The biopharmaceutical industry plays an increasingly pivotal role in providing treatment options for widespread and rare diseases, but a lack of innovation and technology are factors that keep the costs of new medicines high. There are also multiple barriers to implementing new technologies, including their pathway to adoption.
To help clear the pathway, BioPhorum has developed a New Technology Adoption Portal to support any adoption program.
The aim of this best practice resource is to enable new technologies to be adopted more effectively within companies and across the biomanufacturing industry. This resource is a high-level toolbox and guidance for R&D, technology discovery, sponsors, risk managers, and regulatory teams.
It uses a wheel graphic that summarizes the steps to work through and what needs to happen at each stage:
- Business needs – clear objectives, robust business case, technology development, and proofs-of-concept
- Governance – senior sponsorship, stakeholder identity and management, and risk management
- Readiness – regulatory strategy, GMP readiness, and operational readiness.
Asking the right questions
The Adoption Evaluation Tool sits within the Portal and leads you through all the key questions you should ask at each stage, without being too prescriptive.
For example, if you are at the Vision stage, it will prompt you to ask questions like:
- How does your project align with your corporate strategy?
- How much stakeholder involvement has there been to date?
- And are there any early adopters already approaching regulatory groups?
While you are Implementing your technology, example questions include:
- Has your funding been budgeted/approved for initial deployment?
- What are the remaining risks to adoption and how might they be mitigated?
- What is the regulatory environment for this type of approach at that location?
And whilst in the Adoption stage, it will prompt you to consider questions such as:
- What are the key milestones for the implementation plan?
- How visible is key leadership in communicating this approach?
- What change control activities are needed for global deployment?
The Adoption Evaluation Tool is designed to accelerate your progress by helping you think about points in the right order. It will also help prevent your project from getting stuck in the technology adoption ‘valley of death’ where it has run out of support, money, or time.
The aim is not to increase the number of pieces of technology you implement but to ensure that you identify the right technologies to start with and have the confidence that it is implementable – and ultimately, that your project is worth doing.
While the tool’s primary focus is on new technology adoption, it can be used far more broadly, e.g., to help guide the progress of new guidelines, user requirements specifications, and almost anything you are trying to introduce into the industry.
Do you know where your company is in the cycle of new technology adoption? And are you asking the right questions?
The Technology Adoption Portal and Adoption Evaluation Tool are available at www.biophorum.com/technology-adoption
This is a living resource, and BioPhorum aims to build on this by sharing more resources such as downloads, case studies, templates, etc. Do you have a good story to tell or best practice ideas to share? Please get in touch at firstname.lastname@example.org