Brent Janaky, MBA

Ever found yourself facing unexpected hurdles when trying to rapidly scale your biotech or medtech operations to meet increasing demand? If so, you're not alone. In my experience at Accumold, I've observed numerous high-performing engineering teams encountering similar challenges. For all of you high-performing biotech / medtech engineers, R&D and strategic supply chain managers, there will come a time you need to scale fast to meet demand spikes. Here's what happens... Analyzing hundreds of successful rapid-scale projects in my work at Accumold, there are a few patterns you need to know and moves you can make now to anticipate equipment limitations, supply chain disruptions, workforce capacity constraints, and quality control issues. Many engineers came to us facing bottlenecks from insert vendors, material shortages, and quality control issues when scaling. Re: insert vendors: they run into bottlenecks due to limited capacity or lead times, which can slow down production schedules. Additionally, variations in insert quality or compatibility issues may arise, affecting the overall assembly process. We anticipate this by building an extensive network with reliable insert vendors in advance. Close collaboration with these players ensures timely delivery, consistent quality, avoiding compatibility concerns. (A big deal in our micro world.) Re: material shortages: this really hurts production timelines, putting you in a position to compromise product quality, production downtime, increased costs, missed deadlines, and loss of revenue. I've noticed our team works with our suppliers to forecast material availability and anticipate these potential shortages. Expertise in material selection/sourcing allows us to offer alternative materials or recommend inventory management strategies. One final note... when scaling production to meet increasing demand, quality control must remain a focus area. Because we're the sole micro molding partner for a large percentage of our customers—we have to get this right. Rapid scaling without a plan will strain existing quality control processes, leading to inconsistencies or defects in the final product. Unrelenting quality control measures are a big deal. I'll write up more on this and post. The final word here is this: Successful engineering teams like yours should conduct thorough risk assessments, develop contingency plans, and establish clear communication channels with all stakeholders to address any unforeseen issues swiftly and effectively. What did I miss? What challenges have you run into when rapidly scaling? #SupplyChainManagement #QualityControl #CollaborativePartnerships #MicroMolding #Accumold

13

AI is not just changing how we manufacture; it’s redefining what’s possible. Major industrial powers are leveraging AI to stay competitive, automating tasks, predicting maintenance needs, and optimizing supply chains. This technological leap isn't just about efficiency—it’s also driving sustainable practices and reducing waste. As AI continues to evolve, the manufacturing sector stands on the brink of unprecedented innovation. Imagine a future where technology and industry work hand in hand for a better, more efficient world.

614

8 Comments

Here's how we've leveled up in Robotics at Persist 🤖 💵 Level 1: Buy basic liquid handlers Level 2: We realized that liquid handlers aren't good enough. So we integrated stepper motors, X-Y stages, etc. that other companies sell Level 3: We realized that there's too little control built into commercial equipment from Level 2. So, we built our own... Now: We don't even bother with buying equipment, we use OEM components and put them together from the ground up and then write our own software for control

17

I woke up thinking about sample volume today (yes, I am weird like that. I often tell customers to "allow yourself to dream a bit about what protein signatures might be hidden in your sample" so maybe I was dreaming). Anyhow, I digress! Since getting more (data) from less (sample) is a theme I asked Chat GPT to enumerate the potential. Interesting results___ 👇🏽 Look who made the list ❓ Q_ How many multiomic techniques can you do from one blood sample? A_The number of multiomic techniques that can be performed from a single blood sample has significantly increased with advancements in technology. Here are some key multiomic techniques that can be done from one blood sample: Genomics: Whole genome sequencing (WGS) Whole exome sequencing (WES) Targeted gene panels Transcriptomics: RNA sequencing (RNA-seq) microRNA profiling Epigenomics: DNA methylation profiling Histone modification analysis Chromatin accessibility (e.g., ATAC-seq) Proteomics: Mass spectrometry-based proteomics Antibody-based protein arrays 👉🏽 Proximity extension assay (PEA) Metabolomics: Mass spectrometry (MS)-based metabolomics Nuclear magnetic resonance (NMR)-based metabolomics Lipidomics: MS-based lipid profiling Glycomics: MS or liquid chromatography (LC)-based glycan profiling Cytomics: Flow cytometry CyTOF (cytometry by time-of-flight) Microbiomics: 16S rRNA sequencing Shotgun metagenomics Each of these techniques provides different layers of biological information, from genetic variations and gene expression levels to protein abundance and metabolic states. By integrating data from these diverse omics approaches, a comprehensive understanding of biological systems can be achieved. The feasibility of performing multiple techniques from one sample depends on the initial sample volume and the efficiency of the sample processing and extraction methods. Advances in technology and methodologies have made it possible to maximize the information obtained from even small blood samples. 💪🏽 with all these options I UNDERSTAND WHY USING <5UL OF SAMPLE GETS Olink Proteomics CUSTOMERS SO EXCITED!

32

3 Comments

🔥 When Success Becomes a Challenge. We’ve hit an exciting milestone: our products are flying off the shelves! 🌟 But here’s the twist: sometimes, success can be a double-edged sword. Let me explain. 🔍 Our Fantastic Five: HemoTypeSC: The superhero of diagnostics! Detects Hemoglobin A, S, and C—essential for diagnosing Sickle Cell Disease. 🩸 Watersafe Lead Test: Keeping homes and families safe. 💧 Watersafe Rapid Bacteria Test: Fast, accurate, and bacteria-busting! 🦠 Watersafe Drinking Water Test Kit: Because hydration matters. 💙 RapidBacVet: Unmasking bacteria in urine samples like a detective. 🕵️‍♂️ 🛒 The Catch?  HemoTypeSC, Watersafe Lead Test, and RapidBacVet are currently sold out. 🙅‍♂️ 3 out 5. Of course, I'm trying to focus on the other products that are currently available, on marketing aspects like preparing new campaigns and marketing materials, and on working with customer satisfaction as much as I can to keep them happy. Have you faced a similar situation? How did you turn scarcity into opportunity? Share your wisdom below! 👇 #SuccessStories #Innovation #Rapidtest #Sales #SalesStrategy #gruzdev P.S. If you’re reading this, you’re part of our success story! 🙌

5

Wednesday Q&A!! (Sharing stuff I've learned while working at BLUUMBIO) How can we learn about contamination and pollution issues in our area? It's easy to notice issues we sense -- litter blowing around, smokey exhausts, noxious smells, etc. But what about the stuff you can't see/hear/smell/touch/taste? A great place to start is with Clean-ups in My Community. It's a federally-supported map of hazardous waste sites and key info. Simply zoom-in to the areas you're interested in, start clicking, and begin going down the wormhole. (https://map22.epa.gov/cimc) The next best place is your state's database. We're lucky to have EnviroStor in California that can help you drill-down on land-use histories, remediation plans, and get in-touch with those helping to oversee the clean-up process. (https://lnkd.in/gTjNM477) Knowing about contamination near you is just the beginning. Many sites go years without proper treatment for a host of reasons, many having to do with budget and complicated work plans. We're accounting for this at BLUUMBIO by designing nature-friendly products to reduce cost and complexity of in-situ treatments. Cheaper, more straightforward solutions get more done!

8

With protocols becoming more complex and the exclusion criteria stacking up, inherently, screen fail rates will increase. If participant 123 is not eligible for Study 1 at Site A, what tools/safeguards do you have in place to make sure participant 123 does not enroll in Study 1 at Site B just a few miles away? Verified Clinical Trials doesn't just prevent duplicate participants, we make sure your study is enrolling the MOST qualified participants based on their research history. This will pay dividends in the long run as you're weeding out professional participants who will damage the study in terms of retention, medication and/or ePRO adherence, etc. which ultimately delay study timelines, have effects on efficacy, and could even fail a study.

10

Wow, think I might be breaking some actual NEWS here 😝 Just got sent the original unredacted copy of the Pavers' lawsuit. There were 2 redactions in that document, shown unredacted in yellow below. So, now it's very clear why Illumina had them redacted: the board bought $300M (😳) of insurance right before the GRAIL transaction and paid $100M (🤪) in annual premiums for it. This is absolutely insane for two reasons: (1) Illumina previously held $120M in D&O coverage so $300M is more than doubling coverage in the face of increased risk from GRAIL. So they were VERY NERVOUS about this deal. (2) Normal premiums for D&O are about $100K per million in coverage. So Illumina paid more than THREE TIMES the normal rate for this insurance. This means the insurance company was also VERY NERVOUS about the deal. (Think about how risky this situation is - imagine if you owned a $600K house and the insurance company charged you $200K a year in premiums😱). The bottom line here is that (not a lawyer 🤣) it is very clear that the Illumina board knew it taking an extraordinary risk in closing this deal in the face of massive antitrust opposition. Not a good look for them in any of these lawsuits accusing them of well, taking too much risk - and $300M is a giant prize for the winners of these cases. WTF? Why did they do it? 😱😱😱

74

24 Comments

"That's Amazing" was the reply as I spoke with investors, companies, family offices, industry leaders, and international organizations sharing what's happening in Arizona at #BIO2024. In meeting after meeting and from conversation to conversation a theme emerged - what's happening in Arizona's Life Science Sector is amazing. Click the link to check out the amazing #Resources and #Opportunities you will find in Arizona. https://lnkd.in/gemMfPW6 Please SHARE to spread the word! Kate Gallego Jami Mei, MPA, AZED Pro Sean Edmonds Dylan Peay, PhD, Martin Perez Claudia Whitehead, Allison Bakovic, Allison Grigg, Chris Camacho, Michele Oshman, Pete Pellerito, Anne Bruce, Cynthia Ekberg Tsai, Liz Marchi, Melissa Lamson, Kristen Swingle, Thomas Osha, Kyle Jardine, Kim Poole, LEED AP, Caron Davis, MBA, Chris Walker, Madison Walker,  #BIO2024 #PHXisBIO #Bioscience #LifeSciences, Arizona BioIndustry Association (AZBio), AZAdvances. #Arizona, #Phoenix,

77

1 Comment

Dealing with a frustratingly high rate of valuable parts getting scrapped due to process variations? 🤔 We get it, and we've got a solution for you! 👇 Say goodbye to inconsistencies and hello to enhanced production quality with our game-changing technology. Wondering how? By eliminating human subjectivity, our robotic deburring system ensures a consistently high level of quality in your production. You'll experience precise and uniform deburring that meets the most rigorous standards. It's time to elevate your manufacturing game. Reach out to our team of experts and revolutionize your production process! 💡

3

Innovating for Health: The Role of Antimicrobial Coatings in Reducing Hospital-Acquired Infections Hospital-acquired infections (HAIs) are a significant challenge in healthcare, impacting patient outcomes and increasing healthcare costs. However, innovation in antimicrobial coatings is paving the way for safer hospital environments. Recent studies have shown that surfaces treated with antimicrobial coatings can drastically reduce the presence of harmful pathogens, thereby lowering the risk of HAIs. For instance, one study reported a 52% reduction in pooled HAIs following the application of an antimicrobial surface coating. A notable success story is the implementation of antimicrobial coatings at a leading hospital, which resulted in a significant decrease in infection rates and improved patient safety. This case study serves as a powerful example of how innovative solutions can lead to tangible improvements in healthcare settings. Microdome coatings, applied on high-touch surfaces such as door handles, bed rails, and medical equipment, actively inhibit the growth of bacteria and viruses. By integrating antimicrobial technology into hospital design, we can create a proactive defense against infections. This not only protects patients but also supports healthcare workers by providing an additional layer of safety. As we continue to fight against HAIs, it’s clear that antimicrobial coatings are more than just a surface-level solution—they’re an investment in patient health and well-being. Please connect to explore the groundbreaking technology #Microdome from Polyamyna Nanotech Inc which lasts on the surface for 1000 clean cycles equivalent to 500 days of pathogen-free surfaces. Kishan Gorityala Ramesh Kumar Mani Robert Hoyles Sean Warren Apollo Hospitals Kokilaben Dhirubhai Ambani Hospital Fortis Healthcare AIIMS (All India Institute of Medical Sciences, New Delhi) Manipal Hospital (Bangalore) #HealthcareInnovation #PatientSafety #AntimicrobialCoatings #HAIPrevention #MedicalDevices #Schools #FacilityManagement

14

Sometimes when I think about the Seeq Corporation industrial analytics and AI platform and the future, I think about the calculator. Does that sound weird? Let me explain – Before calculators, only a small subset of the population might have been able to do advanced math using tools like the abacus. But the calculator comes along, and all of a sudden a lot more people can do more advanced calculations without having to understand the fundamentals of how the machine works. Not only that, it enabled us to ask questions and compute things previously unimaginable. That’s the kind of innovation I think Seeq offers. Our advanced analytics tools are connecting companies in ways they never would have thought of before. And a more connected company with access to better information is in a much stronger place to innovate.

46

4 Comments

Good overview of the impact of the LDT rule.

11

"Nature" magazine focuses on publishing innovative and impactful scientific research. A study on how the differences between chemically bonded glycerin and naturally bound pure glycerin have changed the concept of wound care could be of interest to "Nature" if these changes were significant and provided new scientific insights. Innovation: This study proposes new approaches to using chemically bonded glycerin and naturally bonded pure glycerin for treating skin conditions such as acne, psoriasis, and atopic dermatitis. For example, the mechanisms by which pure glycerin can enhance the skin's natural regeneration processes and reduce inflammation could be elucidated. Scientific Significance: The research could reveal the biological pathways through which pure glycerin contributes to the treatment of skin disorders, thereby extending or transforming existing knowledge about enhancing skin barrier functions and regulating inflammatory responses. This could provide new insights and strategies for managing skin conditions. Generalizability and Impact: The findings could be applicable not only to specific conditions like acne, psoriasis, and atopic dermatitis but also to general wound healing and skin care. This versatility enhances the potential applicability of the research across various medical and biological fields, broadening its impact. #ScientificResearch #NatureJournal #InnovativeResearch #AcademicPublishing #ScienceCommunication #ResearchImpact #STEM #BiomedicalResearch #EnvironmentalScience #Pharmacology

1

Join my colleagues in presenting our new automated TFF system combined with Variable UV Pathlength Technology. Registration link below

6

Picture this: you're in your molecular diagnostic lab, racing against the clock to produce accurate results. With Grenova's tip cleaning technology, you can say hello to efficiency and goodbye to contamination worries. Imagine the confidence you'll feel knowing that both the CDC and top molecular diagnostic labs trust Grenova's technology to effectively remove any traces of contamination from your precious samples. That's right, Grenova doesn't just meet standards, it sets them! Introducing Grenova's revolutionary tip cleaning products! Get ready to embark on a journey of innovation and sustainability that will transform the way you think about lab practices forever. Are you tired of the traditional, wasteful methods of disposing of single-use plastic pipette tips? Say goodbye to that endless cycle of waste because Grenova is here to shake things up! But wait, there's more! Let's talk about sustainability. As scientists, we have a responsibility to protect our planet, and Grenova is leading the charge. By reusing pipette tips instead of constantly throwing them away, you'll be reducing plastic waste and doing your part for the environment. It's time to challenge the status quo and embrace a greener future. Now, you might be wondering about contamination. Rest assured, Grenova has you covered. Their cutting-edge technology ensures that genomic material remains pristine, free from any lingering contaminants. So go ahead, dive into your experiments with confidence, knowing that Grenova has your back every step of the way. So, are you ready to join the revolution? Say yes to efficiency, sustainability, and innovation with Grenova's tip cleaning products. It's time to think differently, act boldly, and make a positive impact on the world. Get ready to elevate your lab game to new heights with Grenova! DMark Biosciences Grenova #tipcleaning.

13

A quick look at the automated protocols in the RheoSense Initium one plus. Save time and money by running up to 96 samples at once: https://lnkd.in/edSS-34r

2

Couldn't make it to my recent Master Class on FDA pre-submissions? I've got you covered, regulatory peeps. 😁 Here's the video of the full presentation: https://lnkd.in/gUz5pVEB Video TL;DW? I've also published a summary blog to my website (link in the comments below). And as always, the leanRAQA team is ready to assist with any questions, problems, concerns or frustrations you may have. Just give us a call. #medicaldevices #regulatoryaffairs #compliance #qualitymanagement #medtech #biotech #startups #FDA #510k

61

3 Comments