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