by Genesis Plastics Welding Marketing Team Genesis Plastics Welding Marketing Team

Birthing Your Medical Device Idea: Ensuring a Healthy Delivery

Birthing Your Medical Device

Creating a new product is a lot like giving birth: You naturally fall in love with your idea and feel no one knows your “baby” better than you. You also tend to overlook flaws as you marvel at your creation and dream of its potential. But even the healthiest of babies can struggle to thrive without expert input, guidance and monitoring. The same goes for your product.

Want a healthy delivery? Just as important: Want your product to thrive past its infancy to live a long, productive (and profitable) life? Then partner with people who’ve produced those outcomes before: specialists who’ve built successful devices, navigated through FDA requirements, and taken medical devices to market.

Your expertise can severely hurt your device’s performance

A few months ago, we posted about a decades-long research that revealed heavy reliance on your own expertise can severely hurt your performance. There are two reasons for this, as the Harvard Business Review reports:

“The first is overconfidence: believing that brilliance in one area leads to competence in another. The second is when deep knowledge and experience leave leaders incurious, blinkered, and vulnerable — even in their own fields.”The antidote is to approach new challenges with a beginner’s mind, knowing that blind spots are inevitable when your team lacks objective insight or real-world experience to overcome market challenges.

Shielding your product from failure

We won’t repeat the advice we’ve covered about how to discern if you’re at risk of being blindsided and what to do about it. (You can read that here.)

On the flip side, partnering with a reputable, seasoned medical device development firm enables you to identify gaps and opportunities that might have escaped you otherwise. 

Consider, for example, the impact that a single mishap or new discovery in any of these areas could have on your product performance:

  • Market research
  • User experience
  • Product design and key functions
  • Potential hazards, potential for human error or misuse, supply chain risks
  • Prototype testing and de-risking
  • Regulatory/FDA demands
  • Patient safety considerations
  • Materials selection (is there a safer, better, cheaper way to meet product requirements?)
    … and more

The process of bringing a product to life is a complex one, with each phase requiring distinct expertise and mastery. We’ll be blunt: No astute startup trusts their own hunches and limited know-how to navigate this process. Too much is at stake.

Protect your investment by having the right partner bring your “baby” to life.

 

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by Genesis Plastics Welding Marketing Team Genesis Plastics Welding Marketing Team

Medical Device Pitfalls: Beware of Perfectionism, Excessive Bells & Whistles

You’ve had a stroke of genius and conceived an idea for a medical device that can solve big problems for patients and clinicians — plus generate a healthy chunk of revenue.

You’ve also done your due diligence to confirm market demand for your solution, and you’ve thought through the user experience.

That’s a strong start.

From there, it’s natural to fixate on your product and want to refine it, again and again, until it’s PER-FECT. And that’s when things can go south for some start-up leaders.

Medical Device Pitfalls

When perfectionism leads to missteps

Perfectionism is on the rise, and that’s not good news, argues the Harvard Business Review. Start-up leaders who want the first thing they launch to be the end-all, be-all solution tend to end up with a disappointing product, despite the best intentions.

Not only is perfection an impossible goal, “those who become preoccupied with it inevitably set themselves up for failure and psychological turmoil,” the authors explain. That turmoil often translates into procrastination “because perfectionists cannot fail on tasks they haven’t started.”

Invariably, an undue fixation on launching the perfect medical device brings costly side effects, including:

  • Unnecessary bells and whistles your users may not understand or care about
  • Increased costs
  • Longer time to launch
  • Greater potential for risks
  • Greater scrutiny by the FDA

Missing out on invaluable user feedback

Simon Slade, Success magazine writer, cites another casualty of aiming for a perfect first iteration in a new product: You miss the opportunity to have users co-create the kind of product they really want.

“There is a reason why so many successful start-ups have versions 2.0, 3.0 and so on. By launching with the basics, you can not only start earning money sooner, but you’re also able to collect actual customer feedback to determine the future of your product. You might find that the advanced features you were itching to add don’t actually matter to your customers.”

You might also be putting unmerited value on originality, says Slade:

Originality is not only unnecessary; it can also be detrimental to a startup because it can make it difficult to connect with your customers. New ideas are hard to process for the mass market. Better versions of old ideas? Those resonate — quickly.”

Focus on core functions

The antidote to harmful perfectionism without sacrificing excellence, quality and safety is focusing on a handful of core functions: the essential capabilities you need to deliver key benefits.

Identify a handful of essential functions and focus on refining those — not adding a bunch of extras.

It’s how you keep costs, risks and delays at a minimum, while serving your end users well.

In the weeds on development of a first iteration of a new medical device? Chat with our MedTech Launch division and get back on track for launch success.

by Genesis Plastics Welding Marketing Team Genesis Plastics Welding Marketing Team

Boosting Production Speed, Savings with Custom Single-Use Shaker and Rocker Cell Culture Bags

Custom Single-Use Shaker and Rocker Cell Culture Bags

“Better, cheaper, faster biologics production.” It’s how BioProcess Online described rising global needs in biopharma. In recent years, the industry has been moving toward single-use equipment within bioprocessing and bioproduction, especially shaker and rocker cell culture bags. The trend allows for competitive and faster biologics production, especially for R&D, clinical trials and individualized biologics for cellular and gene therapies.

Faster turnaround, lower costs

A few months ago, BioProcess published its Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production. Findings indicated single-use bioreactors allow manufacturers to stay competitive, boost efficiencies and reduce costs. Single-use systems also provide greater flexibility and rapid scaling.

Further benefits identified by survey respondents include:

  • No cleaning requirements, since single-use equipment is used once and then discarded
  • Less time to get a facility up and running
  • Lower capital investment in facilities and equipment
  • Lower risk of cross-product contamination
  • Greater flexibility with a modular approach

2/3 of respondents: single-use equipment led to bioprocessing improvements

“Overall, bioprocessing professionals realize that single-use equipment has improved bioprocessing,” the report reads. “Over two-thirds of survey respondents cited single-use systems as providing some or significant improvement in their bioprocessing within the past year.”

The report cites supporting data from other sources in its conclusion that adoption of single-use systems in biopharma will continue to rise, generally replacing fixed stainless-steel equipment. “In addition, as cellular and gene therapies emerge, we will likely see single-use system technologies created and adapted explicitly for these personalized applications.”

Custom shaker or rocker cell culture bags

Among bioprocessing system components, most survey respondents have moved to adopt disposable fluid and media containment bags. At Genesis Plastics Welding, we’re applying our proprietary radio frequency welding of thermoplastics to produce custom single-use bags suitable for storage, preparation and processing of a variety of liquids including media, buffers, process liquids, and biological products within biotech and pharmaceutical bioprocessing applications.

Why Genesis for Bioprocess Shaker and Rocker Bags?

  • Single-Use Fluid Bag Manufacturing Expertise
  • ISO 13485:2016 Certified
  • Design and Development Consulting Services
  • Medical Grade Material Selection Assistance
  • Class 7 Clean Room Manufacturing
  • Responsive Results-Driven Customer-Centric Team

Looking to improve your bioprocessing system with a custom single-use bag? We’d love to help you clarify next steps and explore a potential solutions.

Contact Michael Finley to discuss your custom shaker, rocker or bioprocess bag.

by Genesis Plastics Welding Marketing Team Genesis Plastics Welding Marketing Team

Medical Device Guidance: Is Partnering with a Third-Party Developer Worth It?

Great ideas are a dime a dozen, as the saying goes. It’s the execution of ideas that determines their long-term success. The same is true for medical device development and medical device guidance, particularly in markets where buyers have plenty of options competing for their dollars.

Reasonably, a medical device that’s steered by a developer with rich market expertise will yield better results than a device whose development is rooted in limited know-how and experience. But is an external development partner worth the investment?

In this post, we explore four considerations for your medical device development, or ways that partnering with a seasoned, impartial developer can pay off in big ways.

Medical Device Guidance

Refining Ideas, Boosting Your Value Proposition

Like any industry, the medical device market is full of hopeful, self-proclaimed innovations that fail to compel users to whip out their credit cards. Creating a device that users will buy, recommend to their patients and peers requires a deep understanding of the user mindset, how they experience the product, and the problems you’re solving for them.

An expert medical device developer helps ensure you’re asking the right questions and considering psychological and physiological principles in your design, for starters. Put another way, they help you think through how humans make buying decisions and use products to create a more compelling offer and experience than your competitors.

(More on product ideation.)

Countering Blind Spots

It’s tough to spot flaws when you’re too close (or personally invested) in your medical device idea. In fact, your expertise can actually hurt you, cautions the Harvard Business Review, citing a decade-long research into top executives.

Two reasons for that: “The first is overconfidence: believing that brilliance in one area leads to competence in another. The second is when deep knowledge and experience leave leaders incurious, blinkered, and vulnerable — even in their own fields,” the author explains.

Put bluntly, blind spots are inevitable when your development team lacks objective insight and real-world experience to overcome market challenges. A reputable development partner can illuminate areas you haven’t considered and pinpoint blind spots before they sink your investment or slow your progress.

Reducing Risks & Uncovering Opportunities

While a zero-risk scenario doesn’t exist, the success of your medical device hinges largely on the level of risk it poses to users.

De-risking considerations include the likelihood and severity of potential hazards, the environment where the device will be used, potential for human error or misuse, supply chain risks, and more. Reasonably, that requires careful testing, risk tracing and mitigation, starting with your prototype.

In looking for ways to reduce risks, your expert device developer can also uncover opportunities to make your device more competitive.

(More on medical device risk reduction.)

Meeting Regulatory Demands

It’s important to know how the FDA classifies your medical device, and what it demands from you. Other regulatory bodies (ISO, ANSI, ASTM) may have additional performance standards you must adhere to.

Your medical device developer can help you assess regulatory considerations so you’re not hit with a costly violation down the road (or worse — hurt a patient). That know-how can also help you discern your acceptable risk level, how much money to invest, and long it will take before you start seeing revenue.

Medical Device Guidance: Expertise as Loss Prevention

All things considered, a reputable medical device development partner is akin to loss prevention, helping you avoid financial, opportunity and reputation hits that could derail your entire investment.

Before attempting to win over your market, ensure you have a winning product. Getting the development of your device right is considerably more economical than launching a flawed product or correcting an oversight post-launch.

>> Related Resource: How to Choose the Right Medical Device Design and Development Partner

>> Follow Us on LinkedIn for Additional Timely Shares on Medical Device Guidance

by Genesis Plastics Welding Marketing Team Genesis Plastics Welding Marketing Team

Medical Device Development De-Risking

Risk analysis is an essential component of a Quality Management System (QMS), and a mandatory task for every new medical device set to launch. Medical device development de-risking is best done concurrent with prototyping.

As a medical device start-up, your first priority should be a functional prototype and user feedback. Devices that have been de-risked early on within the initial concept stages and robust clinical trials done are more likely to succeed long-term.

Moreover, it’s important to have guidance from mentors within the industry that understand design for manufacturability, regulatory considerations and device lifecycles. Consultants and collaborative medical device design and development partners, like MedTech Launch, are key to avoiding costly hurdles that may derail or delay your launch process.

De-Risking within Medical Device Development

De-risking within medical device development focuses on risk assessment in the early stages to address critical challenges, rather than avoiding them until late in the project when hurdles could be costly.

The risk assessment phase of product development is critical to the overall health of your new product and preventing unpleasant discoveries late in the game when your device is near launch. Additionally, focusing on risk reduction early on can help fine tune multiple device concepts and aid in advancing your innovative medical device down the pipeline.

What Does the De-Risking Process Look Like?

The de-risking process begins with risk identification, where your design and development team identifies and maps out the likelihood of hazards occurring, and the severity of those hazards. Risks are identified by evaluating the product design and specifications, the environments in which the product is to be used and the intended use (or misuse). All hazards are identified and their risks then evaluated.

Possible Risk Analysis Questions during De-Risking Phase One:

  • Does the current prototype work as intended? The same way every time?
  • Does it work outside of its best case scenario?
  • Is it sensitive to condition changes?
  • Are there potential user misuse?
  • Are there any functions that are higher risk?
  • Is it scalable?
  • Are there any supply chain risks?
  • Regulatory risks?
  • Market risks? Are there risks associated with the healthcare environment and possible insurance reimbursement?
  • Could it work with fewer bells and whistles? What if features were added?

The second step is risk evaluation. Within this step your design and development team establishes criteria and an associated scoring system to evaluate each risk identified within phase one. For example if your scoring level is one to five, risks scoring three and below are acceptable, and those scoring four and five require mitigation. By focusing on the most challenging risks first, the rest of your development process should flow easier.

Step three within the de-risking process would be actual risk mitigation and design and development changes. This phase also could involve design verification testing to prove implemented changes did indeed mitigate the noted risk(s).

For those risks that require mitigation, the risk must be traced and documented to determine if effective changes were implemented in the design phase. Design verification testing may be required to prove that the changes to design details were implemented correctly in the product prototype or final product. Testing one risk source at a time allows your design and development team to understand potential individual failure sources prior to integrated final device performance testing.

MedTech Launch Top De-Risking Tips:

  • De-Risk Early On Within Your Design and Development Process
  • Collaborate with Trusted Design and Development Partners
  • Stay Focused and Document, Document, Document
  • Score and Weigh Your Risks
  • Test, Test and Test
  • De-risk Concurrent with Prototyping, Instead of After

Have a medical device project you’d like to discuss, call us at 317-482-4250 or email our design and development engineers here.