Why Do Medical Information (MI) System Initiatives Fail?

When does an MI system initiative have the best chance of success?

If you’ve worked in medical information (MI) for a few years now, you’ve probably seen at least one MI system initiative fail.

“Nice to have” doesn’t lead to change because:

• Change is disruptive
• Change produces resistance
• There need to be tangible cost-savings
• People will find workarounds
• There are higher priorities

At some point, perhaps, it seemed obvious that getting a system was “next” for your department… but it’s now either firmly on the backburner, or it keeps being “leapfrogged” by other priorities…

So, what happened?

In our nearly 20 years of experience, the answer almost certainly lies in one or both of two areas:

• The nature of the need for a changed approach to systematic support for MI
• The wider context of a company’s priorities and its stage of development

[Note that neither of these has anything to do with the MI enquiry handling systems available. Their capabilities are important, and it can be good to look at what’s available – indeed, we will be looking next time at the common misconception that “all MI systems are basically the same” – but, to be blunt, until there’s a compelling need for change, and a supportive wider context, these capabilities are largely irrelevant.]

“Nice to Have” vs “Must Have”

The previous article argued in more depth that when a change is “nice to have”– even in support of best practice – it will only rarely be made:

• Change is disruptive, and even if there are clear deficits in the status quo:
  • It must be working on some level, or you wouldn’t be doing it
  • It came to be that way for a reason, and the people, politics and relationships involved in that will often resist change – certainly subconsciously, but often directly
  • In this economic climate, especially, unless there are tangible benefits to be achieved (preferably with associated cost-savings), change will be hard to justify and implement
• Workarounds within the status quo are usually able to adequately meet “nice to have” needs
• There will likely always be an area elsewhere in the company where change is more than a “nice to have”, and this other area will therefore almost always take priority

An individual with sufficient influence and willpower can sometimes push through change on this basis, but our customers have typically found that it usually takes some kind of “trigger event” for change to be actively considered. These vary by company and can be externally or internally driven; pro-active or re-active, e.g.:

• The launch of a new product or affiliate, etc, which leads to a step change in either the number of enquiries, their complexity, or both
• A change in company management or strategic direction, which can transform the goals or outlook of the MI department (e.g. a merger or acquisition, cost controls, technology changes, etc)
• A regulatory issue, such as a failed inspection

…as well as there needing to be a real momentum for change, there also needs to be an awareness of the wider context and issues. Experience suggests that the bigger the company, the greater the challenges tend to be…

Whatever the “trigger event”, though, the key message is that it nearly always takes something from outside the status quo – regardless of the gaps within it, and regardless of whether those gaps are widening – to tip the balance from change being “nice to have” to “must have”.

The Wider Context and Issues

But does MI having a “must have” need mean that that change will automatically happen?

No. As well as there needing to be a real momentum for change, there also needs to be an awareness of the wider context and issues. Experience suggests that the bigger the company, the greater the challenges tend to be in both identifying and dealing with these issues, e.g.:

• The number of affected individuals and departments usually increases significantly
• Working with other affiliates and with HQ (often with a strong “central control” component)
• Increased regulatory scrutiny
• IT constraints – whether that’s because IT is outsourced, or because there are controlled lists of supported technologies and approved suppliers
• Global infrastructure initiatives with e.g. document management or CRM:
  • At best, these can end-up overlapping and competing
  • At worst, monolithic solutions can be imposed with little regard for specific departmental or geographic considerations
• Procurement restrictions and processes, such as RFPs, that are not just time-consuming but arguably counterproductive (NB a future article in this series may look at this topic)
• Initiatives from other departments competing for budget

Even were there to be no “political” implications involved in all this – which is rarely the case – the sheer complexity can seem daunting.

Does this mean the situation is hopeless in larger companies? Not at all.

Rather, it means recognising and acknowledging the reality that projects will be harder – identifying the particular issues involved and developing strategies to manage them – and this is an area in which we believe that vendors should be sharing the responsibility. After all, most MI staff will likely only be involved in one or two MI system projects; in contrast, MI projects are vendors’ day-to-day business, so they really ought to be well-placed to help.

[Again note that system selection isn’t yet an issue at this stage. Accordingly, if a vendor only wants to demo their system to you and/or talk to you about MI needs, both of these have their time and place, but we suggest also asking what experience and assistance they can offer with the wider issues, given that this is the stage where so many projects come unstuck.]

…many [MI system initiatives] fail due to the complexity and challenges of the wider context within which MI lives. However, this isn’t because [that]… can’t be successfully mapped and incisively navigated

On the other hand, does this mean that the situation is potentially more straightforward in smaller, growing companies? Yes.

A Unique Opportunity?

Over the last 18+ years, we’ve observed that there is a unique period in a company’s growth which is optimal for riding the wave of growth and preparing for the future:

• The product portfolio and company are evolving relatively rapidly, which is a fertile environment for “trigger events” – there is a pressing case for change, but the situation isn’t yet overwhelming
• Even if there are several affiliates – or even a clear global HQ – the relationships here are informal and collaborative, and local flexibility and autonomy are significant
• Whilst a sound business case is essential, there aren’t yet the decision-making complexities and IT and procurement constraints typical of big pharma
• Either your company’s already tried outsourcing and found where it works well, or it’s now clear what to outsource and what to maintain control over in-house
• MI is “next” in the queue of priorities, with many of the key upstream areas dealt with that would otherwise be competing for budget and attention (e.g. PV systems, complaint handling, etc)

In Conclusion…

Many MI system initiatives fall at the first hurdle of the requirements not being clear or compelling enough. Of the remainder, many fail – or are more time-consuming, expensive and painful than they need to be – due to the complexity and challenges of the wider context within which MI lives.

However, this isn’t because the complexity and the challenges can’t be successfully mapped and incisively navigated. Rather, it is because the wider perspective is understandably usually not clear from a purely MI perspective, and can be hard to find out. To date, although MI systems vendors ought to have the perspective to serve the industry here, they haven’t done so well enough (and need to earn trust by not “pushing product”, especially before the issue of what system to look at is even realistically on the table).

Having said that, a pharma company’s size and its stage of development do play key roles, and if you’re fortunate enough to recognise that your company is in the unique period of growth highlighted here, you may never have a better opportunity to secure MI’s future with a successful system project.

If you have a need to better understand your requirements, and/or to put together a sound business case, then get in touch, as we have a growing set of resources aimed at navigating these challenges.

Download this page as a PDF (132KB)