ZenQMS recently hosted a live webinar featuring a presentation by Ed Morris, Managing Partner of The Morris Group and a well-known IT and Compliance expert. If you missed it, there is a replay available on-line and I've written up a brief summary here:
Why do emerging pharma and medical device companies consistently overspend on IT Systems?
Most of Ed Morris' clients are still in clinical trials-which means no revenue yet, no commercial operations and every single dime of capital must be allocated to R&D and of course, regulatory submissions.
So why then do sponsors who are struggling to conserve cash go out and buy expensive and unwieldy enterprise IT Systems? According to Morris, there are three common reasons that he sees across his client base.
- Lack of Time – We all know that getting a product through the NDA process is a game of hurry up and wait. We are so busy preparing the critical path for things like PAIs and labeling that the launch date sneaks up on us. Then it’s a mad scramble to get ANY compliant system installed. The problem is you are STUCK with the system you select for at LEAST 3 years. Do yourselves a favor and start defining your requirements in late Phase III and you could save yourself and the company millions in IT costs.
- Lack of Knowledge – Department heads must be internally focused to ensure everything is working smoothly. Pretty much the only time they get to see new solutions is at an industry trade show and even those are getting fewer and far between.
- Fear of Change – Many department heads are not hired until very close to the launch. launching a pharmaceutical or medical device product through launch is a very stressful time filled with lots of risk and uncertainty. Some of these folks may have great operational experience, but have never been through a new product launch.
Beyond the above reasons- reality for these emerging life science companies is that crazy schedules, multiple meetings and regulatory responses are the order of the day. The pressure is really on to be successful in this new role. The last thing ANYONE wants on their resume is to be the cause of a regulatory rejection or launch failure.
Selecting a new IT system for their organization is yet another risk that they would prefer to avoid. Therefore, many take the “easy way” out and decide to go with a system that they used in their last job. Think about it, at least they “know” this system which gives them some perceived control. The problem is the system that was appropriate for their former big pharma job is overkill for their new emerging company.
4 steps you should take to avoid ‘riding dinosaurs’ when selecting systems for your business
- Have a “Scale-Up” strategy
- Define requirements early
- Investigate new products (if you have the time) or higher a consultant(s) to help you.
- Don’t be afraid to use a new system. It will most likely be the LEAST risky thing you do.