The Canadian Association of Radiologists works with recognized experts and selected professional bodies to establish national standards and guidelines to promote safety, efficiency, and quality regarding ultrasound devices in healthcare.

Additional Helpful Findings

Research Strategy

To find information about portable ultrasound practitioner purchase journey in Canada, the research team consulted industry-related reports, government databases, professional bodies’ websites, and surveys. The research team focused primarily on finding information related to the consumer journey of registered medical practitioners such as sonographers, physicians, and radiologists when buying portable ultrasound devices. Regretfully, information specific to the different ways medical practitioners learn about the launch of new products was unavailable. Information obtained under this strategy either touched on some ultrasound devices or the regulatory framework for selling ultrasound devices in Canada.

Secondly, we tailored the research focus towards the launch and purchase of medical devices in Canada. We hoped to find pre-compiled information about the purchase of medical devices in Canada. The motive was to use the general information about the medical devices’ purchase journey and extract the details and statistics specific to portable ultrasound devices. Unluckily, the desired information was missing. The sources obtained under this strategy touched on guidelines for professional practice for medical practitioners.

Finally, we focused on what third-party parties outline as the purchasing journey for ultrasound devices in Canada. Under this strategy, we consulted new sites and databases like Forbes and Reuters. We anticipated finding information, statistics, charts, graphs, and tables on the purchase of portable ultrasound devices among the Canadian practitioners. Unfortunately, we could not find the desired information under this strategy.

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Portable Ultrasound Practitioner Purchase Journey: United Kingdom and Ireland

As previously outlined, the NHS is the primary distributor of medical equipment in the UK. However, several organizations like the British Medical Ultrasound Society, the Society of Radiographers, and the British Society of Echocardiography provide information specific to innovations, new product launches, and advancement in ultrasound technology. Unfortunately, we were not able to find any specific information related to the different ways, licensed practitioners learn, research, and purchase new portable ultrasounds.

Regulatory Framework

  • As outlined in the previous research, the NHS is the primary distributor of medical equipment in the UK.
  • However, there are other websites that provide information specific to innovations, new product launches, and advancement in ultrasound technology.
  • The British Medical Ultrasound Society is a non-profit organization that provides education and information regarding ultrasound to healthcare professionals in the UK.
  • The society was founded in 1969 and has over 1,000 members.
  • The Society of Radiographers is the primary "trade union and professional body for the diagnostic imaging and radiotherapy workforce in the UK."
  • The College of Radiographers is the charitable subsidiary of the Society. Its aims to support radiographers through education and research in the field.
  • The British Society of Echocardiography is a charity organization that represents and supports clinical echocardiography professionals through education and accreditation.
  • The organization holds an annual event that features multiple leading guest speakers in the field of echocardiography that discuss the latest advancements and newest products available on the market.
  • The British Society of Echocardiography has more than 4,000 members.
  • The Society for Vascular Technology aims to "advance non-invasive vascular diagnostic services by promoting training and research in vascular technology."
  • The organization posts quarterly newsletter to its members, featuring topical articles and updates on professional issues, and hosts joint study sessions with the Venous Forum and BMUS.

Other helpful findings

  • A medical device needs to conform to the requirements outlined in the UK MDR 2002.
  • The regulation states that any manufacturer that plans to sell a medical device in the UK needs to first verify that it is correctly classified.
  • The device must have passed a clinical evaluation procedure through an Approved Body that meets the requirements outlined in the UK MDR 2002 amendment.
  • Moreover, the manufacturer needs to notify the MHRA of any safety and performance investigations and register the device with the organization.
  • The UKCA mark is placed on devices as a way to indicate that they conform with the regulations outlined in the UK MDR 2002.
  • There were no additional requirements needed for ultrasound devices, according to the Society of Radiographers, as the only outlined requirements relate to quality assurance and imaging practices.

Research Strategy

Throughout our research, we focused primarily on finding information related to the consumer journey of registered medical practitioners when buying portable ultrasound devices by going through industry reports, government databases, and surveys. Unfortunately, information specific to the different ways medical practitioners learn about the launch of new products was unavailable. We also tried to see whether we could find any information related to the launch of medical devices but a majority of the sources did not specify any relevant statistics related specifically to medical practitioners. We did, however, find that there are several organizations, like The Society of Vascular Technology, the British Society of Echocardiography, and the British Medical Ultrasound Society, that provide training, certification, and regular news updates to its members related to new product developments and advancements in the field.

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Portable Ultrasound Practitioner Purchase Journey: France

This brief offers further information on the areas where the previous brief did not offer sufficient information. A comprehensive search showed that medical practitioners in France learn about new medical devices in the following ways:
1. Colleagues and online searches
2. Advertisements
3. Tradeshows

How medical professionals learn about new developments — general trends not specific to France

  • In terms of preference, a 2015 study sheds some valuable insight on how healthcare practitioners learn about new developments in medicine.
  • The study showed that online search ranks beneath ‘colleagues’ and ‘print medical journals’ when it comes to learning about new developments in medicine. The 2015 infographic study showed that 70 percent of medical professionals learned about new developments in medicine from their colleagues while 69 percent preferred print medical journals.

France

Online Search

  • Online search is one of the preferred methods by medical professionals in France to learn about, research, and purchase medical equipment including ultrasounds.
  • In France, the go-to website for medical professionals seeking to learn about new ultrasound devices [and purchase] seems to be europages — a B2B sourcing platform that connects healthcare facilities to various manufacturers of ultrasound devices across France.

Medical equipment tradeshows

Advertisements

  • Ads form part of the information platform from which medical professionals in France learn about new ultrasound innovations.
  • All ads must get prior authorization from the National Safety Agency of Medicines and Health Products. Medical equipment advertised in France fall into two main categories — reimbursable Medical Devices (MD) for which only classes I and IIa are advertised to the public. The other is the non-reimbursable MD.

Best practices

o Have a CE mark
o Have French-language directions (manual)
  • Ultrasound devices are regulated by Directive 93/42/EEC on medical devices (EU MDD). For the most part, the regulations seem to apply more on the part of manufacturers, distributors, and importers. These entities are required to comply with several annexes of the MDR and IVDR (Annex I, VIII, XIV, and Articles 13, 14, and 15)

Market distribution

The demand for ultrasound devices globally is as depicted below (both present and future projections).

Research strategy

  • Specific habits and trends on how medical practitioners in France learn about, research, and purchase new medical devices were not immediately identifiable using conventional search techniques.
  • Therefore, to develop insights on these trends, we triangulated information using several academic studies that investigated the learning habits of medical professionals. We limited the studies to less than six years old to capture the most recent trends.
  • We corroborated these study findings with real-life scenarios using case studies of medical practitioners from the U.S. The similarities were undeniable. We extrapolated these habits to the medical fraternity in general holding that similar trends are likely to characterize learning and purchase habits of French medical personnel of ultrasound devices.

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Portable Ultrasound Practitioner Purchase Journey: Australia

Further, details regarding the sources that medical practitioners are likely to consult when looking to buy medical devices, in particular, portable ultrasound devices are given below. The extensive research found one example of how a GP was able to make a business case for the purchase of additional portable ultrasound devices. Additional information about the market and the key players within that was also found some helpful findings are noted below in relation to that. Further information about the actual process practitioners follow or a breakdown giving information split by individuals, clinics and, institutions in Australia was not found. The main regulatory bodies and legislation are detailed below for the medical device industry.

How medical doctors and clinics learn about new medical devices in Australia

  • The Royal Australian College of General Practitioners (RACGP)produces a magazine called Good Practice. They ran an article which talks about GPs using portable ultrasound devices in the field to assess and treat patients. This type of article would prove useful to medical professionals considering purchasing a portable ultrasound device.
  • The RACGP also run workshops for GPs. One such workshop on their website, unfortunately, currently postponed due to the pandemic, is entitled Introduction to point-of-care ultrasound for rural GPs. The workshop aims to inform GPs how to use portable ultrasound equipment using five ultrasound workstation. The course is delivered by sonographers.
  • The Consumers health forum of Australia produces blog entries which, medical professionals may refer to for information about medical devices.
  • The TGA website has a list of its alerts involving medical devices and it indicates 14 items, ranging from thermometers to ventilators, that have been the subject of alerts to clinicians and consumers this year. This information would be relevant for medical practitioners considering purchasing new equipment.
  • Digitalhealth.gov.au produce blogs produce posts from healthcare subject matter experts, which would prove useful to licensed practitioners.
  • Australasian Society for Ultrasound in Medicine (ASUM) run workshops and events which may provide relevant information for those looking to keep their knowledge up to date with ultrasound developments with a view to purchasing equipment.

Process for licensed practitioners to purchase portable ultrasound devices

  • In the article in Good Practice referred to above a GP explains how useful she finds her backpack ultrasound and how she made a business case to the RFDS (Royal Flying Doctor Service) to purchase more. The article confirms that this was successful and more devices were purchased for the bases in Western Australia and another for the Rural Women's GP Program.

Medical devices/equipment market

  • Goldstein Market Intelligence analysts forecast the Australian medical device market size to be growing at a CAGR of 10% for the period of 2017-2030. The report notes that intelligent medical equipment is officially endorsed by many hospitals and medical institutions, and by consumers, both of which are adding confidence to the Australian medical device market
  • According to IBISWorld key buyers in Australia of medical equipment include General Practice Medical Services and Diagnostic Imaging Services.
  • A report entitled the Medical Device Industry in 2020-2021: Key Trends & Outlook notes that in Australia, medical and surgical equipment accounts for more than half the industry’s revenue.
  • Industry revenue is anticipated to increase by nearly 4% over the next five years to AUS$5.5 billion, despite the pandemic and weak demand from the country’s mining sector.
  • According to IBISWorld, medical practitioners and hospitals depend wholly on federal and state government funding to staff and equip clinics. The above report notes that Australia’s technological progression, however, is constrained by the likes of governments and public hospitals, as they are incentivized to keep a lid on capital expenditure.

Regulations

  • The main regulations relating to medical devices in Australia are the Australian Code of Good Wholesaling Practice for Medicines and the Therapeutic Goods Act 1989 administered by the Therapeutic Goods Administration (TGA).
  • Advertising is covered by the above as well — under the Therapeutic Goods Act 1989, it is prohibited and is an offense to advertise to any person a medical device that is not included on the ARTG, which is a register of therapeutic goods that can be lawfully supplied in Australia.
  • TGA's website gives details of studies and a record of goods on the above register — doctors and other medical professionals would likely need to refer to this to ensure that any product they were considering purchasing met the required standards.
  • Example of an entry on the register — Phillips Electronics Australia — handheld ultrasound equipment.
  • The TGA take a risk-based approach to regulation which depends on the purpose of the device; the risk it poses to the patient; the user, those within the vicinity of it when it is in use; whether the device is for internal or external use and the length of time it is used for.
  • The TGA operates a tender process and details of all open tenders can be found on their website.
  • The Australian Government Department for Health sets out guidelines for the use of ultrasound in obstetric conditions. These were last updated in 2007 and do not make specific reference to portable ultrasounds, although they are likely to be relevant to portable devices as well.

Research strategy

A review of government sites was undertaken to determine who was responsible for the regulation of the medical device industry and what the applicable legislation was. A review of blog sites and medical publications was undertaken to find more information about the purchasing process used by licensed practitioners and to determine relevant sources they would use. One example was found regarding the recommendation to purchase portable ultrasound equipment and this is noted above. However, more specific detail about the type of sites that practitioners would use was not found. The research did find sites which, were likely to be relevant to that type of search and details of these are provided. The IBISWorld report referred to above and in the previous research contains charts, which would likely be relevant to the research, however, the details of them are held behind a paywall. The Goldstein Market Intelligence report may also contain relevant charts or other statistics, however, they were also held behind a paywall.


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Portable Ultrasound Practitioner Purchase Journey: New Zealand

Licensed practitioners learn about new portable ultrasounds from conferences and manufacturer websites. The Ministry of Health and Medsafe are examples of sources that practitioners trust for new device purchases. Detailed information is below.

How Licensed Practitioners Learn About New Medical Devices

  • Manufacturer sites: Licensed practitioners learn about new medical devices, including portable ultrasounds, from device manufacturer sites. For example, Philips provides information on new ultrasound products and its portfolio, like the Philips Epiq Elite ultrasound.
  • Exhibitions and conferences: Licensed practitioners also learn about new ultrasounds from exhibitions and conferences, such as the Australasian Society for Ultrasound in Medicine conference held in October 2020.
  • Advertisements: Practitioners learn about new ultrasounds through ads. For example, manufacturers and companies use the Australasian Sonographers Association (ASA) publications to advertise ultrasounds to ASA's members, including nearly 7,000 ultrasound professionals.

Sources That Practitioners Trust for New Device Purchases

Medsafe

  • Practitioners trust Medsafe (the New Zealand Medicines and Medical Devices Safety Authority) for information on new device purchases in the portable ultrasound market. Medsafe conducts pre-marketing approval for all new devices, including ultrasounds. Practitioners trust Medsafe to tell them which devices have been approved for quality, safety, and efficacy before buying the products.
  • Medsafe also conducts post-marketing surveillance to monitor the safety of medical devices in use. Unsafe devices are removed, and prescribing practitioners are advised about new safety information for products.

Ministry of Health

  • Practitioners trust the Ministry of Health to provide them with information on new medical devices, including portable ultrasounds, that it has approved for marketing and use in New Zealand.
  • The Director-General of Health must approve any devices for the market.

The Health Navigator

  • Practitioners trust and use the Health Navigator website to assist them when considering buying portable ultrasounds as the site provides information for health providers on ultrasounds.
  • The website offers New Zealanders a single platform to find trustworthy and reliable health information and self-care resources.

MedTech Core

  • MedTech is another source trusted by practitioners for new ultrasound purchases. The site provides information for practitioners on ultrasound devices, including newly manufactured ultrasound devices and innovations like the Uri-Go.

The Medical Technology Association of New Zealand

  • The Medical Technology Association of New Zealand (MTANZ) is a national industry body that represents medical technology companies in the country. It produces the New Zealand MedTech in Action digital publication.
  • Practitioners trust MTANZ for new device purchases as the organization is a "leading medical exhibition management specialist for 30 years."
  • MTANZ has offered exhibition management services for various conferences, including the Australasian Society for Ultrasound Medicine. This experience makes it an excellent source for new ultrasound device purchases.

Regulatory/Government Requirements That Physicians and Clinics Look for

  • When considering buying portable ultrasound devices, physicians and clinics ensure that the device complies with the Medicines Act 1981, including ensuring that the device is safe to use. Physicians and clinics also ensure that the ultrasound devices they are considering buying follow the standard prescribed.
  • Physicians and clinics look for portable ultrasounds that conform to the listed description as required by the Medicines Regulations 1984. The Medicines Regulations 1984 was created by the Governor-General after consulting bodies and organizations representing those substantially affected and on the advice of the Minister of Health.
  • Some clinics and physicians consult the New Zealand Obstetric Ultrasound Guidelines when considering buying ultrasounds. The Guideline was created by a group of expert clinicians with help from the Ministry of Health and are used by health professionals like general practitioners, obstetric doctors, radiographers/sonographers, midwives, and radiologists. The Guideline provides "quality and detailed guidelines for maternity ultrasound, to ensure that diagnostic ultrasound usage in New Zealand is clinically appropriate and uniformly of high quality."

Research Strategy

Although we found three ways licensed practitioners learn about new medical devices in the portable ultrasound market, it was mostly generalized, and no information was found on how they differ for the individual, clinic, and institution practitioners. To find how they differ for individuals, clinics, and institution practitioners, we first looked for pre-compiled reports. This strategy was not successful. The second strategy was to search for the relevant information in medical journals, like the New Zealand Medical Journal, industry reports, and government sites like www.medsafe.govt.nz. This strategy was also unsuccessful.

We also didn't find any statistics for the percentage of purchases made through a source, why they use the source, and any charts, graphs, or tables. To locate this information, we consulted studies and surveys related to the subject. However, none was found. Finally, we searched through news sites and databases such as Forbes and Reuters and hoped to see reports with visual data for the same. However, we found no publications that provided the information required.

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Portable Ultrasound Practitioner Purchase Journey: Spain

There are no specific regulations regarding ultrasound equipment and no proven ranking for top sites where medical professionals visit during their ultrasound purchase journeys. The main body responsible for all technical and quality aspects of medical products in Spain, the Spanish Agency of Medicines and Medical Devices, has disclosed no specific regulations controlling the purchase of ultrasound equipment in Spain.


Purchase Journey Insights


Regulation Insights

  • Experts believe "Spain is far from meeting the Golden Rules standards regarding equipment renewal, and 1 out of every 3 ultrasound scanners is obsolete, with age exceeding 10 years."
  • The European regulatory framework (applicable in Spain) ensures the safety and effectiveness of medical devices.
  • Ultrasound devices from various manufacturers worldwide are welcome in Spain, provided they are approved by the European Union FDA. Spain follows the European Community Regulation 2017/745/EU on medical devices. This FDA authorizes portable ultrasound devices that are suitable for use in Spain.
  • The main body responsible for all technical and quality aspects of medical products in Spain, the Spanish Agency of Medicines and Medical Devices (AEMPS) disclosed no specific regulations controlling the purchase of ultrasound equipment in Spain.


Research Strategy

The research began with a thorough search through press releases, market reports, and market research summaries on Spain's portable ultrasound market from reputable platforms such as Mundo Circuja, Europa Press, and El Economista. This was done to identify the most popular e-commerce websites via top distributors of the equipment in the country. Unfortunately, the publicly available data from this had very little to reveal. However, a detailed analysis of the market with geographical distribution is available behind the paywall.

Prominent medical blogs were also analyzed to determine any popular sites where medical professionals sought portable ultrasound devices. Some articles pointed out top stores that sell ultrasound equipment, 10,235 in total. However, there were no charts or statistics ranking any of these sites, and several of these sites did not have e-commerce websites. Also, there was no differentiation among the medical professionals using the e-commerce tools. All the same, such comparisons were available for cleaning agents for portable ultrasound devices.

Next, the research team looked for articles on how medical professionals buy portable ultrasound equipment in Spain. The results addressed the recently approved ultrasound equipment discussing their uses, manufacturers, and a few features. There were no leads to top sites for these professionals or articles on these devices' purchase journeys.

The research was shifted to the Spanish Medicinal Products and Medical Devices Agency (Agencia Española de Medicamentos y Productos Sanitarios) (AEMPS). AEMPS was carefully searched to pinpoint specific regulations or restrictions on the purchase (and even use) of portable ultrasound equipment. Nonetheless, no such rules were found.

Spain also follows the European Community Regulation 2017/745/EU on medical devices. Therefore, these regulations were carefully combed but revealed no specific regulations on the sale or use of portable ultrasound devices in its jurisdictions. Moreover, the team tried to circumvent the setbacks by looking on government sites for penalties for misuse or illegal purchase of ultrasound equipment, which was equally futile. Therefore, it was concluded that there are no such regulations in place.

Alternatively, all the research steps were repeated in Spanish. While this produced more results, the amount of relevant data was the same. As another alternative, the research steps were repeated for ultrasound devices in general. Unfortunately, this step revealed no pertinent new data. Finally, it was decided that there are no specific regulations regarding ultrasound equipment and no proven ranking for top sites where medical professionals visit in their ultrasound purchase journeys.
Part
09
of nine
Part
09

Portable Ultrasound Practitioner Purchase Journey: Italy

To follow up on our previous research, we have provided additional ways through which medical doctors and professionals buy medical devices or equipment and what do they consider. To enhance their clinical practice careers, Italian professionals like radiologists depend on educational "videos on clinical topics," ePosters, white papers, YouTube, and online libraries to learn about ultrasound imaging devices. The most successful organizations currently marketing ultrasound devices in Italy (such as Esaote) are keying into these preferences. YouTube is the most effective user-engaging platform among professionals seeking to learn about new ultrasound devices in Italy.

How Medical Doctors and Professionals Learn about New Medical Devices/Equipment

  • Italian medical doctors and professionals like radiologists leverage educational "videos on clinical topics," ePosters, white papers, YouTube, and online libraries to educate themselves on new ultrasound imaging devices. The most successful companies marketing ultrasound devices in Italy (such as Esaote) are keying into these preferences and utilizing Youtube videos, "online ultrasound webinars," posters, clinical eBooks, and iOS/Android APPs to educate medical professionals about their new devices.
  • Medical doctors and professionals also leverage the website and other social media pages of manufacturing companies like their Facebook and Instagram pages to learn about new medical devices. One company keying into this preference is Esaote. The company provides general information about its "products, technologies and activities" to professionals through its ultrasound web page and related social media profiles.
  • Esaote's YouTube page has 1,380 subscribers. The company has more than 20 training videos used by professionals to learn about ultrasound devices. Collectively, these videos have over 200,000 views.
  • Medical professionals also use LinkedIn pages to learn about new devices. Esaote's LinkedIn profile has 28,890 followers. Most professionals following Esaote on LinkedIn also view pages belonging to other medical organizations such as Althea, ab medica spa, and GE Healthcare.
  • Esaote has 34 followers on Vimeo. It has 1,798 likes and 2,116 followers on Facebook.
  • A graphical representation of the resultant use of various online channels to learn about the solutions provided by one of Italy's top portable ultrasound providers (based on the number of subscribers and engagement or the number of content-related views) reveals that YouTube is the channel most utilized by professionals to learn about ultrasound devices.
  • The engagement statistics for various platforms belonging to Esaote is as follows:

How Clinics, Medical Doctors and Professionals Buy Medical Devices/Equipment

  • Public hospitals in Italy buy medical devices through public tenders. They leverage public tenders to research companies with products that qualify or meet their requirements. Interested companies willing to sell to these hospitals often submit adequate evidence that indicates their professional expertise and business experience before the hospital board makes a purchase decision.
  • Tenders related to public procurements are published on the website of the National Procurement Center (CONSIP). Through tenders, public hospitals purchase about 75% of medical devices (including diagnostic imaging devices) meant for the Italian market, while the remaining devices (25%) are marketed to the private sector.
  • One of the most successful companies marketing portable ultrasound devices in Italy, Esaote, recently sold 103 portable ultrasound scanners across four Italian regions.

What Professionals Look for When Buying Medical Devices/Equipment

  • The first thing professionals do to consider if they can purchase a new medical device is to find out if the device has a CE mark. Professionals then try to figure out if they can associate the new medical device with an established diagnosis or procedural DRG code before purchasing the device.
  • Professionals often check the National Formulary List (the NTPA or Nomenclature Tariffario delle Prestazioni Ambulatoriali). They also go through the NTPO (Nomenclatore Tariffario delle Prestazioni Ospedaliere) or the DRG in-patient list to verify if a new medical device is used for a listed hospital activity before purchasing a new device.
  • A graphical expression of the decision-making process associated with purchasing new devices in Italy is as follows.
  • The process professionals used to determine whether to buy a device for diagnosing illness among in-patients across Italy is here.
  • A diagrammatic representation of the process professionals used to decide whether to buy a medical device for diagnosing illness among out-patients across Italy is as follows:
  • Apart from the factors highlighted in our previous research, some vital details professionals consider when buying medical equipment or devices in Italy include the details of devices flagged by regulating bodies often referred to as purchase "decision[-]makers" or influencers. The regulating bodies whose regulations these professionals watch out for include the Ministry of Health/Direttorato Generale Farmaci e Dispositivi Medici (DGFDM, or General Directorate of Medicines and Medical Devices), Commisione Unica Dispositivi Medici (CUD, or Commission for Medical Devices), Agenzia Nazionale per i Servizi Sanitari Regionali (AGENAS, or National Agency for Regional Healthcare Services). These regulating bodies often highlight issues associated with the use of some medical devices.
  • Agenzia Nazionale per i Servizi Sanitari Regionali (AGENAS, or National Agency for Regional Healthcare Services) regulates the types of medical devices medical institutions can purchase to the cost-effectiveness of the services they provide to patients. The Ministry of Health/Direttorato Generale Farmaci e Dispositivi Medici (DGFDM, or General Directorate of Medicines and Medical Devices) develops policies to monitor the quality of purchased devices.
  • Medical professionals or institutions that are interested in reimbursement relative to the price of purchased medical devices lookup guidelines provided by the Agenzie Sanitarie Regionali (or Regional Health Agencies), Commissioni Regionali Dispositivi Medici, and the Commissione Prontuario Terapeutico Ospedaliero (CPTO, or Commission for the Hospital Therapeutic Handbook) for device-specific information and guidelines.

Research Strategy

The research brief has attempted to get information on how licensed practitioners (e.g., individual licensed practitioners, medical clinics, and institutions/hospitals) in Italy learn about, research, and purchase new (not used) medical devices specifically focused on portable ultrasounds. We reviewed market survey reports, comparative databases, and trade publications, among other resources. There is limited information regarding sources licensed practitioners use to learn about medical devices such as ultrasound in Italy. Most of the statistics associated with the uncovered details pertaining medical device purchase journey are company-specific and not industry-wide. We studied the most successful companies marketing medical devices in Italy (such as Esaote). We assumed that since they are the most successful sellers, they account for the most significant number of devices successfully advertised, learned about, and sold. The channels they are using may be the most successful channels used by professionals to learn about the investigated imaging devices.

This study assumes that hospitals and clinics in Italy utilize one (the same) sales channel controlled by a similar "group of distributors." In comparison, pharmacies and orthopedic shops leverage a sales channel different from hospitals and clinics. Consequently, sales channels used to market or learn about medical devices to Clinics in Italy are similar to those used to market the same devices to hospitals. The research considers ultrasound equipment as diagnostic imaging devices. There is limited availability of information on the online purchase journey of medical professionals in Italy relative to medical devices. We have utilized information extracted from various social media platforms of one of the most successful portable ultrasound device providers in Italy (Esaote). This information serves as a proxy to explain and graphically represent habits or happenings in the purchase journey of professionals looking for medical devices in Italy. The study concludes that YouTube is the most effective user-engaging platform (based on the amount of viewed content) among professionals learning about new ultrasound devices in Italy.
Sources
Sources

From Part 01
From Part 02
From Part 07