Launching a Medical Device? Don't make these 5 Big Mistakes

Liz Heiman
13.05.22 11:34 PM Comment(s)

Launching a Medical Device? Don’t make these 5 Big Mistakes

Launching a new medical device or any product that requires FDA approval is difficult and time consuming. The process can be long and frustrating. It is particularly frustrating if you make these mistakes that can set you back months, even years! 

Mistake 1: Making the product or prototypes without implementing Design Controls. 

As a product expert, you know how to design a product your customer wants. That might not be enough, If you are seeking FDA approvals or clearances, you must follow a very specific set of rules, called design controls. Design controls requirements vary based on your specific product and the regions in which you intend to market your product. Putting design controls in place during the design process is one of those critical steps. Not putting those controls in place will cost you precious time.

Mistake 2: Getting FDA Clearance, but not having a team, the QM Process, or the funding to launch. 

It is not uncommon to underestimate the time and cost of building a compliant business and manufacture a compliant product. Once you have implemented design controls, and advanced in the design and development process to the point where you receive FDA approval or clearance, the design transfer must be executed. It’s important that you are ready to launch. It will take time to onboard and hire your team. It will take time to get the marketing ready to launch, and to build the relationships that you will need to sell. It will also take time to scale up  manufacturing and purchasing operations. Get your funding as early as possible so are ready to perform design transfer and launch when the approval comes through. You will need a team in place prepared to market, sell, deliver, manage quality and invoice.

Mistake 3: Assuming doctors solely make the buying decisions. 

Many founders believe that doctors have the sole authority to make the decisions about what products they will use. As a result of that belief, they focus their energy on reaching and getting buy-in from surgeons or doctors and wait for them to make it happen. While that may work with surgeons who have their own practice and do outpatient surgeries at a surgery center, that is not how it works in a hospital. Doctors are one set of people who influence a decision to buy at a hospital or in a hospital system. 

Mistake 4:  Not understanding the buying Process.

The buying process of a hospital is complex with many different departments involved in the decision. Not understanding that the buying process can extend the sales cycle or undermine the sale altogether. The first thing to understand is that all purchases in a hospital must be budgeted. All MedTech purchases in a hospital must also be approved by the quality team including risk managers and the purchasing team. Many hospitals require that all vendors go through a pre-approval process and a purchase can’t be made until that is done. If it touches technology in any way, it must also be approved by the IT department. And legal must review contracts before they are signed. It is likely that technicians, nurses, and doctors who will interact with the device will also have a stake in the decision. If the product is going to have a large impact on the hospital or is fixing a problem that has had public scrutiny, the CEO and board may also have to approve the purchase. Understand how the buying decision is going to be made and make sure you cover all your bases. If purchasing, IT or Quality nix the project, the deal won’t close. 

Mistake 5: Underestimating the budgeting process and timeline.

Hospitals have very strict budgeting processes and timelines. The budgets are typically determined once a year and approved by the board. Revising that budget after the cycle is complete is possible, but very difficult. Typically, only an emergency will get funded outside the normal cycle. Before an item goes into the budget, it must either represent a problem the hospital has decided needs to be fixed and may not yet have a solution for, or it is an item that a purchase request has been made and it must go through a series of approvals before it can be considered for budgeting. Find out what that process is and how long it will take for that budget cycle to be completed. Budget cycles can postpone purchase by months or even years. Don’t be over optimistic about how quickly you will be able to sell to a hospital. Plan a year to 18 months for anything that is a large investment. 

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Liz Heiman