Maximizing our Impact – Built for Innovation in Healthcare

Employee Spotlight - Clayton Cole

Nathan White, Co-Founder and VP of Product Design and Development

Nate has over 20 years of medical device product development experience, with diverse roles in technology innovation, R&D engineering, manufacturing engineering, program management, technical leadership, and organizational leadership. He has an extensive background in complex technologies, including minimally invasive laparoscopy, endoscopy, interventional cardiology and radiology, surgical stapling, vessel sealing, and ablation therapies. He is a named inventor on more than 30 U.S. patents. He holds a B.A. in Engineering Sciences from Dartmouth College and an M.S. in Mechanical Engineering from Stanford University, Design Division, and Biomechanics Division. Throughout his career, Nate has helped dozens of companies conceptualize, develop, and commercialize novel medical products and technologies for improved patient outcomes.

When I started my career in MedTech more than 20 years ago, I made a transition that every young graduating engineer goes through: a reality adjustment of the way things actually work in the marketplace. I was surprised to learn the level of risk that investors were willing to take on many young companies trying to make a breakthrough in the same clinical space, knowing that most would fail and only one or two might succeed. I naively assumed that the best technology always wins out in the marketplace, but learned that there is a lot more that goes into achieving commercial success than creating the best products, and many of those forces are entirely out of your control. I discovered that there are thousands of companies providing specialty services to the MedTech industry in niche areas of expertise, and you must seek out and team up with other experts to develop the best solutions. I realized that product manufacturers often rely on other companies to do essential activities – like product development and contract manufacturing – even though you won’t find their names on the product. I experienced how bringing a new medical device to market takes grit, perseverance, patience, and resilience forged on dynamic teams with great leadership.

Funding Innovation

When we founded Meddux in 2017, we brought together all our career experience – at startups, mid-size companies, Fortune 500 companies, product companies, and engineering service companies – and we sought to build a business that would be an engine for the success of innovative new medical device technologies and therapies. We thought hard about what we wanted to be and how we would get there. The landscape for medical device development had changed substantially over the previous decade since the Great Recession of 2008. No longer were investors pouring large investments into clever product concepts; those funds were reserved for companies that had demonstrated treatment efficacy – typically through clinical data – which meant that entrepreneurs with a mission to innovate had to do more with less. How would they reach their development milestones and satisfy funding tranche requirements in a capital-efficient way? How would they use their assets where they mattered most?


Figure 1 – Annual Revenue and R&D Growth of Public Medtechs, 2000 – 2022

Credit: EY Pulse of the Industry – Medical Technology Report 2023

The Medical Device Provider Landscape

In the world of medical device innovation, there is a spectrum of organizational types and sizes and a corresponding spectrum of R&D focus for new product development. This spectrum can be broadly categorized into several profile types:

Physician Entrepreneur

Doctors spend most of their working time in cases treating patients. They see what works, and they notice what could be better. Many love technology and are drawn to identifying ways to use it to produce better results for their patients and their practice. They are intimate with the clinical opportunity and understand the clinicians’ needs. While they often appreciate the engineering and product development world, few have the engineering experience, skillset, or time to develop a new product without giving up their medical practice.

Research Institutions

Several of our country’s top hospital systems have developed research foundations to work with their in-house physician innovators to fund and license new medical device technologies. This model aims to bridge the gap between the physician entrepreneur and the commercial marketplace by creating a structural environment for innovation that can go beyond the research phase.

Incubators

It’s hard to do it alone as a startup. Incubators are structured to support the nascent phase of early-stage startups through physical infrastructure, strategic leadership, financial backing, and shared resources. This model helps particularly with the “Research” portion of “R&D” to advance the technology to a point when it can mature into its own funded company.

Early-Stage Startups

A lot of medical device innovation happens at early-stage startups. Their founders are passionate and devoted to bringing their products to a point of maturity that attracts strategic investment by larger OEMs and eventually may be acquired. They are pioneers willing to face the inherent risks of new product development, and they don’t have an existing brand to damage if their best-laid plans don’t pan out.

Small to Mid-Sized OEMs

These businesses have faced the myriad challenges of new medical device development square in the face and have persevered – they have products on the market, revenue coming in the door, and are growing their customer base. Some have grown organically, some through acquiring adjacent technologies, some through spin-off. They are inherently growth-oriented and are looking to balance the competing pressures of increased demand for their core product offering and the need to continue to innovate to grow their market share.

Large OEMs

The “Blue chips” of medical device OEMs are the names that everyone knows – like Medtronic, J&J, Abbott, Edwards, Stryker, Terumo, and Intuitive. They are the large-cap companies that lead the market and fund innovation internally and externally. They typically lead the product market spaces in entire clinical specialty areas. That type of brand leadership also carries the risk of brand damage if they have a high-profile miss on a new product or technology offering. Their systems are strong and stable, but their stability also carries an inertia that can make disruptive innovation inherently challenging.

Together, these organizations broadly reflect the range of size, resources, and market footprint in the medical device industry. They also represent a spectrum of focus on creating the “New, Unique, Different, and Difficult,” known as “NUDD,” to technologists. These are the innovative medical device technologies and therapies that drive growth. For some, new product development and commercialization is the prime directive; for others, the strength of their current offering keeps the lion’s share of their focus … until outside forces threaten that position of strength.

The Solution Provider Landscape

There exists a corresponding spectrum of solution provider organizations for medical devices. As B2B companies, these are vital within the industry, but their brands are often less visible to the broader marketplace. These businesses range in sophistication, expertise, and scope of capabilities, and they can be broadly categorized into the following categories:

Freelance Engineer

Individual independent contractors can augment engineering horsepower, provide short-term technical expertise where needed, and are often subject-matter experts (SMEs) in a clinical and/or engineering discipline. Their services are typically focused on engineering consulting and support, and these talented individuals are behind many of the innovative early R&D efforts that get new medical device projects off the ground.

Design House

Engineers love solving problems together, and when creative minds band together to form a design consultancy, great things can happen for their customers. Design firms typically have one or a few technical focus areas – industrial design, mechanical engineering, electronics (hardware/software), prototyping, or testing. They often excel at early concept development and rapid prototyping.

Design & Development Firm (D&D)

Take all the strengths of a design house and add expertise in DFX – now you are getting the benefits of a design and development firm. Design for “X” – including Design for Manufacturing (DFM), Design for Assembly (DFA), and Design for Reliability (DFR) – these are the development aspects of design that complement the core technical function and usability of the product. These organizations staff a range of disciplines, including engineering, quality, and project management.

Design, Development, and Manufacturing / CDMO

The breadth of expertise, systems, and personnel needed to cover the medical device lifecycle from user-centered design to detailed product development to custom process development to finished device manufacturing is found at a Contract Design/Development and Manufacturing Organization (CDMO). CDMOs like Meddux specialize in providing end-to-end services across the breadth of the product development process and into manufacturing, combining the strengths of a Design and Development firm with the capabilities of a Contract Manufacturer. 

Early market entry for new medical devices often involves limited batch manufacturing to support First-in-Human (FIH) clinical studies or multi-stage Pilot or Pivotal studies, followed by limited market release manufacturing. These organizations have the quality management systems and operational infrastructure to support the full breadth of design, development, and manufacturing needs to bring a new product through regulatory clearance and into commercial production.

Contract Manufacturer / CM

Many OEMs seek partners to own the rigorous ongoing production business as a product scales into commercial manufacturing. Contract Manufacturers include producers of individual components, value-added subassemblies, and finished goods. Some provide design and development services, some limit design services to DFM for the specific manufacturing application, and some are strictly “build-to-print.” CMs are the backbone for the production of many OEMs and distinguish themselves through operational excellence and consistency of quality, which is essential to medical device manufacturing.

Built for Innovation

Product companies face many constraints in their quest to innovate and deliver new clinical solutions in the healthcare marketplace. Meddux understands these constraints, and we have built our business to be an engine for success in the difficult arenas of product design, development, and manufacturing. 

We have spent years navigating these challenges and are experts in working with our customers to overcome them (for more detail, check out our recent blog post, Why do you need a Design, Development, and Manufacturing Partner?). Meddux is strategically envisioned and built as a CMDO to maximize our opportunity for impact in the innovation of therapeutic medical devices worldwide.

Partner with Meddux as your medical guide. We strive to provide a superior solution that meets your goals while building true partnerships. Contact us today and find out why our customers continue to choose us over the competition!

Here’s what some of our satisfied clients have to say:

“We really appreciate the fantastic technical expertise and responsiveness of the Meddux team.  As an early startup, this support has been so valuable in helping us drive our first product through FDA submission and early manufacturing.”

Co-Founder, Minimally Invasive Surgery Startup

“The Meddux team is great to work with: efficient communication, great technical expertise, and ability to work under tight time constraints.” 

Principal R&D Engineer, Fortune 500 OEM

“Every day, I am thankful I teamed up with Meddux to bring this product to market and make this dream a reality.  It is nice to have a team who is as committed as I am.”

Founder and CEO, Ophthalmology Startup

Contact Meddux to see how we can help you bring your product to market. 

Let us be your strategic partner in navigating the complexities of medical device innovation, from concept to commercialization.

Let’s Team up and Bring your
innovation to Life!