COMMERCIALIZATION
Beyond marketing claims, regulatory approvals, and economics, successful commercialization requires effective compliance, order fulfillment, establishment of distribution channels, and detailed launch planning.
Let us help you. Stillwater MedTech Consulting has experience establishing best practices to ensure sales and marketing compliance, as well as setting up and operating order fulfillment, dealing with distributors, creating launch plans, and handling customer feedback and complaints.
Doing these things right can be the difference between a fruitful launch with sustained commercial success, and a bumpy launch with missed deliveries, disappointed customers, and regulatory exposure.
Stillwater MedTech Consulting has developed and administered compliance programs. We have also led and assisted teams through commercialization of products for all medical device classifications in the U.S., Canada, European Union, and Japan.
Wherever you are in the process, Stillwater Medtech Consulting can help you make sure your commercial launch is a success in the short and long term.
We offer assistance with the following:
Establishing a Distribution Channel
Planning and establishing customer service, order fulfillment, and shipping systems
Establishing commercial and quality agreements with distribution partners
Shipping direct or using 3rdparty distributors
Engaging freight forwarders and customs brokers to facilitate international shipments
Engaging Authorized Representatives in the EU
Launch Planning
Compiling a detailed plan for demand, production, and shipping to support a launch
Establishing customer feedback and complaint handling systems
Facilitating execution of the launch plan
Post-Mark Surveillance
Creating and executing a Post Market Surveillance Plan
Medical Affairs
Scientific exchange
Disseminating off-label information
How to respond to off-label questions and requests for off-label information
Medical Science Liaison training
Medical Information Request Form process
Marketing and Sales
Copy review
Claims matrix creation in light of regulatory approval
Claims substantiation
Competitive complaints
Marketing program compliance assessment
Compliance training
Assessment of compliance with privacy requirements
Engaging HCPs in financial relationships
Performing needs assessments
Direct-to-consumer Advertising (DTCA) and social media use
Collaborative marketing (co-marketing and co-branding with HCPs and health care entities (HCE))
Patient and HCP testimonials
Grants and charitable contributions to HCPs and HCEs
Special sales arrangements including rebates and discounts
Physician speaker training
Physician finders
Referral programs
Premarket approval communications
Meeting the fair balance requirement
Competitive claims
State and federal disclosure
State and federal disclosure
Mobile medical apps
AdvaMed and PhRMA Code compliance
Product evaluations
Loaner arrangements
Careful communications training
Reimbursement and health economic information do’s and don’t’s
Patient Assistance Programs (PAPs)
Temporary reimbursement bridge programs
Reimbursement support programs
Compliance hotlines