Small, Innovative & Compliant: Innovation in Medical Device Domain comes from Small Companies

Design Assurance Engineer at Mallinckrodt Pharmaceuticals

February 2017

< 1 min reading time

A year ago, the panel of medical and academic experts at the US Policy Network’s annual meeting said that the fast-moving medical technology innovations are threatened by established interests and government regulations .

The challenges of getting innovative medical device products out to market are subject to major regulatory audits that take a lot of time and money for the manufacturers. With software being a medical device in its own right when it falls under the definition of a medical device, the medical device software developers have to adhere to the same regulatory requirements as large medical devices do. This means FDA approval for companies placing their products to market in the USA and CE mark for the EU. The path to approval is both time-consuming as well as costly with the average of 77% of a medical device budget required for regulatory compliance in the US. With the majority of innovation stemming from small firms, the ability to maintain the competitive position and to produce technologies to address the needs of patients is put at risk.

By the time that all the required standards are implemented in and regulatory audits are passed by a medical device company, the competition for innovative medical software products might already have increased and the window of opportunity might be closing quickly. It takes more than half a year to implement one standard alone on the path to compliance.

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Posted by Matteo Gubellini

Asked on February 20, 2017 12:00 am

67 views

like 11 comments

	Private answer Julie Omohundro Yes, this is all true. Medical products are not something to get involved in if you aren't prepared to take the risks and go the distance. Marked as spam like Report spam
	Private answer Aaron Liang Well said, medical products require large upfront capital investments and long time horizons for all the reasons the OP has mentioned. It will take years to realize potential returns and you have more risks due to the more regulated environment. That being said, I think it is still a very lucrative domain because of the market potential inherently present with people paying more attention to their health and longer lifespans. There are still opportunities for new market entrants, but the approach will be more grueling compared to other industries. That being said I don't think the biggest obstacle to commercial success is the FDA anymore. if anything, payers and reimbursement are bigger obstacles in the marketplace then the FDA now even if the current regulatory environment is a bit behind when it comes to things like SAMD. Marked as spam like Report spam
	Private answer Stephen Gibney Rather than seeing the regulations as an unfair barrier to market entry the pertinent question to ask is why do the regulations exist in the first place? Do they exist to protect the patient by ensuring medical devices (software included) are safe and effective. e.g. the Therac 25 incident where at least six patients where given massive overdoses of radiation because of concurrent programming errors. patients received radiation doses 200 times then the normal therapeutic amount resulting in death or serious injury. Given this information, it's pretty reasonable to ask that new medical devices are regulated prior to use. Marked as spam like Report spam
	Private answer Stephen Gibney Suggest anyone reading this article should read up on the Therac 25 incident to understand the reason why regulations exist for medical devices (including software) in the first place. Marked as spam like Report spam
	Private answer Matteo Gubellini The point is that the medtech market is missing opportunities, not that the regulations are to blame... Marked as spam like Report spam
	Private answer Julie Omohundro Matteo, then perhaps readers have misunderstood your meaning here: "The path to approval is both time-consuming as well as costly with the average of 77% of a medical device budget required for regulatory compliance in the US. With the majority of innovation stemming from small firms, the ability to maintain the competitive position and to produce technologies to address the needs of patients is put at risk." And/or here: "By the time that all the required standards are implemented in and regulatory audits are passed by a medical device company, the competition for innovative medical software products might already have increased and the window of opportunity might be closing quickly." If you did not mean to convey that the medtech market was missing opportunities due to regulation, then please clarify what other reason(s) you think the market is missing these opportunities? Marked as spam like Report spam
	Private answer Julie Omohundro "the average of 77% of a medical device budget required for regulatory compliance in the US" As far as I know, no one has any idea what percent of a medical device budget is required for regulatory compliance in the US. And no one ever will, unless they hack into a whole bunch of corporate financial databases. "It takes more than half a year to implement one standard alone on the path to compliance" Essentially the same problem here. Do you have a credible source to support these claims? By "credible," I mean one in which the methodology is presented in sufficient detail to be able to confirm its validity? Marked as spam like Report spam
	Private answer I agree that the 77% number appears hugely inflated. A small medical device client recently received 510(k) approval in less than 30 days and this and other compliance requirements are likely to be reduced further with a new administration in Washington. Last year's new PATH Act also helps medical device startups by allowing R&D credits to offset payroll taxes and not just profits. So as difficult as it is for new entries into a deservedly demanding industry to succeed, it's better now than it's been in many years. Marked as spam like Report spam
	Private answer Matteo Gubellini http://www.medtecheurope.org/sites/default/files/resource_items/files/ 01112010_FDA+impact+on+US+medical+technology+innovation_Backgrounder.pdf Marked as spam like Report spam
	Private answer Julie Omohundro Matteo, I'm painfully familiar with this study. It has negative credibility with me. Marked as spam like Report spam
	Private answer Antonin Cuc I am an State investigator HEALTH and Safety Medical Devices in user praxis. In the Clinic test on finished R+D there are most perfect supervised of mixed teams Phyiísicans and Technics, but in user phase there are Mass medical technical illegal misteks without surveillance - because all illeagel mistakes are evaluted in the false Medical Court message "as patient unhappy in frame respects Lege artis". This is a reason why in the Czech Republic yearly are nnedless heavy injured ansd preliminary casual dying about 40 thousands Patiebt CZ with false coding "Usual Patient risk in branches of Medicine" - but there are Mass criminal medical technical illegal working, out of Directive 93/42/EEC MDD, no Criminal Policy whould define the Lack of Physician technical basal skills in respects elementary Biomechanics, Geometry 3D, Radiologic Descriptive implanting - as Mass Murders! I am just dying after illegal assembling THA too. I suggest technical continual sampling of Medical working. Marked as spam like Report spam

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