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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!

Recently I had an opportunity to get caught up with a friend of mine, and former customer, who I hadn’t seen in years.  As we got reacquainted and talked about old times, corporate war stories and the like the conversation began to take a turn in an unexpected direction.
 
Here’s how the conversation unfolded:
 
Friend (F): “I’m working in IT now.”
 
Me (M): As I blinked with disbelief asking ‘Wait, did you say IT?  What do you know about IT, you’re a purchasing manager – and a good one at that.” (we’re old chums, I can get away with crass comments like that)
 
F: Right.  I started with this company and was turning around their purchasing department when out of nowhere they transferred me.  We’re a small company and a vacancy came up in IT doing project management so my boss asked me to slide over for the year.”
 
M: “Slide over?  Bet you enjoyed that nonchalant way of your boss saying “hey, the company needs help and we have no other options but you”.”
 
F: “That’s pretty much how it went down.”
 
M: “So how’s it been so far being in IT?”
 
F: “Awful.  I feel like every day is Monday.  I dread coming to work cause I don’t really know what I’m doing and haven’t received a lot of direction.  It’s been a lot of fake it till I make it type thing.”
 
M: “Have you asked for help?”
 
F: “I have, multiple times but the problem is there isn’t anyone else to provide me with formal direction because others above me are trying to figure things out at the same time.  I’m on Google all day trying to learn about IT project management, the lingo and work.  Honestly, I’m not sure how much more I can take of this.  I’m five months in and while I’m trying to be a good sport about it because I know the company needs the help this isn’t what I’m trained to do.  Or want to do for that matter.”
 
The conversation continued with the two of us going back and forth on his situation, each time the picture of his job becoming gloomier by the minute.  Two weeks after our conversation I found out my friend put in his resignation.  Shocker!
 
So what happened here?
 
An employee was hired to do a job, things happened and the company asked said person to help them out by moving into a new role.  Pretty straight forward, right?  Wrong.
 
Unfortunately, this type of unproductive resource alignment happens all the time.  Steve Jobs is quoted as saying “it doesn’t make sense to hire smart people and tell them what to do; we hire smart people so they can tell us what to do.”  Hiring someone who is an expert in one discipline to then transition them into another that is polar opposites of their skills is in my opinion a poor management choice, one that most often will lead to disenfranchised employees and of course employee attrition.

Let’s be fair here.  There’s a measure of truth in that it’s important we challenge ourselves over the course of our career to learn new things, take on new roles, expand our capabilities.  This is how we become a better, more well-rounded professional.  With that in mind, it’s a delicate balance between expanding someone’s capabilities and forcing them into a situation because it’s what’s best for the company, not necessarily the employee.
 
If you’re in a situation where you need someone to be a good sport and pitch in to help the company out it’s advisable you approach them with the situation in tandem with a strategy to get them in and get them out.  The must be a clear exit strategy to get that employee back into the job you hired them for.  Transitioning someone into a role they don’t want, you didn’t hire them for and is a mismatch with their skill set is a recipe for disaster.  Perhaps my friend could have been more flexible, or perhaps his employer should have realized the band-aid approach they used with my friend should have only been for a short time and not a long-term solution.
 
Back to our story. 
 
I called my friend a week after I had learned about his resignation to ask him what happened.  He then told me when he resigned his employer asked him in the exit interview why he was leaving.  He responded saying “I’m not an IT person.  It’s not my passion and I’m not being given any indication this situation is changing any time soon.  I also have little support in my new role.  I was hired to get our company’s procurement function online and effectively operating yet for the past five months I’m doing IT project management work that I have no experience in, or interest for that matter.  I found a job with another company doing what I’m good at and what I love [procurement].”
 
It’s one thing to ask employees to be team players and have a company first mentality.  It’s quite another to remove them from the job which was the reason you hired them in the first place to patch up a problem area that they aren’t qualified to handle.  In this, we are setting up our employees to fail.
 
Key Take Away:
If possible, try not to position your employees in situation where they are doing the company a solid at the expense of their happiness or capabilities.  If you must ask an employee to take on a task or job outside of their scope be prepared to have a strategic exit plan in place to get them back to the work you originally hired them for.  The work they are best qualified to do.
 
Action Item:
You have no choice, you have to transition an employee into a role outside their capabilities and comfort zone.  Sit down with the employee and explain to them the situation and why you are asking for their help.  Explain to them it is a short term situation then lay out your plans to help them get up and running in the role or task, who they can go to for support and how you will work with them to ensure their success.  Also outline their exit strategy to get them back into their original job so they know there is an end insight.  Lastly, I would strongly suggest offering the employee a bonus or form of recognition as a result of their willingness to help out.  This last piece should never be overlooked, otherwise you may find yourself without the employee in the near future.
 
Are your employees misaligned, doing work that isn’t their specialty?  Contact Square-1 Engineering at www.square1engineering.com to learn how we can help solve your biggest engineering and technical business challenges while helping to get your employees back to the work they love doing.