News

Comic Relief have funded the Open Voice Factory!

Screen Shot 2018-07-11 at 09.16.27

Comic Relief and Paul Hamlyn Foundation are funding thirteen organisations to receive funding from their Tech for Good stream. eQuality Time is one of them! We’re receiving £45,000 to develop the Open Voice Factory, along with lots of support and guidance.  We have so many people to thank, and a sudden big responsbility.  It’s going to be amazing.

This means that the Open Voice Factory is likely to be our major project for at least the next nine months. While we have many funding bids in for other projects, they  won’t ‘mature’ (or not) for quite a long time.  Expect quite a lot of OVF focus from here on it.

 

Open source Medical Device Registration

Several years ago, at the start of the Open Voice Factory project, it became clear that we’d need to register the Open Voice Factory, or some part of it, as a medical device. It was publicised to, in the words of the relevant european directive ‘mitigate handicap’, and so it needed to be registered. There is NO moral way around that.

It also became clear that there were almost NO other open source medical devices. Or at least, none that could be found. The only documentation was largely incomprehensible and everything was guarded. Nobody had put their technical file online, almost nobody wanted to say what their technical file contained.

I swore that by the end of the process I’d write the document I wanted at the start.

It will be a while before I can write that post, but I promise that I’ll put everything relevent here in the meantime.

Currently, that’s relatively little (well, it’s 6,000 words, but most of the good content is at the bottom). But I try and give you most of the information I have.

As a result of the Nesta Prize we had £10,000 in fees we could give to consultant to help us through this process. We wanted to do everything right, and so we got professionals in. I’ve reproduced the majority of the correspondence (or at least everything that might be useful to another project like ours) below. It’s all entirely focused on our situation and, as written below, nobody takes any responsibility for the advice within.

In the coming months I hope to be adding our technical file to this post, as well as doing updates to the correspondence, and some content from the people helping us make the technical file.

Resources

This is the letter we sent to the MRHA originally:  MRHA letter.

04/06/18 17:12:

Here’s were we are at the moment. We’ve consulted with a developer who has experience taking software through medical device registration and who already has some familiarity with our work.  Here’s the understanding we now have:

To register as a medical device you must produce a technical file. Part of that technical file is about the organisation itself – how do you decide what features to add, how do you assess risk and so on.  To show this, we need to have a set of policies that cover the developement of the device, and, we need to be able to show that we are following them.  So the process looks like this:

  • Write and approve policies
  • Wait (while writing the rest of the technical file)
  • Check that we’ve been following our own policies (with evidence)
  • Add the evidence to the technical file and submitt.

Our consulting developer has recommended the following five policies (based on his experience, this isn’t a standard set):

  • Development,
  • Document Management,
  • Risk Management,
  • Continuous Improvement
  • Post Market Surveillance

Now, the medical device rules say that you have to have a ‘state of the art’ process.  It appears that you can either prove your own process to be state of the art, or follow one of the International Standards, on the basis that it’s understand that these standards establish the state of the art.  The relevent standards here appear to be:

  • IEC 82304, 6
  • ICE 2304
  • ISO 14971
  • Possibly  ISO 13485

The standards aren’t publically availible, in fact they are expensive to purchase, which is one of the other barriers to Open Source Projects getting medical device status.    In any case they have statements like “There should be a throught process for X”, whereas the policies say “Our process for X is” so there should be some flexbility.

We’ve tracked the process of producing these policies in this github issue.

30/07/18 17:12:

Okay, the policies have been produced, we’ve been implementing them happily, and we’re now at the point of creating a technical file, which in summary is “The policies and the evidence that we are following them” but which actually contains a few more bits. Our ongoing issue for this is: https://github.com/eQualityTime/TheOpenVoiceFactory/issues/73

 

Communications

It started with:

Jul 11, 2016, 3:44 PM

The first of the emails

Hi Colin, 
Great to speak to you on the phone last week.  I’ve included some information. 
Here are two other software systems that do the same thing, but are paid for: https://thinksmartbox.com/product/the-grid-2/  and http://www.assistiveware.com/product/proloquo2go .  (There are a wide range of other manufacturers – but they produce the hardware as well as the software, so I suspect that would be difficult to untangle).
What’s the next step? 

 

Sep 20, 2016

(I had sent several follow ups)
Hi Joe
Sorry for the delay in getting back to you and thanks for the follow up. I’ve reached out to a member of our consulting team to get their feedback as to whether or not your technology is likely to be considered a medical device in the EU. I’ll be back in touch as soon as I have their feedback.
KR
Colin
followed by:

Hi Joe

I’ve just received the following feedback from our software consultant. I asked him if he thought your technology would be regulated as a device. He noted:

‘Possibly – from the MDD :  “compensation for a handicap” .  Neither of the 2 competitors below mention anything about regulation / consideration as a medical device !

From MEDDEV 2.1/6 – if the software only communicates data, then it is not covered by MDD.

There are 2 questions: is enabling speech is a medical benefit to the patient ?; does the device do more than communicate data ?

I think it would be worth asking MHRA’

If you could provide feedback on the two underlined questions we can consider further.

Kind regards

Colin

Thu, Sep 22, 2016, 3:12 PM

Interesting.  

Very much depends on the definitions.   So enabling speech doesn’t change anything from a medical point of view – (except in the sense that you can tell your doctor that you are feeling faint, or having stomach pains), it’s all about social interaction enpowerment and so on.  Obviously there is a knock on effect on mental health, but I’m assuming that isn’t what is being asked. 
For the second question: 
Depends what you mean by data – the device *could* track usage information and record data in that sense. but in real terms – NO really.  Certainly if there is a hardish or fastish rule then we could design around it… 
Does that make sense? 
For your interest – here’s a video of the tech in use… https://www.youtube.com/watch?v=CZQc1yGMYvM

Tue, Oct 4, 2016, 8:44 AM

Joe
Given the borderline nature of your technology I think we would recommend sending an email/letter to the MHRA to ask for their opinion on the classification. Just in case you don’t know the MHRA are the UK Competent Authority https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency/services-information
We can help draft the correspondence but its always better if it comes from the manufacturer. I’d estimate it would take no more than 4-5 hours work (at £150ph) to prepare the correspondence on your behalf if you’d like to proceed this way.
Kind regards
Colin

Tue, Oct 4, 2016, 11:31 AM

Let’s do it.  What’s the next thing you need from us?
J

Fri, Oct 7, 2016, 12:20 PM

Hi Joe
Here is the short proposal and agreement. If you’d like to proceed could I ask that you sign and return both?
Kind regards
Colin

Wed, Oct 12, 2016, 4:59 PM

Signed and attached 🙂 
J

Mon, Oct 17, 2016, 4:43 PM

(Some emails removed because I hadn’t filled out the form properly…)
Thanks Joe. Our project management team will be in touch shortly to introduce the consultant who will pick up the work.
Kind regards
Colin

Oct 18, 2016, 2:42 PM

Dear Mr. Reddington,

 I hope all is well. My name is Patrice and I am part of Emergo’s project management team coordinating your Device Classification project. I would like to thank you for entrusting Emergo with this project. My primary job function is to ensure that all project related work progresses successfully, so please feel free to contact me if you ever have any concerns regarding your account. Below I would like to discuss some project details with you. 

 

Scope
As per the proposal the scope is currently defined as follows:

Emergo provides support with device classification for AzuleJoe (5 budgeted hours). 

  1. E-Quality Time Limited wants to determine if the technology would be classified as a Medical Device under the Medical Device Directive (MDD).
  2. Emergo will prepare a document to be sent to the UK Competent Authority (MHRA) to ask for their determination of the classification.
  3. It is recommended that E-Quality Time Limited send the final document to MHRA as this, in our opinion, solicits a better response.

<some information removed as it pertains only to Emergo’s internal workings>

 

Wed, Oct 19, 2016, 9:19 PM

Hello Joe,

I have the links and information provided to Colin in September.

I assume I should prepare the MHRA enquiry from the perspective of AzuleJoe *not* being a medical device ?

Kind regards

Brian

Thu, Oct 20, 2016, 3:46 PM

Hi Brian,
That would be nice for us,  but the most important thing is that the decision is correctly made and gives some cover for any future developers doing the same thing.  🙂
J

Thu, Oct 20, 2016, 3:57 PM

Thanks Joe – I will reason the classification using the MHRA guidelines, so that the view we present is clear – and hopefully the MHRA will agree – but point out flaws if necessary.

Regards

Brian

Sun, Oct 23, 2016, 9:06 PM

Hi Joe,

I’ve worked through the MHRA guidance again – please see my discussion doc attached, and the MHRA guidance.

The key question is on the medical definition of what azuleJoe does for a user – if the phrase “Compensation for a handicap” is appropriate for enabling speech, then the device is considered a medical device !

Based on this assumption, it would be class I, which is a low regulatory burden.

Please review and comment ?  if a call would be a good idea, please suggest a time on Tuesday ?

Kind regards

Brian

Tue, Oct 25, 2016, 1:34 PM

Hi Brian, 
One minor thing – although most accesses will be by tablet-  the Open Voice Factory itself is a website.  
Any time good for a call in the afternoons.  My mobile is 07703683028. 
J

Fri, Oct 28, 2016, 9:29 AM

Dear Joe,

Please find attached the letter for the MHRA.

I suggest you could send to X  – who has responded to prior requests about software.

Kind regards,

Brian

(some hangling on the langage of the letter, the version I sent was this one: MRHA letter).

Mon, Nov 7, 2016, 1:25 PM

Hi Brian, 

Just wanted to check in on a few things while we wait for a reply from the MHRA, 
I’ve got some funders to report back to – and they are interested in timescales – I know this is a movable feast, but in your experience, could you tell me what a ‘fast’ and ‘slow’ timescale might look like? 
The other thing I wanted to give a small head’s up on – we’re an open project and thus need to make sure that we are communicating what we do widely, I’m assuming quoting emails from you guys  and so on is all fine – if there is any issue with that do let me know. 
Joe

Mon, Nov 7, 2016, 2:50 PM

Hi Joe,

Timescales on response from the MHRA should be in less than 4 weeks – but no knowing !

After that – if CE mark is required, it can be done fairly quickly – your technical team would do most of the work, but the technical file could be assembled in 2 or 3 months.

In terms of quoting – it might be best to check what you want to quote – we issue disclaimers that information provided is solely for the particular customer, and information for you may not be applicable to a wider audience.  In the regulatory space, it’s seldom a case of “one size fits all” !

Regards

Brian

(consider yourselves disclaimed)

Thu, Nov 10, 2016, 3:27 PM

Hi Brian,

It was in the contact of quoting email conversations when writing up the process of licensing ourselves as a medical device for our blog.  Does that make sense?
 J

Thu, Nov 10, 2016, 7:33 PM

Hi Joe,

Yes – and I think that would be fine if you acknowledge Emergo as the source.

Regards

Brian

(included only because you’re reading that very blog)

 

 

Thu, Feb 2, 2017, 1:21 PM

Hi Brian, 

MHRA have come back to us with:

“Dear Joe,

Firstly I must apologise for the lengthy delay in replying to your enquiry due to unforeseen staffing issues.

With regard to your letter we would tend to agree with your opinion that the product is likely to be a Class I medical device under Rule 12.

Regards.

Rob Higgins

What’s the next step? 

Thu, Feb 2, 2017, 1:40 PM

Hi Joe,

This is a typical MHRA response – they don’t give a strong opinion !  This is perhaps a borderline decision, and the only way to get a firm opinion would be through the courts.

The next step would be to build up a technical file, on the basis of which you can sign a declaration of conformity and apply the CE mark to the product.  

If you’d like Emergo’s assistance in this process, I can request a proposal be sent to you .

Kind regards

Brian

 

Thu, Feb 2, 2017, 1:48 PM

That’s interesting – when you say technical file – what would that look like?

J

Thu, Feb 2, 2017, 3:06 PM

Hi Joe,

A technical file is a summary of the product – how it works, and for a product like this will be about 20 documents, written to comply with 3 standards – risk management, software life cycle development and usability. A few of the documents address regulatory requirements.

Kind regards

Brian

Tue, Feb 7, 2017, 12:40 PM

Cool,  do you have an example laying around somewhere can we could use to get our heads in the right place for moving on? We also need to start talking about US regulation as well.

J

 

Wed, Feb 8, 2017, 9:16 AM

Hi Joe,

There is no “one size fits all” – but below is a typical list of documents you would expect to see in such a tech file:
User Requirement Specification
Software Development Plan
Risk Management Plan
Risk Analysis Report
Software Requirement Specification
Verification Test Plan and Specification
Verification Test Results
Validation Test Plan and Specification
Validation Test Results
Trace Matrix
Risk_Management_Report
Usability Engineering Plan
Release note
Labelling note
Essential Requirements Checklist
Declaration of Conformity
Technical File Table of Contents
Clinical Evaluation Report
Usability Engineering Report
Release Design Review

Kind regards
Brian

Wed, Feb 8, 2017, 12:19 PM

Cool. We’ll get started – what’s our next move in terms of the US?

J

Wed, Feb 8, 2017, 12:29 PM

Hi Joe,

We need to identify a predicate device – a similar device already in use in the USA – can you suggest one/more ?

With this info, I can check to advise what will be required.

Kind regards

Brian

Wed, Feb 8, 2017, 12:42 PM

Hi Brian.

The single most obvious example are  prologue2go (as an app)  (https://itunes.apple.com/gb/app/proloquo2go-symbol-based-aac/id308368164?mt=8) and CoughDrop (https://www.mycoughdrop.com) as a website. Sound good?
J

Thu, Feb 9, 2017, 11:59 AM

Hi Joe,

I’ve searched the FDA databases – and not found anything related to speech or speaking assistance. This leads me to assume that such a device would be 510k exempt or un classified – and the only way to confirm this would be to submit a 513g to the FDA which is a request to confirm classification, which is difficult here as we don’t have one !

Neither of the 2 you listed below show up !  so I suggest that we submit an RFD to the FDA http://www.fda.gov/RegulatoryInformation/Guidances/ucm126053.htm#IID

There are still some hours in this project, and I could draft and send such an RFD in an hour or so – let me know if I should proceed.

Kind regards

Brian

Thu, Feb 9, 2017, 12:29 PM

That would match our understanding.   Please do 🙂

J

Fri, Feb 10, 2017, 7:06 AM

Hi Joe,

Emergo colleagues advised that an RFD is for a combination device, and a better option would be an email – which I’ve sent off – see below…  we should get an answer in a few days…

Kind regards

Brian

—–

Dear sir/madam,

We are assisting a company (in the UK) that has developed a speech aid for those who are unable to speak. The device is software, running on a tablet or similar computing platform.

The user indicates what they want to say by selecting icons on a touch screen, then the software builds a phrase or sentence which is digitally generated and played through a loudspeaker for others to hear.

The device may be viewed here:  http://www.theopenvoicefactory.org/

The device is considered a medical device in some countries, and the company would like to know if this device is considered a medical device by the FDA, and if so, a classification for the device. We have searched the FDA classification database, under the Ear, Nose, Throat panel, but not found any suitable product code.

We would appreciate your assistance,

Kind regards,

Brian

 

Tue, Apr 25, 2017, 9:29 AM

I’ve removed a bit of haggling where I was asking for a summary that I could give to funders.  We ended up with this, which I’ve included as a fair summary.

Joe

Hi Joe,

 

Ok – my text can be as follows:

 

CE Marking

The MHRA have confirmed that the device can be classified as a Class I medical device. CE marking for a Class I medical device is a self-declaration, based on a technical file against which a declaration of conformity can be signed by the manufacturer.

FDA clearance

It is not clear whether the product requires clearance from the FDA. Accordingly, we have submitted an enquiry to the FDA seeking clarification. The standard FDA response has been that “this evaluation process may take 60 or more days”. Other than a request for an update, we are not able to advance the FDA clearance process at this stage.

If this text is sufficient, I can apply to a letterhead. It will need to go through a peer review process within Emergo, which may take a day or two.

Kind Regards

Brian

Mon, Jun 12, 2017, 3:22 PM

Hi Brian, 

I’ve been reviewing the project here and I wondered if you could help us out by answering a couple of questions? Some are for internal use, but most are so that we can answer questions that we are getting: 
  • What is the penalty (other than being sued if it goes wrong) for failing to register a device.
  • What happens when we change the code (as in, fix a bug or add a feature)? Do we have to re-register?
  • Does porting an app to a new piece of software need another registration process (i.e. do we have to do this seperately for iPhone and Android devices)?
  • Are there any examples of tech files anywhere?
  • Is there an open list of other devices that are registered as medical devices? How much information do companies/regulators have to publish on the topic?
Joe

Mon, Jun 12, 2017, 7:51 PM

Hi Joe,

See responses below…

Kind regards

<snip>

 

  • What is the penalty (other than being sued if it goes wrong) for failing to register a device. – I don’t know – would need to check with MHRA / lawyer
  • What happens when we change the code (as in, fix a bug or add a feature)? Do we have to re-register?  No – just sign a new DoC for major revisions
  • Does porting an app to a new piece of software need another registration process (i.e. do we have to do this seperately for iPhone and Android devices)?  – only if intended use or mode of operation changes. You can define the product as multi-platform
  • Are there any examples of tech files anywhere? Not sure – but there is a guidance – attached
  • Is there an open list of other devices that are registered as medical devices? How much information do companies/regulators have to publish on the topic?  Not much !  MHRA has a listing of class I devices, but there is no detail other than company name

<snip>

 

 

Fri, Jul 7, 2017, 10:38 AM

Good afternoon Joe,

I hope you are well.  I am emailing with a quick project update.

Brian last checked in with the FDA in May, but we have still not received a response.  They did indicate that it could take 60 days or more, but we are uncertain when or if they will reply.  How would you like to proceed?  Would you like us to send another reminder?  Please advise.

Project hours: 3.75 hours worked (1.25 hours remain).

Thank you!

Regards,

Patrice

Fri, Jul 7, 2017, 12:48 PM

HI Patrice,

Yes, please do 🙂
 J

Fri, Jan 19, 2:51 PM, 2018

Good afternoon Joe,

I hope all is well. I am emailing to inform you we did not receive any response to our follow up with both the Device Determination distribution group DeviceDetermination@fda.hhs.gov or DICE@fda.hhs.gov (only an automated response). We had also reached out internally to another colleague in the US (who suggested DICE) and she commented that it is unfortunate they did not respond and they have had more than enough time to do so. I have noted that this has also occurred in at least 2 other projects where we sent emails for feedback and I am not certain what the reason for their unresponsiveness may be.

At this time, I wanted to check in to see if you would like any further assistance under this proposal (161007-57210)? Or how would you like to proceed? There are still 1.25 hours remaining.

Thank you!

Regards,
Patrice

Tue, Jan 23, 2018 5:32 PM

To clarify – is that ‘of the three projects we have doing this, none have received a reply’ or ‘of the 30 projects we have doing this, three haven’t received one’ ?

Wed, Feb 14, 2018 11:24 AM

Good afternoon Joe,

I hope you are well.  My apologies for the delayed response.  We have not tracked this for all offices, so I meant in my experience we had this happen a few times (so probably more along the lines of 3/30 although this would be a guesstimate as I do not have numbers for informal FDA email inquiries sent by other offices/Project Managers).

However, as I mentioned, we still have a bit of consulting time left so we would be happy to continue to try to outreach to the FDA to try to push for a response.  Please let us know how you would like to proceed.

Mon, Feb 26, 8:31 PM

Please do.

One other thing: I have to provide a, I think, ‘tech file’ to the UK medical device people but I have NO idea where to start making one.  Do you have an examples or case studies laying around that might provide a starting point for us?
Joe

Tue, Feb 27, 1:18 PM

Good afternoon Joe,

Thank you for your reply.  I will let Brian know to try another outreach to the FDA.

Regarding your other inquiry, I will put you in touch with my colleague in Business Development, Mr. Rehema Mussanzi (in copy), who can assist with providing information on Technical Files and what Emergo can offer to support.

We also have a resource library on our website with some free information to get you started.  For example a white paper on Preparing a European CE Technical file for a Medical Device or a video on In-Depth: Europe CE Marking Medical Device Approval and Compliance with a brief segment on preparing a Technical File.

 

Wed, Feb 28, 6:13 PM

Awesome, will look forward to hearing form Rehema

Joe

Mon, Mar 5, 7:38 PM

Hello Joseph,

Thanks for requesting the whitepaper about European Tech Files. Please click this link to download (PDF):
Download

For additional information about Europe, check out our Library: www.emergogroup.com/resources/europe

Regards,
Rehema

 

Monday, 23 April 2018 3:56 PM

(first ever response from the FDA – sent to Emergo rather than eQuality Time)

Dear Brian Goemans,

Thank you for contacting the Division of Industry and Consumer Education (DICE) at FDA’s Center for Devices and Radiological Health (CDRH) DICE@fda.hhs.gov e-mail account.

If your product meets the definition of a medical device, it will be regulated as a device.

A medical device is defined in Section 201(h) of the Food, Drug & Cosmetic Act (FD&C Act; or 21 USC 321(h)) as “an instrument, apparatus, implement, machine, contrivance, implant, in-vitro reagent, or other similar or related article, including any component, part, or accessory, which is … intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals, or [which is] intended to affect the structure or any function of the body of man or other animals … .”

Other useful information on device determination can be found at the What is a medical device, Is The Product A Medical Device and the Device – Not a Device webpages.

For regulatory information about your medical device of interest, please search the Product Classification and Establishment Registration & Device Listing databases to check if a device similar to your product is listed with FDA.  I found a list of speech related devices on the Product Classificationdatabase. You can use this database to search for other products you plan to import into the U.S.

If you are still unable to determine whether your product is a medical device, please contact the Center for Devices and Radiological Health (CDRH) Device Determination Officers, Office of Compliance, via e-mail atDeviceDetermination@fda.hhs.gov for their determination. Within your email, please include a complete description of your product and its intended use, as well as any draft promotional material and labeling that you might already have.  Please note that they do not determine the classification of a device nor do they determine whether a premarket application is required.  The Office of Compliance will only provide their determination of whether or not your product is a medical device.

If you have more software specific questions I would recommend you email our software experts at digitalhealth@fda.hhs.gov.

Meanwhile, here is a list of digital health related references.

Meanwhile, I will provide you with information on how to market a medical device in the U.S.

Registration and Listing

To register with FDA, please review the Device Registration and ListingWho Must Register, List and Pay the Fee webpages and follow the instructions on How to Register and List. You should also review information on Entry Process and Importing into the U.S.

It is the responsibility of manufacturers to classify their medical devices.

Medical devices are classified based on intended use, risk and the level of control necessary to provide reasonable assurance of their safety and effectiveness. There are three regulatory classes of medical devices: Class I, Class II, or Class III. The regulatory class of a device type is defined in Section 513(a) of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 360c(a)). Review the information on Regulatory Controls to learn about the types of regulatory controls applicable to each class of medical device.

If you need help with classifying your device, you can submit a Request for Classification (513(g)). The 513(g) request fee is on the FY 2018 MDUFA User Fees list. If you wish to directly contact the Office of Device Evaluation, please refer to the CDRH online directory for the appropriate contact information.

If you qualify as a “small business,” you will be eligible for a reduced fee for some types of CDRH submissions that require a user fee. Please review theSmall Business Determination Program webpage, and the FY 2018 Medical Device User Fee Small Business Qualification and Certification guidance document for information regarding eligibility and the application process. A small business is defined as a business, including its affiliates, whose gross receipts and sales are less than $100 million for the most recent tax year.

If a device requires premarket application submission, the owner or operator should send to FDA the required premarket submission such as: Premarket Notification 510(k), Premarket Approval (PMA), Humanitarian Device Exemption (HDE) etc. Review How to Study and Market Your Device for information on premarket submissions. Note that most Class I devices and a few Class II devices are exempt from the premarket notification 510(k)requirements, subject to the limitations on exemptions. Please review theMedical Device Exemptions requirements.

Finally to legally market a medical device in the U.S., manufacturers must register their firms and list their devices with FDA. Manufacturers also have the opportunity to market devices, which do not require a premarket submission, for up to 30 days before they register and list with FDA.Registration is done annually. It is the responsibility of manufacturers to meet all FDA requirements before registering and listing. Importers too should register with FDA, but they do not have to list products. Importers must ensure that their foreign manufacturers or vendors have registered and listed with FDA. Foreign firms exporting devices to the U.S. should have a U.S. based agent. For more information on marketing a device in the U.S., please review the Overview of Device Regulation, and CDRH Learnwebpages.

The Annual Establishment Registration Fee for FY 2018 will is $4,624. See FY 2018 MDUFA User Fees.

Please note that not all medical devices legally marketed in the U.S. are considered FDA “approved.” The term FDA “approved device” specifically refers to Premarket Approval (PMA). PMA devices are usually Class III devices. Similarly, the term FDA “cleared device” specifically refers toPremarket Notification 510(k). 510(k) devices are usually Class II devices and a few Class I devices.. Manufacturers are not allowed use the terms “approved” or “cleared” to describe devices that have not successfully gone through the respective PMA and 510(k) submission processes. Devices not requiring premarket submission can be marketed if a registered manufacturer lists them with FDA. Manufactures can also market such devices up to 30 days prior to listing them with FDA.

 

Sincerely,

Division of Industry and Consumer Education
Office of Communication and Education

Center for Devices and Radiological Health

U.S. Food and Drug Administration

 

Wed, Apr 25, 10:58 AM

 

Hi Joe, 

It’s been a while – but at last there has been a response from the FDA !

Unfortunately the response has come from DICE – a response from Device Determination would have been more helpful !

However, referring to the definition below (linked from the email)

(h) The term “device” (except when used in paragraph (n) of this section and in sections 331(i), 343(f), 352(c), and 362(c) of this title) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is-

(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,

(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

(3) intended to affect the structure or any function of the body of man or other animals, and

I suggest that it would be reasonable to state that a speech aid does not fit in the definition of 1-3 above, so is not a medical device.

Please consider this email below, and provide feedback ?

The interpretation above is informal – Patrice is away this week, but when she is back next week, I will discuss the next step – in Emergo an internal peer review is required to provide a determination of your device being a medical device or not.

Kind regards

Brian

Thu, Apr 26, 10:56 AM

That’s somehow worse… I’d assumed they’d burned it, rather than this simply the length of their backlog.

Let’s see what Patrice thinks…
Joe

Fri, May 4, 2:39 PM

Hi Joe,

I hope all is well.  I have not had any other informal device classification inquiries (for other clients) since last year, so I am not certain if they are having a substantial backlog.  I can ask again internally with our US team if they have any recent feedback. I am also wondering if the FDA had just crossed it off their list (or forgot about it) until Brian sent a follow up.

I see that Brian has suggested that it would be reasonable to state that a speech aid does not fit in the definition of 1-3 below, so is not a medical device.  If you would like for Brian to research this further to make a formal (peer-reviewed) report and opinion, we could add around 4 hours to the project via a scope change.

Please let us know how you would like to proceed.

Best regards,

Patrice

 

Tue, May 8, 3:12 PM

Bit confused, is that:  “Brain can spend four hours writing a report for you” or “Brian can spend four hours writing a report and sending it to the FDA”?

Joe

Tue, May 8, 3:40 PM

Brian can write a report for you.  He can do a more in-depth research and provide a formal advice/standpoint (from Emergo’s point of view).

 

Tue, May 8, 3:46 PM

I understood we are paying you because you know this area already.  Why do you need four more hours to make a recommendation?

We put a lot of faith in you, on a project that is incredibly important to us, and it looks a lot like we have nothing to show for it.
Joe

Tue, May 8, 4:21 PM

Hi Joe,

We certainly understand your frustration as the FDA did not provide conclusive answers.  I can assure you that your business success is important to Emergo and we endeavor to support you however possible.

The initial proposal (161007-57210) was for Emergo to determine if the technology would be classified as a Medical Device under the MDD.  Emergo recommended preparing a document to be sent to the UK Competent Authority (MHRA) to ask for their determination of the classification.  We had up to 5 hours budgeted for this activity.  Brian provided this deliverable (classification letter for the MHRA) in October 2016 and MHRA feedback was discussed in Feb 2017.

After the initial deliverable was completed, you engaged Brian to assist with reviewing US regulations under the remaining budget.  Brian conducted a search of the FDA databases/reviewed competitors and, not finding anything related to speech or speaking assistance, determined the next logical step would be to submit an informal request for determination to the FDA.  Brian drafted and sent the initial email to FDA Device Determination along with numerous follow-ups last year, finally drawing a conclusion from the FDA feedback we received that it would be reasonable to state that a speech aid does not fit in the definition of 1-3 the FDA had listed, suggesting it may not be a medical device. Since there was limited budget from the initial ad hoc, Brian could not conduct a more in-depth review and instead supported as I’ve outlined here.

In order to provide an alternative approach to continuing to contact the FDA repeatedly (to no avail), we proposed a formal Emergo report.  We base our approach on the experience we gain across many projects, but we do bespoke research and write reports for each customer since we cannot and do not claim to have the same understanding as the regulators.  Therefore, we quoted the additional hours.  Typically for a regulatory research project (from scratch), we quote up to 20 hours, so the 5 hours we quoted here took into account that Brian was already familiar with your product and had been working on the MHRA and FDA requests.

We look forward to your feedback on how you would like to proceed.

Best regards,

Patrice

———

 

 

 

Real Flexible Work

In an team with real flexible work you would be able to shut your laptop at any time without any guilt.

There’s lots of reasons you might want to. Maybe you are sick. Maybe someone you care about is sick. Maybe you want to spend some time on your mental health and maybe someone has broken into your house and you need to ring the police. The reason isn’t important. What is important is that you know the system will be fine.

We know this is possible because Wikipedia works that way. So do the writing camps that we run in schools: sometimes students are sick, or suddenly expelled, or drop out. The system continues.

I want eQuality Time’s work to be real flexible work as far as it can.

To make that happen, we have to build it in from the start. Here’s what we need to be doing:

No hiding
Unless a file contains confidential info (in almost all cases this means ‘personal information about an individual), it is shared. All our files are in Dropbox or Google Drive. No exceptions.

Always act like someone else will be the next person to work on this
eQuality Time uses github issues to manage our work. On each issue we (try to) list all things we need, and the steps needed to meet the goal. If we’ve done that right, then someone else can come along and say “Oh, this is a funding application – I see they’ve created the folder in Dropbox and marked that off, and the next thing to do is to copy and paste the question information into a new word file – I can do that for them”. If we act like someone else will do that, then we get really good at writing specific plans.

No locking
We never write: “I’m going to do X” on an , because then the project needs you before it can move forward. Instead we write “The next thing to do is X”. That way someone else can do it when they have a free moment. You might have been looking forward to doing X, or you might worry that someone else would do X wrong – in which case you should either have done X or you should give so much detail about X that it’s hard to do wrong.

Rewrite a process every time you follow it
There are lots of activities that we do again and again. A good example is publishing books from White Water Writers. For these activities, we’ve put the list of steps and advice into a wiki so that people don’t have to work it out every time. The important bit is this: when you are working through a process on the wiki, you should also be rewriting it. This might be because you are dealing with a special case, or because there’s something you missunderstood at first and you want other people to be warned, or because you want to add photos or reword. You might be rewriting it because you want to do it a bit differently this time and that’s fine. We rewrite so that the next person to follow the process finds it easier, and also so because it keeps us honest.

We work on the most important action first
If we have real flexible work, then we have NO locking. Without locking, it’s impossible to know what you are going to work on before you log in. Someone might have logged in overnight and finished off the last project you were looking at or someone working on an important project might have fallen ill. So when we log on, we should look at the most important project first (they are sorted by importance).

By definition, working on the most important project is the most important thing to do.

The last person to work on it should have followed “Always assume someone else will be the next person to work on this” and there will be a written down action for you to take. If it’s something with a process (like publishing a book) then it’s easy for you to do the next action and move the project along. If there isn’t an action written, then it’s worth pinging Joe (or, in future, the person on call) and finding out what the action should be. Work on the second most important issue while you wait.

Bottom line
Of course, there are deadlines. This system only works if there is someone that you can pass the work onto. Or, someone who is senior enough to say “Okay, we can drop that ball”. At eQuality Time, both of those people, are, sooner or later, Joe. Sometimes he might make the call to abandon a project – because we put worker’s heath above projects. Sometimes he might do it himself. But there is somewhere that the buck stops.

The funding applications that made us a better charity (even when we didn’t get them)

Screen Shot 2018-04-20 at 16.12.29
People who manage funds that give money to social projects are, by definition, great people having to make hard choices about the best place to put money.
It’s also important that people who manage funds keep to the lowest possible overhead.  It takes money to keep applicants up to date and give feedback and we accept that it’s often the best choice to save money there.
Some funders do provide a lot of support when you apply to them, even without the money. And that support can really make your organisation better. If you are a new organisation, then these are the funders you should apply to early.
This post has two aims:
  • Give other organsiations some pointers on which grant funders will help their organsiation get off the ground fastest
  • Give me an oppertunity to review our funding bids and see if we should change strategys
Most of eQuality Time’s money comes from grants. This means we have to apply for a lot of grants. I’m going to list the applications we made in the last 12 months and talk about how much developement was involved.
I’ve also been making notes on how much time I spent on each application, so I’ll also talk about if I felt that the application was worth making compared to other funders with shorter processes.
I find short application forms followed by interviews are much more developing than a long application form.  They are also quicker and cheaper (for you, NOT for he funder), and much much more fun (for you, probably NOT for the funder).  An interview can be hard, but if you have trouble answering the questions it’s a sign you need to make your idea better; go home and make the changes to your idea so that the answers are easy. Some interviews are better than others – there is a difference between “I am assessing your project and making a recommendation to the final panel” and “I am working with you so that I can best sell your project to the final panel”,  if you get one of the second type you should take all the notes you can.
So, let’s look at the what I’ve been working on.

Children in Need

This year I’ve spent an hour and ten minutes updating an application to Children in Need before I found I needed to spend time elsewhere.  It’s in this list because a) I did spend some time on it and b) last time we applied, we found it very useful.  Going through the Children in Need application meant that our Child Protection processes, training and policies  got a serious bump. We’ve never had any funding from Children in Need, but they were good for us.  They also have an assessment interview, which is always excellent.
Will be applying again.

Comic Relief Tech for Good

First Application
The Comic Relief Tech for Good application was fun (make a video and fill out a simple form). It took 5 hours 16 minutes, was written by someone who understood what the sort of projects we produced, and, importantly was run by the sort of people who are really easy to reach and ask questions of.   It was a nice process to go through.
Shortlist
We got through to the shortlist,  and so were required to do a training day and two half day interviews (both of which could be done over Skype.  That’s a fair investment of time, but both worthwhile. Training days mean meeting other shortlisted projects, all of which were interesting, and the interviews made our organisation better (“Do you have a reserves policy?” “No, but we will send you one within a week”).  Comic Relief also had a technical person in the room for one of the interviews, which is something I think all funders should have: there’s less confusion, it’s easier to concentrate on the idea, and I suspect it is easier for Comic Relief to detect when applicants are talking rubbish.
We don’t know if we will be funded by Comic Relief, but certainly we’ll happily be applying to the same stream in the future.

Lloyds Bank Social Entrepreneur Start Up

Initial Application.
The first application form too the Lloyds Bank Social Entrepreneur Start Up  about 5 hours 20 minutes (not including other staff members who prepared files or reviewed), and now I look back over it I filled it out very casually.
Shortlist
After being shortlisted there was an interview with an funder who complained about a funder-related blog post I’d written. I remember being quite impressed that the assessor had taken the time to read our blog.  The interview that followed was thorough and made sure that we had ticked the right boxes. I recall that the project came out much as it had gone in, (we  weren’t given money) – I think that’s because it was a well-established project with a solid plan – had we gone with a different project it probably would have been really useful (although less likely to be funded).
Would recommend.

UNICEF Innovation Fund

Initial Application
The Initial Application took 8 hours 55 minutes (not including other staff members who prepared documents or reviewed).
Shortlist
We were one of eight or so projects shortlisted, the full application that followed took another 35 hours 3 minutes. (not including the excellent work of other people on the bid team) plus interviews held at very short notice.   We eventually found out that we didn’t get it by reading the press release congratulating the successful teams.  No feedback at any stage (the interview was of the ’same questions asked to every candidate’ variety).
Given the amount of time  (and in this case, social capital) taken for the bid, it wouldn’t really make economic sense for us to bid for against a similar structure again.  It also simply wasn’t fun.   It’s only in reviewing the last year of bids that I realise how many other bids we dropped to get this right.
Building a Stronger Britain Together
First Application
This was an interesting one: the first application was to the Home Office, took 4 hours and 17 minutes and it was near-impossible to find any help, or work out who to talk to with questions.  We stuck with it because it was the first funding we’d seen that really matched up with the purpose of the Supertitle Project
Shortlist
(Shortlist might be the wrong term, all bidders might have been shortlisted)
It turns out that the Home Office contracted another group to do the fund admin, and so shortly after the application was made I got a call on my mobile from a smart funding officer who had many relevent questions and had clearly read the bid in detail. She pushed me on some details of the research background that should have had evidence and let me spend some time correcting any absenses in the application.   Was actually very pleased with this stage.
We are yet to find out if we got the funding, but it’s been mostly positive so far.

Arts Council

Our consistent applications to the arts council are best read about in another post. In total I’ve spent exactly eight hours on rebids in the last year.   Once you get over the first round, the feedback you get is quite good – it focuses on the bid rather than the organisation (or at least, our feedback does).  I will also say that the Arts Council staff are very helpful when you ring them up.

Virgin’s #iwill Take Action Fund

We wrote a fair amount about the application process here.  It was a relatively simply application process that took up three and a half hours of my time, but lots more from volunteers and staff. Pleasant, but we’ve had no feedback and didn’t develop the organisation (which, as I wrote in the beginning, is totally fine)

Reducting Social Isolation Fund

This is here for completeness – I worked on it for two hours and one minute, then dropped it to work on the UNICEF bid above.

Henry Smith

I’ve got four hours and three minutes marked for the Henry Smith Charity.  My notes tell me that two other people worked on it, for about the same about of time.  The application form itself was relatively simple, but I recall there being something strange about the form – a heavily restricted Word document if I recall.   Henry Smith also requires application forms to be posted, which was a headache – I assume it helps them cut down on applications, but I also feel like there are better ways to do that. We got a form letter back telling us that we weren’t getting funding.   In hindsight – applying to a fund that requires application forms to be posted probably isn’t an ideal stratergy for a charity that designs very technology focused interventions…

Reviewers wanted for BATTLECRY

eQuality Time has a project we’ve been working on for some time.   It’s an artistic project and we’ve submitted to the arts council. We’ve been rejected.    Six times.

Each time we got back over the project, make big changes or little changes (there are two ways that the arts council can reject you, one has a wonderful amount of artistic feedback, and the other gives almost no feedback, we’ve had the feedback twice) and send it back, and each time we get rejected.

I truly believe that transparency is the silver bullet, so I wanted to share the application here in the hope that some kind passer-by might look over it and say something like “Oh, you need to make X clear, that’s what the Arts Council Like…”

The elevator pitch for the project looks like this:

The 2015 report: ‘Writing the Future: Black and Asian Writers and Publishers in the UK Market Place’ found that BAME authors were less likely to be published or have an agent and were pushed to have their characters match cultural stereotypes. The 2015 Diversity Baseline Survey Results found massive underprepresentation for disability at all levels in the publishing industry, At the same time, writers are more likely to been privately educated and older.

The results are novels far from the perspective of most UK readers, losing sales in an world that puts more and more value on ‘now’ and ‘real’.

Our project is the answer. Twenty of the best young British writers will team up create a topical novel that is relevant to the changes in life in 2016/2017. They will go from blank pages on Monday morning to a publication on Sunday night and show that the long-form novel remains a reflection of life rather than a memory of it.

eQuality Time will select these writers for their words and for their ability to speak to audiences that feel their voices aren’t heard in mainstream publishing. Audiences will be hit by the twin shock of characters that both like them and are reacting to events that they themselves are still processing.

This is a ‘time to write’ project, compensating two groups of ten professional- standard writers for the time over week-long periods to produce two full length literary works on topics in the ‘now’.  It is supported by industry figures whose testimonials are attached and our methodology and has been shown to produce spectacularly strong, heartfelt work with writers from primary school age to university students.

 

We know we can make this work – White Water Writers has been successful over 100 times and there are a dozen of those were university level writers.

Here are our files:

If you are passing, and you fancy a glance. Please get stuck in.

(If you are wondering why it’s called BATTLECRY – after the first four rejections I’ve started naming the projects alphabetically so I can tell which one is current in the arts council applications list)

 

Postscript

This application was submitted and later rejected, as was the one after it. The interested reader may find much to enjoy in the feedback we got here: export (and indeed, the feedback we had for our previous application, which actually scored better… export.1)

 

Research Snapshot: White Water Writers Novel Analysis

In the last post I talked about my (Joe’s) failing to get good results about the White Water Writers project.    By contrast, today I’m posting about the far far better science done by our team at Keele University.  Below is  the abstract that they have sent to the AERA conference recently.  Some bits that I’m particularly interested in:

  • “The process allows young people to explore issues through their novels, which creates an innovative methodology for exploring their views and understanding of topics.”   I’ve long been advocating that White Water Writers is an amazing way of unpicking complex social systems in a way that no focus group or survay could.
  • scientists were described as ‘mad’, ‘loopy’ and ‘dangerous’.  There was also a lot of discussion about how scientists had ruined the world, for example by turning people into robots and ruining the environment: ‘They thought the scientists could be totally unaware of the effects their experiments are having on the outside world’. ”  it is interesting to me that while we as as society spend a lot of time promoting STEM, we haven’t spent much time looking at the cultural picture of ‘scientist’ compared to, say, ‘programmer’.

Abstract

A novel way to explore young people’s views of science and scientists via their writing

Although there is a generally positive view of science, with 81% of people surveyed feeling that science will make people’s lives easier, only 55% think the benefits of science outweigh harmful effects (Public Attitudes to Science Survey, 2014).  Furthermore, young people often see scientists as ‘brainy’ and this can put them off science careers (ASPIRES, 2013).  Indeed it has been found that young people who do not view science and scientists positively may be dissuaded from pursuing a scientific career (Barma et al 1997).  However, much of this research has been explicit and asked young people to report their attitudes.  The current study explored attitudes more implicitly by exploring stories which had been written by young people.     

 

“White Water Writers” gives groups of young people the chance to collaboratively write and publish their own full length novel in a week.   The participants plan, write, proofread and develop their novel as a team. The book is placed for sale on Amazon and a few weeks later we host a book signing.  The project has demonstrable effects on literacy, soft skills and feelings of control.  The process allows young people to explore issues through their novels, which creates an innovative methodology for exploring their views and understanding of topics.   In this study we did not specifically invite writers to produce a book about scientists, but gave them a broad brief, namely that something strange was happening in their city and a group of young people had come together to solve the issue. 

In this study, sixty young people aged 15 wrote six novels based on this brief.  We thematically analysed the books and found a very strong theme of “elitism”.  Specifically, scientists were described as ‘mad’, ‘loopy’ and ‘dangerous’.  There was also a lot of discussion about how scientists had ruined the world, for example by turning people into robots and ruining the environment: “They thought the scientists could be totally unaware of the effects her experiments are having on the outside world”. 

Scientists and other authority figures were presented as being entitled “The way he spoke sounded like he was posh, Ava thought. Ava hated posh prats. They got away with everything. They didn’t earn a simple penny to their name.”  Scientists were also seen as unreachable “Lily tries to talk to the government about it in hopes of getting them to acknowledge the fact the loopy scientist was destroying lots of their things, their people, their crops, their animals. Strangely, the government brushed it off as if it were nothing.”

Thus experts such as scientists were seen as entitled, uncaring, arrogant and dangerous. They were also disconnected from the world around them and, for the young people in the stories, unreachable.  This negative perception of science and authority might explain why many young people do not aspire to these sorts of careers.  However, this also suggests novel ways of encouraging young people, by changing perceptions of scientists rather than focussing on perceptions of science.

 

 

 

Counting ‘good’ edits, failing at science, and sneaky writers

The books we make with White Water Writers help the writers get better at writing and feel better at life.

I’ve always believed that part of this was the time spent on checking the work – two whole days at the end of the week is nothing but checking.

Or so I thought…

We’ve been gathering information to create a research paper on White Water Writers. The ‘feel’ bit is mostly done – the writers answer questions at the start and end of the book about how they feel, and the school gives us year-long results later on.

Working out the changes in ‘writing’ is much harder. Nobody can turn a poem or book into a (helpful) number.

I did think that we could look at our younger writers and see how much of a change ‘checking’ caused. Some or our writers are 11 years old, and so they make the sort of errors that a computer can see: like writing “He will goes to the shop”.

I’ve been working on this for a couple of days and have to say that my idea of using the computer to do this has run into the sand. I’ve written code that looks at each book at different points in it’s history and takes a note of unknown spelling and if a word is in present tense when it should be in the past.

I’ve come up short – I’ve got lots of numbers, and I could tell you about the ones that were really good, but I like to think we do real science here and the truth is that this method doesn’t show the changes that we see in our writers.

It looks like we can show the changes, but only by going through each page and marking them by hand.

There is some good news. The work I did for this has also been added to IMPS, the software that runs our writing camps, and our camp leaders will be able to use it soon to notice if one writer is writing in a different tense than the others.

Back to the “two whole days at the end of the week is nothing but checking.” part.  While I was writing the code, I also noticed that the books were growing a lot more than they should during the ‘checking’ part of the week. It looks like some of our writers are trying hard to add more words rather than polish the ones they already have. I understand why they do this (and it means they really do want a good book), but we need to guide them to make the best possible book, not the longest. I’ll be looking at the best way to sell our young writers on that in the coming weeks.

(the young writers seem to manage this even when I’m at a camp in person, and working with them all myself – I’m kind of proud that one group snuck 8000 words past me while I thought they were checking their work over on paper)

eQuality Time is offically a registered Charity!

“Dear Contact

You have applied to register the above organisation as a charity.

We are satisfied that EQUALITY TIME LTD is a charity and it has been entered onto the Register of Charities with the Registered Charity Number 1177233.”

Yes, we have finally found time to offically register as a charity!

The process involved jumping through a few hoops – changing our objectives as an organisation (the CC thought that they could be more charitable) and filling out some forms.  We’re now offically a charity, rather than a social enterprise with charitable aims. This has a few advantages:

  • It’s much easier to say what we are; “a social enterprise with charitable aims” doesn’t roll of the tongue
  • We are much less likely to have to pay corporation tax
  • A number of funding streams open up to us that were closed before.

eQuality Time’s Trustees did a lot of work making this happen, and I’m very proud of them.

Open Source Medical Devices

The Open Voice Factory is an Open Source Medical Device, so when I saw a video called “Are We Ready for Open Source Medical Devices?” from Hackaday, I was interested. Althought Ashwin is much more hardware-focused than we are, but it’s worth watching the whole video, and my main highlights were:

  • Ashwin gives a nod to the difficulty in registering medical devices “More than the topic of a PhD” – I’d aggree with that, registering a medical device has been by far the hardest part of bringing Open Voice Factory to people.   It was interesting to me that Ashwin starts by saying he’s going to avoid talking about it, and then is forced by the topic to keep aluding to it right through the talk. I particularly liked (paraphrased) “The countries we want to work in don’t have standards anyway”
  • “about 90% of the world’s investment in medical research benefits only the most affluent 10% of its population” – that’s pretty awful.
  • There are *cheap* medical devices, but it’s hard to trust them – poor documentation and ‘questionable compliance’.   This was a reminder for me – I tend to think about Open Source being ‘cheap’ (because it’s free) and standing in contrast to expensive but much more well supported commerical solutions.  That’s true, but it’s incomplete – there are also ‘bottom of the market’ manufacturers that are also ‘cheap’ but also low quality.
  • “If it’s NOT easy to deploy, it’s NOT relevent”

Cover story

The books of White Water Writers have some amazing covers. Here’s two of my favourites.

Screen Shot 2018-02-18 at 18.39.27 Screen Shot 2018-02-18 at 18.39.06

These were make by artists from the same schools as the writers. I love getting great art because yet another student will see their work be part of something really real.

Like the writers, the artists work best when they know what to do and when to do it. Here’s what we ask of our artists and the writers working with them):

1. A deadline is a deadline. The words will be finished by end of the working day Friday, so the cover should be as well. No exceptions. Good cover artists talk to the writers on Monday, show a draft by Wednesday, and are handing over the cover on Friday morning. Great cover artists are handing in on Thursday (because we can get Amazon to check the cover over Thursday night to see if there is a problem).

2. Writers don’t do covers. If you have time to do a cover, you aren’t doing your job as a writer.

3. Artists don’t get to ask for changes to the book. Writers don’t get to ask for changes to the cover (unless something is factually wrong with it)
4. It’s 2019, covers are handed over digitally or not at all.

5. Cover artists can expect the book title by Thursday morning and the blurb by Thursday afternoon.

6. You may have heard that good artists steal. This is a lie. Even if it was true, good artists certainly don’t nick images from Google. If you are using a copyright-free image, you have to declare it, and that is the only type of image you can use (other than your own).

7. If you would like to start from a word template, it’s worth altering this one using your own images:  Walking Through The Ashes, and we also have Photoshop and pages templates available.

8. Laying out a book cover is hard. And printing is less precise that you think. It turns out that there are a hundred little rules about covers. We regularly have to make small changes between you handing a cover over and the printing starting.  If you give us all the original sources and easily editable files (Word, Photoshop) then it’s easy to make small changes. If you give us unchangable ‘final’ files (jpeg, ect) then it’s more likely we have to scrap it entirely.  Make it easy for us.

In general, we like giving another student the change to do something real and cool and get their work published. However, unlike the writers, we don’t have any clever techniques to get the best out of a cover artist, for this reason we only recommend using artists from year 11 and above (ideally 6th form), even if the writers are much younger.