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
As we have discussed on many occasions on the Healing Innovation blog, most clinicians have a drive to improve medicine. Many clinicians come up with great ideas in the course of their work. They see a problem that needs to be solved, and a better way to do something that can improve the implementation method, outcomes for patients, or both. Unfortunately, many of these medical professionals that have great ideas, do not know where to begin to put these ideas into action and ultimately into a product. Of course anyone can look online for information on how to start a business, however it always seems easier “read” than done. Read More
Healing Innovation posted a blog over one year ago about medical device startup companies hiring infrastructure before needed. We have also blogged about medical device virtual companies. All medical device companies outsource some aspect of their business, but our premise is that in the early stages, medtech startups should focus on their core competency and outsource everything else. Read More
I’m not sure why it has not received more attention in the medical device start-up world, but the Entrepreneur Access to Capital Act (EACA), which recently passed in the U.S. House of Representatives, has the potential to open the door to intriguing fundraising possibilities for individual medical device innovators and start-ups. Read More
In a recent post on PEHUB (Private Equity Hub), John Lonergan, Managing Member of Mach Ventures, made the case for virtual medical device product development. Mach Ventures’ business model is “we sell our medical devices just after we’ve proven that they work, or after FDA approval—no infrastructure, no management, and no duplication that the acquirer needs to get rid of.” Although he doesn’t use the term, that sounds virtual to me.
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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







