Many medical device companies want to go to Japan since it is the third-largest market in the world. Oftentimes, device companies want to register their devices quickly in Japan to be on the market and are not focused enough on the initial medical device reimbursement they will get. This can lead to an unprofitable business if the Japanese reimbursement price is not higher than the sales price in Japan. Are there strategies to increase reimbursement?
The FDA conducts approximately 12,000 domestic inspections and 3,000 foreign inspections each year in more than 90 countries. U.S. manufacturers undergo frequent, unannounced inspections, foreign firms have often had weeks to prepare, undermining the integrity of the oversight process.
The industry’s heavy reliance on waterfall project management has resulted in long, siloed, and high-risk product development cycles. This model does not accommodate evolving regulations, shifting geopolitical realities, or fast-changing healthcare needs.
Evolving regulations and market requirements have kept medtech companies on their toes for years. EU MDR, for example, has been a top priority and now, more companies are moving toward EU MDR sustainability. As we look ahead to an unpredictable year in medtech, three areas stand out as opportunities for medtech to drive meaningful progress. AI, recall management, and regulatory intelligence could be key differentiators for medtechs — if approached strategically.
Under IVDR, clear and specific IVD intended use criteria are required and introduce significant challenges for manufacturers seeking CE Marking and global market access. With updated compliance deadlines approaching, how can manufacturers manage risk and avoid regulatory delays and disruptions in their market strategies?
Clear and specific IVD intended use criteria are required and introduce significant challenges for manufacturers seeking CE Marking and global market access. With IVDR compliance deadlines approaching, how can manufacturers manage risk and avoid regulatory delays and disruptions in their market strategies?
Neo-Tee T-Piece resuscitator is being removed due to a undersized spring in the controller.
Speed control circuit board issue that may cause the motor to be unresponsive to the user.
Use instructions updated for Varipulse ablation catheter due to a high rate of stroke or transient ischemic attack.
The FDA hasn’t released official numbers on the terminations, but former FDA officials have pegged the number at roughly 700, with more than 220 coming from the medical device center. That would represent roughly 10% of the program’s total staffing.
