Need Help Getting Started?

Getting your medical startup off the ground is not easy. We provide this Resource Center as a tool to help entrepreneurs and early-stage companies as they grow.  We have assembled talent from each discipline to support our clients and help them achieve their business goals.  The options below provide an overview of all the disciplines covered by the resources in the center.  You can choose which areas you would like to engage to augment your existing team and you can review and select the specific partner you want to work with.

Contact Ashley Mooneyham for an introduction to our partners, or peruse their information below.

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Educators & Accelerators

Learn how to scale quickly and avoid common, early pitfalls.

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Legal & IP

Find the right corporate counsel to establish your company and secure IP.

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Clinical Studies

Establish whether clinical studies will be necessary and define key elements of the study.

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Research & Development

Bring your idea through proof-of-concept to commercialization.

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Marketing & Sales

Plan your commercialization strategy, define value proposition, identify sales opportunities

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Regulatory & Compliance

Plan your FDA regulatory path and establish a compliance program

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HR, Finance, & Accounting

Developing a device? Get expert administrative advice from start to finish.

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Grant Resources

Submit a competitive grant application for non-dilutive funding in 10-12 weeks.

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Quality Management

Develop and implement a comprehensive quality management system.

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Sean Bittner, M1 Medtech

The M1 MedTech Accelerator program is a highly technical virtual accelerator. Our program is designed to aid medical device founders in rapidly advancing toward commercialization and prepare them for critical early investment stages. M1 MedTech offers capital, entrepreneurial expertise, and CRO services, as well as an immersive, hands-on experience to guide founders as they become MedTech executives and advance their companies.
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KC Caine, gBETA Medtech (a gener8tor program)

gBETA Medtech is a free, seven-week accelerator for early-stage companies across the medical device, medtech, and digital health fields. Each program is capped at five teams, and requires no fees and no equity to participate. gBETA accelerates the growth of early-stage companies through its network-driven curriculum which includes virtual Lunch & Learns, curated mentoring & introductions to investors.
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Duane Mancini, Project MedTech

Project Medtech is the gateway to Medtech resources for start-ups, from inception to market.  Project Medtech focuses on two major services.  Our Media and Network group that produces an original podcast series (Project Medtech and Medtech Money), hosts virtual and in-person events, and maintains a broad network of referral partners.  Our Consulting and Advisory group helps build successful Medtech companies with end-to-end services, adaptive support, analysis-backed strategy, multi-disciplinary expertise, and access to our far-reaching, Medtech-focused provider network.  For more information on our offerings, please check out the consulting page on our website.
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Playbook Strategies

Playbook Strategies, LLC is an innovative new firm dedicated to supporting startup and midmarket businesses through the most exciting and challenging phases of growth, change,
and reinvention. Bringing considerable experience solving complex government problems, and hands-on history leading startup operations and mid-market business turnarounds, Playbook Strategies will draw up and implement the playbook to solve your gnarliest problems.
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John Fallone, Fallone SV

John began practicing law after he spent some time in the shoes of an entrepreneur. John co-founded SendHub, a startup dedicated to simplifying business phone systems, which was a member of Y Combinator’s Winter 2012 Class and NAR REach’s 2014 Class; it has also raised ~$10MM from family, friends, angels, VCs, and a public company. While running ops, finance, and, of course, legal at SendHub, John realized he liked building legal strategy more than anything else. After selling SendHub, John transitioned to the world of law practice so that he could help many entrepreneurs build something special. Fallone SV focuses on helping entrepreneurs and early-stage companies navigate the legal hurdles of formation, operation, commercial contracts, fundraising, and M&A. John earned his JD from George Mason University School of Law and his LLM from Duke Law School. In a former life, John earned a BS from FSU, where he walked on the football team and threw shot put for the Seminoles.
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Wes Schwie, Gallium Law

Wes Schwie is a patent attorney with over 18 years of experience in the medical device industry covering the cardiac, vascular, orthopedic, and hearing aid markets. He has worked in a variety of capacities as a design engineer (at Medtronic), manufacturing engineer (at GN ReSound), Chairman of the Released Products Board (at Medtronic), and now as a patent attorney serving clients with wide-ranging medical device applications. Wes earned a Juris Doctorate from the University of Minnesota Law School, where he graduated magna cum laude. He also holds a Bachelor of Mechanical Engineering from the University of Minnesota Institute of Technology and a Master of Business Administration from the University of Minnesota Carlson School of Management. He enjoys writing comedy sketches, playing cards, and hiking. Wes was an accomplished rower in college and set an American record for distance rowed in one hour.
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Claire Houston, Clinical Consultant

US and international experience with providing a strategic plan and writing clinical protocols. Provides a range of clinical documents e.g. CRFs, CEC charter, safety plan, monitoring plan, etc. Works with database organization(s) for eCRFs. Recruits thought leaders for participation in clinical trial
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Brady Hatcher, Switchback Medical

Brady has spent a career developing novel catheter technologies for neurovascular, cardiovascular, and peripheral vascular applications. He brings deep engineering expertise combined with comprehensive capabilities in the design and fabrication of your device. Switchback Medical helps customers meet their targets and accelerate their time to market.
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Mirabolic Consulting

Mirabolic Consulting provides guidance on AI and Machine Learning projects. They have built predictive models for clients in pharma, medicine, insurance, real estate, and defense. Their work typically begins with a series of conversations with their clients to articulate their underlying business needs as clearly as possible and translating them into technical requirements for a model. Mirabolic then propose data corpora, clean data, build software pipelines, train models, evaluate the predictions, optimize hyperparameters, and serve the results. They have been very successful at using advanced statistics to extract evaluations from real-world data. They also have a great deal of experience visualizing and narrating esoteric technology, e.g., for pitch decks and fundraising.
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Rajan Ramawamy, NOVO Engineering: “Better products to market. Faster.”

NOVO Engineering is a MedTech design and development firm that supports product development from inception through commercial launch and beyond. For nearly two decades, NOVO has provided system-level hardware and software development for major medical device companies and startups. Strong program management and a robust development process promote innovation and efficiency. Project plans are built around risk management and requirements verification. The process is integrated into NOVO’s purpose-built eQMS, which is certified to ISO 13485:2016. NOVO has developed FDA Class I, II, and III devices in a range of clinical applications that include drug delivery, diabetes care devices, catheter-based delivery systems, surgical robotic systems, and diagnostic platforms.
NOVO employs more than 60 full-time technical and support staff in Minneapolis and in Southern California facilities. NOVO’s engineers will blend seamlessly with customer’s internal development team or operate independently as a stand-alone development team – in either case, delivering rapid commercialization of unique and outstanding devices.
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Andy Schieber, Ingenarious Consultants

Ingenarious consultants specializes in early stage medical devices, our expert team guides start-up companies through all stages of the product development process. Ingenarious employs a phased approach to product development that is uniquely tailored to early stage design feasibility. This approach provides a growing set of resources as the phases progress to bring your idea from proof-of-concept to clinical studies and beyond. In addition to engineering consulting services we also provide regulatory, quality and clinical consulting services. We assemble a custom team for your project that utilizes the expertise you need. Our staff includes experienced engineers in Mechanical, Manufacturing, Electrical, Software, Optics, Fluid Dynamics, Ultrasonics and Material Science. Ingenarious also provides prototype fabrication such as 3D printing, machining, silicone molding, device assembly and testing. Our full service lab can tackle prototyping challenges big and small.
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Kirsten Scholte, Cortex Design: “Advancing the human experience.”

Advancing the human experience. This ethos manifests itself through every element of Cortex Design. As an award-winning ISO 13485:2016 and ISO 9001:2015 design and engineering firm established in 1999, we focus on how the products we develop advance the human experience. Our clients engage us when they need a flexible, responsive team to support and/or augment their internal resources. While we have the formality of our QMS and internal processes to deliver for some of the biggest clients in the world, our Design for Commercialization™ methodology is creative and agile in nature. As a result, our team can meet a client where they are and engage in a project however the client needs us to.
Areas of expertise include; Stakeholder Engagement, User Experience, Empathy-led Industrial Design, Mechanical Engineering, Electronics & PCB Design, Embedded Firmware, Quality & Regulatory Services, Product Testing, and Production Management.
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Emily Rusk, Device Development Consultant

Emily has spent 20+ years in medical device engineering and product development, across a wide range of products – from bioabsorbable drug-eluting scaffolds to complex minimally invasive delivery catheters and multi-component systems with capital equipment. She recently worked with a team that was granted emergency authorization from FDA (EUA) on a ventilator for use during the COVID-19 emergency. Emily particularly enjoys helping teams advance innovative products into the clinic.
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Brett Williams, Volare

Volare, Inc. was founded with the vision of leveraging decades of experience in contract design, development and manufacturing to improve the medical device startup model. Volare was established to accelerate development timelines, streamline business activities, align incentives and maximize value for life changing medical device technologies. 
Volare partners with entrepreneurs with novel technologies, forming joint ventures with aligned vested interest in success. Each joint venture leverages Volare’s infrastructure to reduce upfront costs for the product development process, facility, quality system, etc. By aligning incentives for all stakeholders (founders, employees, investors, strategic partners) we can more efficiently develop novel technologies while maximizing value for acquisition in a compressed time frame. Volare’s focus on design for manufacturing saves development timelines and reduces cost on potential manufacturing transfers to strategic acquisition partners.
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Prevailing Medical

Prevailing Medical provides medical device development services. We can assist with a range
of devices. We have a lot of experience in catheter based device development including
neurovascular devices, cardiovascular devices, access sheaths, structural heart valve delivery
systems, endoscopy devices and electrophysiology devices. Services include, full device
development, prototyping, extrusions, braided and coiled shafts and sheaths, tipping,
overmolding, laser welding, and cleanroom assay.
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Keith Kallmes, Nested Knowledge

Keith Kallmes is a serial entrepreneur in clinical research, medical device, and medtech with relationships at leading strategic device companies and US hospitals. He has led acquisition strategy, distribution, and personnel at three startups: Keith is one of the original co-founders of Superior Medical Experts, and now serves as the president of Nested Knowledge.
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Kalms Group

With extensive experience of reimbursement issues and commercialization, the Kalms Group supports established companies as well as start-ups in the fields of medical technology, (in vitro) diagnostics, BioTech and health IT from product idea to market entry and market success.
The Kalms Group’s focus is on the development and implementation of strategies in the areas of market access, reimbursement, and governmental affairs. The Kalms Operations business unit handles fulfillment for manufacturers, including warehousing, logistics (3PL), cold chain, customer service, customs matters and equipment maintenance.
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Chris Bouchee, Medical Engineering Consultants

Medical Engineering Consultants (MEC) is a consulting and training firm that provides services that cover design and development, quality management systems (QMS), manufacturing, and regulatory submissions.  These services range from individual contributors to full scoping, staffing and execution of small or large scale projects.  Our founders are industry veterans with over 40 years’ experience in R&D, Operations, Quality and Regulatory roles and truly understand your individual project needs.
Please get in touch to discuss your consulting, contracting or training needs!
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Mark Gardner, Gardner Law, Medico-Legal Experts

Gardner Law, PLLC provides legal and regulatory counsel to the medical technology, pharmaceutical, and biotech industries. Our pragmatic and responsive attorneys have worked in industry—which sets them apart from other lawyers. They provide practical advice to leaders across the world navigating the complex healthcare regulatory environment. Gardner Law provides advice at all stages of the product life cycle from ideation, R&D, clinical testing and regulatory submission, to manufacturing and commercialization.
Practice areas:
• FDA approval pathways, quality and regulatory assessments
• Healthcare compliance assessments
• Design/implementation of compliance programs, investigations, & training
• Advertising and promotion review
• Interactions with healthcare professionals
• Responding to, and negotiating with, regulators and prosecutors
• Sunshine reporting
• Clinical research
• Privacy matters
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Ross Meisner, Basil Systems

We can help you better understand your competitor’s technologies and strengthen your FDA applications to achieve a faster approval. Questions we can help you answer include: Who else is in the market? What quality problems have they had? Which predicates should we use?
Basil Systems modernizes how RA/QA teams and business leaders can accelerate FDA submissions, streamline post-market surveillance, and inform competitive due diligence. By using our SaaS platform, companies, investors, and RA/QA consultants can quickly master these questions and the relevant regulatory landscape in record time. Basil helps you find all related products, visually navigate the 510(k) ecosystem, and plumb the details of PMAs, De Novos, and HDEs with just a few clicks. We make it easy to find product recalls and research adverse event trends and causes. In addition, we serve up related clinical trials and provide time-to-approval statistics to help get your product to market faster.
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Anne Quinlan-Smith, Surgical Information Sciences

Anne is the Sr. Vice President of Quality, Regulatory and Clinical Affairs at Surgical Information Sciences. Anne is an experienced Division President with a demonstrated history of working in the medical device industry. She is a strong business development professional skilled in U.S. Food and Drug Administration (FDA), Clinical Research, Medical Devices, Life Sciences, and CRO Management. Anne understands corporate goals to plan practical regulatory strategies, and has experience developing clinical study designs to collect clinical evidence and reimbursement data supportive of regulatory and reimbursement strategies. She can help you budget for clinical, regulatory and quality costs and prepare for meetings with Regulatory Agencies.
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QRx Partners

Your business complies with regulations because it must, and conforms to standards because it’s expected, but those aren’t the reasons you’re in business. Delivering the highest quality products and services is what ensures business success. So, why treat your quality management system as a necessary evil, when you should be leveraging its potential for real competitive advantage? Let QRx Partners help your quality management system to be value-added, effective, efficient, and yes, compliant.
Services Offered:
• Quality System Assessment & Auditing
• Quality System Development & Improvement
• Education & Training
• Software Solutions Services
• Regulatory Submission Support
• Regulatory Interaction Support
• EU PRRC Representation
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Ray Mead, TriNetHR

Ray Mead brings more than 25 years of experience working as an entrepreneur, strategic HR executive, and trusted advisor to human capital based SMBs. He currently leads the life sciences practice for TriNet. TriNet HR is a Human Resources platform including Payroll, Benefits & HR Compliance Services for Life Science teams of four (4+) or more W2 employees. For early-stage life science firms TriNet provides turnkey, scalable HR infrastructure, large group buying power for benefits, a toolbox of HR programs and direct access to a team of experts. TriNet handles HR so that life science firms can focus resources on innovating.
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Janine Whited, CPA

Janine Whited has a 35+ year track record in accounting and finance. She is a CPA with an MBA from the University of Wisconsin-Milwaukee and a B.S. in Accounting from the University of Iowa.
She has worked in various industries in both the public and private sector; she has served in a wide range of roles including treasury management, bank relations, staff development, and executive team strategic planning.  Having recently completed 25 years in her CFO role in the printing industry, she is currently self-employed as a contract CFO for several start-up companies.
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Ashley Mooneyham, Superior Medical Experts

Dr. Ashley Mooneyham has 8+ years of scientific research and communication experience. She holds a PhD in Microbiology, Immunology, and Cancer Biology from the University of Minnesota -Twin Cities and a B.S. in Biochemistry/Molecular Biology from the University of Wisconsin – Eau Claire.
As President of Superior Medical Experts, Dr. Mooneyham has overseen the successful submission of 100+ grant applications which have received over $8M in funding since 2017. Superior Medical Experts provides comprehensive grant drafting services including compliance and research document preparation. SME specializes in small business (SBIR/STTR) grant submissions to the National Institutes of Health (NIH) and National Science Foundation (NSF), and also has experience with academic research grants, cooperative/contract agreements, and Department of Defense (DoD) submissions.
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Chris Bouchee, Medical Engineering Consultants

Medical Engineering Consultants (MEC) is a consulting and training firm that provides services that cover design and development, quality management systems (QMS), manufacturing, and regulatory submissions.  These services range from individual contributors to full scoping, staffing and execution of small or large scale projects.  Our founders are industry veterans with over 40 years’ experience in R&D, Operations, Quality and Regulatory roles and truly understand your individual project needs.
Please get in touch to discuss your consulting, contracting or training needs!
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George Martinez, ICON

ICON is the first medical device training center specializing in manufacturing and R&D. We offer hands-on training for your incoming or current employees on the essential tools and techniques used in the medical device field. Our goal is to have your employees familiar with the tools and processes you require when they enter your production area.  With professionally trained employees, quality increases and rejects and scrap decreases. We offer custom courses specifically designed to meet your needs. ICON can also assist with process transfers and process development. At ICON we are dedicated to helping you provide quality products to your customers.
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Kristin Mortenson, Nirin Inc.

The foundation for bringing medical products to market began with a Bachelor of Mechanical Engineering, from the University of Minnesota Twin Cities, and continues to this day with ~30 years of industry experience and continuing education. The combined experience bridges across Research, Design, Development, Quality, and Regulatory through a broad range of products and companies ranging from small to large multi-national. Specializing in start ups, and using project management practices for product development, utilizing design control steps and integrated risk management.
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Anne Quinlan-Smith, Surgical Information Sciences

Anne is the Sr. Vice President of Quality, Regulatory and Clinical Affairs at Surgical Information Sciences. Anne is an experienced Division President with a demonstrated history of working in the medical device industry. She is a strong business development professional skilled in U.S. Food and Drug Administration (FDA), Clinical Research, Medical Devices, Life Sciences, and CRO Management. Anne understands corporate goals to plan practical regulatory strategies, and has experience developing clinical study designs to collect clinical evidence and reimbursement data supportive of regulatory and reimbursement strategies. She can help you budget for clinical, regulatory and quality costs and prepare for meetings with Regulatory Agencies.
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Mike Cremeans, Life Sciences Practice Leader

Top Five Areas of Expertise 
  1. Subject Matter Expert in Insurance and Risk Management in Multiple Industries
    • FDA-Regulated (e.g., med device, med-tech, pharma, biotech)
    • Highly Innovative (e.g., AI, remote healthcare solutions, SaaS)
  1. Worldwide Knowledge and Expertise:
    • Clinical trials
    • Insurance
    • Risk issues
  1. Enterprise Business Risk Evaluation:
    • Identify risks that will impact strategic objectives
    • Develop an actionable approach to implementing risk transfer (insurance) and mitigation  programs (contractual reviews)
    • Provide executive-level reporting to Board 
  1. Insurable Risk Optimization:
    • A complete audit of your portfolio’s insurance suite
    • Match contractual obligations to the insurance portfolio. “Look under the tent” to assure  the policies cover the “ship sinkers.”
    • Establish controls for verification of third-party risk transfer mechanisms (e.g., contracts)
    • Help develop detailed submissions for the insurance market – provide a clear view of the  risks and exposures to loss
    • Benchmark your current program and develop a methodology to assure future exposures  are covered
    • Reduce the Impact of an uncovered claim 
  1. Problem Solver and Connector:
    • An expansive, world-class network of professionals (finance, PEO, HR, regulatory,  quality, AI, legal, marketing, product development) FDA-focused
    • Connected at the highest levels of all major insurance providers
Additional Services 
  1. Help and support the portfolio to prepare for scaling the business or exit. A well-executed risk  management plan and appropriate insurance portfolio can improve valuations. (think: Importance of Quality Management Systems). We’ve guided IPOs.
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