Providing a World Class Inflammatory Bowel Disease Service with Fraser Cummings at University Hospital Southampton – Notes on the Gastroenterology Training Day (20/9/17)

National Standards:

  • Crohn’s and Colitis UK

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  • IBD standards 2013 update:

http://s3-eu-west-1.amazonaws.com/files.crohnsandcolitis.org.uk/Publications/PPR/ibd_standards_13.pdfht

  • NICE – Feb 2015:

https://www.nice.org.uk/guidance/qs81/resources/inflammatory-bowel-disease-pdf-2098903535557

These are the 4 NICE standards:

  1. People with suspected IBD should be seen within 4 weeks.
  2. The services should be age-appropriate and supported by a multidisciplinary team.
  3. People having surgery for inflammatory bowel disease have it undertaken by
    a colorectal surgeon who is a core member of the inflammatory bowel disease multidisciplinary
    team.
  4. People receiving drug treatment for inflammatory bowel disease are monitored for
    adverse effects.

What is required to run a great service?

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The commonly forgotten elements include – managerial, clerical support, Surgical, pharmacy, nutrition, pathology and psychological support. All of these and gastroenterology, IBD nurses, endoscopy access, radiology and much more are needed to set up a world-class service.

Where is the data?

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Data is King! You need the data in order to get the money, and actually push forward your service.

We need to capture this to inform the patient, drive research, perform audit and benchmarking, plan the service and drive things forward at a national level.

At present we have:

  • Hospital episode statistics
  • NHS statistics
  • IBD clinical teams
  • Data from IBD patients

98 trusts are currently connected to the registry. 60 are connected to NHS digital.

This all feeds into NHS digital where it is pseudonymised. It is then passed to the IBD registry where it can be analyzed and deployed.

At present there are the following available platforms which patients can use:

  • Patient view – this has come out of the renal patient view
  • Patients Know Best
  • IBD BioResource
  • Improve Care Now – Paediatric IBD system

These above systems should hopefully help us to monitor the patients better in future.

Pharmacy:

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The specialist pharmacist’s role is to monitor for changes in the liver function tests and other blood tests.

This will help to mitigate possible delays and cancellations.

They are heavily involved in the approval/funding process. NICE approval is subject to a 90 day implementation period. This is locally commissioned and agreed. After 90 days access is granted. Occasionally NHS England will commission the drugs to be given at specialist centers.

If people don’t meet the criteria then sometimes they require an individual funding request. Eventually, however, the ‘individuals’ become a group. At that time a group agreement is required.

Commissioning pharmacists are really important people when it comes to improving the service.

The pharmacy also keeps accurate records of who is on what biologic agent.

Drugs are classified as either:

  1. Blue – Primary care only,
  2. Green – Primary and Secondary.
  3. Yellow – specialist initiated/recommended but suitable for continuation in primary care (e.g mesalazine). In these situations there may be a shared care agreement in place.)
  4. Red – is for specialist use only (ie. Biologics).

Local shared care agreements are all listed in the West Hampshire CCG website. They exist for azathioprine, mercaptopurine, methotrexate, sulfasalazine, lubiprostone, and prucalopride.

Homecare is another part of an IBD pharmacists role. Home-delivered medications (such as Humira) attract a no VAT tariff so there is an incentive to do this.

Nutrition

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The following criteria constitute malnutrition:

  1. BMI <18.5kg/m2 or
  2. Weight loss > 10% (indefinite of time) or > 5% in 3 months combined with either low BMI (age dependent) or low fat-free mass.

A lot of patients with IBD who are malnourished are actually BMI either normal or obese.

Nutritional deficiencies are common.

Micronutrient deficiencies are also common: magnesium and zinc, vitamin A&E, selenium and all the other common deficiencies are present in up to 30% of patients. (Vidarsdrottir et al.)

The dieticians spend some time discussing this all with the patients. A lot of patients have strictures and diet can help in preventing obstruction. Then addressing the malnutrition and maintaining the nutritional status, identifying food ‘triggers’, correcting deficiencies, reduce stomal losses (preventing dehydration), dietary treatment – liquid diets, and re-educating people about nutrition all form part of the IBD dieticians role.

Radiology

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Roles of imaging

Diagnosis is for:

  • Defining disease extent
  • Assessing disease activity
  • Extraluminal Manifestations

Often the first suggestion of IBD can be seen on CT scans.

Available Techniques with their respective pros and cons:

Fluoroscopy for the small bowel, enterography, and enteroclysis (enterography is oral and enteroclysis is via an NG tube). The barium bolus dives deep. Fistulograms and Loopograms are other options.

Fistulograms and Loopograms are other fluoroscopic techniques.

Pros: provides good luminal information at a relatively low dose.

Cons: No transmural or extraluminal assessment. The methylcellulose makes the patients feel sick. Plus, availability is limited.

CT – With or without IV or Oral contrast.

Can be enterography or often enteroclysis as well.

Pros: High spatial resolution and extra information, sensitive and reproducible.

Cons: Radiation, IBD patients are young. Not dynamic, lower contrast resolution (particularly without contrast).

MRI – Again can be with or without IV or Oral contrast.

Tends to be enterography.

Pros: Excellent contrast resolution. Different sequences, better neural detail. Reproducible. Dynamic.

Cons: Time consuming, access. (There are 5 or 6 at Southampton, but even despite this each study takes at least 30 minutes). Oral contrast is poorly tolerated. Reduced spatial resolution.

USS 

Pros: No radiation. V.high spacial resolution. Doesn’t rely on dilatation.

Cons: Operator dependent, Less reproducible, Patient dependent (obese, scarred abdomens are difficult to scan.) The propensity for missing complications – abscesses and perforations.

Ustekinumab

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A new biologic which has recently entered the IBD scene.

Most of the trials in IBD are now endoscopy based. Endoscopy + CDAI or Mayo score will be used to assess response.

If they respond then they stay on this arm of the study. If they don’t they either switch arm they go onto the open-labeled maintenance part of the study.

Lots of patients are excluded from trials because of comorbidities, a long disease duration, difficulties in treating them and fallibilities in the clinical scoring systems.

Ustekinumab is an antibody to IL-12 and IL-23. 3 trials: UNITI 1 and 2 + IM-UNITI.

UNITI 1 was for those who had failed on anti-TNF therapy.

UNITI 2 was for those who were TNF naive.

CRP’s and calprotectin’s are also improved.

Relapse studies were also done showing that those no placebo over a year are at a significantly higher risk of relapse.

The drug loading dosing should be weight based. It is administered in a similar fashion to adalimumab but there is a loading dose. Standard dosing is 12 weekly.

There are a lot of known potential side effects, as such, it is not advised as first-line biologic therapy. It is licensed for Crohn’s but not UC at present.

IBD in Pregnancy

The aim is for a:

1) Healthy Mother:

  • Pre-Conception education,
  • Control of IBD:
  • drugs,
  • Effect of IBD on pregnancy,
  • Effect of pregnancy on IBD,
  • Mode of delivery (think about long-term continence in some patients).

2) Healthy Baby:

  • Drug exposure,
  • Mode of delivery,
  • The effect of IBD on the baby.

This area causes significant anxiety.

Many patients consider voluntary childlessness, half worry that they might not be fertile, two-thirds worry about passing the disease on to their children. This is not often discussed in clinic.

Regarding the drugs used in pregnancy: See the ECCO guidelines summarised below:

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Ideally, patients should be in remission 3-6 months before they conceive. The chances of having a stable pregnancy are then much higher. The converse is also true so getting patients into remission early before conception is of paramount importance.

Treating depression can help IBD patients get pregnant!

The babies will arrive slightly earlier and be slightly smaller. There is an increased risk of severe perianal Crohn’s disease in some patients and some should be referred for a c-section.

Anti-TNF should potentially be stopped in the third trimester. This needs to be an individual decision.

Note: No live vaccines must be given for six months post delivery. (BCG, rotavirus, polio) – regardless of what you do during the pregnancy.

Post delivery certain drugs are also contraindicated during breastfeeding:

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Getting the Diagnosis Correct – Excluding Infection

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Rare infectious mimics –

  1. GI Schistosomiasis. Extremely difficult to diagnose, sometimes you can pick up the eggs on a colonic biopsy. Serology after about 3 months is highly reliable. Treatment is with praziquantel.
  2. HIV/Immunosuppression with other infections such as CMV, TB. Diagnosis of CMV is on PCR positivity on biopsy and viral inclusion bodies. The prognosis from CMV is poor.
  3. Other viral infections including VZV and HSV can also complicate the use of biologics and the consequences can be extremely serious. Infliximab is probably more immunosuppressing than adalimumab, which is more than others like etanercept. Particularly intracellular organisms in the first 90 days of administration. In particular septic arthritis (staph), TB, NTM, listeria, and Legionella are all associated. As are hep B, C, CMV colitis, HSV, VZV and respiratory infections. Apart from being screened for these conditions, the patients should have pneumococcal, influenza, and possibly hep B and VZV vaccination.
  4. Acute colitis can be mimicked by c.difficile and all sorts of other bacterial infections as well as some of the above viral causes and rotavirus. Near patient testing for gastrointestinal infections are currently under research.

Dare to be different! Why sticking out from the crowd means you might be on to something


CATEGORIES:

Matt Stammers, Clinician Software Developer, Gastroenterology specialist registrar, healthtech entrepreneur and founder of Clinical Developers – an organisation that supports the cross-fertilisation of medicine and computer science – writes about the mental outlook and cutting edge skills it takes to change the face of healthcare. He wants to get you inspired

medical innovators

As Mark Twain once wrote, ‘whenever you find yourself on the side of the majority, it is time to pause and reflect.’ It’s not always good to go with the flow. 

And here’s a good example. In 1985, young maverick Australian doctor Barry Marshall drank a broth containing helicobacter bacteria. It was an act of defiance that brought years of condemnation from the establishment. At that time, he had been working on this bacterium for two years following advice he received from a senior histopathologist colleague. Despite many attempts to culture it in animals, he had failed. Their theory was that this bacterium was the cause of stomach ulcers. But, like several others before him, they had been unable to prove it in the lab.  

Taking the poison 

Fortunately, Barry Marshall was not like most other doctors. Out of sheer desperation, he tricked an endoscopy colleague into performing a gastroscopy on him in order to prove he did not have the bacteria. Without ethical approval – and without even informing his wife – he drank the bacterial broth in secret. At the time he thought he would probably develop an ulcer in a year or two. In fact, it only took a few days for him to be admitted to hospital with severe gastritis.  

Barry Marshall

Many others had tried (and failed) to prove that helicobacter was the cause of stomach ulcers. They failed because the medical institution and big pharma at the time had no interest in such a discovery. Such a ‘cure’ would end the need for a whole generation of ‘ulcer surgeons’, and the vast quantities of drugs that treated but didn’t actually cure the disease. 

But why did Barry succeed where others failed? Many have asked and attempted to answer this question over the years. Was he smarter than the others? Was he more ambitious? Or foolish? Was he just lucky? The answer isn’t straightforward, and to reduce the answer to just one word would constitute ambitious folly itself. However, I’m convinced that Barry Marshall possessed some key components that none of the others had:  

  1.  He was fully, personally invested in the success of the project 
  2.  He was ‘different’ – while surrounded by ambitious colleagues, he was personally driven by the desire to find the answer above everything else 
  3.  He was fearless! 

In short, he was completely invested in solving this problem. Unlike all the others who had gone before, Barry Marshall drank his own poison because he was more invested in it, cared more about it, and was totally committed to the project, not himself. In that moment he acted selflessly – something the others couldn’t and wouldn’t countenance. 

Is he a one-off? 

We see this pattern again and again throughout history. Would Ignaz Semmelweis have discovered the cause of ‘childbed fever’ had he not lost a colleague to sepsis and then chosen to take selfless action? We owe the discovery of modern medical hand hygiene to this selfless Hungarian. Ignaz Semmelweis suffered heavily for his selfless convictions – roundly derided and rejected during his lifetime for his work, he gave us what couldn’t have been discovered in any other way and latterly became known as the ‘saviour of mothers’. Many of us owe our lives to him. 

John Snow

Would John Snow have isolated the Broad Street pump as the cause of cholera had his heart not gone out to the people dying all around him from the disease? This generous man put himself in jeopardy in order to discover the cause of cholera. While all his colleagues were fleeing London he stayed, and because he was so personally invested in the problem he saved many lives, founding the field of modern epidemiology in the process.  

So my summoning call to readers is this: become invested in the problems you face daily. And do the work for the sake of the work, not for ambition or any other reason. Take positive action and commit to solving a problem that is meaningful to both yourself and others. 

Why don’t more people do this? It’s because there’s a high price to pay. It requires learning new skills to solve problems, plus not buying into the falsehood that only ‘professionals’, big companies or others can solve these problems. The truth is they can’t. Only you can solve the problems you are uniquely positioned to solve, and you might just create a new field of science in the process. 

Barry Marshall was just a Gastroenterology registrar (like me) when he made his discovery. It is only now, with hindsight, that he’s recognised as a great example of the ‘clinician scientist’ – a now well-recognised phenomenon. It cost him his reputation – for many years he was rejected and mistreated by colleagues and industry alike. Only in 2005 was he finally awarded a Nobel Prize for his work, and today he is considered a medical hero.

Ignaz Semmelweis

Ignaz Semmelweis, the father of modern hygiene, only became so because he was curious about something he observed. Where many would have let the unexplained death of a colleague go, Semmelweis couldn’t: he was intrigued. Intrigue led to discovery, which led to conviction, which led to commitment in the face of adversity, which ultimately led to breakthrough. He received little glory for his work during his lifetime.

The modern field we now know as Epidemiology did not exist before John Snow. Through his commitment he drew the first epidemiological map and began to turn the tide on cholera. He was one of only very few physicians in London at the time and so one of only very few people who could actually have made the discoveries he did. He worked out where he fit in the world, and he ran with it. 

These three heroes share threads of commonality. None of them were entirely alone in their endeavours (even Semmelweis and Snow had communities of support), all of them were ‘square pegs’, all of them were fully committed, all of them had to learn new skills, all of them did the best with what they had, and all of them acted selflessly. 

Enter the clinician developer 

I came up with this name by mistake. I was trying to explain to some colleagues what kind of doctor I wanted to become, and the name popped up. Not that the name is important. Indeed, it may well change. What is important is what it stands for – which is the ‘builder’ clinician. Traditional pathways for clinical staff have generally been: clinician ‘specialist’, ‘generalist’, ‘manager’, ‘teacher’, ‘scientist’ or more recently ‘entrepreneur’. All of these pedigrees (apart from the entrepreneur) have very long histories and the routes to becoming on are well established. However, I’m convinced that the time has now come for a seventh type of clinician – the ‘clinician developer’ or builder.  

In a sense all clinical staff are builders – from writing protocols or business plans to conducting research. However, what I’m referring to is a particular kind of clinician who has their feet in two different worlds. They straddle the world of the clinician with all its arcane knowledge and tradition, and the world of the software developer with all its flux and change, constant upgrades and machine intelligence. I believe that the fusion of these two worlds is the future. I believe that both worlds can learn a lot from one another, that they fit together hand in glove. 

Medicine has become an increasingly complex domain, so complex in fact that my brain physically aches every day as I try to assimilate and sort vast quantities of information. Humans do not do this very effectively. As Daniel Kahneman points out in 2011’s Thinking Fast and Slow we tend to oscillate between two types of thought – Type 1 (fast, automatic, frequent, emotional, stereotypic, subconscious) and Type 2 (low, effortful, infrequent, logical, calculating, conscious). As healthcare requires much more Type 2 than Type 1, this poses a significant problem for us as clinicians, and sometimes proves dangerous to our patients. We need software solutions that can help ease this Type 2 burden, but so far they don’t exist. In fact, most of the IT solutions we currently have are very good at collecting and presenting vast quantities of information… just not in a way that helps us as humans or healers. 

Software developers and data scientists alone cannot help us. Even when a clinician works in close proximity with a developer (a combination that can work) success is not guaranteed. Granted, you can make progress – but this is where I come back to my original point. The issue is one of selfless investment. The software developer or data scientist doesn’t actually have to deal with the problem themselves, so therefore they are not fully invested in it, and they’re probably not acting selflessly.   

We easily forget nowadays that these problems are by their very nature extremely difficult to solve and some are effectively intractable. Therefore, it’s only someone who is possessed of several skillsets and is fully selflessly invested in solving the problem that can actually solve it. All the heroes listed above needed to be both deeply involved in the problem and to have the technical skills to solve it.  

Yes, teams are incredibly important in scaling and bringing products to market. But that first spark – that initial burning ember of innovation – is formed in the fire of heavy individual investment. These clinician developers are one such catalyst, and I believe that without them healthcare technology will continue to lag 15+ years behind every other industry. 

That’s why we formed Clinical Developers. We’re just getting started, but together we are determined to accelerate one another towards success. If you have the skills and determination, now’s the time to start solving the difficult problems only you can selflessly solve. We’d love to help.

Branding: Adam Devey-Smith #NHSClinEnt

How do clients build brands?

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The One Off (Top 10 agency). They are idea agitators. Their team is broad with multiple people across disciplines working together. They live by their promises. The biggest one is respect – you have to respect your client and your customers.

How will AI affect consumer behaviour – people are not dumb. They get what is going on and they will vote with their feet. Your brand has to stay ahead. The branding has to fit with the product.

Things they have learned:

  • Manage Risk – evolve and collaborate
  • Listen all the time
  • Don’t hang out with the wrong people
  • Well research your ideas and market
  • Good branding and communications

Don’t assume that you know what the competition are doing.

  • What’s your secret. Your story? Vision, mission, values.
  • What are your promises? (Give them something to believe it).
  • Why should I believe you? (Do something compelling).
  • How do you tell your story?
  • Where should you tell/sell it?

Is it sustainable? It needs to be more than just you and the product. Vision and love – do you fall in love with the idea?

Just GYSD – ‘Get your shiz done’

Q&A, actions, age breakdown. Ask everyone what do you think? Why you? What are your competition doing?

Big Promises: Align the vision/brand promise with the behaviour of the company – have a really strong passion!

Little Promises: ‘By 10:30 AM’ – that’s crap don’t do that.

Brand Matrices – Get these nailed down!

Do the groundwork – why are the customers here! Go back to basics and the history of ‘what the company is about’.

Logo’s

  • Don’t get hung up on your brand logo early on. Do get hung up on the name and vision.
  • Vision and Brand Values
  • Articulate your brand promises and belief points across all media.
  • Your logo does not need to do everything
  • Align your business to your brand – branding is a promise.
  • This will build a brand map.

What is your BHAG – Big Hairy Audacious Goal – Anita Roddick, Body Shop

The tech, fashion and sports industries are the most demanding. They want an idea now – if you can crack those industries you can iterate really quickly and build great stuff.

Spend at least a day doing this – sit down with others and beat around each others’ ideas. It is important – a VC will be looking for a sustainable business.

 

Make sure your pitch is understandable by investors, customers and colleagues.

You will succeed when you identify a problem that needs solving. Listen to 5 good people and your customers. When you see this as a journey you never give up!

When you get the team and customers behind you… really understanding, believing and loving your brand. (Not just you and not just your product.)

Ustwo

300 people, 4 centres round the world. Collaborations to build great products.

They are excited about what can be done in health.

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It’s so important to be authentic. Ctrl group – Wearables, Babylon Health, Echo – hacking the service to get prescriptions delivered locally, Dr Focused – to minimise the amount of note taking in order to focus more on patient care.

‘Move fast and break things’ – but this has to be adapted in health as ‘breaking’ things definitely has limits. Patients, clinicians and designers together can achieve great things.

It’s not easy but by building bridges is key. Collaboration is more than just joint stakeholders – it’s sharing all the problems. Everyone has to care equally about each aspect.

Moodnotes

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They wanted to help people to cope with their mental health better. Depression may become the number one cause of mental disability by 2030. This is something they are passionate about.

The biggest challenge of any health app is to ‘hide the vegetables in the meal.’ This is what Ustwo did with Moodnotes. They managed to build the products in a very quick timescale.

iWantGreatCare – Neil Bacon shares a few predictions

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He explained that patient ratings are directly related to outcomes, patient satisfaction, absenteeism and cost.

Transparency drives performance. Relative’s ratings of cleanliness in hospital predicts MRSA and C-diff rates.

In 5 years time your professional reputation will be determined by what Google says about you.

Your colleagues will be threatened by your ambitions. He had to sell his house in order to start doctors.org.uk and then invested all the money he got from doctors.org.uk in iWantGreatCare. It is going well but taking time to scale. Watch this space.

Mike Casey – Future Nova – FlipPad #NHSClinEnt

Mike Casey – FlipPad – a clean case for iPad.

A spray resistant and protected iPad cover for hospitals.

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The idea was to replace the mobile computers in hospital.

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They managed to get funding and got Apple involved. It takes a long time to get Apple to get used to the company. However, they loved it and it went into their enterprise range.

Then a surgeon in the US left a review on medgadget after he tried to destroy the product in a surgical theatre and failed: Their sales took off!

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Then companies including a super glue factory became interested and sales took off so much that they had to move factories.

At one point a German factory challenged them on whether or not the product could survive a various list of chemicals. It turned out to be the only product that could!

Cognition X on the challenges of applying AI in Health #GiantHealthEvent

Healthcare is rapidly becoming the biggest market in AI. The opportunities are enormous.

Prescriptions, Surgery, Diagnostics, Drug discovery and Nursing will all be involved.

The big challenges are: Acquiring enough data, navigating regulation and privacy are the main obstacles slowing down progress here.

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Zero knowledge: minimising the number of systems who have a full view of anything.

Cognition X already has 500 AI related products listed. They provide a vertical search engine for AI to find the right machine learning tools.

 

Cognitive Computing in Healthcare – IBM Watson #GiantHealthEvent

The term AI tends to bring up negative connotations. IBM prefer the term cognitive computing now.

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Watson is a service – built to be consumed. It understands, it reasons and then learns.

Watson has no biases but rather creates answers based on evidence.

IBM believe that care is delivered in an archaic way and there are much better ways to deliver it. They see medicine as experts drawing on the experience of generally just one person and they feel that there are going to be better ways to come to clinical decisions.

A computer human team if you like.

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atson can help to structure data. It can then analyse and rank that data and provide various different options. They feel that the MDT process can be greatly improved because at present decisions are often made my the most senior people rather than taking in the evidence from all the different perspectives.

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Another area they are working in is clinical trials and patient matching. The final major area they are looking at is genomic insights.

The example was given of protein discovery. The Baylor team managed to find 6 new proteins using Watson in only 30 days of use. Prior to this 28 protein targets had been discovered in the past 30 years.

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IBM’s next plan is to further open up the Watson API to enable teams to work together on projects.

Basic things you can do to improve your investability as a startup

Things you can do to improve the investability of a company.

Contracts – make sure these are all signed and dated.

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IT systems – check the website has general website terms of use, a data privacy policy and terms of sale.

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Data protection – make sure you can protect your data

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Consumer protection – can you prove you can protect your customers?

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IP – Is this protected? Have you bound any contractors? If everything filed at companies house?

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Company Secretarial – make sure all the official forms are correctly filled in.

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These are the bare bones essentials to be able to receive investment.

@Mikebiselli talks about how they made Colorado the number #5 health cluster in the US

The story began with the discovery that Colorado already had birthed 4 large healthtech companies. They then set about starting to build a hub.

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They analysed the local data set and found out there were at least 70 healthtech startups in the city. They then formed @catalystHTI.

Then they found that millennials were flocking to the city of Denver. They were coming because they couldn’t afford to live in the surrounding areas.

Then politicians took notice and started to promote the area in this way. VC firms and other ‘money’ started flowing in as well.

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That’s when they decided to build a campus to bring all these elements together.

This all came about due to ‘serendipitous collisions’. That is what they believe leads to new innovations and progress.