Developing medical devices for pediatrics brings both engineering and business challenges. The medical device industry is beginning to understand that kids are not simply smaller adults, but have unique design requirements. Unfortunately, major medtech companies just don’t know what to do about it. Read More
We have all read entrepreneurial experts push the idea of allowing yourself to fail. They even want you to do it fast. Basically, the longer it takes, the more “wasted money”. But, for a medical device inventor or company, the more precise advice may be to challenge your weaknesses early because they might fail in time for you to adapt or correct.
As inventors and start-up medtech companies, we are often afraid to show our warts, which means avoiding testing our potential Achilles heels, often until way too late in the process, when our decisions are more strained and our options are limited. Read More
The Healing Innovation (HI) blog has spent the last year making the case for greater collaboration between the medical device industry and clinicians. HI, however, has also blogged extensively about the conflicts of interests created by clinicians becoming PR mouthpieces for new products and clinical trial results. Read More
I grew up in the medical device industry when revenue-producing companies actually had internal R&D groups (and, I don’t even have any gray hair). Not “commercialization teams” or “New Product Development”, but actual investigation of novel medical device candidates.
Despite the many challenges that larger companies have in developing new products, to their credit most medical device companies have mastered the process of Stage-gate portfolio management. Start-ups and single product development efforts don’t typically manage a portfolio of projects, and hence have not paid as close attention to following a stage-gated approach. Read More
Incorporating clinical studies prior to design “freeze” into a medical device product development plan is foreign to some organizations, including supposedly nimble start-ups. Changing a company’s clinical research philosophy requires well-defined goals, proactive collaboration between functional areas and discipline. Read More
The current state of medical device product development has relegated clinical trials to achieving two goals: 1.) reaching a milestone for funding or exit, or 2.) supporting regulatory submissions. Unfortunately, what has been lost is the pursuit of learning that drives refinement of the device.
The standard for start-up companies these days, even prior to demonstrating feasibility, seems to be hiring a full operational management team. Considering the long clinical and regulatory pathway for novel medical devices, is there a justification for a dedicated executive team from the outset? Read More
