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Challenges of Building A Tech Product In The Pharma Industry

We have had an intense journey for the past 3 years in building OneSC, learning firsthand all the complexities that come with this industry. There are intricate specifics needed in the pharmaceutical industry that will catch you off guard, and rightly so, as you are dealing with medicines and health. Here’s what we learned:
  • Take time to understand the business processes and user activity before jumping into tech.
  • Be aware of the regulation and ensure your processes work with this – GxP, GAMP, FDA CFR 21, EudraLex Volume 4 Annex 11.
  • Be prepared to change and iterate, even when you think something is complete.
  • It takes time for users to learn a new tech system and adapt established ways of working.
  • Detail and document everything, even if it slows down the process.
  • Understanding the process and customer

    Listen and understand feelings and frustrations. Do not be afraid to take time, lot of time, to understand the business domain and processes – what is the activity, why are the users doing this and why are they doing it this way. Back this up with research.

    There will be tiny details that affect how you digitise activities and processes. It’s better to invest time in research to truly understand the user pains and what makes them do their job in a certain way. Create user journeys and workflows to help understand.

    Using design thinking and ethnography, we discovered key challenges and opportunities which were categorised by impact, complexity, and cost. Only once this was clear to us we proceeded to develop OneSC. Also, keep in mind that not every activity or process is worth automating.

    Regulation

    Software validation is critical in the pharmaceutical industry as it directly affects drugs and health. The stages of testing are broken down according to the ‘V model’ and key functionalities need reviews and approvals from customer quality personnel.

    Do take time to understand what is required, plan and set this up before you embark and allocate sufficient time and resources for your regulatory efforts.

    Behavioural Change

    The pharmaceutical industry is as old as time itself. There is good reason why things are done the way they are. We often hear, “why change” when nothing is broken. That’s a fair point, however, people need to be taken on a journey of change which enables them to grow and improve as well increase their productivity.

    Do not underestimate this as change will be required and needs to be managed. Users will embrace the change once they see the end goal and how their cognitive burden will be reduced. Take them through this new journey, do not rush the process, as everyone adapts to changes in their own time.

    Make sure they understand whilst the the old ways are functional the new ways will drive the business forward in a sustainable manner. Work with key stakeholders, identify your super users and champions first, then progress.

    Detail & Document

    It is true that the devil is in the details. Small intricate and finer processes may seem unlikely to add value but in the long run, you will be glad you took time to understand. Document every detail down to a T.

    The End Result...

    Remember that whilst these are big challenges, they can be solved in time. We are extremely proud of what we have built, our platform – OneSC. It has surely made an impact in the pharmaceutical industry for the better and we hope to help you in your journey through our experiences and learnings.

    Get in touch if you have any questions. 

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