MEDICAL DEVICE

MANUFACTURING

PART OF A

REVOLUTION

Below is a small sample of the services we perform for our clients.

 

Touch here to learn more about all of the services that we offer.

DEVICE REGISTRATION & APPROVAL

Blue Pearl provides consulting new and existing production processes for the manufacturing of medical devices.  With the continued growth of the medical device market, medical device companies are venturing into innovative development and applications.  We have helped companies evaluate and develop a manufacturing strategy – including evaluating and vetting contract manufacturers for the entire or partial manufacturing portion.

 

Additionally, the FDA approval process includes the manufacturing process detail, GMP (Good Manufacturing Practice), and requires more extensive process validation.  This also includes looking at the best practices and the use of reduced contamination areas / clean rooms.

Touch here to learn more about our work.

PRODUCTION

STRATEGY

Blue Pearl provides consulting new and existing production processes for the manufacturing of medical devices.  With the continued growth of the medical device market, medical device companies are venturing into innovative development and applications.  We have helped companies evaluate and develop a manufacturing strategy – including evaluating and vetting contract manufacturers for the entire or partial manufacturing portion.

 

Additionally, the FDA approval process includes the manufacturing process detail, GMP (Good Manufacturing Practice), and requires more extensive process validation.  This also includes looking at the best practices and the use of reduced contamination areas / Clean rooms.

There are numerous things that can complicate and frustrate the development and introduction of a new medical devices, to learn more about Blue Pearl’s experience touch here.

Touch here to learn more about our work.

MARKET / REIMBURSEMENT

STRATEGY

With expertise in finance, marketing and sales, Blue Pearl brings the expertise to help companies formulate a commercialization strategy for their device. We also believe, part and parcel of the market strategy, should be a comprehensive medical device reimbursement strategy.  It is key tool available for medical device companies align to investor expectations for increased margins and profitability.  Blue Pearl brings expertise in:

 

Code Creation –

  ICD-10, CPT, HCPCS

 

Payer Group Strategy

 

Timelines for new codes

 

Touch here to learn more about our work.

BLUE PEARL

CONSULTING

We are a boutique management and operations consulting firm dedicated to creating customized, research-based solutions for our clients.

980 N Michigan Ave.

Chicago, IL 60640

 

info@bluepearlconsulting.com

(312) 878 - 7230