News
Your Medical Innovations, the FDA & Regulatory Strategy
Your Medical Innovations, the FDA and Regulatory StrategyAs you strive to speed your innovations to the medical marketplace, it can feel challenging to explore development while also balancing US Food and Drug Administration (FDA) regulations. The good news is, it’s clear to see the FDA both wants to support industry innovations and advance discovery as
The Importance of Organizational Risk Management in the Medical Technology World
Risk management is a vital planning step for any organization. Risk management involves identifying and minimizing potential risks for your company. It’s essentially the process of anticipating potential risks a company could face, and taking the necessary steps to reduce the possibility of them occurring. Risk management is important because it protects both your organization
Kinetic Leap – Part One …
The rear view mirror on Year One of entrepreneurship. Cheers to year one! In the spirit of paying it forward, here are a few reflections on our journey to date: 1. Get comfortable wearing multiple hats (just know when and which one(s) to outsource). 2. Identifying your competitive differentiators can be challenging. Thankfully, our clients
The HEAT is on …
Yes, it is summer time for sure – but the HEAT in this instance is the “Health Care Fraud Prevention and Enforcement Action Team” initiative, which was announced in May 2009 by the Attorney General and the Secretary of Health and Human Services in order to combat health care fraud. Two recent enforcement actions against
Resources
The below companies provide services in the medical device, life science and / or biotechnology sectors and are potential resources for our clients.
D1ASP0RA specializes in formation of startups in the biotechnology sector. This includes prototyping the concept, developing a financial model, assessing the market, and preparing the story for investors. Our goal is to democratize the path to new discoveries by providing each new idea an opportunity to reach investors.