Diagnostics Consultant Partner

---

Entrepreneurs tackle and overcome challenges every day - - expected and unexpected!  Those new to the FDA-regulated diagnostics industry face an endless list of new "must do's" that often seem huge and without rhyme or reason. There will be the dreaded periods of paralysis and spending precious time going down a rabbit hole.    

The biggest bottleneck areas for new diagnostic ventures that I've seen are in gaining an understanding of what needs to be done, and when, for: 

-Integrating FDA Design Control and Guidelines into the R&D Work Plans.

-Defining Customer Needs and Translating into Product Requirements.

-Making Sense of the Quality QSR/ISO/GMP/GLP Alphabet Soup.

-Building out a complete strategy for R&D, Commercialization, Operations, and Manufacturing. 

I provide tips and tools in speaking engagements and hands-on workshops to help entrepreneurs navigate out of the diagnostic forest and see the trees that need to be cut down or climbed, and help by providing "the why."  Clarity on "the what" drives the prioritization and efficacious planning of "the how," "the who," "the when," and "the where" to keep you moving forward on your path to success .

  FDA Design Control in IVD Product Development Consulting:  

Get planning advise, tools, and strategic plans for study design that fits your diagnostics regulatory strategy, the do's and don'ts to de-risk your diagnostics product design and studies, and implementing a FDA quality system with design control without breaking the bank. 

The expression "measure twice, cut once" is great advice for some industries, but in the human healthcare industry it is "measure many times, launch once without recalls."  Luckily the FDA provides guidelines to help establish your strategic plans to achieve your goals of timely and successful FDA submissions, and passing FDA inspections with flying colors.

 Designing the strategy with you that fits your diagnostics product and your company. Get a comprehensive R&D strategy and pipeline portfolio aligned with a commercialization strategy and that encompasses design concept, feasibility, optimization, characterization, product development, design transfer, quality, and manufacturing. 

  Efficient and effective product design & development plans give you the power to deliver the right product on time and on budget. 

 Making sense of expansion planning of people, places, process, technology, and data. When is the right time and what is the right scale for you?

An organizational transformation plan that is “fit for your purpose” makes it easy to put the right people in the right place with the right tools at the right time.

 Is industry right for you? How far can you go?

Scientists have many career choices in the health care industry yet the paths and the pros/cons aren't always clear. 

Scientists contribute significantly to world health in many different roles from the lab bench to the executive offices, and in many areas such as R&D, Marketing, Quality, Regulatory, Manufacturing, Operations, or Sales.  

Together we will collaborate to define your real options and the specific path details that best fits your career desire.