GxP Lifeline
Medtech Startups: How to Survive Cutthroat Competition
In the fierce arena of medtech startups, competition is intense and investor confidence is high. A recent Ernst & Young report shows that early-stage medtech firms captured 52 percent of seed funding last year and surpassed the total amount for later-stage companies, the first time it has happened in 10 years (1).
If you’re a startup, is it time to sit back and relax? Hardly. Underneath this rosy picture is a ferocious business environment that calls for decisive leadership and a competitive edge through technology-driven processes. As the report puts it, medical device companies will need to invest in new technologies (2).
In my career, I’ve had the opportunity to work in small and large medtech firms alike. I wish I knew back then what I know now when it comes to startups, regulatory compliance and market competition. I would like to share some lessons that come only with experience.
Four Critical Elements
If you’re a startup, these four elements are critical to your survival and success in a cutthroat business environment. They are imperative if you are looking for capital investment or planning to sell your company.
#1 Establish design control and the risk management process from day one.
It’s do-or-die when it comes to design control. This was true when I first started as a product development engineer many moons ago and is still true today. Last year, 13 percent of Form 483 observations and warning-letter citations pertaining to 21 CFR Part 820 stemmed from design control issues (3). My advice to you: Avoid becoming “statistics!”
Design control and risk management are two discrete areas, but I see them as working hand in glove. Risk management is an inherent part of design control. If you have set up your design control procedures correctly, you will already have a good risk management process in place.
Regulations and standards require both. Under Part 820, design control procedures are meant to ensure that specified design requirements are met. In a similar vein, ISO 13485 requires device manufacturers to “control design and development changes.” It also requires the establishment of a risk management process for product realization.
If you don’t establish an effective design control system from the get-go, you will end up wasting a lot of time trying to backfill a design history file (DHF) when it’s time for 510(k) clearance or premarket approval submission. But if you perform design control properly, you will get the device right the first time and you will succeed in addressing the customer need at hand.
A final note about the relationship of design control and risk management: Use a risk-based approach during the design process to reduce waste and cost. You will also minimize the likelihood of failure once your device is on the market.
Matt Lowe has served MasterControl for nearly two decades across several different executive leadership roles including product, engineering, sales, and marketing, and now will continue his tenure as Chief Strategy Officer. In this role, Lowe brings vast institutional knowledge of the market, MasterControl’s products, and customers to identify growth strategies and expansion opportunities for the company. He also serves on the MasterControl Board of Directors.
Lowe is a medical device expert with experience in product development and product management at Ortho Development Corp. and Bard Access Systems, a subsidiary of BD. Lowe has successfully launched more than a dozen medical devices. He has five patents issued and one pending. His regulatory experience includes writing a 510(k) that was cleared by the FDA and managing a multi-site, multi-year post-market clinical study for orthopaedic devices.
Lowe has a bachelor's degree in mechanical engineering from the University of Utah and an MBA from Indiana University.
