Innovation, efficiency and design for value are necessary driving forces behind successful life science companies. However, these must co-exist with a clear, market-driven business strategy and consistent, cross-functional product development processes and practices.
At AfR, we work with our pharmaceutical, biotech and medical device clients to ensure the successful design, development and delivery of their products – from Discovery through Launch. We do this by scrutinizing existing processes, identifying assets, strengths and gaps, and partnering with our clients to build capabilities, methodologies, and tools to complement their existing framework.
Product Development Process (PDP)
Having an efficient and effective product development process, consistently applied, enables your organization to deliver high quality products that create business and customer value.
AfR is highly experienced in producing and implementing PDPs in pharmaceutical, biotech and medical device environments, including consistent stage gate processes* and governance models. We can develop a PDP from the ground up or assess and improve your existing processes and governance structure. In particular, AfR has extensive expertise in combination product development and its related processes.
AfR methodologies specific to combination product development include:
- Delivery system platform development
- Combination product integration and program management
- Drug and device development processes
- Life sciences project management
- Quality system alignment to meet combination product requirements
View an example of PDP key concepts and best practices here. PDP_Key_Concepts*Stage-Gate® is a registered trademark of the Product Development Institute Inc.
Quality System Integration
At its essence, the stage gate process is a business process that has been applied across all types of industries. However, for it to be truly effective in pharmaceutical, biotech, and medical device companies, it must be well integrated with the company's quality system processes.
Since AfR's focus is on the life sciences industry, we have a strong understanding of requirements management, design controls and risk management, as well as the experience to dovetail them with each other and with the stage gate process.
Platform Design & Technology Development
New product development efforts are commonly derailed due to technical challenges resulting from the team trying to "invent a new technology" versus "developing a new product." Product Development Processes (PDPs) are not intended for inventing new technologies. Often, new technology is only one part of the overall product - and best practice is to take the new technology offline of the PDP effort and develop it using a specific Technology Development Process (TDP). AfR can help you implement a TDP, as well as create an integrated product & technology roadmap.
Platform Design is a fundamental strategy for reducing risk and increasing the leverage of product development efforts - design once and use many times. However, it also requires unique application and integration of the PDP, technology development, project management, and portfolio/pipeline management processes. At AfR, we understand the intersection of these key processes and can help you start-up or fine-tune your platform development efforts.
You can’t manage what you don’t measure….so what should you measure?
AfR will determine the right key performance indicators to provide insight into how your product development is performing, allowing your organization to make process adjustments proactively. We will go beyond short-term performance metrics and define both the predictive and long-term strategic measures necessary to building sustainable outcomes and business value.
Portfolio & Pipeline Management
Pharmaceutical, biotech and medical device companies that take project selection, prioritization and data-driven decision making to heart deliver more successful products to market than their competitors who lack the same rigor in governing their project pipeline.
AfR will review your current processes, document gaps and needs, define important next steps and implement an effective and comprehensive system to ensure that the optimal decisions can be made.