The amount spent by pharmaceutical firms, medical-device manufacturers, and other life-sciences companies for the regulatory guidance to move products to market is estimated at a staggering $20 billion to $30 billion a year.
Time spent on the work is typically a big number, too - more accurately measured in months, not minutes.
In that, Priya Bhutani saw business opportunity.
She launched RegDesk in November 2014 to provide, in part, a marketplace to crowd-source regulatory consultants who would help medical-device and pharma companies launch their devices and drugs faster in more than 170 countries.
Bhutani, a 35-year-old Delaware resident, also has an altruistic motive behind increasing speed-to-market:
"If we can save one life, it's worth it," she said, citing the loss of family members whose deaths have left her wondering whether they could have been avoided or delayed had some treatment in the regulatory pipeline been green-lighted sooner.
She did not set out to head a high-tech consultants-matchmaking company - a business she acknowledged as "a very unsexy idea."
With bachelor's and master's degrees in biomedical engineering from the University of Illinois and a master's in quality assurance and regulatory sciences from Northwestern University, Bhutani worked briefly as a new-product development engineer for a medication delivery company before - craving more interface with customers - she got into marketing and sales.
She "realized how complex the regulatory landscape is," and how trying it is for companies to have to maneuver through it to get their products in consumers' hands.
"All that effort and money that has been invested is in vain without regulatory approval," Bhutani said. "It is a very, very critical aspect of our ecosystem."
Daunting, too, given that regulatory requirements differ per country and per drug - and are ever-changing.
"So if your product requires a certain regulatory pathway today, that may not be true the following year," Bhutani said. "There is a lot of anxiety around global expansion."
That's especially true for small businesses, where capital and personnel are limited, as is the know-how to break into, for instance, the prescription-drug market in India, Bhutani said. Among the hurdles she cited were language and cultural differences and a lack of knowledge over where to run clinical trials.
"We have created this streamlined, Web-based technology. . . . It makes it easier for companies to expand," she said.
Currently consisting of a five-member operations and development team with headquarters in co-working space in University City Science Center, RegDesk offers three specific features, rolled out in phases over the last 17 months:
A marketplace where companies can find, hire, manage, and pay for regulatory services in more than 170 countries.
Regulatory intelligence from vetted experts.
An alert system that updates clients of any regulatory changes affecting their products in their target geographic markets.
Annual subscriptions for the intelligence and alert services cost upward of $40,000 each.
For the marketplace service, RegDesk gets a 15 percent cut of the fee negotiated between clients and the regulatory experts they contract through RegDesk's platform.
Bhutani would not disclose revenues but said the company is able to cover its overhead.
Impressed with the RegDesk concept, DreamIt Health Philadelphia, the health-care investment arm of start-up accelerator DreamIt Ventures, has provided $50,000 in funding.
Bhutani herself was a big reason for that, especially her "grasp of the space, the opportunity, and the regulatory sphere," said Elliot Menschik, who started and ran DreamIt Health Philadelphia for three years.
That's not to say the road ahead is without challenges.
"The biggest risk or challenge is getting prospective customers to change their standard behavior to working with RegDesk," Menschik said, noting its target market is "a very risk-averse industry. People may not be rushing to try something new, even if it may shave a year off their time to market."
"The challenge for RegDesk is winning over enough customers to be a self-sustaining business and having enough wins and proof points to start to sway the more conservative customers to try something new," he said.
Tissue Analytics, an 18-month-old start-up in Baltimore that developed a human skin wound-analysis system, has used RegDesk for two projects involving "the kind of moving target that is mobile compliance with patient information and the changing regulatory landscape," said Kevin Keenahan, cofounder and CEO.
"It allows crowd-sourcing in this really specialized area of medical legal affairs that's usually really, really difficult for start-ups to access," Keenahan said.