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Ensuring the smooth progression of a medical device through product development is more than just having a good idea and the money to back it up.

In the ever-evolving landscape of healthcare, the development of cutting-edge medical devices demands a strategic and disciplined approach. At the heart of this process lies several key drivers each with their own distinctive value, yet all of which work in harmony bringing us to the conclusion we are hoping for - getting our products successfully through each phase of product development and eventually out the door to patients in need.  This article explores the 'key drivers' which will keep your product development efforts successfully moving forward. 

Let’s begin with looking at what may very well be an obvious statement – what problem are you trying to solve and is it worth solving in the first place.  The second portion of this question is key – is the problem you want to solve, via the technology you intend to develop, actually worth solving.  Some advice – not all problems are worth solving, especially in the eyes of investors.  It’s going to take deep pockets to build a product, upwards of $100 million on average for a PMA device, which is why its so important to be able to confidently answer this first two-part question: what problem are you trying to solve and is it worth solving in the first place.

Once you know your technology front and back, understand the macroeconomics associated with it, it’s time to put a well-crafted plan into place to help keep you on track throughout each phase of the development cycle.  Here enters project management.
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Project management plays a critical role in the success of medical device product development as it holds your team accountable to keeping focused on the key strategies which contribute to a seamless progression from concept to market.  This should include:

​Developing A Clear Project Plan
A well-defined roadmap is the cornerstone of any successful project as it delineates tasks, milestones, and dependencies. Roles and responsibilities are outlined, laying the groundwork for a collaborative and efficient work environment. Regular updates and adjustments ensure the plan can accommodate change while staying aligned with the overarching project goals.

Timely Decision-Making
Delays are costly endeavors. Projects which embrace prompt decision-making empower team members to make informed choices within their spheres of expertise. This can minimize bottlenecks, fostering an environment where decisions were made swiftly, keeping the project on a forward trajectory.

Risk Management
A robust risk management plan provides continuous assessment of potential challenges.  Glen Rabito, COO of Nidus Biomedical, advises “identify the top three (3) risks and go tackle those things first.  This will allow us to understand the technical and clinical risks” [associated with the development of your technology].

Effective Communication
Clear and transparent communication is the lifeblood of successful projects. Regular team meetings facilitate discussions on progress, challenges, and potential solutions, creating an environment where everyone is well-informed and engaged.

Resource Allocation
Efficient resource allocation is essential for maintaining momentum throughout the development process. Teams which carefully monitor the allocation of human, financial, and technological resources tend to fare better than those who don’t. Also, what should you keep internally as a core competency versus outsource to someone better set up to facilitate a portion of your work. 

Adaptability
Flexibility in the face of change is a hallmark of successful product development efforts. Project plans should be designed to be adaptable allowing the team to accommodate shifts in scope, requirements, or unforeseen economic challenges.

Regulatory Compliance
Navigating the complex landscape of medical device development requires a keen understanding of regulatory requirements. Staying informed of regulations and incorporating specific milestones related to regulatory submissions in the project plan is crucial to your success in keeping things moving forward.

Prototyping and Iterative Development
Teams which embrace an iterative development approach are focused on continuous improvement, allowing the team to make necessary adjustments based on user and stakeholder input. The result is a product which meets regulatory standards AND user needs and expectations.

Quality Assurance and Testing
Ensuring the highest quality standards is non-negotiable. Thorough quality assurance and testing processes should be integrated at every stage, whereas multiple testing iterations are planned for and issues identified during testing are promptly addressed.

Documentation and Traceability
Many of us love to gloss over this step – yet doing so is a monstrous mistake.  A disciplined approach to documentation is critical for accountability and traceability. A team which maintains accurate and up-to-date documentation throughout the project, establishing clear traceability between milestones, design inputs, and verification/validation activities will be better positioned for success down the road, while mitigating project efforts being put on hold.

In the intricate dance of medical device development and effective project management is the guiding force which better positions your team and company for success. The strategies outlined above, from meticulous planning to continuous improvement, collectively contribute to the seamless progression of a product and the overarching project. As the healthcare landscape continues to evolve, these principles will remain essential for navigating the complexities of medical device development and delivering innovations which make a lasting impact on patient care.

​The quickest way to overcome a business challenge is to get help from those who are experienced in besting your beast!  The team at Square-1 Engineering is comprised of a variety of technical and project management professionals who are subject matter experts in the areas of NPD, Quality, Compliance and Manufacturing Engineering.  Learn more about how we can solve your work and project problems today to get you back on track!

Executive Summary:
If your company lacks a ‘gold standard’ for its product design practices you are inevitably wasting time, resources and funds.  Implementing and running a gold standards program is essential to operating at peak performance. Start by developing a best in practice plan.  From there setup a review plan to provide feedback on all work performed. Once the infrastructure of your new gold standard system is established you’ll want to assess the skills of your team and develop a training program which can be offered to both new and existing employees. 

​Author(s): Travis Smith & Tim Humphrey

Read the full article by downloading the below PDF attachment

​Recently our firm took on a project which offered an interesting perspective and remainder having to do with the importance of thinking long term and planning accordingly. When you’re developing a product, regardless of which phase of the development cycle you’re in, it’s crucial to always consider the DFM (design for manufacturability) side of things.  Otherwise, you could end up in a situation like our customer did below.
 
Our customer had a novel approach to addressing a problem on the market which hadn’t been dealt with in years.  The other companies and people in this space just keep doing the same thing over and over while accepting patient outcomes which at times were and still are mediocre.  In here lies opportunity.
 
Our customer hired a design firm to develop a prototype based off their concept to address this patient problem.  What came of this partnership with the design firm was an incredibly neat, novel and quite frankly cool technology.  Plus it looked awesome!  The design firm, at first glance, hit it out of the park.  Well done, chaps.
 
The prototype was impressive.  It was so impressive it even garnered a new round of funding, series B, for our client.  All was good in the world.  Right?
 
Wrong. 
 
While the approach for this prototype was indeed cutting edge it failed to address a crucial area of the product development lifecycle – manufacturability.  Our customer had a really cool product, and boy did it look cool in action, but unfortunately it couldn’t be commercialized due to its associated COGS (cost of goods sold) and manufacturing time per unit.  Basically, what happened was our customer hired a design firm to develop a really cool looking product that couldn’t actually be manufactured because DFM hadn’t been taken into consideration.
 
This is akin to what happens in the automotive industry all the time.  A really cool concept is developed, often times to allow a company to flex its technological muscles yet what ends up being produced and available to the masses is quite different. (as shown below with this example of Chevy Volt’s Hybrid, side by side)

Notice the different in the design elements and ergonomics.  The concept looks stealth, sleek and modern.  Almost like a Camaro.  Who wouldn’t want to drive that car!  Whereas the production vehicle is a dumbed down version, not nearly as cool looking, almost rather plain and forgettable.  It’s now a commuter vehicle designed to do one thing, put on the miles and get you from point A to B.
 
So why does this happen, where concept and production product are two different things?
 
Often times the simplest explanation is that the cost (COGS) of building the concept to meet production volumes would be so high that it would far surpass the cost point which the product, or in this case, the vehicle needs to be sold at to be competitive on the market.  No one is going to buy a non-luxury 4-door commuter car made by Chevy which costs $80,000 US.  If the company kept to the original concept design and tried to manufacture that at high volumes that’s exactly what would happen.  Few would be sold and the vehicle would tank in ratings and Chevy would lose money in the process.  As a result, they dumb down the design and features to meet the needs of the target customer audience.
 
In the medical device industry things work much the same way with one slight difference.  Cost of a product per unit is most often based on what a company can get reimbursement approvals for.  If you’re developing a medical device that relies on reimbursement to make money it’s absolutely crucial your COGS per unit are below the rate in which you can get reimbursed for, otherwise you won’t make any money.  A professor of mine back in college used to say (and do so with a flair of arrogance that was most fantastic), “It’s economics.  You can’t spend more than you make.  Duh”
 
Duh, indeed.  So back to our story.
 
Our customer is now left with a really impressive paper weight.  They can’t manufacturer it in its current state and do so at a price that would allow them to make money.  They’ve spent an incredible amount of time and money to be in a position that doesn’t allow them to move forward and get a product to market.
 
When we were brought in to help the customer the story we learned along the way wasn’t unlike many others we’ve heard before.  In fact, we see this all the time.  Fortunately over a period of 6 months we were able to work with he customer to make some small design changes along with manufacturing process changes, in particular their test fixtures and work flow, to finally get to a point where the product could be ready for commercialization.  What made this outcome come to fruition was the customer was very open to ideas and changes as this was critical to getting the product to a commercialized state.
 
Key Take Away:
If you’re developing a product, regardless of the industry or market you’re in, never take your eye of the importance of DFM (design for manufacturing).  A novel, emerging technology that can’t be manufactured is basically a really expensive paper weight.
 
Action Item:
If you’re developing a product and are considering using a design firm or supplier to help you with that effort make sure you vet them to understand what their experience has been getting a product to market.  Anyone can design something that looks cool.  Designing something that can actually make its way to the market and ultimately the end user is another thing all together.  Ask the supplier for examples of design work they’ve done which ultimately got to a full commercialized state.  Once you have these details you can better determine if this company is the right fit for your needs.
 
It’s important to recognize there are plenty of times where a company needs design help and it’s purely for the purposes of having a concept, not for the purposes of having a product on the market.  It’s important to understand the differences between the two and where your needs are with your own product.
 
Interested in learning more about the case study attached to this article?  If so, click HERE.