Media and Technology

New MHRA guidance: designing medical devices that lower chances of human error
18 October, 2017

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance on taking human factors and usability engineering into account when designing medical devices. Take, for example, devices that automatically administer drugs: the way that these machines are designed may increase or decrease the likelihood of delayed delivery of medication or overdose as a result of human use. The interactions between person and machine are known as “human factors”.

The guidance is helpful for both manufacturers and notified bodies. It applies to the design of future products and changes in user interfaces of existing products.

The guidance refers to the essential requirements under the three existing EU Medical Device Directives (which have been incorporated into UK legislation) and the guidance specifically states that it will be equally useful in supporting demonstration of compliance with the new EU Medical Device Regulation (applying from May 2020) and In Vitro Diagnostic Device Regulation (applying from May 2022). The USA Food and Drug Administration already has extensive information and guidance on human factors related to medical devices and this new MHRA guidance is intended to be consistent with the FDA guidance.

The guidance clarifies and focuses on two things:

  1. That usability engineering is an iterative process, involving design, testing and validation of design stages. This extends to after the product is on the market because it may become apparent that, on using the device in clinical practice, the design requires further improvement.
  2. Ways in which human factors can be applied to medical devices, so that they are designed and optimised for use by intended users, in the environment in which they are likely to be used, for safe and effective performance.

Click here to access the MHRA’s guidance in full.


Bell Pottinger – what went wrong?
12 October, 2017

The recent Bell Pottinger public relations scandal is a cautionary tale of how professional risk and reputation can be overridden by the interests and objectives of clients. In the absence of proper safeguards and reporting it really highlights how an ill-judged campaign managed by a few individuals can jeopardise the reputation and ultimately bring down one of the UK’s most well-known public relations firms.

Bell Pottinger’s UK operations entered administration on 12 September 2017 following revelations that rocked the PR world and led to their ejection from the Public Relations and Communications Association (PRCA) in early September on the basis that it had “brought the PR and communications industry into disrepute”.

60 staff were immediately made redundant, leaving around 100 staff in the business in the UK, with tax bills of up to £1m and debts totalling a reported £6m. Bell Pottinger’s Asian subsidiary, Bell Pottinger Middle East, was the subject of a management buyout (and re-brand to ‘Klareco Communications’) around a week after its parent went into administration, and both founder members of the business, Lord Timothy Bell and Piers Pottinger, have now resigned.

Bell Pottinger’s collapse was triggered by the release of a report on 4 September by Herbert Smith Freehills LLP, who was commissioned to conduct an independent review into Bell Pottinger’s account with Oakbay Investments Pty Limited (controlled by the wealthy Gupta family). The report found that the Oakbay campaign run by Bell Pottinger in South Africa “was potentially racially divisive and/or potentially offensive and was created in breach of relevant ethical principles”.  Oakbay has widely been accused of exerting undue influence over South African President Jacob Zuma.

BDO, the administrators appointed, have shored up the UK business by taking steps to prevent staff from taking business away with them and preserving rights against those individuals responsible for the failure of the business. Work for existing clients will continue during the administration, though much of its client base, including a number of high-profile clients such as St James’s Place, Carillion and HSBC, departed in the wake of the release of the Herbert Smith Freehills report.

Action taken by Bell Pottinger executives came too late when it left the Oakbay account in April, and subsequently fired one partner and suspended another, as well as 2 other employees in July as a result of the campaign.

Bell Pottinger was no stranger to controversy, having acted for the Pentagon following the US invasion of Iraq in 2003 (being paid at least $540m over 4 years), Oscar Pistorius, the former Chilean President Augusto Pinochet and Alexander Lukashenko. The Oakbay scandal was a step too far, however, and illustrates the fine line to be trodden between lucrative and high profile accounts, and PR disgrace.

For many in the industry, the cause of Bell Pottinger’s demise was who it chose to represent. Lord Bell’s justification for such ‘challenging’ clients was, interestingly, that everyone had the right to the best PR representation they could afford – not dissimilar to the stance taken by the legal and accounting professions.  The difference here, perhaps, is that PR work is less tightly regulated than the legal or accountancy professions, and so the internal safeguards and processes around risk management that exist in those sectors are not as well-established in the PR industry.

Ultimately, the management of Bell Pottinger did not really know what its account managers and employees were doing, and the Oakbay campaign took an ill-judged path without proper oversight or consideration of the wider implications for the firm (a key factor highlighted by both the Herbert Smith Freehills report and the PRCA).

If you are interested in advice on reputation management and brand protection please contact Joanna Ford at joanna.ford@cripps.co.uk.


Surge pricing, it’s older than you think, but not without risks
6 October, 2017

Surge in the spotlight

“Surge” or “variable” pricing is once 

again in the spotlight – also known as “dynamic pricing”, “demand pricing” “time-based pricing” or sometimes “personalised pricing”.  Recent BBC reports have highlighted supermarket trials in which different prices are applied at different times of day. Less transparently, some e-retailers are using data to tailor prices to customer’s buying habits or assumed wealth. Although many will associate variable pricing with Uber, the use of technology to customise pricing has been around for a long time. Mac users were directed to more expensive hotel rooms than their PC counterparts in 2012, and Coca Cola tested a vending machine that charged more in hot weather in 1999.

The risks and benefits

Businesses wanting to vary prices for consumers will however need to be aware of the different legislation regulating this area, including potential discrimination issues and breaches of consumer protection law (business to business contracts are not as heavily regulated, although you would still need to be wary of potential competition concerns). The Office of Fair Trading (now superseded by the Competition and Markets Authority) consulted on the issues back in 2013. Since then, the ability and willingness of retailers to collect and use information about customers to inform pricing has only grown and new data protection laws coming into force in May next year will also bring new compliance challenges. Dynamic pricing has also moved into bricks and mortar retail where, responding to pressures from new market entrants (discount retailers in particular), the big supermarkets are investing in digital shelf labels which enable prices to fluctuate much more quickly than regular price labels. Purported benefits include the ability to change 10 million prices within 24 seconds, cut food waste and bring greater price accuracy.

Discounts not price-hikes?

The media focus on variable pricing illustrates that it can prove unpopular, particularly when businesses are not transparent about pricing policies, and even more so where pricing is based on assumed wealth or other personal characteristics. Promises about price equivalence with competitors could also be difficult to maintain if prices are fluctuating in this way. Targeted discounts (rather than potential increased prices) are a more popular way of personalising prices. Overall, retailers still need to tread carefully and consider all the angles in order to benefit from this growing trend.

For more information on data protection and consumer law issues, please contact Elliot Fry at elliot.fry@cripps.co.uk or on +44 (0)1732 224 034

For updates from us and the latest Tech news follow us on Twitter @CrippsTechLaw


ICO fundraising… IPO fundraising… What’s the difference?
22 September, 2017

What is ICO fundraising, and what sets it apart from IPO fundraising?

Most people are now familiar with the term IPO (initial public offering) (not to be confused with “Intellectual Property Office”), where a company transfers from private to public status and investors gain shares in the ownership of the company as part of the process, however, many are unfamiliar with its cryptocurrency counterpart – an ICO.

So what is an ICO?

ICO is the abbreviated term for “Initial Coin Offering” (not to be confused with “Information Commissioner’s Office”) a new unregulated fundraising phenomenon that appears to offer a transparent and speedier way to fundraise than traditional methods (such as share issues or loans) through the use of digital currency. ICOs have rapidly gathered momentum in 2017, more than 90 have taken place already this year.

How do they work?

Typically, an ICO involves selling digital currency via platforms, such as “Ethereum”, often referred to as “tokens” or “coins” to investors as a way for a company to raise money to fund future business development. Each “coin” or “token” contains rights, for example: the right to vote on business decisions or the right to receive a share of future earnings. Ultimately, if the digital currency purchased gains in value, in the same way that shares do in the public market, the investor will realise a profit.

What are the downsides?

There are risks however, mainly from the high potential for fraud, legal ambiguities and the lack of formal documentation provided at the time of investment.

From a legal perspective, the official status of an ICO is currently undefined and hence ICOs in most jurisdictions (including the UK) are not yet regulated. The benefit of this is that they can often be completed quickly, without paper and the red tape associated with other fundraising routes. However, the risks associated with ICOs mean that they are very much on the horizon of financial regulators in many jurisdictions. In the UK, for example, The Financial Conduct Authority (FCA) has issued a warning, labelling the offerings as “very high-risk speculative investments.”

What next?

Overall, ICOs seems to be a revolutionary fundraising method, likely to change the fundraising landscape beyond recognition. Undoubtedly regulations applicable to such offerings will tighten over coming months and years, however, if the regulations imposed are flexible enough to accommodate and encourage growth of this innovative concept, is it possible that ICO-generated digital currency will become the stocks and shares of tomorrow?

For more information on fundraising, please contact Laura Wilson at laura.wilson@cripps.co.uk or on +44 (0)1892 506 047

For updates from us and the latest Tech news follow us on Twitter @CrippsTechLaw


Product Designers – Listen Up!
21 September, 2017

The way designers can register and protect their products is changing from 1 October 2017.

What happens now?

Owners mark their product with the registered design number and the word “registered” (or an abbreviation). If someone creates a product with the same or a similar design but is able to prove that at the time they did not know the design was registered, they may avoid paying damages for making an infringing product (although the owner may still be able to obtain an injunction to stop the infringer and claim an account of profits from them). By applying a the registered design number and “registered” wording on the product, owners can prevent infringers from arguing they weren’t aware of registration, and so open up the possibility of claiming damages.

From 1 October 2017

Owners will be able to mark their product with an internet link which the public can access (free of charge) which links directly with a list of clear and current information about which registered designs and associated registered numbers apply to the product. Note that the owner’s website home page will not be sufficient unless the product information happens to be on the home page.

What are the benefits?

For the owners – potentially reduced burden/costs associated with marking products and increased chance of successfully claiming damages in infringement proceedings.

For the public – easier access to current information in respect of each design and reduced risk of inadvertently copying a registered design.

For more information on registered designs, please contact Harry Partridge at harry.partridge@cripps.co.uk or on +44 (0)1732 224 092

For updates from us and the latest Tech news follow us on Twitter @CrippsTechLaw


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