Yesterday we had the pleasure of hearing a talk from Brad Slaker, Founder of DesignWise Medical. Pediatric medical devices are used to diagnose and treat diseases and conditions for children (up to age 21 years). Although some products are designed exclusively for children, other devices are borrowed from adult applications. Because children are smaller, more active, and have different body structures and functions, designing pediatric medical devices may be very difficult and challenging. Also, because a child’s body changes greatly during childhood, implanted materials raise concerns about long-term exposure to certain equipment and about device longevity. Unfortunately, children have not received the level of attention they deserve from either the medical device industry or the pharmaceutical industry. Where the problem lies is in the more niche areas of pediatric medicine where the financial story of these products cannot compete with those that are found in adult medicine.
“One thing I am realizing is that It takes a village to develop a pediatric medical device.” Katie Waitzman, RN, Inventor of SurTubeTM feeding tube system
This quote Brad presented really resonated for me. For the past 3.5 years, have been developing a lactation support product for mother’s separated from their baby at birth due to prematurity or other health issue. I have interviewed 20 clinicians, tested the device with new mothers, created over 14 iterations of the device and spent thousands of dollars on legal to protect the intellectual property. My team consists of an MBA/BioEngineer, a pulmonologist and myself. Our advisors are a list of clinicians and moms who have experienced the clinical problem we are addressing. I am working with a manufacturer who has walked me through regulatory pathways/manufacturing options, and QMS set-up. Finally, I have been fortunate to have recently won an award from the New England Pediatric Device Consortium and gotten further guidance finding my way through the labyrinth of considerations and concerns associated with medical device design. This area of design is not for the faint of heart. Once you are in it, and you believe in it, there is no way out!
Some of the key points Brad wanted to transmit to our students when working in medical device design were:
- Iterate Often and Fast
- Find A Clinical Champion
- Focus on Improved Outcomes &/or reduced Costs
- Design Testing & Evaluation Methods
- Seek data when none exists
- Understand The IP Landscape
- Understand The Regulatory Pathway
- Clinical trials needed?
- Minimum Viable Product
- Small Market funding challenges
- Understand buying challenges of customers
- Capital Equipment threshold
- Reimbursement landscape
Brad’s slide deck will be posted on the “Inspiration” tab of this class’s website.