Interim Leadership I Business Development I Consulting
SUCCESS STORIES
Stay agile with on-demand medtech leadership that drives profitable results.
Medical device company redefines strategy and lands meetings with investors
Challenge
Hyblate Medical developed a self-adjusting ablation catheter to treat atrial fibrillation. It needed an interim CEO to lead the company to a decision point, raise funds to complete product development, and initiate clinical trials.
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Actions
I analyzed and re-evaluated the company’s technology, business model, market fit, industry trends, competitive advantage, budget, value proposition, regulatory strategy, clinical trial strategies, managed fundraising activities.
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Results
Company technology was aligned to the market trends.
The R&D plans and the budget were updated to support first in human studies.
Landed meetings with key opinion leaders, market leaders and potential investors.
Company overcomes R&D roadblocks and increases manufacturing capacity, product quality and management efficiency
Challenge
The company’s cardiology product was in an advanced concept stage, and aimed to be tested in an initial human study. The company struggled with major technological manufacturing roadblocks that stretched both the schedule and the budget.
Actions
Analyzed the technology, project structure, project team and management, and found the main roadblocks. To overcome the roadblocks, implemented root cause analysis and problem-solving methodologies, reorganized the project structure, and implemented product development and project management methodologies.
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Results
Overcame major R&D and manufacturing challenges. Decreased design cycle time, increased manufacturing capacity, product quality, project visibility and management efficiency, plus empowered team members.
From one product challenge to multiple viable product plans
Challenge
A promising product got held back by a significant technological challenge.
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Actions
I led think tanks with R&D and marketing. Initiated and implemented the innovative SIT (systematic inventive thinking) methodology.
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Results
Found a creative solution that helped this product move forward to First in human studies, plus initiated viable product plans for multiple additional products.
New medtech company receives project plan and budget, which support its fundraising efforts
Challenge
A MedTech CEO developed a next generation, multidisciplinary IVD device, and needed support in developing a project plan and budget.​
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Activities
Learned the niche quickly, managed subcontractors (software, hardware, optics, mechanics, QA and RA), built a project plan and created a budget.
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Results
The company received clear project and budget plans, that reflected the actual required resources, which supported the CEO with funding efforts.