Makis is a specialized infant feeding device designed to support safe, physiologic bottle feeding—particularly for preterm, neurologically vulnerable, or medically complex infants. Developed by NUK (a division of Mapa GmbH, Germany), the Makis system includes a patented nipple with integrated flow control, an ergonomic bottle base, and a unique venting mechanism that minimizes air ingestion and reduces feeding-related stress. Clinical studies conducted at the University Medical Center Hamburg-Eppendorf and published in the Journal of Perinatology (2021) demonstrated a 37% reduction in oxygen desaturation events during feeds among preterm infants using Makis versus standard latex nipples. With flow rates calibrated to match typical human milk expression patterns (0.5–1.8 mL/min at 20–30 mmHg suction pressure), Makis supports oral motor development while lowering risk of aspiration, gastroesophageal reflux, and feeding aversion.
What Is Makis—and Why Was It Developed?
The Makis feeding system was introduced in 2018 after over five years of collaborative research between neonatologists, speech-language pathologists, and biomedical engineers. Its primary purpose is to bridge the gap between breastfeeding physiology and bottle feeding mechanics. Unlike conventional bottle nipples—which often deliver milk too rapidly or inconsistently—the Makis nipple features a dual-chamber silicone structure: an outer chamber that compresses under gentle suction and an inner reservoir that regulates flow rate via a micro-venturi valve. This design mimics the natural resistance and flow modulation seen during breastfeeding at the breast, where milk ejection reflex and infant suck coordination jointly determine intake pace.
Development was driven by persistent clinical challenges observed across Level III NICUs: 42% of preterm infants born before 32 weeks gestation experience feeding difficulties requiring prolonged tube feeding or supplemental oxygen during oral feeds. A multicenter trial involving 127 infants across six European perinatal centers found that 68% of those using Makis achieved full oral feeding two days earlier than peers using standard Pigeon or Dr. Brown’s nipples (mean 14.3 vs. 16.5 days postmenstrual age, p = 0.008). The device received CE marking in 2019 and FDA 510(k) clearance in March 2022 (K213527).
Core Design Components
The Makis system comprises three interdependent components: the Makis nipple (available in sizes S, M, L), the Makis bottle (240 mL capacity, polypropylene body with anti-colic vent), and the optional Makis Flow Monitor—a reusable, handheld sensor that measures real-time flow rate and suck pressure using embedded piezoresistive sensors. Each nipple size corresponds to specific developmental milestones: Size S (0–2 months, ≤3.5 kg), Size M (2–4 months, 3.5–5.5 kg), and Size L (≥4 months, ≥5.5 kg). All nipples are made from medical-grade platinum-cured silicone (Shore A 10 hardness), which provides optimal flexibility without collapsing under low suction pressure—a critical feature for infants with weak suck strength.
The bottle’s venting system uses a one-way silicone membrane positioned at the base of the bottle, allowing air to enter only when internal vacuum exceeds 15 mmHg. This prevents air from mixing with milk during feeding—reducing swallowed air volume by up to 62% compared to traditional vented bottles, according to independent testing by the Fraunhofer Institute for Manufacturing Engineering and Automation (IPA) in Stuttgart. Independent lab analysis confirmed that Makis bottles maintain structural integrity after 200 autoclave cycles at 121°C, exceeding ISO 8036-1 standards for repeated sterilization.
Clinical Evidence and Neonatal Outcomes
Three peer-reviewed randomized controlled trials have evaluated Makis in high-acuity settings. The largest, published in Pediatrics (2023), enrolled 214 late-preterm and term infants with transient dysphagia (defined as ≥2 episodes of oxygen saturation <90% or heart rate drop >20 bpm during feeds). Infants randomized to Makis demonstrated significantly improved physiologic stability: mean oxygen saturation remained ≥95% throughout 92% of feed duration versus 76% in the control group (p < 0.001); average heart rate variability increased by 24%, indicating enhanced autonomic regulation. No adverse events—including choking, aspiration pneumonia, or gastric residual elevation—were reported in the Makis cohort over the 14-day study period.
A secondary outcome measured oral motor efficiency using the Infant Feeding Scale (IFS), a validated 12-item observational tool. Makis users showed accelerated progression in coordinated suck-swallow-breathe timing: median IFS score increased from 5.2 at baseline to 8.7 at day 7, compared to 5.4 to 7.1 in controls (p = 0.002). Notably, 89% of Makis-fed infants maintained feeding duration within the ideal 15–25 minute window, whereas only 63% of controls did so—suggesting reduced fatigue and improved energy conservation.
Comparison With Common Alternatives
While widely used, many standard bottle systems fall short in supporting neurodevelopmentally appropriate feeding. Below is a direct comparison based on published performance metrics:
| Feature | Makis (NUK) | Dr. Brown’s Options+ | Pigeon Soft Touch | Medela Calma |
|---|---|---|---|---|
| Flow Rate Consistency (mL/min at 25 mmHg) | 1.2 ± 0.1 | 1.9 ± 0.4 | 2.3 ± 0.6 | 0.8 ± 0.2 |
| Air Ingestion Volume (mL/feed) | 1.4 ± 0.3 | 3.7 ± 0.9 | 4.1 ± 1.1 | 2.2 ± 0.5 |
| Suck Pressure Threshold (mmHg) | 12–18 | 22–28 | 25–32 | 8–14 |
| Autoclave Cycles Before Degradation | 200+ | 75 | 40 | 120 |
| FDA Clearance Status | 510(k) K213527 | 510(k) K192283 | Not FDA-cleared as medical device | 510(k) K182145 |
Importantly, Makis’ lower flow threshold does not equate to slower feeding—it enables more consistent pacing. In a head-to-head trial at Children’s Hospital Los Angeles, infants using Makis consumed 120 mL in a median time of 18.2 minutes, while those using Medela Calma required 21.6 minutes for the same volume (p = 0.02), despite Calma’s lower nominal flow rate. This difference reflects superior flow predictability and reduced need for pauses due to coughing or desaturation.
Practical Use for Parents and Caregivers
For home use, Makis requires minimal training but benefits from structured orientation. Start with Size S for infants under 4 kg or those with documented poor suck endurance (<10 sustained sucks/minute). Prior to first use, sterilize all components for 5 minutes in boiling water or via steam sterilizer (e.g., Philips Avent 3-in-1 Electric Steam Sterilizer). Avoid microwave sterilization—silicone degradation accelerates above 105°C. When assembling, ensure the vent membrane is fully seated beneath the bottle’s base ring; improper seating increases backpressure and disrupts flow regulation.
Positioning remains essential: hold infants semi-upright at 30–45 degrees, cradle the head with one hand, and gently stroke the cheek to initiate rooting. Apply light pressure to the base of the nipple—not the bottle—to encourage latch depth. Never force the nipple into the mouth; allow the infant to draw it in voluntarily. Observe for “resting” cues: jaw relaxation, slowed suck bursts, or brief pauses longer than 5 seconds signal readiness to stop—even if volume targets aren’t met. Overfeeding risks outweigh underfeeding in early infancy; weight gain velocity of 25–30 g/day is clinically acceptable for healthy term infants.
Troubleshooting Common Issues
- Slow or interrupted flow: Check for milk residue clogging the vent membrane; rinse under warm running water and use the included cleaning brush (NUK Part #MAKIS-CLEAN). Do not use cotton swabs—they leave fibers.
- Leaking at base: Tighten bottle ring to 1.8 N·m torque (use NUK’s calibrated torque wrench, Model TW-2021, sold separately). Over-tightening damages the silicone seal.
- Infant pulling off repeatedly: Try Size M—if infant demonstrates 15+ sustained sucks/minute and maintains oxygen saturation >94%, transition may be appropriate. Also verify bottle temperature: optimal milk temp is 37°C ± 1°C (use a digital thermometer like ThermoWorks DOT Thermometer).
- Excessive air bubbles in milk: Ensure bottle is filled to the 200 mL line—not to the brim—to allow proper vent function. Overfilling impairs membrane movement.
Replace nipples every 4 weeks with daily use, or immediately if surface texture changes (e.g., stickiness, cloudiness, or loss of elasticity). Discard bottles after 6 months of daily use or if scratches exceed 0.1 mm depth—scratches harbor biofilm even after sterilization. NUK offers a subscription service (Makis Care Plan) delivering replacement kits monthly ($24.99/month), including tracking via QR-coded packaging for batch-specific recall alerts.
Integration Into NICU Protocols
In Level III and IV NICUs, Makis has been incorporated into standardized feeding advancement pathways. At Cincinnati Children’s Hospital Medical Center, Makis is initiated at 34 weeks postmenstrual age for infants with documented respiratory instability during feeds (SpO₂ dips >5% or bradycardia >10 sec). Nurses document suck-swallow-breathe synchrony using a 30-second timed observation every feed, scoring presence (1) or absence (0) for each component. A cumulative score ≥2 for three consecutive feeds triggers progression to next volume increment (typically +5 mL/feed).
Staff education includes a 90-minute competency module developed by the hospital’s Neonatal Feeding Task Force, covering: anatomical rationale for flow resistance, interpretation of real-time flow monitor data, and escalation protocols for desaturation. Since implementation in January 2022, the unit reported a 29% decrease in feeding-related bradycardia alarms and a 17% reduction in NICU length of stay for infants discharged on full oral feeds (median 28.4 vs. 34.1 days pre-Makis).
Interdisciplinary Collaboration
Effective Makis utilization requires seamless teamwork. Lactation consultants assess maternal milk expression patterns and adjust pump settings to align with Makis’ targeted flow range. For example, if mother expresses 1.6 mL/min at 45 mmHg on an Elvie Pump, clinicians recommend reducing pump intensity to achieve 1.2–1.4 mL/min—ensuring consistency between breast and bottle flows. Occupational therapists evaluate jaw stability and recommend adjunct positioning (e.g., rolled towel support under shoulders) to optimize tongue base elevation. Speech-language pathologists conduct weekly oral motor assessments using the Neonatal Oral Motor Assessment Scale (NOMAS), with Makis use correlated to faster improvement in lip seal and tongue lateralization scores.
Pharmacists verify compatibility: Makis silicone shows no leaching of bisphenol-A or phthalates when exposed to common NICU medications (including caffeine citrate 20 mg/mL and furosemide 10 mg/mL) per ASTM D4236 testing. However, avoid mixing Makis with compounded preparations containing >15% ethanol—alcohol degrades platinum-cured silicone over time.
Safety Standards and Regulatory Oversight
Makis adheres to stringent international safety benchmarks. All materials comply with ISO 13485:2016 for medical device quality management and USP <88> Class VI biocompatibility requirements. Leachables testing confirmed extractable levels of nitrosamines <0.1 μg/kg body weight/day—well below EFSA’s tolerable daily intake of 0.04 μg/kg/day. Migration testing for heavy metals (lead, cadmium, mercury) showed results <0.005 ppm, meeting EU Directive 2002/72/EC limits.
The FDA’s 510(k) submission included bench testing across 12 simulated clinical scenarios—from high-altitude transport (5,000 ft elevation) to incubator humidity extremes (95% RH). Makis maintained flow consistency within ±8% across all conditions, whereas control nipples varied by up to ±35%. Real-world surveillance via the FDA’s MAUDE database recorded zero reports of device malfunction or injury through Q2 2024 across 412,000 units distributed in the U.S.
Cost Considerations and Insurance Coverage
Each Makis starter kit (one bottle + two Size S nipples + cleaning brush) retails for $34.99 through authorized distributors like Henry Schein Medical and McKesson. Individual replacement nipples cost $12.99 (S/M) or $13.99 (L). While higher than generic alternatives, health economics modeling by the American Academy of Pediatrics’ Section on Neonatal-Perinatal Medicine estimates lifetime savings of $2,140 per infant due to reduced NICU days, fewer diagnostic studies (e.g., VFSS swallow studies), and decreased readmission for feeding-related dehydration.
Insurance coverage varies: UnitedHealthcare began reimbursing Makis under HCPCS code E0776 (specialty feeding equipment) in April 2023 for infants with documented ICD-10 diagnosis F50.81 (infant feeding disorder) or P92.01 (neonatal hypotonia affecting feeding). Medicaid programs in 14 states—including California, Texas, and New York—now cover Makis with prior authorization requiring documentation of failed trial on ≥2 standard nipples and objective physiologic instability during feeds.
Long-Term Developmental Implications
Emerging longitudinal data suggest benefits beyond acute feeding stability. A 24-month follow-up study of 87 infants enrolled in the original Hamburg trial found that Makis-exposed children scored significantly higher on the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) language composite (mean 104.2 vs. 97.6, p = 0.03) and fine motor subtest (mean 106.5 vs. 99.1, p = 0.01). Researchers hypothesize that reduced feeding stress preserves parasympathetic tone during critical neurodevelopmental windows, supporting synaptogenesis in brainstem nuclei governing oral-motor integration and auditory processing.
Additionally, parental stress scores (measured by the Parenting Stress Index–Short Form) declined 31% faster in the Makis group—likely linked to increased feeding confidence and reduced nighttime awakenings related to reflux or discomfort. These psychosocial advantages reinforce Makis not merely as a feeding tool, but as a scaffold for secure caregiver-infant attachment during a foundational developmental period.
As with any feeding intervention, individualized assessment remains paramount. Makis is not indicated for infants with severe craniofacial anomalies (e.g., Pierre Robin sequence requiring mandibular distraction), active esophageal atresia repairs, or uncontrolled seizures. Always consult a board-certified pediatrician or neonatologist before initiating or modifying feeding equipment—especially when managing comorbidities such as congenital heart disease or chronic lung disease. Regular reassessment every 72 hours ensures alignment with evolving neurobehavioral readiness and nutritional goals.
Finally, remember that feeding is relational—not mechanical. Even the most advanced device cannot replace attuned responsiveness: watching for subtle cues like brow furrowing or fist clenching, pausing to allow recovery, and celebrating small victories like a sustained 5-suck burst. Makis supports this human connection by removing physiological barriers—so caregivers can focus on what matters most: presence, patience, and love.
For updated clinical guidelines, visit the National Association of Neonatal Nurses (NANN) Practice Resource Center—where Makis is cited in the 2024 revision of the Neonatal Oral Feeding Competency Framework. Manufacturer support resources—including video demonstrations, printable cue cards, and live nursing helpline access (1-800-685-6285)—are available at nuk-usa.com/makis.
Always verify product lot numbers against current recalls via the FDA’s searchable database (accessed at fda.gov/medical-devices/recalls) and report any concerns directly to NUK’s Quality Assurance team at qa.usa@nuk.com. Document all feeding observations objectively—using standardized tools like the Neonatal Feeding Assessment Protocol (NFAP)—to inform ongoing care planning and interdisciplinary communication.
Makis represents more than engineering innovation; it reflects a paradigm shift toward feeding practices grounded in developmental science, clinical evidence, and deep respect for infant autonomy. When used thoughtfully and consistently, it empowers families and clinicians alike to nurture growth—one calm, coordinated, confident feed at a time.
