Hack & Associates, LLC.


Welcome to H&A Consulting

**Currently H&A is not accepting new clients**

Hack & Associates is a life sciences firm specializing in medical devices.  We provide valuation and due diligence for intellectual property and FDA regulated devices.  Hack & Associates provides clients with the following products:

Regulatory due diligence:  Specializing in orthopedic and electro-stimulation devices, in- vitro diagnostic devices, H&A provides due diligence, market place mapping, and regulatory strategy for clients who are looking to develop or invest in medical device technology.  H&A services include regulatory strength assessment, analysis of direct and indirect competitors, and portfolio analysis.  H&A can also help clients plan portfolios, build strategies for existing portfolios, and assess new potential portfolios.  H&A uses a proprietary rating system to rate the regulatory strength of a device.

Regulatory risk management:  Hack & Associates utilizes its experience with medical devices to provide clients with detailed risk management plans.  Risk is a part of the regulatory process but can be mitigated.  With H&A, clients can use regulatory risk maps, alternative approval strategies, market trend analysis, and indication for use analysis to help mitigate and control the risks inherent to bringing a product to market.  By building strong, effective, and efficient regulatory plans utilizing H&A, companies can better forecast their post-market success.