Michael Smith’s Post

If you're at BPIA this week, be sure to check out this panel: "EPA Pesticide Registration Overview: Conventional, Biochemical and Microbial Pesticide Registration: What’s the Difference?"

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Looking forward to seeing everyone at the 2024 Association for Federal Enterprise Risk Management (AFERM) Summit tomorrow! For those looking to learn more about what being a Risk Champion looks like, come join Nikki Wood, Jovandra Sanderlin, CIA, CFE, MSM, Dr. Temika Edwards, and me for a great discussion on the topic, and ways to identify and elevate risk champions in enhancing Enterprise Risk Management in your institution! #RiskChampion #ERM #EnterpriseRiskManagement

Interesting discussion about AI in construction & design industry

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Building off of the key takeaways from Kelley Kendle it's so exciting to see where Med-Tech (Devices, Dx and Drug Delivery) is going with respect to prioritization of usability, accessibility and leveraging broad user/patient insights in all phases of development and the TPLC (total product life cycle). The proliferation of connected devices, gen AI, home healthcare and more complex user interfaces has increased the importance of incorporating user centered design considerations into product user interfaces, companion apps, and portals early in the ideation and design phases of development. Companies who get this right will have higher user acceptance, lower post-market development costs, and the ability to access real world data/evidence that will provide continuous insights from your customers and end users. Also loved to see the focus on advancing Women's Health - clearly one of the most under-represented groups in terms of device design, clinical representation and physician training (to name a few). Amazing to see the increasing focus and investment, and kudos to Tracy MacNeal who articulated the challenges and the path forward that we are all a part of, as well as her amazing work Materna Medical in all of these key areas.  So excited to see the continued push to improve and expand access to quality healthcare for all users and that key leaders from across Med-Tech are invested in these initiatives. ClariMed, Inc. #usercentereddevelopment #medtech #transforminghealthcare

Joe Dobkin and I had an amazing time at Medical Device Innovation Consortium (MDIC)'s Annual Public Forum. It was a wonderful group of change makers and leaders talking about discussing the needs of our industry and what they are doing to make it happen. One of the more poignant questions and answer was - why now? these problems have been around for decades….the answer, there is a realization that it just makes business sense and technology is enabling massive opportunities for improvement   Among the topics were:   1) Real word evidence and the power that it has to access diverse and underserved communities and bring them into the story, it also has the ability to support your reimbursement and move you through your conversations with CMS- data drives these conversations and reasonable and necessary is the key 2) Women and people of color are underserved and underrepresented in research and in healthcare, however 80% of the healthcare decisions are made by women for their households. We are changing that, but there is much work to be done. Changes still need to be made - from funding, to inclusion in research, in teaching about women’s health in education, in women and people of color being heard and trusted for knowing their own bodies and for the payer system to recognize and reimburse treatments so that the system can support this movement. Thank you Tracy MacNeal from Materna Medical for laying this out so clearly. 3) Patient engagement and usability is key in us creating products that not only meet the regulatory hurdles but that address the key problems that our patients and users are facing. This isn’t just about approval, this is truly about accessibility and gaining broader/deeper insights. Thank you Suzanne Schwartz, MD MBA for making that significant point and to Allen Keel for leading the way in sharing your research and tools on participant engagement across the lifecycle of design and development. Remember that accessibility means market share, which is just good business. 4) Quality matters, and not just that you have it, documenting and creating a robust, interoperable and collaborative eQMS to support your development and maintaining that earlier rather than later streamlines your activities and time and makes your business and your product more valuable to the market. According to Samantha Scott, PhD, CEO at JuneBrain Inc., all investors and prospective acquirers have asked whether they have an established eQMS and she is relieved to say that she does now, but learned from her mistakes by spending the first years in a paper excel based system.   There was so much more to learn and take away. I am already looking forward to next year to see the progress we've made on some of these initiatives. It doesn’t happen overnight but the momentum is there and the right people are listening and doing the hard work for the benefit of all. ClariMed, Inc. #medtech #transforminghealthcare #bettertogether

People underestimate the value of carbohydrates in wound healing. Water is a chemical that is held in place not by adding water, but by adding carbohydrates that can hold the water and oily type carbon compounds that can provide a barrier, this is true especially in cosmetics. Seems weird to discuss, but your facial dermis is very thin, and everyday sustains some type of trauma. Utilizing a really nice polymeric hydrogel such as hyaluronic acid coupled with collagen will help in holding water near and on the skin for absorption, and then layering with a final layer of oil based application will help provide a type of barrier, but also be absorbed into the skin allowing for better elasticity. Work like this has a very promising future in all areas.

Will be speaking about data storytelling & visualization, with a sprinkle of Stakeholder Whispering, in about 30 minutes #CAIR2024. See you soon!!

🎥 Missed a session at #GPUC24 or want to rewatch your favorites? You're in luck! 🙌 All recordings are available for up to 6 months on the event app and website. Don't miss this chance to revisit valuable insights, tips, and strategies shared during the event. 📲 Check out the app or visit our site to start watching now! #ImplementationSpecialists #IS #GPUC #Conference #EventRecordings