What are the most effective R&D frameworks for developing medical products?

currently or in future, there would be hybrid approaches to adopt R&D frameworks in a medical sector as the world is rapidly advancing in medical technology, processes and delivery of services. Therefore, based on the nature of product or service we want to do R&D, the famework need to be identified and implemented. some products require expertise in knowledge, techniques and setup formulation, drug research etc but some require combination of medical, software, hardware, integrations, data models etc so for each stage of development right framework may vary and need to be adopted to achieve the best output from the frameworks used.

Any R&D approach requires a clear understanding of the customer, particularly in the Lean approach (iterative feedback loop). In medical product development, the biggest challenge is getting the customer defined properly… because there are significant gates to market access (various stages of regulatory approvals) the tendency to focus on regulators, who historically have listened to physicians, is understandable. Fortunately, regulators are now listening to the patient perspective, so frameworks like Lean are more compatible. Traditional product manufacturers could learn from Digital Technology companies who are a hybrid between consumer and medical product developers, and have been implementing the lean framework for years.

Lean Startup for Medical devices is easily the most efficient methodology, and also carries the highest risk if misunderstood across the product development process (PDP). As a lean sigma practitioner; the methodology allows quick iteration of hypothesis testing, while always evaluating the value proposition of process step or design elements under review. This can however impede priorities if the non-negotiables of design are not clear or vague. For instance, product safety attributes, quality, reliability and regulatory requirements are non-negotiables. A lean methodology should reinforce this while paving the way for an optimal development process including efficient PDP stage gates and feedback loops.

To build or adapt an effective R&D framework, one must understand the major factors of med dev development that discerns them from any other product development. 1. First and foremost is you are building a device or product for people who are experiencing an undesirable medical state, aka; patients. Understanding the patient needs early on is very critical, whether be it human factors or patient preference of treatment attributes. 2. Then there are regulatory and coverage factors that must be integrated into your development, this can impact the cycle times and cost of development. 3. Verification and Validation (V&V) including Clinical Trials (CT): This can be one of the most labor, and cost intensive process step.

Still my 'fav', "In Search of Excellence" offered great insights. One of the most poignant chapters discusses "Management by Wandering Around". The new warehouse manager just didn't "get it". So, arriving at 03:00 one morning, by opening time, basic fork lift operation 'bedamned'...the warehouse layout was redone in a logical manner. "I would have done it, boss." The authors of 'In Search..." spoke to front office managers and marketers: "get out into the back and on the production line and into the field". Great advice. Each road trip was the same: sales guys go to 'loaded accounts' and there was only "the best things' in the warehouse and manufacturing. Take clues from "Undercover Boss". Nothing is ever 100%.

The most often discounted segment would be the intrinsic characteristics of the clinical need, patient use factors and market acceptance of the treatment option being developed. These elements often run through a standard gambit in PDP & V&V phase, and can skip key learnings that are needed for product success and adherence in the market. Risk based decision making that's augmented with macro factors is critical in defining the value proposition of the overall outcome or solution being developed.