Welcome! We’re thrilled you’re interested in joining the Milkdrop Clinician Program.
This page provides more information for Lactation Consultants, Midwives, Doctors and Physical Therapists on Milkdrop cushions, including clinical observations, medical device registration and usage.
About the Milkdrop Clinician Program
Join a growing community of clinicians who are finding Milkdrop helpful for making pumping more comfortable and sustainable for their clients.
When you join the program you will receive:
- A Milkdrop cushion for you to demo with your clients
- A unique discount code for your clients
- Educational materials on how to use the cushion and exclusive access to our comprehensive evidence-based pumping guide, which will be released in late 2022.
- Potential giveaway opportunities to expand your audience reach.
What is the Milkdrop cushion?
The Milkdrop breast pump cushion is a soft silicone cushion that stretches over the head of most traditional breast pumps.
It is to be used by lactating women to provide a softer interface between the breast and the existing breast pump. It is included in the ARTG (#352892) as a Class I medical device and registered with the FDA.
Why did we design and manufacture the cushion?
Whilst feeding at the breast is typically clinically preferable to using breast pumps, a majority of women own or use a pump to express milk (Johns et al 2016, Clemons & Amir 2010, Labiner-Wolfe et al 2008).
There are benefits to using breast pumps; however, nipple pain and damage have been identified as adverse effects, occurring at a rate of about 15-17% (Qi et al 2014, Clemons & Amir 2010).
We designed the cushion with the objective of reducing nipple pain and discomfort by softening the interface between the breast and the pump.
Have there been any clinical evaluations of Milkdrop?
We undertook a pilot study to develop initial observations of the cushion. Two more formal clinical evaluations are planned for mid-2022. For now, you can download the results of our pilot by clicking the report below.
The pilot study was conducted in March 2021, which found:
- 92% of women found pumping more comfortable
- comfort increased (score: 5 /10 to 9 / 10)
- nipple swelling decreased (score: 6 /10 to 0 /10)
- nipple swelling decreased (6 /10 to 0.5 / 10), redness decreased (6 /10 to 0.5/10) and damage decreased (4/10 to 0/10) for women identifying as having an uncomfortable pumping experience.
- 73% of women collected about the same or more milk.
Further benefits will be evaluated through post-market studies, including the effect of the cushion on the perception of pain, comfort and milk production.
The cushion is 3-4x softer than existing breast pump cushions and over 10x softer than existing breast pump heads. The Milkdrop cushion measures 10A on the Shore Hardness scale measured with a durometer. Most breast pump heads inserts or cushions measure between 35 and 45A, and most breast pump funnels measure over 100A.
The softness and stretchiness also allows the nipple and areola to move down the flange and funnel with the pump suction. The nipple draws through completely, and the areola close to the nipple (normally also dragged into the pump even if sized well) is given some extra support.
We provide reusable, sterilisable cushions for use within your clinic or practice, and discount codes for patients ordering on your recommendation. Join our clinician program for more info. We'd be very happy to hear from you.
The cushion is designed to make pumping more comfortable for women experiencing pain, damage or discomfort from using breast pumps by providing a softer interface between the breast and the pump, and by allowing supported movement of the nipple and areola during suction.
Preliminary observations from our pilot in January 2021 indicated that lactating women perceived lower levels of pain, redness and swelling in the nipple, and higher levels of comfort when using the cushion on their existing pump. Most women perceived that they collect the same or more milk when using the cushion on their existing pump. However, 15% of women had difficulty with milk flow due to the 'bulkiness' of the cushion. We have since developed a second cushion design specifically for these women, which has been available since October 2021. This has reduce the rate of lower milk collection down to 5-10%. In September 2022 we will release our third design, which has four different sizes for nipple width: XS (15mm), S (20mm), M (25mm) and L (30mm).
Download our pilot preliminary observations report from early 2021. A clinical study is currently underway to assess the new cushion versions.
As of October 2022, Milkdrop cushions will come in four sizes: XS (15mm), S (20mm), M (25mm) and L (30mm).
To find the correct size, measure the nipple (not the areola) in milimetres, and choose the next largest size. The silicone is very soft and moulds (stretches or compreses) to the shape of the nipple, so there is a bit of leeway 1-2mm either side.
The XS, S and M cushions fit all pump flanges except XL (32mm+) flanges. Your client doesn't need to buy an additional flange to fit the Milkdrop cushions, although they work best on the original flange size that comes with the pump (usually a 24mm).
The L cushion fits XL flanges (32mm+). These sizes are quite rarely used, so please be sure to measure the nipple, not the areola when determining size.
Milkdrop fits these pumps.
Please contact us if you don't see the pump you're looking for. Chances are if it's a traditional pump style (not a wearable 'cup' style pump), that the Milkdrop cushion will fit.
The cushion is designed to withstand months of use if pumping up to 4x / day. If pumping more than that, please replace after 3-4 months or if your client notices any cracks or abrasions or yellowing, please replace.
The cushion is designed for re-use. Clean by washing in warm soapy water, then air dry on a clean towel. The cushion can withstand the dishwasher and steam sanitisers.
The silicone has been tested to withstand steam, ethylene oxide and gamma radiation sterilisation methods as specified by the silicone manufacturer (Wacker Chemie) without materially affecting the mechanical properties of the device:
- Steam - DIN EN ISO 17665 – ageing test specified in DIN EN 868-8, 134°C for 5 minutes
- Ethylene oxide (ETO) - DIN EN ISO 11135: 1h, 54°C, 600mg/L ETO
- Gamma radiation - DIN EN ISO 11137-2, 2007
If your organisation needs more detail on sterilzation procedures, please contact us at email@example.com
The device is made from USP Class VI silicone certified to ISO 10993 and manufactured in clean environment to ISO 14644. The silicone meets the food regulation requirements of FDA CFR Section 177.26000 and BIR Recommendation XV Silicone. Routine toxicology testing is undertaken on packaging. The device is included in the US, NZ and Australian registers for medical devices via the FDA, MedSafe and ARTG (#352892) as a Class I non-sterile, non-measuring device under GMDN code 35337: Shield, nipple, reusable.
The device is manufactured and sponsored by Milkdrop Pumps Pty Ltd from Bright, 3741 Australia.