Retail colossus Amazon is expanding into the market for selling dental and medical devices but some existing dealers in the UK have patient safety concerns, reports Adrian O'Dowd.
At a time when retail giant Amazon seems to be on an unstoppable expansion into many markets, it could also be about to enter the world of dental and medical products/devices in the UK.
Any such development has been met with a stoic response from the companies who currently supply devices to the UK's dental market and some are worried it will not be too long before unsafe and unregulated devices make their way into dental practices potentially leading to unintended patient harm.
The development of Amazon moving into this market has already attracted controversy in the USA.
Amazon Business was launched in 2015 in the US and in April 2017 in the UK as a marketplace for business customers offering business-only pricing and selection, analytics tools and free, rapid shipping on qualifying orders. People working in various industries including healthcare, such as dentists, can sign up for a free account to access products.
It is estimated that Amazon Business is now catering to more than one million customers in the US and has more than 85,000 business sellers.
Impact on the US market
In late 2017, shares in dental supply distributors fell after an analyst at US investment banking company Morgan Stanley said that Amazon was buying supplies directly from oral goods manufacturer Dentsply Sirona.
Both distributors Henry Schein and Patterson Cos saw their shares value fall as a result of the comments but a story1 from CNBC quoted a Henry Schein spokesperson at the time saying: 'We are unaware of any market-leading dental manufacturer that has a direct relationship with Amazon.
'We believe that at this time Amazon is a minor player in the dental consumables markets, with an insignificant market penetration.'
Amazon was also quoted at the time, saying: 'We don't comment on individual relationships, but Amazon Business customers have a choice of products from numerous dental suppliers and manufacturers.'
Nevertheless, the comments made at the time by Morgan Stanley were closely followed by a more than 4% drop in the value of shares on the stock market for both distributor companies.
A news report2 published last year by Dental Products Report (produced by Modern Dental Network), said that at that point, more than 40,000 results were currently listed for professional dental supplies on Amazon Business from companies like 3M, Hu-Friedy, Premier Dental, Dentsply, DenMat and Sunstar GUM. These covered a wide range of products including fluoride gel, xylitol mints, scalers and curettes.
The Dental Products Report article quoted Chris Holt, global healthcare leader at Amazon, as saying: 'Amazon Business was started because we heard from business customers that they love the convenience of shopping online and want an experience at work that is similar to how they shop at home.
'With the launch of Amazon Business back in 2015, we delivered an expanded marketplace that brings the selection, convenience and value of Amazon to business customers, manufacturers and sellers with new features and unique benefits tailored to the needs of businesses.
'Dental practices have access to a multi-seller marketplace where products from professional dental products to supplies needed for the office, breakroom or patient waiting area are available.'
The retail giant has made assurances that it values the importance of safety when medical supplies including dental products are sold, so dental professionals keen on buying supplies from Amazon Business have to add their license to their Amazon Business account and be verified in order to be eligible to purchase items.
“It could mean that unsafe and unregulated medical devices are making their way into dental practices in the UK. It wouldn't surprise us to see a case of patient harm as a result of the use of an unregulated device bought online in the next 12 months. Paul Adams, Managing Director of Dental Directory”
Dentists overseas appear to be taking to this new way of buying their dental supplies as a survey carried out by CNBC in December 2017 found that 34% of physicians said they were using Amazon to purchase medical and dental supplies even though not all device manufacturers were authorising Amazon to distribute products.
UK market now on the cards?
Whether a similar pattern is likely to follow in the UK is uncertain, but there is a profitable market here.
Dental Directory, one of the largest full service dental dealers in the UK, supplying around 12,000 dental practices with everything from toothbrushes to specialist medical equipment, is watching the situation closely and has concerns.
Asked about Amazon's enthusiasm to grow its sales of dental and medical supplies in the UK through Amazon Business, Paul Adams, Managing Director of Dental Directory says: 'Yes, they've made no secret of their ambition to diversify into different categories and dentistry is one of those, but by no means the only one.'
So far, he has not seen any direct impact in the UK, and adds: 'We only operate in the UK and it's a different market with a different regulatory regime to the US.
'We're focused on fulfilling our customer requirements in the UK and offer a level of service, before someone buys a product and after, that can't be replicated by any online only market place. That gives us an opportunity to demonstrate the value a dental wholesaler adds to the buying journey for our customers, if anything.
'When you buy online from a supplier whose business model is focused only on the transaction, there's no opportunity for people to be involved who have knowledge of the product and can reassure buyers or help them understand how a device is going to benefit their business. There's no relationship and that's what our customers value and what makes us different.'
Patrick Allen, Managing Director of Henry Schein Dental UK - large dental specialist laboratory supplier that has been in the business for 86 years - agrees and told the BDJ that he was confident that the company's customers valued the expertise of a company such as itself over online-only sellers.
Allen says: 'The UK has always been a competitive market, and we continue to believe that our high-touch, full-service value proposition - which provides world-class supply chain systems, e-commerce ordering capabilities, practice management software, digital technology and equipment, and an extensive array of services - will stand the test of time because it serves the unique needs of our customers.
'Our customers are not the average consumer. They are healthcare professionals who are often operating small businesses. These professionals rely on Henry Schein's knowledgeable network of field sales consultants for solutions to improve clinical outcomes for patients and operational success for their practice.
'Our knowledge, expertise, and personal relationships provide the specialised information, education, and consultation they need to operate a successful practice and provide quality care, for practices of all sizes.
'We deliver high-quality products, solutions, and support at price levels that we believe fairly reflect the value we provide. We do not believe online-only distributors can provide the value-added services and solutions that we offer and which healthcare professionals need.'
When asked if the company had noticed a growth in Amazon selling dental and medical supplies in the UK, Allen says: 'We've seen no impact thus far in the UK.'
Eye of the regulators
There is a regulatory and safety dimension to sales of devices involved in the potential of Amazon expanding into this market.
A spokesperson for The British Dental Industry Association (BDIA) - the UK's national trade association that represents and supports the collective interests of manufacturers and suppliers of dental products, services and technologies - says it is unable to say much specifically regarding Amazon.
'Whilst we are aware of Amazon's involvement in the dental industry in the United States it is not the Association's role to comment on specific commercial matters,' says the spokesperson.
'Our approach to the supply of dental products by Amazon would be the same as to the supply of such products by any other company. That is to say that such suppliers need to ensure that they meet all of the relevant regulatory requirements, such as those set out by the EU Medical Device Directive and the more recently introduced EU Medical Device Regulation.
'We work closely with MHRA [Medicines and Healthcare products Regulatory Agency] as part of our CSIDI [Counterfeit and Substandard Instruments and Devices Initiative] campaign3 to ensure that all dental devices, regardless of origin, meet these requirements and to promote purchasing from compliant sources.
'In addition, all BDIA member companies agree to adhere to our comprehensive industry Code of Practice, which has been developed to ensure that the highest standards of self-discipline are enshrined in the conduct of Members of the Association.'
“We do not believe online-only distributors can provide the value-added services and solutions that we offer and which healthcare professionals need. Patrick Allen, Managing Director of Henry Schein Dental UK”
Dental Directory's Paul Adams says he is confident that the current dental product and device suppliers are a trusted resource, arguing: 'The dental wholesaler proposition is superior to an online transaction in every way. We work closely with manufacturers to ensure the products we supply meet regulatory requirements and we're regulated and responsible for what we supply.
'Online only sites provide a route to market for sellers and manufacturers without any of the responsibility for the safety or adherence to regulations that dental wholesalers provide. We're also able to supply an order in one delivery by packaging up a number of products so avoid the multiple deliveries and lead times associated with buying through a market place with different sellers fulfilling different elements of an order.'
Nevertheless, he is concerned about what could happen if the likes of Amazon were to become dominant in this market.
'What impact could it have on the current supply situation of dental equipment and supplies? It could mean that unsafe and unregulated medical devices are making their way into dental practices in the UK.
'There is a reason medical wholesalers are regulated by the MHRA, it's to provide reassurance for customers that what they are buying is safe, reassurance for patients that medical devices used in their mouths are safe and reassurance for the insurers that patients won't come to harm in the dental chair. It wouldn't surprise us to see a case of patient harm as a result of the use of an unregulated device bought online in the next 12 months.'
Regulator the MHRA says it is aware of the potential problems but is confident that monitoring systems should protect patients.
A MHRA spokesperson told the BDJ: 'The MHRA is aware medical devices are sold via Amazon, and other online marketplaces, to a variety of customers, dental practices included.
'All medical devices placed on the UK market must meet the performance and safety requirements set out in EU legislation. Devices that have demonstrated conformity and have been legitimately CE marked can be marketed freely across the EU.
'There are no 'point of sale' restrictions specifically controlling the sale of devices online; devices sold via the internet must be compliant in the same way as those sold via other means.'
However, the spokesperson said the MHRA was aware that the quality, safety and performance of medical devices sold via online marketplaces could vary, adding: 'Some are perfectly legitimate, others can be non-compliant and or counterfeit. The internet generally is an easy platform for manufactures to sell directly to the consumer.
'Where the MHRA becomes aware of a non-complaint/counterfeit medical device for sale via a UK online marketplace, we will liaise with the company concerned in a bid to bring them into compliance with the legislation. When cooperation is not forthcoming, we will remove device listings. Outside of Europe, we endeavour to have product listings taken down where possible.'
The MHRA said it had a long-standing relationship with the BDIA and both organisations had worked together over the years to raise awareness of the risks posed by purchasing non-complaint/counterfeit dental devices available over the internet.
There was even a page on the MHRA's website with top tips for buying medicines and medical devices online safely (https://www.gov.uk/government/news/know-what-youre-buying).
Steps to boost safety further are also in the pipeline as the MHRA said that from May 2020, the new Medical Device Regulation 2017.745 would be implemented, placing an increased expectation on market surveillance authorities (such as MHRA in the UK) to scrutinise the activities of fulfilment houses, meaning businesses that stored, packed and delivered products sold by overseas traders like Amazon.
'New powers will be introduced enabling market surveillance authorities to investigate all manner of businesses active within the medical device supply chain,' he said.
Dental Directory's Paul Adams is still sceptical, saying: 'If you buy online from an unregulated supplier or middle man that has no responsibility for the quality of the device being sold, we're creating an opportunity for unscrupulous manufacturers to make money by supplying fake branded devices.
'It's already happened with clothing and handbags, it's naïve to think it won't happen with dental devices and the consequences could be devastating for patient and dentist.'
However, he adds: 'We've seen evidence that the MHRA is aware of the issue and is taking decisive action where there is evidence of substandard devices that could have an impact on patient safety.'
Amazon was asked to comment on the various issues raised and a spokesperson told the BDJ: 'Unfortunately we don't comment on our future plans and I am unable to provide any comment in response to your other questions.'
Franck T. CNBC. Shares of dental suppliers drop on potential new threat from Amazon. CNBC. 2017. Available at https://www.cnbc.com/2017/12/06/amazon-to-disrupt-the-dentist-next-dental-supplier-stocks-drop-on-new-threat.html (accessed February 2019).
Mott K. How Amazon Business is shaking up the dental industry. Dental Product Report 2018. Available at http://www.dentalproductsreport.com/dental/article/how-amazon-business-shaking-dental-industry?page=0,1 (accessed February 2019).
British Dental Industry Association. Counterfeit and Substandard Instruments and Devices Initiative. Available at https://www.bdia.org.uk/what-we-do/csidi (accessed February 2019).
European Union. EU Medical Device Directive (93/42/EEC). 1993. Available at https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31993L0042 (accessed February 2019).
European Union. Medical Devices Regulation (EU 2017/745). 2017. Available at https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745 (accessed February 2019).
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Dental device market prepared for Amazon growth amid safety fears. Br Dent J 226, 309–312 (2019). https://doi.org/10.1038/s41415-019-0047-7