Much like drug development and commercialization, medical device design, development and commercialization follows a defined pathway to patients. While less expensive and less time consuming than getting a drug to market, getting a device to market requires the same regulatory, IP, market-product mix, reimbursement and business model rigor.

Here’s the secret sauce, at least according the director of the Stanford Biodesign Program.

There are several differences between biomedical (biopharma and medtech) innovation compared to clinical innovation.

Here are the Cliff’s Notes. Read them before reading the rest of this article. Yes, it will take more than the usual 2 minutes to read the post so prepare yourself.

Now, let’s move on.

Here are the stages:

Understanding customer needs and designing a product to satisfy them

Here’s how to do that

Biodesign: Once you have identified a customer need and created a solution to solve their problem, reducing an idea to practice involves following the standards set by international regulatory agencies. An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)s require clinical data to support the application. Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated.

For more information about how to get an IDE, go to the FDA website.

Here are the parts of the design control process.

Creating a prototype is one thing. Being able to manufacture it at scale is another. Here are the issues and some caveats.

Following the appropriate regulatory approval pathway: There are two primary pathways for medical device clearance or approval-the 510(k) pathway or the PMA (premarket approval) pathway. 

Medical devices that do not require FDA review before the devices are marketed are considered “510(k) exempt.” These medical devices are mostly low-risk, Class I devices and some Class II devices that have been determined not to require a 510(k) (named for a section in the Food, Drug, and Cosmetic Act) to provide a reasonable assurance of safety and effectiveness.

These devices are exempt from complying with premarket notification requirements subject to the limitations on exemptions; however, they are not exempt from certain general controls. For example, 510(k) exempt devices must

• be suitable for their intended use
• be adequately packaged and properly labeled
• have establishment registration and device listing forms on file with FDA
• be manufactured under a quality system (with the exception of a small number of class I devices that are subject only to complaint files and general recordkeeping requirements)

Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.

Here are 10 regulatory traps that kill valuation.

Did you know that 69 percent of 510(k) submissions were rejected the first time between January and June of 2015? Here are some tips to prevent that from happening.

Here is a useful link describing the differences between the US and European clearance processes.

Getting a CPT code, coverage and enough payment to generate a profit

Translational and human subjects research

Launch, marketing and sales after regulatory clearance: Medtech, like biopharma, is facing many challenges that is forcing them to reconsider their business models and sales and marketing approach.

Here are some differences between marketing and selling drugs and marketing and selling devices.

Post market surveillance: Here are the requirements

Here is the milestone map for developing a medical device.

In some instances, your product might be a hybrid of a drug and a device and a digital health product. Having such a combined product has a somewhat different pathway. Here are the basics.

For every stage of device development, there are career opportunities for biomedical, engineering and medical entrepreneurs and ways to add value.

You will also need to have partners and service provider relationships to help you. Here are the main ones. Don’t forget your reimbursement strategy.

Here are 5 Steps To Faster-To-Market, More Profitable Medical Devices

Here is my list of the top medtech entrepreneur mistakes:

1. They don’t think they have a “device” as defined by the FDA so they forgo the process. A new category of digital therapeutics, sitting somewhere between drugs and devices, has introduced a new set of commercialization challenges

2. They don’t incorporate a reimbursement strategy from the beginning

3. They create something that is not patentable

4. They miscalculate the total addressable market

5. They don’t price the product properly

6. They start selling without a marketing or strategic communcations plan

7. They grossly underestimate the time and money it will take to sell their product

8. They create a product that is really not that much better than the competition. It just costs a whole lot more.

9. They don’t have a supply chain, sales or distribution plan

10. They don’t pay attention to quality system and good manufacturing processes

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/

Here are some tips on how to work with BIG DEVICE.

Getting a device from bench to bedside to boardroom requires careful planning and execution and simultaneous efforts to minimize not just clinical risk, but regulatory, IP, market and reimbursement risk as well.