Guest Column | June 20, 2022

The 5 Common Medical Device Startup Challenges (& How To Overcome Them)

By Peggy Fasano, Boulder iQ


The medical device market is diverse, fast-moving, and powered by dynamic customer needs and ongoing demand. Anticipated to reach $734.39 billion by 2027, the market is a land of both opportunity and risk for enthusiastic, innovative developers. Understanding the most common challenges device developers face, and how to successfully navigate them, can provide the competitive edge an entrepreneur needs to succeed in this environment.

1. Understanding And Accepting That Time Is Money

In medical device development, the old adage, “time is money,” is a constant. The sooner you can get a device on the market, the sooner it moves from an expense to a source of revenue. The quicker you get to market, the less risk you have of a competitive product or technology usurping yours. Many companies today also find that the longer their time to market stretches, the more problems they have in acquiring the parts and materials they originally specified in design.

Speeding time to market also can provide more opportunity for partnerships with other companies and for potentially integrating your technology into other devices. In short, there’s a lot to be said for being the market leader in a given segment.

How To Overcome The Challenge

The first step in meeting the challenge is to acknowledge that getting a device from prototype to market is going to take more time than you think. The second step is to truly understand each step of the process and accept that you will be unable to handle everything on your own.

In order to determine the path and timeline your device will take, you must be very clear – up front – on the problem you are looking to solve, on your potential customer base, and on the market for the device aiming to solve that problem. Get out and talk to potential users to get crystal clear on what they need. Putting in that effort will help ensure that the time and money you spend in developing your device will produce maximal return.

Determine needed assumptions and analyze the risks. Then decide which steps you can perform in parallel and which you’ll need to do sequentially. Pay particular attention to those with the longest lead times. Accept that 0% risk is unrealistic for any medical device and that you will be unable to perform every step on your own. Know when to bring in help.

2. Acquiring The Needed Breadth Of Resources

It is no secret that the breadth of resources required to get a medical device to market is daunting. Expertise in project management, product design and engineering, regulatory strategies and submissions, quality managements systems and quality assurance support, manufacturing services, sterilization, and packaging is critical. In fact, one of the FDA’s expectations is that medical device personnel are qualified and competent to perform their assigned functions – no small feat in a startup or small business.

The real challenge is in how best to acquire this expertise. Many device developers attempt to handle many of the functions on their own. Particularly with smaller businesses, owners understandably wear many hats. But whether the business is large or small, the reality is that no one person can wear them all. And, the challenge in acquiring talent has become bigger in today’s tight labor market, where it’s difficult to source, hire, train, and retain qualified staff.

How To Overcome The Challenge

Because time to market is critical, finding the specific services and personnel to expedite your commercialization efforts must be a top priority.

Assess if it makes sense for you to bring your product development needs in-house or if contracting subject matter experts in designated areas will make better use of your limited dollars. If you can support bringing some services in-house, make sure those individuals will be able to flexibly interact with contracted subject matter experts in other areas. Also consider bringing in quality and regulatory training necessary to lay a solid foundation from which your company can grow.

If you go the contract route, find a service provider with the experience to streamline your product development efforts from prototype through commercialization – and beyond.

In short, don’t spend a dime until it is time, but when it is time, reach out to those who have the experience to assist.

3. Evaluating And Managing Vendors For Competence & Efficiency

It is not unusual for a device developer to engage with a contract manufacturer or to work with a variety of subject matter experts and sources for different parts of the development process. Evaluating, qualifying, working with, and managing multiple vendors can be draining – of both time and money necessary to support long-term company objectives.

Device developers also face a challenge in making sure that all vendors are aligned and similarly motivated on the singular common goal of getting their device to the market as quickly and efficiently as possible. Today, they face the added challenge of making careful choices to avoid supply chain issues to the extent possible. Finding contracted vendors who communicate and coordinate well with you, and with other vendors, is crucial in getting a device to market and in achieving standardization of processes and procedures so that the device meets its intended use every time.

How To Overcome The Challenge

A single-source expert contract consulting firm may be the most cost- and time-efficient way to handle both this challenge and the challenge of finding needed breadth and depth of expertise. Working with established systems, processes, and relationships, a single-source contract firm will provide a team of experts who know the ins and outs of bringing a device to market.

While expert contract consulting firms sometimes work with contractors themselves, it can be helpful to find a firm with a stable of in-house expertise. This type of team will be able to step in and work together seamlessly. They often can bring on board a proven ISO 13485-certified quality management system, too, that allows simple and standardized records, documentation, and training management for the entire development process.

If you go this route, thoroughly vet any potential firm for experience and a track record of success. Make sure you will be dealing with the actual experts who have worked in and with device firms. If they’ve walked in your shoes, they will be best-positioned to help you avoid missteps and get you on the clearest, straightest, most time-effective path to market.

4. Tackling Regulatory Hurdles

Dealing with regulatory requirements requires specific knowledge, expertise, and experience in working deeply with device development firms and with regulatory agencies. Why? Because you can design, manufacture, and validate your medical device – and even secure intellectual property protections – and still face the reality that you also must determine the most efficient pathway to regulatory clearance and/or authorization.

Key to regulatory submission efficiencies and cost savings is understanding how to determine product codes, when to employ the 513(g) process, and how to use the FDA Q-Sub program to speed time to market. Add in more complicated needs, such as clinical trial management or international medical device registration and licensing, and the risks of a mistake loom large.

How To Overcome The Challenge

Outsourcing the regulatory affairs function is typically the most effective way for startup and smaller companies to obtain the required experience and expertise. Here, again, it is critical to work with people who have “been there, done that” more than once. Whether it’s determining classification of the product, communicating with the FDA, or making calls on expensive testing, experience really does matter.

Beyond bringing pure legal or regulatory knowledge to the table, experienced regulatory affairs experts will know how, when, and where to integrate regulatory affairs throughout the development process. What may seem obvious in regulatory approval often isn’t. For example, experienced professionals might determine that a seemingly straightforward regulatory pathway will actually work better as a series of multiple smaller steps.

Or, they may know that tweaking a device’s intended use and/or indications for use or removing a function or feature could be valuable in getting the device through the regulatory process and into the market faster. The resulting initial device may appeal to early adopters and provide all the benefits of market introduction – including revenue. Later, with a footing in the market and an established safety profile, you can go back and add features and functions through abbreviated pathways.

Only a professional – or team of professionals – with solid experience in device development will be able to identify and implement regulatory paths in this way, with focus on speeding products to market and obtaining the greatest return on investment.

5. Managing The Budget

No matter what the device, how brilliant the inventor is, or how sharp that individual’s management skills, it takes significant budget to get through the entire development process for any product. There is no shortcut to quality and success, and the cost of poor planning, repeat testing, and/or noncompliance can quickly erode even the most carefully planned budget.

How To Overcome The Challenge

The tendency of device firms is for the founder and/or device inventor to handle the finances. If this is the case, the founder needs to carve out time to really think through the budget and be wholly responsible for it. The founder needs to ensure funds are being allocated appropriately between product development, marketing, sales, and other areas.

Too often, funds are not carefully controlled, and budget is used in areas where it is not necessary or not yet necessary. An example of this is building up a sales team too early. If something happens to the schedule and the market release is delayed, you now have an entire sales team that is on the payroll. Another example is purchasing manufacturing equipment that will be needed for production while still in the design phase. Do you really need that automated equipment for a pilot build of 50 units? Think hard in terms of “need” or “want” when it comes to any purchase or use of funds.


The rewards in medical device development can be great, but there are challenges – anticipated and unanticipated – to recognize. Smart device developers can overcome many of the hurdles with planning and perseverance. Creating and managing efficiencies and assembling the right team (internal and external) are essential. If your goal is to enter the medical device market in the most cost-efficient, cost-effective, and compliant manner, keep these five challenges, and suggestions on how to overcome them, in mind as you move forward.

About The Author:

Peggy Fasano is chief operating officer at Boulder iQ and has expertise in product development, project management, and engineering within the medical device and biotech industries. She has held the positions of senior consultant with Deloitte Consulting, managing director of the Deming Center Venture Fund, product development and engineer consultant for Boulder BioMed, and project manager and mechanical engineer for Sophono, Inc. She also has worked as a mechanical engineer and project manager at Polestar Technologies. Fasano holds a BS in mechanical engineering from Tufts University and an MBA from the University of Colorado. She can be reached at or on LinkedIn.