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Medtech Snapshot presents Rodney Brenneman, medtech start-up exec, who shares his winning strategy on what is needed from a leadership perspective in order to propel a pre-clinical company forward.

Hear how emotional intelligence, adaptability and long-term strategies make the difference!

If you're enjoying these Medtech Snapshots, be sure to check out our archives of past episodes HERE.

#medtech #snapshot #podcast #medicaldevice #startup #entrepreneur #strategy #commercialization #emotionalintelligence #EQ #leadership

​In this episode of Medtech Snapshot we're joined by Philippe JEAN who walks us through strategies for medical device supply chain management, in particular dual sourcing for critical components.

Want more Medtech Snapshot? Check out our archives featuring dozens of episodes covering medtech content from NPD, Quality, Clinical, Ops and Manuf Engineering HERE

#supplychain #sourcing #logistics #supplychainmanagement #strategy #medtech #medicaldevice #snapshot

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!

The art of attracting talent!

Nuvaira, Inc. CEO Dennis Wahr M.D. joins us on Medtech Snapshot to discuss strategies in attracting great talent into a small company, especially how to lure talent away from big businesses.

Check out https://lnkd.in/gFwF9GYN for our past episodes of Medtech Snapshot.

#medtech #news #strategy #talent #hiring #snapshot #podcast
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​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! VISIT HERE

We’ve all experienced it – too much work, not enough time or resources to complete it.  Day after day passes, the work doesn’t slow down but your timeframes become shorter and shorter furthering the stress of the looming workload.
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All companies, start up to conglomerate, experience this same situation.  They’ve got work they can’t get to given the circumstances of their business.  Usually it’s…

• Don’t have enough time to complete all the work we have
• Don’t have enough resources to complete the work
• Don’t have the right resources to complete the work
• Work isn’t mission critical, so it gets shelved for other more important work

We can all agree we’ve seen this first hand and very well may be living it now within our current companies. The key question then becomes, “How do we address the ‘too much work, not enough [blank]’ commonality we all share?”

First, we need to assess the work in question and is it mandatory to keep close to the chest?  Meaning, are we the only ones who can do the work?

If your answer is:
NO – “the work can be done by someone else”; we should begin looking for alternative means for getting the work done via our supply base or strategic partners.  First, review your existing base of suppliers and their capabilities to see where work can be sent out.  Second, identify firms which provide outsource services.  Many times the word ‘outsourcing’ is used as an all encompassing description for service providers that offer project or work package support, often which can be done onsite with the client just as easily as offsite – which would be the traditional method of outsourcing.

YES – “the work can only be done by our organization”; we should review the matrix of resources versus project loads.  Undoubtedly there are resources within the organization that aren’t working at full capacity and or are assigned to projects which aren’t immediate.  The trick with this approach is it may not satisfy the situation long term, often times when we try to keep things in house all we do is push off the situation to a later date.  If that doesn’t work, test your bias on ‘the work can only be done by us’. 

If you are in fact going to consider using an outsourcing or consulting firm to support you in your work projects be sure to follow this simple three step process to ensure you’re picking the right partners:

1. Location – it should never be understated, working with outsourcing firms which are local provides loads of advantages, cost being a major factor as you don’t have to pay for out-of-town travel expenses; this also helps ease potential communication issues or unnecessary time spent dealing with language barriers or fixing work after the fact due to said barriers
2. Flexibility – consulting firms that offer flexible services, tailored to your specific needs are always advisable to utilize; remember – it’s your work and your way, not vice versa; also, they should have a multitude of ways of approaching your projects, not a one size fits all approach
3. Understand Your Business – stay away from paying someone else to learn your business/ product or industry; consulting firms that have been there and done it before will know what’s needed and can step in quicker making measurable impacts faster

Key Take Away:
Sometimes the best business decision we can make is deciding what work we want to do [internally] to increase our capacity and efficiencies while outsourcing work to suppliers or service providers which specialize in project work.  In turn, this means we can focus on the mission critical work, that we enjoy and are great at doing while giving someone else the work and or projects we can’t handle or don’t want to deal with.
 
Action Item:
Utilize the below decision tree diagram (yes, it’s overly simplified) to help you determine if the work you have in question should stay internally versus would benefit from being handled by an outside source.

Are you looking for an outside services firm to help you with your projects? 

If so, our company Square-1 Engineering, would be happy to speak with you about your needs.  Check us out and let us know how we can help by clicking HERE.

As a child I dreamt of being a business owner. While the other kids in the neighborhood were talking about being pro athletes I always imaged myself starting a business.  At the spry age of 10 I opened my first business in the early 90's in my parents basement in rural New York selling used skateboard parts.  It was exciting!  I had a business sign which proclaimed ‘Sk8 Parts’, a rack to display my shoddy products for sale and even a chair to sit on while waiting for the sales to come rolling in.  After a summer being in business I had only made one sale a set of dirty and worn out skateboard wheels for a measly fifty cents to a kid down the street.  That sale bought me a pink panther ice cream from the neighborhood ice man.  While the business didn’t rocket me to instant success like I had envisioned I was hooked on the idea of being a business owner in the future so I could buy the whole ice cream factory, not just one pink panther.

As I got older I tried my hand at inventing all sorts of things, products that I thought would get me rich, if I could only figure out a way to sell a few million of them.  First it was a gaming chair, then workout towels and even a handheld flashlight projector.  My entrepreneurial dreams ended at the time with a website I tried to start in 2006 that would allow people to ask questions and get advice based off real life business situations they were dealing with.  That was a $2k boondoggle which went nowhere. 
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It wasn’t until the summer of 2015 that I would find my way, diving head first into entrepreneurship by starting Square-1 Engineering.  Thankfully I had a lot of help from many close people around me (wife, parents, friends) who all were incredibly supportive.  Four years into my current entrepreneurial journey I’ve learned and experienced firsthand many things which have helped me navigate my way to present day.  Of all these experiences, learning lessons and awareness gained there are eight which have brought about the biggest positive impact in helping me weather the entrepreneur start up storm:  

1.Get A Mentor
This is the single second best decision you’ll ever make in business.  The first best decision is to become an entrepreneur.  Mentors have experience which you can learn from helping you avoid mistakes along the way. 

2.Support Gets You Over The Hump
Make sure those close to you understand your vision and support it.  They don’t have to buy in 100% but if it’s you against the world there are going to be some very long nights in store.  If you are married it’s vital your spouse understands the opportunity and supports it, even in the down times.

3.Some Things CAN Wait
Some people will tell you it’s important to write a business plan, vision, mission, blah blah blah, right away.  Unless you’re in a situation where you need to ask for capital to start the business the best thing to do is put those things aside and focus all your efforts on how to make money.  Ultimately being an entrepreneur means you’re selling something to someone so the more time you spend on how you’re going to get paid for the product or service you’re providing the better off you’ll be.  

4.You Can’t Be Everything to Everyone
I failed miserably here.  When I did start to get customers I tried to offer them everything under the sun in order to get their business.  Some times it worked, often times it created a nightmare for me as now I had to deliver the goods.  Never over promise, you’ll most likely end up under delivering.  Find one or two areas you can become an expert in, one or two problems you can solve for your customers.  Do that and only that before you start getting into other areas of opportunity.

5.Having a Plan-B is Dangerous
I’ve read countless articles about “the power of having a ‘plan-B’ ” or an alternative course of direction.  I hate that advice.  As an entrepreneur if you don’t believe in what you’re doing and have a plan-B set up in case you fail you’re almost destined to set yourself up for disappointment.  I’m not saying it’s not important to plan ahead for bumps in the road but if you’re going to start a business that should be your one and only focus.  Anything other than a mentality of success has no place for you.  Visualize to materialize.

6.Outsource Work
The first several months I attempted to handle all the accounting and finance portions of the business only to realize two things: 1 – I’m not good at it nor do I like it; 2 – I created more problems than I remedied.  Best advice I got was to pay the money to get a reliable CPA that understood my business and could help scale it up by making good decisions.  Best money I’ve ever spent was a CPA.

​7.The Power Of Saying ‘No’
Crucial to your success as an entrepreneur is the ability to politely and professionally say ‘no’.  Similar to ‘you can’t be everything to everyone’ saying ‘no’ is harder than it sounds.  Naturally you want to say yes to everyone, making everyone around you happy, especially if it’s a customer.  Unfortunately, when we do this we get pulled in a hundred directions which causes us to deviate from our destined course.  If you are asked to do something and it doesn’t align with your top 2 or 3 priorities politely decline and thank the person for the opportunity to be considered, even if it is a customer.

8.Breathe, It’ll Be Okay
Very few things in life actually have the ability to stop you from moving forward in your new business.  When bumps in the road momentarily derail you (you will experience plenty of bumps along the way) take a deep breath and be thankful for the opportunity to learn and grow as a professional.  Stephen Covey put it best when he gave us the 90/10 principle:
 
“10% of life is made up of what happens to you, 90% of life is decided by how you react.” – Stephen Covey

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