Don’t fall into the trap of over-engineering Regulatory solutions as ambitions grow: the view from K2 Consulting’s Kelly Hnat

by Kelly Hnat | Dec 23, 2022 | Blog


As 2022 wraps up, we asked some of our revered industry partners and popular BE THE EXPERT event speakers for their views on the biggest developments in the Life Sciences Regulatory sphere over the last 12 months – and to predict the most prominent themes and priorities for 2023.
Here’s what Kelly Hnat, IDMP/SPOR and business process/program management expert at K2 Consulting, had to say.

What, for you, is the single biggest issue of importance in relation to the Regulatory function right now, and why?

For me, the main challenge that Regulatory organizations face now is how to establish complete and accurate structured data representations of their registration information – and manage it in a meaningful way. We’re in the midst of a kind of a revolution in regulatory submissions at the moment, and it’s changing everything about how we need to look at, manage, think about, and share data across pharma organizations.
I liken it to the changes we saw when eCTD was implemented – all the contributing functions and regulatory were impacted, and we needed to re-educate ourselves about how to operate in a new paradigm. At that time, the change brought some far-reaching benefits and improved quality and efficiency in how submissions were produced. In a similar way, the current advance toward structured data and new submission paradigms will have benefits for Regulatory, and across the enterprise, as we begin to tap the value of clear, accurate, and complete data representations of registered medicinal products.

How do you see all of this playing out over the next year – and beyond (eg. 3-5 years ahead) – and what do companies need to watch out for?

Many, if not most, organizations are already well into preparations: implementing or updating their registration systems, thinking about how to integrate those systems effectively across the enterprise to effectively share data, and about what business processes to establish to get this all to work.

But there has been a bit of a reprieve with the changes in the EMA strategy – from the previously expected requirement to prepare SPOR FHIR messages, to the focus on the new DADI electronic application form replacement – so the runway has grown a bit longer.

For most organizations this is good news – because this change is much more challenging than many organizations understood when they started planning their implementation programs. Over the next year these implementations will continue and, for those companies which are a bit further along, we’ll start to see how the various implementation approaches play out in production – and have a chance to learn from the successes and challenges that result.

The main thing that organizations need to watch out for is not over-engineering their solutions. In the mid-to-late 2010s, a lot of people thought that the key was to flow data in some automated way from supply chain and other systems to create the IDMP datasets.

On the face of it, this is a logical way to approach it: components like manufacturer information; formulation details; and packaging hierarchy are created and changed in tech ops and supply chain, and that data sits in ERP and BOM data sets – so let’s just use that! The problem is that the data in those systems is created and maintained to support the manufacturing and distribution processes (producing what is approved), and that is fundamentally misaligned to regulatory processes (proposing what should be approved).

That leads me to what I think the main watch point should be for all organizations – that structured regulatory data is only partly a technical problem. Mostly, the challenge ahead is a business process problem. Most of the commercial registration management systems have long had the ability to capture and manage the data we need to structure, and I believe if we establish the right business process around that, the solution can be quite straightforward.

It then becomes a problem of getting people to change how they work. Again, I draw the parallel with eCTD: then we had to change how authors worked with technology. Now we need to change the way our Regulatory product teams work with technology.

What do you see as being the main facilitators? In other words, where do companies need to focus their efforts now, and what decisions/actions in particular will be important in determining how well they do?

In addition to what I’ve already mentioned, I think Regulatory needs to be sure it is setting its sights beyond its own borders – both in how data is collected and created, and also in how and where it is consumed.

The main benefit of the structured regulatory data future is what this data can be used for. And Regulatory Affairs will not be the only consumer of this new, deep, accurate and complete set of data that is coming into being. This information will have great value across the enterprise – for Supply Chain, Commercial, and beyond.

We use systems for two reasons: first, to enable a business process; and second, so we can make business decisions based on the data they contain. I’ve always felt that we should design our systems with the end in mind. In other words, how can the information we collect and manage be consumed to support business success?

Thinking about the key potential consumers of data will help build its value beyond the regulatory compliance use case, and shift Regulatory’s role within the enterprise as a data producer.

If you could convert one misconception, or make one breakthrough, to change companies’ thinking and plan of action for 2023, what would it be and why?

It’s critical that organizations do not rely on the technology to solve their problems – technology is only a tool. The key to success is always going to be manifested through business process and organizational culture.

Many perfectly good registration management systems are seen as a failure within organizations that have not taken the time to establish the processes and organizational support for them to be successful. When the data is then poorly managed and becomes untrusted, it’s seen as a failure of the system and the software vendor – in which case the expected solution is to replace the system.

But the business process and organizational components are the actual foundation for success – in our research with Gens & Associates over the year, we’ve consistently found that there is no correlation between top-performing companies and any one software provider or system strategy. Top-performing organizations excel at the process and organizational work, along with strong implementation execution. These strengths can overcome the weaknesses with almost any software platform… but the opposite is never true.

Kelly Hnat

Kelly Hnat

Principal at K2 Consulting

About the author

Kelly Hnat is a leader in RIM and IDMP with over 25 years’ experience in the biopharmaceutical industry leading IT, RIM, and Regulatory Operations organizations.  Kelly is a globally recognized expert in IDMP and is a key subject matter expert supporting the EU implementation of IDMP as a member of the EMA SPOR Task Force, the SPOR PMS sub team, and the SPOR EU Implementation Guide Focus Groups.  Additionally, she is a member of ISO TC215/WG6, is a member of the Core Research Team for the Gens & Associates World Class RIM survey, and serves as President/CEO of IRISS Forum, a global nonprofit organization that brings together industry, vendors, and health authorities to address topics related to submission standards.  Kelly leads K2 Consulting, a boutique consultancy that provides business process, organizational strategy, and technology strategy services for Regulatory Affairs organizations.