I think one of the biggest challenges is when developing a novel device, you have to answer to the FDA and the corresponding regulatory agency for your device, and it can be months and months (even years) of trials and testing before your device ever comes to market. A team must be prepared to see the project to its end even with a lengthy project timeline. A lot of employees may get burnt out or be disappointed at certain points of the timeline, where they may need to go back and make changes or something in the specification gets rejected. 

I think you bring up a great point. In Medical Device/Healthcare Project management patient safety and data privacy are at stake. Healthcare is indeed heavily regulated due to laws concerning patient confidentiality and HIPAA compliance. With these regulations, obtaining approvals for devices can ultimately be challenging. With constantly evolving technology in the medical field, patient data and privacy are at a higher risk for data theft. Therefore the phases of approval are stringent in ensuring that patient data remains confidential. 

I would agree that the regulatory guidelines are definitely a more complex aspect of healthcare that not other industries have to deal with. In addition, these regulations can change with countries such as the FDA in the US and the EMA in Europe. If you're trying to sell a product in multiple countries not only do you have to answer strict regulatory authorities in your own country but you have to be familiar with the intricacies of those in other nations as well which may also mean additional testing to prove the safety and efficacy of the device. 

I think the biggest challenge of developing medical devices is the design process. Design medical devices could be a complex process and the designers have to consider a number of problems the device and the patient might be faced with. The clinical trial and the FDA approval could be complex and time consuming but they can ensure the safety and the efficiency of the devices. However, safety and efficiency are not the only properties of a popular device. The designer also needs to consider the patients’ habits and the unique properties which make the device differ from other similar products. The market reaction might be important for the medical device since it could affect the following updates of the device. For this reason, the reaction of the market could also affect the design of the product.

So I currently work with GE Healthcare and their Medical devices and one of the biggest concerns hospitals always have when setting up these devices is patient records/data. Some hospitals prefer to use our data management program called MUSE which collects patient cardiac test information into the GE database. Most hospitals trust this application however others prefer different applications with third-party companies to ensure patient confidentiality. Another one of our medical devices called a PDM (Patient Data Module) has recalls sometimes due to cyber security bugs which can lead to patient data being leaked. So I think an ongoing issue med device companies have is reassuring hospitals and healthcare providers that these devices are as secure as possible when it comes to patient data, but even then you can sense there are trust issues. 

One of the largest pain point for most medical devices is probably phase 2 trials since that is where efficacy is tested or phase 3 where safety and efficacy is tested and compared to what's available in the market currently aka the "Gold Standard". Similarly to drug development, medical device development, testing and trials can cost millions just to be rejected. There exists no way to recoup that cost and the effort put in by hundreds of scientist and engineers. It is a brutal line of work and only market approval is awarded since the research conducted has no monetary value, even if something novel came out of the process. 

Like @njq3 and @ridmehta mentioned, it is vital that your medical device is approved by the appropriate governing agency. In the United States, we have the FDA. The European Union has the EMA. Health Canada is the governing agency for Canada. Prior to submission to the appropriate agency, the medical device needs to go under numerous tests that can last for months, even sometimes years. These tests are done to ensure that the medical device is up to the standard put out by the governing agency. More often than not, the agency will reject the medical device. In that case, certain specifications of the medical device need to be retested and then resubmitted. This process goes on until the agency is pleased with the results; it can be days, months, or even years of a virtuous cycle. Once that happens, it is ready for market in the area of that governing agency. 

Medical device companies indeed have a certain level of hoops to cross when it comes to project managing. For starters the most important aspect as said by the question mmd55 is the regulatory ramification and hope that the product dosent fail. This is because if a product fails while in the patient, it has serious legal and also human life ramifications towards the company. So it is in the best interest to spend as much time trouble shooting and making sure that the risks of failure are next to nothing. Additionally another unique condition for medical device is testing on human and animal formats. For obvious reasons, medical devices need to factor in in-vivo affects on the body.