Critical success factors for a medical device company include developing a strong business plan, securing adequate funding, building a capable team, navigating the FDA approval process, and establishing reimbursement. The business plan should explain the vision and strategy, understand the market and competition, and include financial projections. Funding typically comes from personal investments initially and then venture capital. Assembling the right people with relevant expertise is also crucial. Navigating FDA approval and establishing reimbursement are major hurdles that require understanding regulations which are complex and changing.

21. Success