Clarkston Consulting recently completed an enterprise systems assessment project for a client. This client is a U.S. based manufacturing organization that designs and manufactures equipment for production of hyperpolarized xenon or helium gas. When used in conjunction with MRI, these gases offer a fundamentally new and non-invasive functional imaging platform. Current investigational uses include identifying early diagnoses of respiratory diseases as well as monitoring progression and therapeutic response.
At the onset of a new year, the organization was looking for early Q4 FDA approval of their first product. As part of this process, they partnered Clarkston to help them assess and define their enterprise system roadmap to support their expected commercial launch and growth plans.
Clarkston interviewed key stakeholders to understand the current state systems, processes, and regulatory requirements for commercialization, along with post-commercial expectations and future growth strategy. The primary objectives included the detailing of key business processes to support pre- and post-commercialization, defining an organizational structure to better align with the pending launch and future need, and developing an enterprise system roadmap to meet the needs of the organization now and prepare them for expected future growth. This resulted in the team analyzing current systems and the timing of future systems/capabilities based on value proposition and criticality to commercialization. Also, as part of defining key current and future business processes, the team also identified quality and regulatory components, most importantly around pharmacovigilance and product release, required for launch. The culmination was a working roadmap that focused on standing up critical systems and capabilities for product launch along with a detailed long-term approach to support organizational growth.
The key benefits from the Clarkston Consulting and client partnership on the enterprise system assessment project included alignment on key processes and organizational structure to support new areas of responsibility required for commercialization, an approach to spread organizational and budgetary impact while balancing near-term requirements with long-term plans for scaling, and ultimately, a timeline with key business milestones, dependencies, and the supporting technology that will be needed for future scaling and growth.
Contributions by Kevin Merchak