Guest Column | January 3, 2022

How To Untangle Your Medtech Regulatory, Engineering & Business Decisions

By Jim Kasic, Boulder iQ

Simplification GettyImages-1257126545

Making decisions in medical device development is tough. From initial concept to market introduction, countless factors – many of which are outside of the developer’s control — influence almost every decision. Compounding the issue is that it’s easy to confuse and intermingle engineering, regulatory, and business decisions. Knowing which type of decision you’re making can make all the difference in how quickly and effectively you can bring your device to market and maintain market presence once it’s there.

Typically, regulatory and quality decisions are the most straightforward ones. While dealing with these issues can be complicated, there is a silver lining in that regulatory bodies — including the FDA and EU Notified Bodies – try to be very clear on how to obtain regulatory clearance and remain compliant. And when circumstances are not clear, the FDA has mechanisms, such as 513(g) and Q-Subs, to gain clarity on the path for regulatory clearance.

Once a device is on the market, regulatory and quality decisions continue as product features change. Again, there’s good news in that the regulatory bodies provide guidance documents and decision flowcharts to help accurately determine all requirements. However, there are times when seemingly straightforward business and engineering decisions actually become regulatory decisions in disguise.

Regulatory Decisions In Disguise

For example, let’s say a company looking to lower production cost on a single-use sterile disposable product decides to move production to Asia. It may be a clear business call in terms of cost, but the regulatory implications may be significant enough to sway the decision. Depending on the class and risks associated with a product, the FDA may require inspection of manufacturing and sterilization facilities — even if they are outside the country. The ultimate decision may then actually be more of a regulatory one.

In another case, a company using outdated integrated circuits in its device may determine it’s time to redesign to use more reliably available components and to lower manufacturing costs. That decision seems clear on both the engineering and business sides. But the company must consider the regulatory implications, referring to FDA guidance documents. It will likely need to perform risk assessments per ISO 14971 and redo verification and validation testing before it can release the updated device. The final decision may rest with the regulatory implications.

Sometimes, employees with startup device companies may lack extensive experience in bringing products to market, and as a result, may not always understand the extent that regulatory environment and medical indications are intertwined. From a regulatory perspective, therapeutic claims and indications for use must be defined narrowly. The FDA will require evidence of every claim made in the indications, as well as authorization through the 510(k) or other process. For example, if you have a technology that can be used in shoulder, knee, and hip surgery, you’ll need to supply evidence that the product works in each of those scenarios. Three uses means three times the amount of required testing. What may seem like a clear-cut product design decision may actually come down to a regulatory call.

Early Information For Your Engineers Is Crucial

Short of unobtanium, almost any device can be designed, tested, and built to obtain regulatory clearance…with enough time and money. From an engineering perspective, decisions on which product designs to develop can be quite clear. But not all engineering decisions are good business or regulatory decisions. Along with product requirements and user needs, engineering must design for a target manufacturing cost at predetermined volumes so the price of the product can compete in the marketplace. Business decisions sometimes trump engineering ones.

Putting in place a regulatory strategy from the beginning of the design process will help ensure that engineering decisions do not inadvertently become regulatory ones. With knowledge of key standards and verification and validation testing requirements, your engineers can design effectively and efficiently.

For instance, if engineering staff knows up front that a sterile product requires a five-year shelf-life claim, they can plan packaging design appropriately. Without that information early on, a company can be looking at the need for redesign — of the device or the packaging — late in the game. At that point, what to do can easily become more of a business decision than an engineering one.

Monitoring The Landscape In Making Business Decisions

We know that time and money are not infinite and are, in fact, typically in very limited supply. We also know that things change over the course of device design and development: staffing, the regulatory environment, competition, technology advances, and other external factors. The bottom line is that business decisions are affected by regulatory and engineering factors as often as regularly and engineering decisions are impacted by business conditions. A device developer’s business team must constantly monitor the competitive landscape and adjust accordingly.

Here’s one example of how technology advances and external conditions can impact a device developer’s business decisions. The developer may be working with a time frame of five years for a device design, qualification, and regulatory approval project. At the start of the project, the market has expressed eagerness for the new device. A few years into the project, though, a new technology is introduced that will dramatically impact the market potential of the device. The developer must now make a critical business decision: continue the project to completion or stop and see if there are ways to apply what has been learned and developed in other ways.

In fact, one device developer with which our company has worked developed a tissue aortic heart valve with replaceable leaflets. It was implanted in the traditional open-heart surgical way but needed only minimally invasive techniques to replace the leaflets. Initial market excitement was high. But during the product’s development and clinical trials, transcatheter aortic valve replacement (TAVR) technology — a better solution for most patients — was approved. Because of this, the company pivoted from its original product plan and adapted the technology it developed to a different use.


The medical device business involves a never-ending stream of decisions, most of them requiring trade-offs. While few are clear-cut, black-and-white choices, it’s important to separate the issues to determine whether they can be addressed with a business decision, an engineering change, or a regulatory adjustment. In some cases, all three might be appropriate.

About The Author:

Jim Kasic is the founder and chairman of Boulder iQ. With more than 30 years of experience in the Class I, II, and III medical device industry, he holds more than 40 U.S. and international patients. His career includes experience with companies ranging from large multinational corporations to start-ups with a national and international scope. Kasic has served as president and CEO of Sophono, Inc., a multinational manufacturer and distributor of implantable hearing devices, which was acquired by Medtronic. He also was the president of OrthoWin, acquired by Zimmer-BioMed. He received a Bachelor of Science in physics and a Master of Science in chemical/biological engineering from the University of Colorado and a Master of Business Administration from the University of Phoenix. He can be reached at or on LinkedIn.