Is it a Business, Engineering, or Regulatory Decision?

Is it an Engineering, Regulatory or Business Decision? 

After being in the medical device industry for over 30 years and consulting for hundreds of clients over the last 10 years it’s amazing how often medical device developers get confused about what kind of decisions they must make; Engineering, Regulatory or Business decisions. I have seen many moments where a startup is thinking a decision is one of these categories but is actually another. It is important to discern what type of decision is being made and the effects on the other two categories. All three can easily and naturally effect the others. In this article, I explore examples of many different decisions that a medical company need to make. 

Regulatory Decisions in Disguise 

The easiest, but least understood decisions are regulatory and quality decisions. Many decisions during product development and after-market release will affect regulatory and quality, it is woven throughout an organization. However, there is a silver lining in that regulatory bodies (FDA and EU Notified Bodies for example) try to be very clear on how to obtain regulatory clearance or stay compliant. When circumstances are not clear, the FDA has mechanisms (513(g) and Q-Subs) to gain clarity on the path for regulatory clearance. Once your product is on the market, there will likely be regulatory and quality issues that arise in the case of proposed product changes, for example. Will a proposed change require submitting an amendment to the 510(k)? You don’t have to guess. The FDA provides guidance documents and decision flow-charts to allow you to arrive at the correct answer.

Business or engineering decisions can turn out to be regulatory decisions depending on the impact of the change. 

For example, in order to lower cost on a single-use sterile disposable product, the company decides to move production to Asia. What are the regulatory implications? First, realize that the company is always responsible for making sure that its products are safe and effective and perform as claimed. Period. No matter where they’re produced. Depending on the class and risks associated with a specific product, the manufacturing and sterilization facilities may need to be inspected by the FDA even if they are outside the USA proper. This business decision of moving production has regulatory side effects, understanding the implications of the regulatory impact could affect your business decision. 

In another example, let’s say the integrated circuits are outdated and your company decides to redesign to use more reliably available components and to lower manufacturing costs. From a “black box” perspective, the circuit cards perform the same functions as they did previously and the overall product intended use and claims are unchanged. This is an engineering decision to redesign with more available components and a business decision to continue production and reduce cost, but what are the regulatory implications? Again, refer to the FDA Guidance Document referenced above and perform risk assessments per ISO 14971 along with re-doing applicable Verification and Validation (V&V) testing and documenting the results as a minimum prior to releasing the change. Retesting to confirm compliance with standards such as IEC 60601-1 will also likely be required. Regulatory and quality considerations will be present in most decisions, but the regulatory bodies try to make it clear what actions you need to take to stay compliant. 

There are times that a business and a regulatory decision and perspective are extremely intertwined. Startup founders commonly don’t understand the regulatory implications for the medical indications for use. These are significantly different domains. From a regulatory perspective, therapeutic claims and “Indications for Use” need to be relatively narrow. Every claim made in this context must be backed up by evidence and authorized by the FDA through the 510(k) or other process. For example, if you have a technology that was designed for hip surgery but can, say, be used in shoulder, knee, and hip surgery. The regulatory body will require evidence that indeed the product works in each of those scenarios. This has now likely tripled the amount of testing you will need to do. Also, be careful about using claims that doctors might make for your product in peer-reviewed or other publications or presentations. The doctor can say something like “I’ve cut my patients’ hospital stay time in half with this product!” Great! You can suggest that people read the doctor’s article, but you can’t make the claim yourself without adequate evidence and FDA authorization. 

Quality Decisions: Black and White 

Decisions regarding manufacturing process issues can be confusing as well. I once found a young quality engineer who stopped production and was ready to write a CAPA because the new batch of product had one dimension that was slightly bigger than the last batch. When confronted, I asked if both batches were within the specification and passed QC testing. The answer was yes. I also asked if the new batch, being larger, increased any risk to the patient. The answer was No. So why was production stopped? Because “something was different”. Medical device manufacturers need to live by their specifications. The product is either “in spec” or “out of spec.” That being said, it’s always appropriate for a production worker to raise an issue or ask a question. 

Another example was a company who was selling product faster than they could make it. They asked me to take a look at their processes. It was very clear that they were using bench top operations to manufacture, just like they did during the research phase. These processes couldn’t scale. When presented with higher volume processing techniques the QC team got stuck asking “how do we know the product in is the same using the new technique?” The answer is simple, “Did it pass the specification and QC test?” If yes, then it is the same. The problem was that this company did not have good specifications, process validations, or QC tests for each step in their manufacturing process. We put those in place and the questions disappeared, the answers were obvious in light of the new specs and procedures. 

Engineering Decisions 

The next set of decisions to make are the engineering decisions. Short of “unobtanium,” almost any device can be designed, tested and built to obtain regulatory clearance given enough time and enough money. But not all engineering decisions are good business or regulatory decisions. Engineers need to have not only the product requirements and user needs in mind they must also be designing for a target manufacturing cost at pre-determined volumes so that the price of the product can compete in the marketplace. Having a regulatory strategy from the beginning of the design process is also important. The engineering team should have an outline of the key standards, verification and validation testing that their design must meet. For example, if a sterile product requires a 5-year shelf-life claim, that consideration must be taken into account when designing the packaging. 

Business Decisions 

Finally, there are business decisions. Time and money are not infinite and typically are in very limited supply. Let’s assume a product design, qualification and regulatory approval project will take 5 years. At the time of the start of the project, the market looks like it will be eager to receive the new device. A few years into the project, however, a new technology is introduced that dramatically impacts the market potential of the product under development. A business decision must now be made. Do we continue the project to completion, spending the additional time and money? Or do we stop the project and see how we might use what’s been learned and developed in other ways? 

A real-world example is a company I’m familiar with that developed a tissue aortic heart valve with replaceable leaflets. It was implanted in the traditional open-heart surgical way, but when the leaflets needed replacement, the exchange could be done using minimally invasive techniques. The market was excited about this idea. During the product’s development and clinical trials, however TAVR (Transcatheter Aortic Valve Replacement) technology was approved, a much better solution for most patients. 

Things change. The business team must constantly monitor the competitive landscape and adjust plans accordingly. 


In summary, the medical device business involves a never-ending stream of decisions, most of them requiring trade-offs. 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 involved. In all cases your company is responsible for evaluating all changes for safety and effectiveness and making regulatory submittal amendments as needed. Continued business success depends upon clear thinking and efficient execution. By seeing issues from these different perspectives, implementing solutions to problems can be done in the most efficient way possible.

Larry Blankenship, Director, Boulder iQ