A Goal Without a Plan is Just a Wish
Our customer journey starts with the Customer Product Requirement (CPR) and this is a critical stage in our planning process. The CPR builds a framework for the test’s technical make-up, market requirements and how it should perform. We ask our prospective customers to fill this out at the start of our discussions. Not only is this the first step to provide customers with an accurate project plan, but it also allows us to start building a budget plan. The more information that can be provided in a CPR then the more refined we can make the project plan.
Once the initial plan is agreed, there are several critical areas to focus on to ensure we don’t get any “surprises” further down the line.
For example, consideration of critical parts of the supply chain early in a development or manufacturing project is essential. By looking at the project requirements and calling on previous experiences with established suppliers, it allows Abingdon Health to support our customer in selecting primary and contingency supply routes, which help secure firm pricing and surety of supply.
Another key factor to consider is the regulatory requirements. In the clinical market, regulatory submissions can be a significant cost and also have an impact on timescales and product launch dates. We always consider this from the outset of project and throughout the project we keep an eye on changes to the regulatory landscape. At the outset it is important to define the key requirements for each territory and build these into the development plan and consider the need for any applicable clinical trials or evaluations. Abingdon Health’s regulatory team work alongside our development team and provide input to possible future costs associated with regulatory submissions. Our in-house regulatory team also manage the regulatory process for our customers whether it is CE-marking, UKCA marking, FDA etc. This allows clients to have a clear understanding of what is coming down the line.
Communication and Timely-Information: Staying On The Same Page!
Regular communication is essential between Abingdon Health’s project team and the customer. The best projects are those where we have a regular calls and check-ins to ensure that we are all working with real-time information.
We recommend regular fortnightly meetings are held to discuss project status. These will involve a range of our team members, depending on the critical elements under discussion, from supply chain, regulatory, development, project management to technical transfer and manufacturing. For research and development projects we get our operational teams involved at an early stage to ensure the product is being developed with a focus on scalable manufacture. If this is considered too late in the process it will have an impact on the project timescales and costs. Our approach looks to mitigate this through early consideration.
Planning is essential in ensuring projects progress on time and on budget. In addition, regular communication is essential to ensure the customer is fully informed as to the project status. We are all aware of recent geopolitical events and the impact that these have had, for example on supply chains and input prices. Therefore, regular dialogue is incredibly critical.
From our focus on continuous improvements to planning for regulatory submissions early, or offering close to market supply chain solutions, all our activities contribute to creating the best possible customer experience. Our key aim is to ensure our customers’ projects are delivered on time and on budget and we work closely with our customers to achieve this.
To understand more about Abingdon Health’s proactive and collaborative approach to managing lateral flow projects, contact a member of our team.