- Thomas Edison
“HELL, THERE ARE NO RULES HERE... WE’RE TRYING TO ACCOMPLISH SOMETHING.”
Facts on the FDA Approval Process THE
FDA CLEARS DEVICES EACH YEAR
Source: Emergo Group
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what GUIDANCE DOCUMENTS say what FDA REVIEWERS say
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during the review process Source: Northwestern University
Medical Device Manufacturing The thought of investing thousands of hours and millions of dollars into designing and manufacturing a medical device is daunting. Yet, we know every long night in the lab, every day spent at a tradeshow, every endless government form filled out, is worth it. When you see your medical device making a difference in the world, it’s more than enough motivation to get to work on the next big thing. Blue Pearl Consulting knows how important medical device manufacturing is to our clients and the community. We also know the immense challenges to getting your product from concept to market, including manufacturing options, outsourcing, and compliance—just to name a few. We’ve overcome these obstacles for clients at various stages, from established companies to entrepreneurs with nothing but a garage, a computer, and a revolutionary idea. We’ve helped them make their vision a reality through our experienced team’s innovative approach and commitment to truly customized solutions. Read on to discover how we’ve helped our clients —and how we can help you too.
WHEN OUTSOURCING IS A BAD IDEA...
Blue Pearl Consulting was needed when an established manufacturer of transfusion devices was looking to cut costs anywhere it could. They were looking at outsourcing their quality control because it was a relatively short process, yet cost them over $700,000 per year. The answer is simple, right? If you can save over $700,000 simply by outsourcing your quality control process, you should do it. But if there’s anything we’ve learned about Medical Device Manufacturing, it’s that the answer is never simple. To perform the quality control process, the outsourcing partner must have intimate knowledge of your entire design, and therefore your intellectual property. You’re effectively giving them the years of research, development, and FDA approval processes you went through. Based on the demonstrated risk of IP theft and our analysis of our client’s unique circumstances, we advised them against outsourcing.
While the company was resistant to our recommendation, when we explained the true impact to their bottom line, they agreed. We were then able to help them find alternatives to improving their bottom line.
A FEW MONTHS LATER...
Our client had a friend who manufactured a device in the same field (we’ll call the friend’s business “Company X”). Due to the competitive nature of the industry and the short life span of the product, Company X had decided to outsource their quality control process to cut costs. The co-manufacturer leaked Company X’s intellectual property to a competitor who was able to reproduce the device significantly cheaper. Was this legal or moral? No. Does that matter? Sadly, no. By the time your IP has been stolen and repurposed, you have two choices: Give up, or engage in a lengthy and pricey legal battle. You’ll be worrying about saving your company instead of growing it. Some businesses can survive this, most don’t. This is not to say one should never outsource. However, the decision to outsource must be a nuanced conversation that delves into all the factors that impact the bottom line, and not just the easiest areas to cut costs.
IP Stolen. Device Copied. Was this legal? No.
YOU’LL BE WORRIED ABOUT SAVING YOUR COMPANY INSTEAD OF GROWING IT.
By understanding the unique factors of their company and industry, we saw beyond the most common solution. We saved them from a risky decision that had the potential to derail the future of their company. Most importantly, our advice helped a large manufacturer focus on expanding the potential of their product and their business, leading to increased profits, hiring, and global expansion.
WHEN OUTSOURCING IS A GREAT IDEA... Every company, every device, every objective is different. You know this, we know this. That’s why there simply is no rule when it comes to outsourcing. We were brought in to help an entrepreneur who had designed a groundbreaking Class III blood and plasma medical device. And…now what?
How will he take an idea on paper, turn it into a physical device, and get it to market? How will he manufacture it? How many should he produce? Where will he store his device? And where will the money come from to fund all of this? These were some of the numerous questions that were bogging down his progress. We came in to help him move forward. Our client couldn’t build the product in his garage (as much as he may have wanted to). He needed a production facility. This would not only cost a lot of money, but would also delay getting it to market by at least six months. Given the short product life and the tremendous expense required, we recommended initially partnering with an experienced co-manufacturer.
After his first generation was created, he could then decide whether he wanted to bring production in-house or not. With our client on board, we tapped into our resources and found him a co-manufacturer. By outsourcing, our client was able to get to market faster than his competitors, maximize his time and resources, and defer much of the risk associated with manufacturing your own device. Best of all, he maintained control over his company and his vision.
This isn’t always the right answer and we won’t create some sort of rule for outsourcing based on his experience. Rather, we will do what we always do: ask questions, listen closely, get to know the unique circumstances and objectives of our client, and provide creative and complete solutions.
Blue Pearl Consulting We started Blue Pearl with a rather simple premise. We believe that businesses are happiest when they are accomplishing goals and making progress. Yet every time a problem arises, you get farther and farther away from achieving your vision. That’s why we solve problems—distractions, detours, potential derailments of your entire business. By crafting truly customized solutions, Blue Pearl enables owners to reach their highest potential. We empower businesses to solve problems in the world, instead of fighting problems in their own company. We help them become the best possible version of themselves.
That’s the truer you.
M.H. Powelson Analyst “One of the greatest things about this industry is that it’s always changing. It’s a constantly moving target with innovative technology that gets devloped almost every day. At Blue Pearl, we have extensive experience in rapidly changing markets. We also don’t stop until we get it right for the client.”
Medical Device Manufacturing We get to be a part of revolutionary products in science and medicine that solve important problems. If we can help a medical device manufacturer figure out the least painful and most accurate way to dispense insulin to children with diabetes (as we have done in the past), then we know we’re making the world a better, safer place. There are a lot of challenges within this industry and we’re prepared to tackle most of them, including: Code Creation Outsourcing Distribution Costing Market Research FDA Compliance Clean Room / Expansion / Relocation
WE DO THAT AND MORE... We love working in the medical design and manufacturing industry. However, we’re a jack of many trades and rarely say No to someone who needs a problem solved. We frequently solve problems within these industries:
Manufacturing
Distribution & Wholesaling
Warehousing
SERVICES Market Research Inventory Management Operational Efficiency Improvement Costing/Pricing Product Offering Expansion Outsourcing Compliance Relocation Succession Planning Revenue Cycle Management Branding Marketing / Web Services And More‌
Medical Service Providers
Joel Freimuth PRESIDENT
“From very early on, I’ve learned to always ask questions. The person who asks questions can explore more paths. The better the questions, the better the paths.” Characterized as passionate, intelligent, irreverent, and curious, Joel Freimuth started Blue Pearl Consulting to create truly customized solutions. Since 2011, Joel has grown Blue Pearl from a small startup into a cutting-edge firm widely known for its innovative approach, wide-ranging capabilities, genuine interest in its clients, and effective solutions. Before founding Blue Pearl, Joel had, according to his mother, “itchy feet.” He spent a number of years overseas working as a currency trader and equities analyst. Upon returning to the United States, he furthered his career with one of the largest asset managers in the world. Joel is often sought after for his opinions and perspectives. He has been quoted or contributed to articles in the Washington Post, ABC News.com, Motley Fool, Daily Finance.com, First Business News, and many more. Joel also speaks at numerous trade shows, symposiums, and panels, including last year’s MD&M East Conference. Joel received a J.D. degree from Loyola University of Chicago Law School and a BA in Economics and Math from Emory University. He lives in Chicago with his wife Jill and their daughter Zoe.
“WE’RE NOT A 9 TO 5 FIRM. WE’RE A GET-IT-DONE FIRM.” -JOEL FREIMUTH
As a seasoned strategic executive leader, Geeta Singh brings over 23 years of experience in strategy, finance, and strategic business development into her current role as EVP-Business Development at Blue Pearl Consulting. Geeta has worked in a variety of environments, notably multi-national corporations, such as Allstate Corporation and ABN AMRO London, as well as start-ups and social enterprises. She has worked with primarily C-level, senior leadership, and executive boards of public and private companies, as well as government and philanthropic organizations. She excels at identifying and executing a wide range of strategic initiatives, managing cross-functional teams, implementing change management, and developing relevant business models to help drive business transformation. Her transaction experience includes joint ventures, partnerships, collaborations, and merger/acquisitions ranging from $25M to $10B. Having worked in several early stage start-ups, she has also helped build all areas of business including revenue growth, marketing/sales strategies, managing client relationships, and strategic business partner development. She lives in Chicago, Illinois, where she serves on several advisory and executive boards for non-profits, and is a committee member on the Illinois Governor’s Task Force on Social Innovation, Entrepreneurship and Enterprise.
Geeta Singh
EXECUTIVE VICE PRESIDENT
As a Partner at Blue Pearl Consulting, Stacy Braack is a leader in client services. She develops productive relationships with potential clients, identifies and defines projects, and prepares proposals that effectively address client issues. Stacy is considered an expert in highly regulated environments, including process improvement, cost reduction, resource allocation and revenue growth in both medical and industrial operations. She also has expertise in operational improvement in Medicare and private insurance environments. Prior to Blue Pearl, Stacy worked as a consultant at AT Kearney, Inc. where her experience ranged from building purchasing programs to warehousing optimization, developing and implementing outsourcing strategies, and operations consolidation following mergers and acquisitions. Stacy went on to serve as Vice President at ABN AMRO Bank where she ran a team that consolidated procurement, marketing, telecommunications, and other support functions across global operations. Stacy earned an MBA from the Kellogg Graduate School of Management at Northwestern University and a BS in Industrial Engineering from Stanford University.
Stacy Braack
PARTNER
IRPTIM
IRPTIM is the difference between a solution and a Blue Pearl solution.
I
DENTIFY
We start by Identifying the issue. This should be the easiest part, right? Your bottom line needs to improve, productivity needs to increase, you need to maximize efficiencies. However, finding the real source of a seemingly typical problem is where our crack team of detectives comes in to look at the big picture. Okay, they’re not real detectives, but they are smart, experienced, detail-oriented people who will isolate the real problem.
R
ESEARCH
Once identified, we Research. We roll up our sleeves and start to dig. We uncover what’s unique to your business and your industry, then explore all the contributing factors to your problem until we know it like the back of our hand.
P
ROPOSE
We then Propose several hypotheses for the answer to your problem. The best hypotheses will take into account numerous components, including cost efficiency, effectiveness, time horizon sensitivity, and employee adaptability.
T
EST
We gather the best proposals and Test them using a number of methods. From field studies to advanced scenario testing, we’ll do whatever it takes to find the best solution based on hard data and expert analysis.
I
MPLEMENT
After testing, we Implement your solution. We don’t just hand it to you in a glossy binder and pat ourselves on the back. We’re a hands-on company and we’ll be there to help you transition into your new and improved way of doing things.
M
ONITOR
Your business isn’t a computer. We can’t install a solution on your hard drive. It’s owned and operated by humans who aren’t impervious to outside factors or falling back into old habits. Blue Pearl Monitors the progress of your solution for up to a year to make sure we really have uncovered the Truer You.
To ensure that the problem is truly solved, we monitor each project for up to a year after implementation. After all, you hired us to accomplish something, not just hand you a blueprint.
Blue Pearl 980 N Michigan Suite 1110 Chicago, IL 60611 info@bluepearlconsulting.com www.bluepearlconsulting.com