Chapters in Stage 5
5.1 IP Strategy
5.2 R&D Strategy
5.3 Clinical Strategy
5.4 Regulatory Strategy
5.5 Quality & Process Management
5.6 Reimbursement Strategy
5.7 Market & Stakeholder Strategy
5.8 Sales & Distribution Strategy
5.9 Competitive Advantage & Business Strategy
DEVELOPMENT STRATEGY & PLANNING
Failing to plan is planning to fail.—Alan Lakein
Always in motion is the future.
—Yoda
Regardless of the validity of the need, the ingeniousness of the concept, and the size and scope of the market, at the end of the day, sound business underpinnings are essential if a product is to be delivered to the bedside, in a box, with a 1-800 number on the side for sales and service.
Getting to this reality requires a balanced consideration of the rules of the road with the addition of a series of overlying and overlapping strategies: (1) intellectual property integrated with ongoing research and development and clinical plans, (2) regulatory strategy including process management and quality, (3) reimbursement strategy, (4) basic business blocking and tackling—marketing, sales and distribution, and (5) combining all assets and strategies together to develop a sustainable competitive business advantage.
What to do first? Gordon Bethune’s book chronicling the turnaround of Continental Airlines was entitled Everything, All At Once. The lessons are that few things are simply sequential, that nothing can be considered in a vacuum, and that time waits for no one. Given the fast pace of change in the medtech space, a six-month delay may leave you behind your competitors.