Professional Solutions
Device Strategy Solutions (DSS) is a consulting firm specializing in strategic guidance, operational support, and regulatory expertise for medical device startups. Founded by a team of experienced medical device consultants, DSS is dedicated to accelerating innovation in the medical device industry by equipping startups with the tools and strategies needed to succeed in a competitive and highly regulated market.
Target Market
Early-Stage Startups: Providing comprehensive, end-to-end consulting services tailored to the unique needs of startups, encompassing clinical alignment, market analysis, regulatory navigation, operational excellence, and utilization strategies.
Growth-Stage Startups: Companies with working prototypes looking to navigate clinical trials and market entry. Pilot site launch and implementation. Market entry and commercialization strategy.
Investors: Venture capitalists and angel investors seeking due diligence and market insights for medical device investments.
Core Services
Regulatory Strategy and Guidance: Regulatory pathway analysis. Quality management system (QMS) implementation.
Product Development Support: Clinical trial design and coordination.
Market Entry and Commercialization: Market landscape analysis and competitive benchmarking. Go-to-market planning.
Operational Efficiency: Supply chain and manufacturing process optimization. Project management support for timely product launch.
Investor Relations and Fundraising Support: Preparation of investor pitch decks. Business case development. Valuation and fundraising strategies.
Value Proposition
Expert Knowledge: Industry experience and a deep understanding of medical device challenges, led by the owner's expertise.
End-to-End Support: Comprehensive services from initial development to market entry.
Results-Oriented Approach: Commitment to delivering tangible outcomes, such as regulatory approvals and successful product launches.
Owner-Driven Leadership: Hands-on involvement in all client engagements. Personalized consulting services tailored to each client’s needs.
Partnerships: Collaborations with key opinion leaders and strategists.
Client Engagement Process
Initial Consultation
In-depth assessment of client needs, goals, and challenges.
Strategic Roadmap Creation
Customized plans for market entry, company structure, and operational strategy.
Execution Support
Hands-on assistance in clinical trials, pilot site launches, and sales/marketing alignment.
Ongoing Advisory Services
Post-launch support for optimization, scalability, and long-term growth.