Typically, regulatory and quality decisions are the most straightforward ones to deal with. While these issues can be complicated, regulatory bodies, including the FDA and EU Notified Bodies, are very clear on how to obtain regulatory clearance and remain compliant. And when circumstances are not clear, many have mechanisms, such as 513(g) and Q-Subs, to gain clarity on the pathway required.

Once a device is on the market, regulatory and quality decisions continue as product features inevitably change. Again, regulatory bodies provide guidance documents and decision-making tools to help accurately determine all requirements. However, there are times when seemingly straightforward business and engineering decisions become regulatory decisions in disguise.

Disguised decisions

Let me give you an example; a company in the US is looking to lower production cost on a single-use sterile disposable product and decides to move production to Europe. It may be a straightforward business decision in terms of cost, but the regulatory implications of such a move may be significant enough to veto the decision. Depending on the class and risks associated with a product, the FDA may require inspection of the manufacturing and sterilization facilities, even if they are outside the US. Therefore, the ultimate decision may be more of a regulatory one.

In another example, a company using integrated circuits in its device may decide it’s time to use more current versions and thus lower manufacturing costs. Again, from a business and even an engineering point of view, this decision is a no brainer. However, from a regulatory perspective, the company will be required to undertake extensive risk analysis, testing and then re-validate before it can release the updated device. Again, the quality/regulatory burden may determine that the change is a non-starter.

Make decisions earlier

Almost any device can be designed, tested, and built to obtain regulatory clearance if you throw enough time, effort and money at it. As already discussed, from an engineering perspective, decisions on which product designs to develop can be quite clear cut, but do not always make good business or regulatory sense. Along with product requirements and user needs (human factors and usability), engineering must design for a target manufacturing cost at predetermined volumes so the price of the product can compete in the marketplace. Therefore, as the fundamental requirements of any company are to generate something of commercial advantage, Business decisions will tend to trump engineering ones.

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

For instance, if engineering staff knows up front that a 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 either the device or the packaging (or both) late in the development process. At that point, what to do can easily become more of a business decision than an engineering one and is a fast way to kill the project. Using tools such as Failure Mode and Effects Analysis (FMEA), Pareto charts etc. can help identify and communicate any potential conflicting decisions as soon as possible. 

Business decisions during development projects

Time and money are not infinite and changes such as; staffing, regulatory environment, competition, technology advances and other external factors are inevitable during any development project. These changes actually impact business decisions more than engineering or regulatory decisions are impacted by business conditions. Therefore, a device developer’s business team needs to be involved in pretty much every decision you make, as they must constantly monitor and adapt to the competitive landscape for the entire life of the product, not just the development phase.

By fully understanding the impact of every decision made on a project you give your business every opportunity to adapt at a stage that is not critical to the completion of your development journey. It allows the business to either, continue the project to completion or stop and pivot, applying what has been learned and developed in other ways.

Key take-aways

The medical device business involves a never-ending stream of decisions, most of them requiring trade-offs. It is therefore important to have a robust way of completing a basic form of impact assessment which covers critical business units when evaluating all project changes. 

Identification of potential key decisions or changes at an early stage is vital to allow the project or company to pivot and find new ways to apply the knowledge gained thus far in a commercially successful direction. 

There are many risk based tools at your disposal, such as Failure Mode and Effects Analysis (FMEA), Pareto charts etc. to allow you to identify potential decisions and communicate them to the wider business in good time.