Rapidly growing start-ups, in a very real sense, feel that their medical technology products (particularly the first products) are their "babies". DW Medtech Advisory's Medtech Midwife™ process supports, guides and assists medical technology companies to successfully develop and launch their products. DW Medtech Advisory works with your team to provide practical support, monitoring knowledge, insight, and intervention to overcome product development difficulties and enable successful delivery of products/services to market.
Comprehensive review and assessment of product requirements, program design, manufacturing process, and quality control systems.
Intervention and support tailored to a particular development stage or to the needs of your management team.
Senior level risk assessment and action planning to address deficiencies in the technology program plan.
Hands-on design review, design control documentation review, and IDE/PMA/510(k) submission review including document editing.
A plan to manage and implement design transfer, scale-up, and stabilization of manufacturing operations (in-house, outsourced, or virtual).
An approach that will sync your operating plans with market demands and forecasts.