Who'll fill the neonatal innovation pipeline?

Who'll fill the neonatal innovation pipeline?

MacGyvers with Scissors and Tape

Thank you NICU Nurses! 

It seems appropriate this Thanksgiving weekend to give a shout out to champion NICU nurses who are often the unsung heroes in the healthcare system and the hidden MacGyvers in neonatal innovation.

During my stint shadowing Neonatal ICU nurses while trying to find unmet needs for a neonatal (preemie) startup, it became clear to me these nurse champions were a deep well of solid, untapped ideas. But more than people with ideas, they came up with real solutions. I often thought of Nurse Carmen like a Western gunslinger, but her weapons of choice were scissors and tape. Never have I seen a professional so adept at sizing, cutting and fixing tubes in place with such speed and accuracy. They truly are the MacGyvers of the healthcare system!

NICU nurses by necessity implement positive workarounds and find better ways to customize solutions for their tiny preemie patients. Why? From this entrepreneur’s viewpoint, the underlying cause is directly linked to market size. Neonatal healthcare is a niche market segment, less attractive to both large multinationals, midsize firms and the majority of startups. Product lines in medical consumables are often discontinued or some products are just too expensive to manufacture for the low demand. Combine this business reality with the challenges of conducting clinical trials on neonates for new devices or drugs, and the outlook is grim. In both medical device and drug development, we just keep seeing unacceptable shortcuts — miniaturization of adult medical devices or off label use of existing drugs. Encouraging Innovation in Neonatal Medicine.

Since 1999, there has not been a single new therapy approved by the Food and Drug Administration (FDA) for the newborn population.

Where is the innovation pipeline in neonatal care?

I never really thought of premature birth as a rare disease given the global numbers in developed, low and middle income, and developing economies (15 million premature births annually) yet neonatal innovation keeps getting the short end of the stick.

Proposed legislation in Congress offers some hope and will incentivize industry to develop more drug therapies via a voucher program with The Promoting Life-Saving New Therapies for Neonates Act of 2016. But the jury may still be out on whether vouchers will in fact spur innovation in drug development (Rare Diseases: Too Early to Gauge Effectiveness of FDA’s Pediatric Drug Voucher Program). [Keep track of progress on this bill at The Newborn Health Initiative.]

Likewise, medical devices may get a boost from the FDA’s recent Guidance on Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices. Extrapolation of adult data for pediatric use may benefit pediatric (and neonatal) patients by increasing the availability of medical devices and filling the evidence gap due to a lack of clinical trials supporting new devices.

However, these incentives and policy changes will take time.

Trends to watch

Patient-led, physician-led, healthcare-led innovation is gaining uptake. Patient-centric initiatives are now giving way to empowered patient/healthcare-led initiatives, co-creation opportunities and living labs. Nurses at leading children’s hospitals are becoming innovators and makers through initiatives such as the Institute for Pediatric Innovation and MakerNurse. Designers from Stanford’s D School program embodied their patients through design thinking and worked on Redesigning the Neonatal ICU.

The curtain is slowly being pulled aside in healthcare delivery. Startups today need to partner, co-create and get into the skin of the medical team, caretakers and patients. We are moving away from patient-centric concepts to healthcare-led initiatives. User-centric design of both products and services is also fueling this trend. The simple idea that design must begin and end with a deep understanding of the user, what they need to do and in what context/environment will dramatically change healthcare delivery in the coming years.

The American Medical Association’s physician-led innovation challengeempowered physicians, residents and medical students to submit their ideas, prototypes and solutions on how to deliver better healthcare (sadly no preemie projects posted). Crowdsourcing ideas with peer review has started to enter mainstream medicine from within. Who better than healthcare providers? They are a critical part of the solution.

Crowdsourcing ideas and solutions from every parent, grandparent, nurse, doctor, entrepreneur, designer, engineer or tinkerer is an essential driver in neonatal innovation. Only insights and input from the entire ecosystem can truly raise the standard of care and healthcare treatment options for premature babies.

The greatest ideas are the simplest and often found right under our nose.



Preemie Science

Preemie Science

It Takes A Village!

It Takes A Village!