Days of Future Past

As I was working on a design update for the DWMEDTECH.COM website, I was pleasantly reminded of why I love doing this work. The designers pulled up some public domain graphics of medical devices for consideration for the background of the landing page. One of those photos was of a device I worked on with a major monitoring company more than a decade ago. My team and I were only with the development a short time, but our contributions jumpstarted the development work for the client. That device is still monitoring sick patients today and our work is still recognizable if you know where to look.

That is why Medtech Midwife is apropos for the contributions we make. We are there to provide the extra talent and/or skills to get the device to market. We are not the mother or father of the idea. Neither are we owners of the patents or the device design. We contribute to the success by finding and knocking down the risks and uncertainties that stand between the development team and the patients they strive to serve. It many ways, advisors and consultants are part of the overall ecosystem or architecture that assures innovation continues.

DW Medtech Advisory LLC was formed and operates to work with and for Medtech Developers and Investors. We do not get to take credit for the product launches or the rescues of problematic manufacturing. We do, however, take pride in their existence and place in the panoply of medical technologies saving and improving lives.

Recently, I have become more involved in the growth capital investment stage of Medtech. Without torturing another metaphor too much, that stage is somewhat like evaluating scholarship applications for university applicants. As investors, our job is to make sure that the applicant can make the best, most productive use of the funds and deliver a successful, new device or service. And, yes, we expect to make a profit on those funds if we are mutually successful. Investment should never be confused with altruism or charity. In many ways, the smart investors are like midwives too. They bring their experience, skills, network connections and, yes, that critically important funding. I have never worked with a truly successful investor who did not put as much or more sweat equity into a company as money.

Please don’t misunderstand, funding is an absolute necessity for Medtech Innovation. Incubators and accelerators do a good job for early innovation. Venture capital is also vital to get through the middle stages from proof of concept to final product. But when it comes to achieving scale and competing in (or even just breaking into) commercial operations, it often (I would say, almost always) takes a larger more powerful model. For the last 15-20 years, this stage has been shifting away from larger established companies making investments to private investors. The big strategic companies want further risk reduction before exposing their share holders (you and me) to big investment risks. Personally, my 401(k) is grateful for that restraint. This is the growth equity realm. It is where both the risks and the rewards become substantial. It is also why success in that realm requires savvy and courage in the investors.

So this growth stage is where the Medtech Midwives of the world really earn their fees. The stakes are substantial. Failure (or significant delay) will cost the investors large sums of money and the reputations of the leadership team will be damaged.

At the end of the day, it comes back to my favorite topic: RISK. How do we mitigate the risks of this enterprise so that we get to and stay in the market, help patients and generate revenue. It helps to be able to recognize the risk and the opportunities quickly and effectively.

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Returning to the playing field

I have recently restarted DW Medtech Advisory and the Medtech Midwife Blog after having joined a rapidly-growing Surgical and Chronic WoundCare company for a period of time.

Conducting that business in a pandemic that saw lock-down of wound centers and surgical theaters was a monumental challenge, but the company worked quite hard to assure that our products were getting to the patients and has continued to grow throughout 2020 and 2021. After revamping the Quality Systems and modernizing complaint handling and support processes, it was time to move on again.

So I return to the consulting business and the welcome challenge of helping get your products out into the field where the patients are waiting.

The challenges to developing, qualifying, obtaining commercial clearance and ultimately supplying medical devices have not decreased in the last year and a half. Indeed, we have discovered that long and geographically dispersed supply chains add significant risks to supply. In this we are no different than Automakers or Furniture Manufacturers, except that often our customers (patients) cannot afford to wait.

In Medtech Midwife fashion, then, the task is to make sure that the supply chain presents a low risk to the continued availability of the device in the marketplace. This aspect of the product risk, like much of what I discuss in these posts, can be investigated and fleshed out using Risk Management techniques.

Risks that come to the fore in this ‘recovery’ period:

• Supply sources in high-infection level locales
• Quarantine or stay-at-home orders in those locales preventing labor from congregating
  • direct labor
  • indirect labor
  • shipping/receiving
  • testing laboratories
  • customs and import offices
• Raw material supplies from other further afield countries
• Higher product or component quality variances due to labor inconsistencies
• Distribution gaps due to labor bottlenecks in commercial territories

Robust (and marginally pessimistic) risk assessments as product readiness is ascertained is the key. If you can identify a risk, it can be managed. That does not mean it can be eliminated, but you can be prepared to intervene and shore up the system when it manifests.

This type of somewhat ‘paranoid’ thinking enables even a lean team to be prepared for foreseeable circumstances. It also means you can plan and execute under pressure because, foreseen or unforeseen, you and your team are biased toward action in the event that the risk becomes reality.

Debunking the ‘loophole’ myth of the 510(k)

As I have mentioned in this blog previously, I have committed my reputation and career on delivering medical devices to patients, safely and effectively. In recent expose reportage , and on Last Week Tonight with John Oliver, the myth that the 510(k) pathway is a loophole to avoid doing expensive clinical investigations for medical devices has been getting a lot of air time.

Make no mistake, I think Last Week Tonight is hysterically funny, and it holds a not very flattering mirror up to many things in todays culture. In this instance (and maybe every target says this), the use of a limited number of sensational examples creates a false narrative.

The incidents described are pretty accurate and some are horrific. However, I think it is grossly unfair to the millions (yes, John, millions) of dedicated professionals who produce 510(k) cleared devices to say that we are somehow cheating.

The essence of the 510(k) exemption to the Food Drug and Cosmetic Act(s) is that a product that can be demonstrated through objective evidence is, and this is the critical phrase, ‘Substantially Equivalent’ to predicate devices. Historically, it has been up to the manufacturer to select the predicates, test their device against those predicates and demonstrate those test results and analyses to the FDA. In the most recent decade or so, FDA has tightened up the requirements for these results and, indeed, no longer allow most (nearly all) class III devices to be run through the 510(k) pathway.

Indeed, there is a further hurdle where the most daring class II devices are required to demonstrate clinical data (the key shortcoming quoted by the reporting) for even 510(k) clearance.

I think one further point in defense of the 510(k) and my professional colleagues is that some of the clinical situations we are addressing are not amenable to Randomized Clinical Trial protocols. There are many reasons for this. Sometimes there is no other therapy besides the predicate device and the candidate device. It is usually unethical to do any sort of placebo trial if you are going to surgically or interventionally invade a patient’s body to pretend to do therapy. There is no equivalent to a sugar pill in medical devices. A third reason revolves around the statistical challenge of recruiting enough patients to gain sufficient (caution, statistical term) power to determine the confidence interval of the effect. A sub-effect of number 3 is that often, for an implant, one would need to follow all patients to either the end of their lives or the removal of the device. There is not a practical way to do that in many instances.

So, I will bring this diatribe to a close with a few thoughts. For the small audience of readers that see this, please don’t miss an opportunity to debunk the loophole myth. It discredits a substantial body of work that you, your colleagues, predecessors and I have spent our careers, reputations and commitment bringing to market that have saved and improved lives. Please share this article with those who are skeptical and invite them to see how many devices go through the pathway versus the ones that through error, ignorance or malfeasance create the headlines. No patient death is justified, but you cannot force all devices through the PMA path. That is fundamentally denying patients relief from their conditions just like running a sham trial.

Why we do what we do

In the past couple of months, I have received the kind of news that makes everything in Medtech Midwife land worthwhile. One client company received a PMA for a implantable cardiac therapy. Another was granted 510(k) clearance for their vascular flow monitoring system.

Each of these engagements revolved around building traceability for the device back to requirements and then using risk management techniques to fill in any gaps in the knowledge chain.

The cardiac device presented a really interesting challenge, because the device was built on a platform that goes back to the earliest days of implantable pacer/defibrillators. As different devices were implemented on that platform, basic features, which did not change, were verified by reference to earlier V&V activities. Over the course of twenty-odd years, these references can get harder and harder to support. We built a framework traceability matrix that enumerated all of the current requirements and then determined which foundational V&V supported those functions. In some instances we needed to go back to the archives of previous programs (some long retired) and assure that the requirements we had mapped adequately to the original intent.

By exhaustively tracing every requirement, we were able to demonstrate both safety and effectiveness. We also used the pivotal and preceding clinical trials to generate objective evidence to support the V&V. This holistic data set enabled the regulators to be comfortable that we were diligent.

The Vascular monitoring device puts color flow doppler into the hands of intensive care nurses to directly monitor vascular graft potency over time, post-operatively. The device needed to be as close to ‘point-and-shoot’ as possible to fit into the nursing workflow without requiring monographers for less than 10 minutes every hour. Again, we took a risk mitigation/risk management approach and were able to simplify the instrument workflow to generate meaningful data on potency without a lot of confusing technical jargon.

I am so grateful to these clients for allowing me to contribute to these milestones and wish them all success both clinically and commercially.

It is called HealthCARE for a reason

Almost everyone I have met in Medtech over my career opted for the industry because it was not enough to do well for yourself. Most of us are compelled to improve the lives of patients, professionals and the families of those patients in one way or another.

Many of the unsung heroes of our Medtech ecosystem work on therapies, products, technologies and services that are not appropriate topics for ‘polite company’, as they used to say. Not withstanding the US advertisements aimed at seniors for continence products, the general public does not know about these products. Only those who specifically need them, or their loved ones, become experts. The conditions in this space tend to be chronic, progressive and permanent.

• Ostomy patients live their lives with a collection bag under their clothes because their intestinal or urological plumbing does not work.
• Dialysis patients endure A/V fistulae or central line catheters to allow their treatment
• Urinary incontinence patients have to teach themselves to insert and remove catheters if they are not to be housebound.
• Patients with COPD, Emphysema and other breathing disorders may wind up attached to an oxygen generator or other breathing apparatus
• the list goes on…

My point is that these products and technologies are every bit as important, significant and critical as the ground-breaking interventions that make the press.

To the professionals who work to serve these patients, let this be a small tribute. There are certainly more glamorous ways to make a living, but few that have such a direct impact on the health and quality of life of your patients.

To our colleagues who are looking for an opportunity to really deliver improved outcomes, please consider these ‘paths less traveled’.

And for the rest of us, remember why we got into healthcare in the first place. Every medical device development should be driven by doing the absolute best we can for our patients and their caregivers.

 

 

 

The Song Remains the Same…

Over the last wee while, I have had the privilege to be asked to work with three Medtech companies with very different profiles. One is an early stage start-up in the pressure cooker to get their first products through premarket notification and launch. Another is a long-established player in a set of very difficult markets that is rebooting with new leadership and a strong need to innovate and recapture markets. The third is one of our global 800-pound gorillas reintroducing a strategic product to the market after a significant rework of the design and processes to overcome reliability and yield issues and address complaints from the field. Between them, they cover class I, II and III FDA regulatory classes.

The specifics of the clients vary significantly, but in each case, there are themes (not to torture the music metaphor of the title too much) that are common and consistent.  In each case, a leader or leaders in the organization started asking a simple question:

“Are we missing anything?”

For the start-up, the CEO, who has also been the document control officer, responsible person, procurement officer and IT specialist, needed assistance in structuring the Integration, Verification and Validation of what is mostly a software system that is downloaded into an already cleared device for a very specific set of indications. The table of contents of the FDA 510(k) submission, while a good deliverables list, does not provide the structure, level of detail or prioritization to get those deliverables. Doing the work of creating and compiling the submission itself is a project and one that no one in the organization has tackled before.

The rebooted company’s new CEO has set out to organize the company in a very market-facing and responsive structure. The good news is that the R&D and Operations teams are well-established and well-staffed. The bad news may be that they were built and organized around a very different business model and have observed a lot of change in strategy over the last few years. Launching new products or line extensions have seen timelines and milestones missed. R&D resources have also been pulled away for Continuing Engineering.  The question is, “Can we organize and operate more effectively to get product launch more timely?”

For our 800-pound gorilla, the withdrawal of a product from the market was a profoundly risky decision. But not doing so would have meant less than acceptable quality and field complaint levels. Relaunching in a timely fashion, but only with the improvements implemented, was mission critical. Being a large company with a high profile program, resources were not the issue. Organization, disciplined investigation and rapid effective design and process improvement were going to be the defining attributes of success or failure. So the question became, “Can our processes and discipline sustain and get results from a massively parallel, technically complex, and existential crash improvement program?”

I’ve written in past posts about the difference between uncertainty and risk. Each of these clients illustrates this. Risks can be managed.  Uncertainty means that you, often, literally, do not know what you do not know.

In our start-up, the uncertainty arises from multiple directions:

1. What is the content behind the Table of Contents for our 510(k) that will hold up to scrutiny by the agency?
2. With everyone in the company going full tilt to complete development, who is going to coordinate, edit, review, etc.?
3. Can we get it done?

We needed a plan. Going down the table of contents doesn’t do much to tell you what any one line item looks like (especially a good version). Working with the entire team, we developed a gap analysis that allowed us to convert uncertainties to risks. We are delivering on that plan now.

In the reboot, there was a mix of both mature processes that had stood the test of time but for different market and competitive environments, and relatively new cross-functional processes that we designed to accelerate both Voice of the Customer/Patient and time to market. So why were projects bogging down?  It turns out that teams had adopted an either/or policy to those processes and mostly for the tried-and-true. As a result, compliance with the regulations became the paramount drivers and projects would approach scale-up or launch asymptotically (always getting halfway closer, but never crossing the goal line). Remember that this is a reboot. Delivering the NPD pipeline  is vital to the company attracting and retaining investors. Success lay in getting the organization and the processes (yes, both of them) in sync. Again, a disciplined approach reduces uncertainty and guesswork, even if the risks are substantial.

Finally, our Strategic had very few true uncertainties. However, the risk register could give the Marvel Avengers the flop sweats. In this instance, the project leaders and project managers, the working engineers and scientists, took the lead. First, the whole team adopted a ‘let the data lead’ discipline and followed through with robust experimentation and design. Second, a rigorous adherence to those decisions supported by the data even if there was dissension  when alternative solutions were not adopted.  The result has been stunning. The program, not yet across the finish line, but at pace and on target, is recognized as a best practice case study in Data Driven Insight (my term) in the company.

I am very proud of each of these organizations. Discipline, process and not just a little bravery can allow you to deliver great Medtech solutions for patients.

For want of a nail, a shoe was lost…

In developing next generation medical devices, it is important to do a thorough a job on the ‘routine’ elements as the break-throughs.  For instance, as we are developing a large-bore vascular delivery system, we are often focused on flexibility, steer ability, tip geometry, etc. However, the device also has to provide reliable and expected performance for the basics. This delivery system is most likely a catheter. Does the design have features for guide wire management?  How about purging air and flushing? The design of these basic, must-have features require as much discipline and diligence as, say, a woven nitinol stent, a micro electrode or a valve prosthesis.

I’m picking on large-bore systems for a reason, but only to illustrate a point. Most of us would much rather design a small-bore system for a lot of reasons, not least of which is controlling the vascular access point simply and effectively. Large-bore solutions require more sophisticated and aggressive closure and management of those access points. But, with the larger diameter of our device, why not use that space efficiently and effectively. What shall we do with all of that real estate within the diameter?  One common answer is multiple lumens where each of these serve a different function.  A main lumen may carry the implant (whatever it is). This may or may not be over-the-wire. If its not, then a second lumen is a guidewire (GW) lumen. Then there may be various steering and control mechanisms whose end-effectors are at or near the distal end.

An aside for illustration, for any of you of my generation of Medtech engineers who worked in endoscopic or arthroscopic instrumentation, you will remember how fascinated we were when innovators created devices that could be manipulated into complex shapes once in the surgical field.

So in a multi-lumen catheter, there is a lot of ‘open space’ that will need to be flushed and otherwise prepped before insertion into the vasculature. That means flush ports. These may or may not have other procedural functions, like GW insertion, introduction of contrast media for imaging, etc.

This is where a real design challenge and the potential for both patient hazard and performance risk can appear.  Once the device is in the vasculature, the device is now a potential point of blood leakage. Design and qualification of the port is a serious matter.

It is not sufficient to just select a luer fitting or other off-the-shelf device and graft it into the design of the device’s hand-piece or proximal end of the catheter.  Here are some questions that MUST be considered:

1. Is the fitting or design suited for the pressures, both forward and back that the lumen will see under worst case conditions?
2. Will the design withstand multiple interactions through the assembly and testing regime the device will undergo?
3. Are the fittings or components compatible with the sterilization and cleaning requirements for the overall system?
4. Will you need to modify the components?  If so, have you done the analysis to demonstrate the modified component is still fit-for-purpose?
5. Does the orientation of the port present a handling risk that would damage or otherwise compromise the integrity or performance of the device?

So why have I been nit-picking on ‘stuff we all know’? Because an issue as basic as the integrity and fitness-for-purpose of a luer fitting becomes obscured by the large challenges of the implant design, the complexity of the deployment and visualization of the implant, the material compatibilities and shelf life.

BUT, this routine and necessary feature of the system is critical to performance and critical to quality. When it is overlooked, and subjected to the variability of normal manufacturing, it almost certainly will complicate getting devices to perform reliably in the field. Even if there is no patient hazard, a leaky catheter or delivery system is a potential reputation killer in prep or in the Interventional Suite.

We all get excited, and rightly so, to work on cutting edge, life-saving medical devices. We need to recognize that if we overlook the basics, we will not have a successful product.

Uh-Oh… What now? Uncertainty comes calling

When designing a first-in-class device, the development team is often working at or near the leading edge of capabilities of the components or the processes that are required to produce those components. Further complexity comes from attempting to assemble these novel components. The CAD models and tolerance analysis will often say that the device will go together every time, but those models assume a known set of variances in dimensions, material properties, mechanical properties, etc.

Often, the development team has a great deal of success assembling prototype devices, even from the first run components from suppliers.  The lab-assembled devices work perfectly under all kinds of scenarios. The Engineers have developed concise and constrained work instructions to guide trained operators. Great!  So why don’t the devices assembled for the pilot run function the same way?

This is the realm of Uncertainty (cue cheesy, anxiety-inducing organ or theremin music).

What is different from the lab to the assembly line? Very nearly everything.

Familiarity Bias

The Engineers have lived with the device from its earliest proofs of concept through the pilot run.  Further, they have developed their own techniques of assembly that have suited their needs hand-making individual devices. Also, the Engineer at the bench has the luxury of ‘tweaking’ and adjusting the device as it goes together. Finally, they know which parts require those tweaks and adjustments and often do them unconsciously.

I refer to this as Familiarity Bias. Also contributing to this is the tendency for developers to be very conscious of which components they are selecting. It is only natural to be discerning the ‘best’ representative components to accelerate the assembly of the prototype for testing/experimentation.

The Fallacy of Small Samples

Even the best Manufacturing Engineers cannot distill the hard and soft knowledge of the Development Engineering team into work instructions. By definition, they are tasked with documenting and formalizing a repeatable, consistent process to which operators can be trained and inspectors can observe and test.

As we transition into the manufacturing environment, and we ‘lock down’ on these processes (and the measures of product and process that will define them), the Development Team and the Manufacturing Team (in many start-ups, these can be the exact same people wearing multiple hats) should be prepared to conduct pilot runs of critical, risky or difficult segments of the process, in advance of product release and attempting to scale up. These tests should be guided by on-giong and progressively more detailed Process Failure Mode and Effects Analyses (pFMEA) and on-going process risk analyses that expand on the design risk analyses.

Reduction to Practice

At the end of the day, the device is not really a product until we can obtain appropriate regulatory consent AND produce sufficient quantities that meet all of the product requirements at a price that is acceptable to the payers, be they governments, insurers, physicians or consumers.

Reducing the manufacturing to practice means that you obtain a fully compliant product every time you release one.  Once we have successfully implemented the learning from the pilot runs, we are still required to validate the manufacturing process. A product validation means that any product released from the production environment (including actual assemblers/operators, and complying with the QMS and the Device Master Record) meets all product specifications. Traditional validation (3 lots with appropriate variations of sensitive production parameters, etc.) are often appropriate.  However, there are other statistical and procedural methods that continue to evolve.  The ultimate arbiter of validation will be the regulatory agencies, so staying safely within the guidance is recommended unless you as an organization are prepared for the evangelism and advocacy efforts of educating the agencies on your method.

There are no shortcuts for these disciplined approaches, but they can (I would argue, must) be planned for to prevent undue and potentially costly delays in getting your baby delivered to the people who need it. You will go through these exercises, it is always more efficient and effective to have planned to do so, than to be forced into a crash program by the unexpected.

 

Engaging in Risky Behavior

In my first post, I introduced the concept of the Medtech Midwife as an experienced, insightful, and, usually, calm professional guide for a transitional Start-Up facing new challenges.  In this one, I introduce risk as a tool and how understanding of risk and mitigation can be one of the most powerful tools in a Start-Up leader’s armamentarium.

By my definition, a Start-Up is an extremely risky behavior.  Most entrepreneurs will likely agree.  The whole notion of introducing new products, services or skills to the world is ripe with risks:

• Will it work?
• Will someone buy it?
• Will someone believe the story to help fund it?
• Will the regulators buy into our rationale?
• Can we actually build it?
• Can we actually build it at reasonable cost?
• Will somebody else beat us to the market?
• Will somebody else make us irrelevant or obsolete?

This is some of my personal list, you can feel free to add your own.

So why do it? Because the benefits of the solution are substantial and, in the case of many Medtech start-ups, transformative to the lives of patients. Those benefits are the motive force driving a medtech start-up.

This does NOT mean we ignore risk.  In my experience, risk is the entrepreneur’s ally and a powerful tool. Risk assessment and risk mitigation can make the difference between a really elegant concept and a viable medical device or service delivering results for the patients and practitioners who use them.

Risks, as the list above shows, are not contained to design issues, or manufacturing solutions.  Every element of the business of the start-up has risks that need to be managed.  There are risks in the science and how well we understand our own concepts. There is risk in the market and what alternative therapies or alternatives to therapy are going to compete with our solution. There are risk with the investors and the security and availability of funds to get through milestones. There are people risks – are the teams correctly staffed, focused and motivated? Successful leaders embrace risks as indicators of what is really important.  The items with the highest risk should get a lot of focus.  But even low risk items can impact on the objectives, so it requires a holistic approach.  The best leadership teams know how to keep a handle on the portfolio of risks, with the aim to drive each one as low as reasonably practicable (or ALARP, for the QMS folks out there).

In fact, that portfolio approach is well served by the tools of the Engineering teams like Failure Modes and Effects Analysis (FMEA ,or FMECA, if you add Criticality to the title), Fault Tree Analysis, etc.  The outputs of these analyses can become tracking documents that provide prioritization and focus for the Leadership Team.

Dimensions of Risk

In the world of FMEA, we dimensionalize risk as a means of determining priority and attention for solution.  The dimensions can vary, but the most common ones are:

• Severity – What is the impact of this event occurring
• Likelihood – What is the likelihood of this event occurring
• Detectability – Will we be able to detect the occurrence

Armed with those dimensions, we derive a number that enables us to prioritize our attention.  The higher the number, the more attention.

The objective is to mitigate each risk to a point that is tolerable.  A tolerable risk is one that we keep an eye on, but don’t necessarily intervene unless its status were to change from one review to the next.

Risk vs. Uncertainty

There is another, related issue that should be on the dashboard of every Start-up leadership team:  Uncertainty.  I define uncertainty as anything that has more dimensions than we currently understand or is a very poorly defined, amorphous risk.  Uncertainty is where surprises come from.

As stated above, Risk is the basis for every day for the Start-Up. But Uncertainty is NOT KNOWING WHAT WE DON’T KNOW.  So it is quite difficult to dimensionalize as we did with risk.

The way to deal with uncertainty is to attempt, whenever possible to convert it to risk.  Risk is a KNOWN UNKNOWN. We know how to deal with risk. If we cannot break it down into manageable risks, we should attempt to make our business as resilient as possible to broad-based risks. Also, one dimension that is more easily applied to uncertainty is likelihood of occurrence.  With this one assessment (and periodic follow-up) we can put uncertainties in context of the overall health of the enterprise.

I hope this short piece provides you with some food for thought as you think through your challenges.

 

 

Welcome to the Medtech Midwife Blog

The word Midwife has a long and respected history.  Before childbirth was a medical procedure, our ancestors depended on these knowledgeable, experienced and calm practitioners to guide the delivering mother through the experience.  She would let the mother-to-be know what was coming and how to prepare for the pain of contractions and how to cope. She was the voice of reason and a calming influence, especially for the first-time parent.

Modern midwifery practitioners are medical professionals who perform the same role, but with discipline and knowledge based on both the natural process of birth and the tools of medicine for Obstetrics.  In today’s birthing rooms, they are the partners of the obstetrician.

For the last few years, I have referred to myself as the Medtech Midwife.  My role has often been to assist later-stage medical technology start-ups through the ‘labor pains’ of late-stage development, regulatory submissions, scale-up of manufacturing and delivery of the product to the practitioners and patients who will use it.

OK, so why midwife?

Often, the leadership teams of start-ups have not all been here before.  The demands and practices of actually launching a product are not the same as those involved in the invention and development of the technology.  Also, those leaders have had to refine critical skills to manage the earlier stage development process and keep the company moving forward.

My role, and that of people like me, is to guide the leaders through the inevitable crises and interruptions that arise when putting new technology into the world.

• There are crises of ‘proof’, where the regulators and stakeholders want evidence of safety and efficacy that is consistent with their experience and robust
• There are crises of ‘management’, where the manufacturing staff and/or contract manufacturing partners are creating processes, work-instructions, training that may well be totally novel.
• There are crises of ‘confidence’, where the product that first comes of the assembly line does not perform as the earlier, hand-built and protected prototypes

The Medtech Midwife’s job is to guide the new enterprise over these types of hurdles.  We use our experience across the industry (and from outside of it, as well) to let the expectant ‘parents’ that while their ‘baby’ is unique and precious, there are well-tried means of getting him or her out safely.

I intend to use this blog as a vehicle for sharing some of the things I have learned over 30 years in Medtech product development and launch.  I hope to use stories from these experiences to illustrate real-world solutions and thinking.

I hope that you, dear reader, get something out of the experience.