Product Launch

Product was in extensive clinical trials with no definitive date for regulatory approval.  Revenue opportunity required preparation of a launch and go-to-market plan in a very short time in order to be ready when approvals were received.

Obstacles: Resource constraints and lack of internal processes for product launches.

Actions: Established a team for collaboration among upstream and downstream marketing and sales representatives to develop a launch plan, create sales tools (print media and web tools), and a launch package.  Provided weekly updates to senior management on status and maintain support for activities.

Results: All launch materials completed ahead of receiving regulatory approvals.  Ultimate sales growth went from $14M (pre-market clinical sales) to $52M (60% of total company revenue) in 4 years.


Establish KOLs

The business had never assembled a set of consultants (Key Opinion Leaders, KOLs) to review product plans and provide feedback on products.  As a result, there was no regular method to establish the voice of the customer.

Obstacles: Resource constraints and access to KOLs was limited.  Management was skeptical about spending money on developing a panel.

Actions: Established a collaboration between R&D and marketing to demonstrate the value to the business.  Gathered funding for the first KOL panel as part of the R&D budget and incorporated it into the product development process.

Results: Established the company’s reputation among thought leaders and improved the quality and timeliness of product feedback.



Sales for two new and innovative point-of-care tests were lagging due to lack of test-specific Current Procedural Terminology (CPT®) codes and payment rates.  Payment was low and claims denials were high.  Company needed to establish new codes and position the tests for appropriate reimbursement by payers.  Note that CPT is a registered trademark of the AMA.

Obstacles:  No existing reimbursement staff or expertise

Actions:  Submitted applications for new CPT codes to the American Medical Association (AMA). Built coalition support for codes with key industry stakeholders.  Developed economic analysis supporting appropriate reimbursement and presented recommendation to the Centers for Medicare and Medicaid Services (CMS).

Results:  Awarded new codes by AMA and favorable payment decision by CMS.  Product sales increased 50% per year due to increased returns to the physician.


New product initiative

Business with strong market position in a slow-growth segment.  Emerging competitors posed a new threat to existing products.

Obstacles: Time to develop a new product line may exceed the window of opportunity.

Actions: Completed a strategic market assessment with a cross-functional team (corporate development, market research, R&D, marketing management).  Identified IP that would help facilitate development and provide future protection, worked with corporate development for licensing.  Established intense development program with R&D, including co-locating the cross-functional team.

Results: Product launch in 18 months, including regulatory approval.  Increased business growth rate from 3% to 9%.  Division annual revenue grew from $279M to $352M over 5 years.


International market development

Start-up company needed to develop a revenue stream.  No regulatory approvals were available and the timing for receiving them was unpredictable.

Obstacles: No existing staff or infrastructure.

Actions: Established a strategic relationship with a distributor partner for EU, established a single-person office to support new distributors.  Identified and established a partnership with a local company to assemble, complete local regulatory requirements, and ship products to distributors.

Results: Established a revenue stream to support on-going US operations.  Developed in-house capabilities to meet regulatory requirements.  Established a pattern for expanding to other countries (went to Japan after EU), with successful roll-out in the western Pacific rim.


Organize for success

Marketing department was staffed with people with strong technical skills while there was a need for people with strong marketing skills (reading market trends, developing business plans, completing forecasts, conducting effective product launches, developing promotions, expanding the media mix).

Obstacles: Existing staff with “old school” skills, limited resources (budget).

Actions: Eliminated selected positions, shifted people to other departments where possible, upgraded talent when finding replacements (created two opportunities to do so).

Results: Reduced staff by 15%, increased effectiveness of existing staff, increased motivation.