4 Tactics to Boost Innovation in a Regulated Industry like Medical Devices

By Matthew Stott, PMP, Senior Project Manager

Before joining Product Creation Studio, I spent eight years working in aerospace and defense.  During that time, I led the qualification and certification of aircraft systems destined for commercial and military customers. It was here that I learned firsthand how regulations can impact development timelines. 

While it felt like they were slowing me down at the time,  I came to appreciate how regulations build safety into the design process and improve the outcome for the customer and the company. My own confidence in commercial air travel increased after seeing what it takes to comply with the regulations.

In the medical device space, the regulations may be different but the intent is the same – to protect the public and build confidence in a product’s safety and effectiveness. It’s easy to balk at the additional time and money regulations cost, especially if you are still early in the innovation (or “proving out”) cycle. I get it. 

But it’s important to remember that an innovative device that is unsafe or does not meet the patient’s needs is not “innovation”, it is negligence.

Regulations and Innovation Can Coexist

Mistakes cost lives in high-stakes industries like medical devices, aerospace, defense, and healthcare. The high degree of regulation is meant to protect citizens and maintain confidence in the safety and quality of the industry’s services and products. 

However, regulations can get a bad rep. Slow approval processes and onerous guidelines lead many to feel that the regulatory process greatly hampers innovation in competitive markets. 

While ensuring compliance can be a challenge, especially when you need to move fast to seize a new opportunity, regulations can have a positive effect on product innovation. 

After all, there are plenty of businesses that have gotten creative while remaining in compliance with their industry’s regulatory authority.

To successfully bring your medical device to market, it is important to adopt a process that allows you to innovate without compromising compliance.

4 Tactics to Boost Innovation in a Regulated Industry

So how do you keep your innovation on track under a regulated design process? Here are 4 ingredients to help you do just that:

 1. Understand your product and why you are building it.

Many products start with an idea to build something new and exciting. Truly great products start with understanding your user’s needs, then developing a product or service that meets those needs. Making decisions centered around these needs will lead to a better overall product and prevent you from spending time and money in the wrong places.

There’s a well-known concept in the UX design and product management communities that states some version of: “Don’t just focus on building your product right, make sure you are building the right product.” Building the right product not only satisfies the user's need, but it gives the developer more time to focus on the features that matter and more space to innovate around core technologies.

If you have an idea for a new product, consider the following: 

• What is the problem that your product solves?

• How does it solve the problem better than the competition?

• Is the value proposition clear and compelling?

• Remember to get targeted user feedback during product development to ensure your design process stays aligned with your ‘why’. 

2. Learn the regulations in your industry.

If you don’t understand the regulatory framework in your field then you’ll be at a severe disadvantage when it comes to product innovation. Learning the system is the first step to operating within it.

Find an experienced professional who understands your industry, or educate yourself on the specific regulations and how they safeguard the public. 

Misunderstanding or misinterpreting the regulations will show in your submissions to the regulatory authority, which will only serve to lengthen the overall development timeline and increase your costs. It’s a good business decision to know the requirements and how to meet them.

At Product Creation Studio, we have the regulatory domain knowledge to help you succeed in a go-to-market strategy for your medical device. We work collaboratively to understand your priorities and develop a product development approach that is anchored around regulatory compliance.

3. Prove technology functionality BEFORE entering into product development.

Technology advancements are moving faster than today’s regulatory environment, which can pose serious challenges to both innovation and patient protection. This is why the two - regulation and innovation - are often seen as adversaries. The truth is that knowing when to innovate can make all the difference.

At Product Creation Studio, we follow a 4-phase product development lifecycle. However, for products that are still in technology development,  we utilize a ‘Phase 0’ approach where critical technical features can be investigated and refined. Phase 0 is a powerful tool for mitigating development risk as it’s common that prototypes produced during product development do not function correctly.  When things inevitably fail or require rework, this adds time and cost to the process.

By conducting a proper technical risk assessment, you can hone in on the key technologies that need to be proven out, ideally well in advance of any regulatory design process. Design, prototype and test as many iterations as you need to until you have confidence that your core technologies are robust and reliable. Do this upfront and outside of the more strictly controlled parts of the design process, and you will save time, reduce costly iteration cycles, and reduce the risk for the later stages of your development.

4. Manage risk across the product life cycle.

Successful innovation is in large measure an issue of identifying and managing risk.

Building on #3, there are more than just technology risks to consider. A strong product development team with experience in regulated industries knows that risks must be evaluated across the entire continuum of the product life cycle (from medical device classification, clinical trials, handling, packaging, training, and reimbursements).

Managing risk is the most important thing you can do to ensure your medical device meets the user's needs and complies with all requirements. Identifying key risks, analyzing their impacts, and developing mitigations will allow you to prioritize where you spend your time and focus your innovation efforts. 

A prime example of this would be if you had an unproven, but critical technology that underpinned the marketability of your entire product. That critical technology risk (does it work as intended within the device and can we prove it?) should be front and center with a plan to mitigate by whatever means possible (bench test, breadboard prototype, etc.). 

You do not want to find yourself deep into a regulatory submission process and still iterating on the core functionality of your product. That is a sure-fire way to kill your budget and your schedule.

Regulations - A Catalyst or a Hindrance

When it comes to innovation, regulation can be a catalyst or a hindrance. Successful development of innovative products in regulated markets, quickly and cost-effectively, demands a robust process, deep domain knowledge, and creative solutions in the face of technical challenges. 

My hope is that by following these simple tips you can become knowledgeable in the regulations of your particular industry, spend less time innovating in the wrong direction, and more time focused on the things that will improve your customers’ lives.