guidedsolutions.co.uk | Global Executive Search in Medical Devices

Map & Connect – Radiology

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December 28, 2018

The Context

Our client is a once fledgling, now established Radiology Medtech operating at the forefront of product innovation within their field. Encouraging international growth had led the business to a tipping point where a decision had to be made as to whether consolidation or pursuance of aggressive global expansion should be the strategy.

The company elected to go after growth, and this necessarily required great increases in headcount as well as plans in place to ensure a steady flow of talent into the future as the business continued to scale up and reach new milestones.

The Campaign

Within this context, the role of Guided Solutions was three-fold:

Phase 1: Value proposition

Our client had elected to enter several Asia Pacific markets where they had a negligible level of brand and product recognition. These included Australia and Singapore, significant though relatively small medtech communities. Before undertaking any kind of market mapping action, therefore, we sat down to work with our client to understand and develop a compelling value proposition harmonised with each of these localities.

Phase 2: Market mapping

The company were operating with a distributor sales model in all of the new markets they were entering. On that basis, they had elected to hire clinically focused customer support and product training experts to augment the indirect sales teams. Once viability had been fully established within a particular market the plan was to phase out the distributor sales model and replace it with direct sales. We got to work identifying the potential sources from which we could draw this kind of talent, building a comprehensive list of commercial organisations as well as educational institutions operating within or close to our client’s niche.

Phase 3: Brand nurturing

We commenced the promotional part of the process establishing a dialogue with individuals of interest to the company.

The primary activity was pursuing clinically focused talent and connecting them with the business as soon as possible. The secondary activity focused on cultivating a longer-term talent pipeline, targeting the salespeople the company expected to need in the future. This process involved more speculative conversations to build an understanding of what factors would be most important for candidates in considering future career moves.

As a consultancy we have maintained contact with these individuals over a two-year period, continually updating our client’s perspective on available talent as their presence in the region has developed.

At Guided Solutions we deliver search and consulting services designed to match the intricacies, subtleties and challenges facing Medtech SMEs globally. Contact us today to find out how we can apply 20 years of Medical Device talent market expertise to your business needs.

Editors’ Choice: 2018 in Medtech

Guided Solutions

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December 21, 2018

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In 2018 the number of medical devices on the market grew larger than ever before. At Guided Solutions we keep our ear to the ground and provide daily updates on the most important industry developments across innovations, clinical trials, funding achievements, mergers and acquisitions, and regulatory approvals with our global community of medical device professionals.

Here is our editors’ choice of the most popular industry updates we’ve shared with you throughout the year:

Medical devices that changed the world in 2018

According to MedTech Europe, and average of 10% of Europe’s GDP is spent on healthcare, with 7,2% going straight to medical technologies. Europe is indeed one of the world’s hotbeds for medical device innovation, developing solutions for patient conditions ranging from the most trivial to the rarest of all.

Some of the most fascinating products that could one day change millions of people’s lives forever include EnduraGel, an injectable hydrogel for the treatment of aneurysms; CueStim, a smartphone-controlled device that helps overcome some of the daily challenges caused by Parkinson’s disease; and a groundbreaking graphene-based biomaterial capable of regenerating diseased heart tissue.

A novel transcatheter aortic heart valve was successfully implanted into a patient to treat aortic regurgitation. The device, designed and developed by JC Medical, is the first single solution on the US market to treat pure aortic regurgitation as well as a combination of aortic stenosis and regurgitation.

Back in February, various clinical procedures involving a revolutionary endoscopic surgical robot were performed successfully across Germany. The robot supports surgeons during minimally invasive surgery by moving and holding the endoscope, and is part of startup Medineering’s innovative platform for hybrid robotic surgery.

Regulatory highlights

One of the most important clearances achieved over the past 12 months belongs to Neural Analytics, a US company known for its Lucid M1 Transcranial Doppler Ultrasound System for brain blood flow assessment. Neural Analytics won FDA approval for its NeuralBot robotic ultrasound positioner, which works together with Lucid M1 as the Lucid Robotic System. The new technology will boost progress in the treatment of neurological disorders by providing objective patient diagnostic information that will help clinicians assign more appropriate treatment to patients.

Following major media upheaval on the safety of medical devices available on the market, the FDA announced that it will modernise its medical device legislation. The current procedure known as the 510(k) pathway is an expedited approval process that was launched back in 1976 and is the most common way device makers bring their products to market.

The EU strikes back with its own revamped Medical Device Regulation, which is causing widespread industry confusion. Read our dedicated MDR editorial here.

Clinical trials

2018 saw the completion of the largest prospective neuromodulation study in the field of epilepsy with a 9-year follow up. The trial evaluated the Next-Gen RNS® System for refractory epilepsy launched by Silicon Valley-based medtech company NeuroPace, involving 256 patients across 33 epilepsy centres and nearly 1,900 combined patient implant years of follow up. NeuroPace announced the results of the landmark study at the 2018 American Epilepsy Society Annual Meeting.

Mergers & acquisitions

If we have to pick one medical device company that made a profound impact on the industry through M&A activity in 2018, that has to be Stryker. The global leader in orthopaedics made several strategic acquisition deals throughout the year, but the one that stands out the most is the purchase of K2M for $1.4 billion, with K2M chair & CEO Eric Major becoming President of the Stryker’s spine division.

Stryker’s established leadership in the orthopaedic and neurosurgical market, combined with K2M’s culture of innovation and leadership in complex spine and minimally invasive solutions represent a powerful opportunity to strengthen leadership in the $10 billion global spine market.

Follow our blog for more 2018 industry highlights we’ll be sharing after the holidays.

Guided Solutions is the executive search partner of choice for the global medical device industry, with a continually expanding network of 120,000+ medtech professionals across the entire product lifecycle.

Get in touch today to make sure your next hiring decision is made the right way.

EU Medical Device Regulation 2017: What it Really Means for You

Guided Solutions

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December 20, 2018

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EU Medical Device Regulation 2017: What it Really Means for You

“Biology and Technology are evolutionary processes in which the information processing tools of prior generations are used to make those of the next. As these tools improve, the time between advances in order and capability decreases exponentially” – Ray Kurzweil.

Each round of technological improvement begets another and these rounds replace their predecessors at a continually quickening rate. Medical Devices is no exception to this pattern. The industry has moved on frighteningly quickly in recent years morphing from a predominantly standalone hardware and equipment manufacturing industry into one that delivers digitally integrated tools and treatments, connecting physicians with patients and their pathologies like never before.

One unfortunate by-product of these rapid cycles of innovation is that governmental bodies are destined to produce retrospective legislation which does not reflect contemporary market safety, efficacy and usability issues. The new Medical Device Regulation, which will come in to full effect on May 26th, 2020 following a 3-year transition period which officially commenced on May 25th, 2017 is a response to this deficiency and an attempt by European Authorities to bring Medical Technology and legislation into equilibrium.

Regulatory Compliance Professional

A recent report by Lloyd’s Register found that device makers must be prepared for investment in significant increases in personnel and financial resource when the MDR kicks in. There has always been a disparity between supply and demand of talent in Medical Devices and the new MDR highlights this fact once again. Article 15 sets out the requirement for each organisation to have available a ‘Person responsible for regulatory compliance’.

These individuals must be able to demonstrate the following qualifications:

A formally recognised qualification within a closely related discipline
Minimum of four years professional experience in regulatory affairs/quality management relating to medical devices

These individuals will carry out the following duties:

Ensuring conformity is adequately assessed before device batch release
Keeping technical documentation and declarations of conformity up to date
Ensuring that new post-market vigilance reporting obligations are met

There is some provision within the article to protect micro and small entities from the financial brunt of this provision, however. Businesses with fewer than 50 employees and a turnover not exceeding €10 million are not obligated to house this individual within the organisation. They are required only to have such an individual ‘permanently and continuously at their disposal’.

Greatly increased pre-market scrutiny for high-risk devices

With increasingly complex technological advances have come new, previously non-existent threats to patient safety, whether that be through accidental malfunction or malicious ‘hacking’.

The obvious dangers have led to the gradual building of more robust device scrutinising processes before they reach the market. Since 2013 for example, notified bodies (independent 3rd party organisations responsible for giving new devices the go-ahead through a ‘conformity assessment’) have had their independent authority trimmed by the introduction of joint assessments carried out by other member states and the European Commission itself. Such has been the success of the initiative, it will now be codified within the new regulation.

For Class III and Class IIb devices (drug delivery) notified bodies will now be required to consult with a panel of experts who will present their view of the notified body assessment of the clinical file.The notified body may reject the panel’s findings, this must be justified and held as a digital record within EUDAMED.

Classification changes

Whilst the new regulation has not fundamentally altered any of the device classification divisions (still 4 basic divisions, 90% of devices expected to remain in the same class), the boundaries themselves have been redrawn to decrease the number of Class I devices, shrinking the overall percentage of devices placed on the market without conformity assessment through a notified body.

Here’s a list of the key modifications on their way:

Any substance-based devices intended to be introduced into the human body via an orifice or skin application cannot be Class I (Rule 21)
Many software-based medical products or apps are set to be reclassified, moving from predominantly Class I to Class II (Rule 11)
Active therapeutic devices, including closed loop systems or automated external defibrillators, will also now be re-classified as class III. (Rule 22)
All devices incorporating nanomaterials will be classified as Class IIa and above, variable dependent upon the likelihood of internal exposure (Rule 19)

Some opportunities

At first glance, the new 175-page regulation appears to overwhelm manufacturers, notified bodies, member states and the European Commission itself with a mountain of bureaucratic legwork. Certainly, the 3-year transition period is causing upheaval as all parties’ scramble to ensure that they are doing their part to minimise disruption in the flow of devices to market.

But when the dust settles the long-term outlook for commerce is positive for the European Medical Device market. Here are a few reasons why.

Effective federalisation of the CE mark

Under the new MDR, CE marking will move closer in spirit to the federalised FDA accreditation whereby approval in the EU will give device makers access to all member state markets. The previous system of member state specific notified body conformity assessments has led to uneven, convoluted approval processes for device makers. In the long term the effective federalisation of the CE mark will enable the EU market to compete with the dominant US market, developing greater levels of confidence, particularly amongst US device makers in the viability of OUS expansion.

Another step towards global harmonisation of accreditation processes

The accepted wisdom is that achieving CE mark is comparatively simple versus the more elaborate and unforgiving FDA approval process. One of the overarching themes of the new regulation is knowledge sharing, accountability and the need for further professionalisation of the CE marking process. These elements are going to create a more exhaustive regulation system, mirroring many of the best practices already necessary for gaining access to the US market. Continued steps in this direction can only serve to level the playing field and break down international trading barriers for SMEs who are hopelessly outspent on market access and regulatory accreditation by their blue-chip competitors.

Concluding Thoughts

The new MDR will require more than the acquisition of new skills. it will require a shift in mindset as the EU market overhauls an outdated system and brings legislation into line with the experience of end users and patients. Businesses will require strong, able leaders not merely to cope with regulatory changes but to prepare themselves to capitalise on long-term opportunities which the new regulation will bring.

At Guided Solutions, we specialise in connecting growth-orientated medical device businesses with our network of industry specialists.

If you have an open vacancy or are interested in finding out how our executive search service could help you meet the coming challenges and changes get in touch.

Brexit is Coming: What’s in it for Medtech?

Guided Solutions

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December 7, 2018

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Brexit is Coming: What’s in it for Medtech?

With the inevitable onset of Brexit looming closer and closer, more and more questions arise regarding the future of the medical device industry in the UK and the EU.

As medtech associations, companies, investors and professionals alike are trying hard to maintain a level of cautious optimism, day-to-day developments on what the relationship between the UK and EU will look like after 31 January 2020 continue to engender concern.

No matter what politicians ultimately agree on, Brexit will affect trade, regulations, and, most pertinently, patients on both sides of the channel.

So let’s take a look at what the most important anticipated changes will be, and how to prepare for these…

At a glance: The UK medical device industry

The UK is the third largest medical devices market in Europe and the sixth largest in the world. Over 50,000 people are employed in the sector which is worth an estimated £16 billion. The country has a prominent manufacturing presence, most notably in the orthopaedic, diagnostics, cardiovascular and imaging verticals. Over 80% of the 3000+ UK medical device companies are classified as SMEs.

The EU is the UK’s largest export market for medical devices. Every year, European member states receive around £2 billion worth of medical device products from the UK. The UK also relies heavily on the EU for its own medical devices supply, as more than half of the £5b billion imported medical technology is attributed directly to EU member states.

Regardless of the Brexit and post-Brexit climate, Europe will remain a priority market for the UK’s SME-driven medical device industry, and vice versa.

To deal or not to deal

Over the last couple of months various scenarios have been plotted around how the UK medical device industry will be affected in the case of a no-deal Brexit. Since the draft agreement was submitted last month by the British government and subsequently approved by the EU, however, it’s become clear that the withdrawal agreement is a lose-lose deal in itself.

Whatever the outcome of these painful and protracted negotiations, it is of utmost importance that the UK and the EU remain in close collaboration in the fields of medical device trade, regulations, research, innovation and patient safety, and businesses have as much clarity as possible as to the ways they will continue to operate.

What businesses need:

Assurance that medical devices currently used in healthcare systems are exempt from any new tax arrangements
Pre-shipping clearance and guaranteed easy access across export and import areas
Continued compliance with current certification systems
Continued validity of products which are already existing and available on the market

Brexit 101 for UK-based medical device businesses

Are you operating a UK-based medical device business? Regardless of whether you are a manufacturer, distributor or importer, Brexit times will be easier for you provided these three things are prioritised:

Communication
Supply chain
Notified bodies

Be proactive and open the dialogue with all your international partners, including those based in EU member states. The earlier you let them know that you are, and will remain open for business, the better.

As soon as the withdrawal comes into full effect, the UK’s relation to the EU will become the same as that of any other third country. This means that if you are a distributor, you will become an importer; and if you are a manufacturer, you will need to appoint an authorised EU representative within the Union if you wish to continue to place your products on that market. If you have been the EU Notified Body for any third country international partners, you will need to notify them that you would lose that status and that they must designate an authorised representative within the EU to continue selling there.

For any future trade models proposed so far, try and map out all possible outcomes. This will involve a thorough audit of all your current processes, from source and supply to end-user product. Once you have an awareness of what possible cost increases or other hurdles you might encounter, get in touch with your Notified Body and make sure they’ll be able to support your product line properly in the future. Existing Notified Bodies will remain recognised during the transition period, currently fixed at December 31 2020. There is a possibility that the transition period may be extended once by two years, meaning it could last until 31 December 2022.

What about the NHS…?

The EU sources over 60% of all medical devices supplied into the NHS, and most of that is being done on very stringent terms of delivery. Any disruption in the smooth and timely flow of these products will be inevitably to the detriment of patients.

In addition to that, the NHS is also heavily dependent on international workforce. The system needs continued free access to skilled and qualified professionals on a global scale in order to keep operating according to set standards.

Regulations, regulations, regulations

The Brexit withdrawal document contains a dedicated section on medical devices, which clearly states that EU laws continue to apply during the entire transition period. This means that business should continue operating as usual, both in the UK and the EU, and Notified Bodies will remain valid. What will happen once the transition period is over is not clear, as this would be subject to an entirely new agreement.

The section covers five directives and regulations that will apply to the industry in a soft-Brexit scenario:

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
- If a manufacturer wants to import their device into the UK market, the requirements outlined in this directive will apply.
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
- All IVD devices exported from the UK into the EU fall under this directive. According to the draft agreement, the directive will regulate post-Brexit IVD devices as well.
Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
- All active implantable devices must meet the requirements outlined in this directive, covering safety, instructions for end-users, design, CE mark approval, quality assurance, clinical investigation and manufacturer registration.
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC6
- This regulation protects the competitiveness of the medical device market as well as public health and safety. It will come into effect in 2020 and will essentially restricts the range of substances and materials used in the design and manufacturing of medical devices.
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU1
- Similar public health and safety directive coming into effect in 2020.

It is in both sides’ interest that the UK remains part of EMA – the European Medicines Agency, as well as other regulatory bodies so that safe and effective supply of medical devices is maintained in both UK and the EU member states.

Looking ahead

When the whole world is so focused on the negative repercussions implied in any Brexit/post-Brexit scenario, we must also not forget that in these difficult times there are some opportunities, as well.

The UK government seems keen on investing in high-technology healthcare solutions utilising AI and IoT. As long as the purchasing models and utilisation of such products are driven by a value-based approach, patients will not be affected and industry should keep moving in a positive direction.

Regulatory, socio-political, demographic and commercial developments worldwide will continue to shape the market. Some doors close while others open. The growing demand for medical devices in emerging economies such as China, India, Mexico and Brazil should be kept in mind by manufacturers. Initiatives like the Global Medical Device Harmonisation task force by WHO come to show that the medical device world will continue to move closer together against wider political disunity.

In addition, the European market has demonstrated that the strategic development of sustainable people pipelines is a step not to be overlooked by budding medical device businesses. Solutions delivery that not only changes patient outcomes but also optimises costs involves an ability to attract and retain exceptional talent in the very first place.

Navigating the dynamic, often disruptive changes of today’s market requires robust leadership and conscious efforts at facilitating the collaboration of key industry players: academia, the medical professionals community, business angels, investors and seasoned start-up entrepreneurs. This is the only way for medical device companies not just to survive, but to thrive and grow.

Guided Solutions is Europe’s largest executive search consultancy recruiting solely within Medical Devices.

We deliver impact by connecting growth-focused, technology-driven medical device businesses with our continually expanding global network of 120,000+ industry professionals, helping you access talent across the entire product lifecycle including R&D, QA and Regulatory Affairs, Market Access and Reimbursement, Sales & Marketing. Clinical Applications & Support.

Get in touch to find out more.

3 Reasons to Talk to a Medical Device Recruiter

Guided Solutions

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November 21, 2018

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3 Reasons to Talk to a Medical Device Recruiter

Are you pursuing a career in Medical Devices? It might be tempting to think that you do not need to talk to a recruitment consultant unless you are actively looking for a new opportunity. However, let us share three reasons with you why it is a good idea to take our calls after all!

1. It could change your life, even if you don’t take the job!

A great example is how we recently came across a very talented individual that had been working as a Product Manager for most of his career. We knew our client would immediately see his talent and we were not surprised when they offered him a Sales Director position with a significant improvement in career trajectory as well as a significant pay rise straight away.

When his current employer found out about the interest from our client, they put a blank paper in front of him for him to write down exactly his preferred role and salary. Needless to say, he remained with his employer and has now significantly improved his position, both career-wise and financially.

As we recruit exclusively within Medical Devices, we deal with industry-specific salary requirements on a daily basis. As a result, we have a pretty good idea of what each employee should be getting paid and how their talents should be valued. One of the best ways to find out your market value is by talking to a consultant. If you then find out your current employer undervalues you, you may be able to improve your situation.

(It’s worth adding that we did find another skilled individual for our client who they hired and is doing great!)

2. For future reference

Even if you are perfectly happy in your current position and are not looking to make a move, building a relationship with a recruiter will prove helpful later on. Companies merge, managers change and happy today does not mean happy tomorrow!

Once people like us know about your existence and your career goals, we can keep you in mind for future opportunities. When such an opportunity then comes up we can quickly give you a call.

In the long run, this means we will present you with suitable roles when they arise, putting you ahead of many of your peers. It also helps you avoid missing out on matching opportunities or struggling to find the right role when your circumstances change and you are rushing desperately for a new position.

3. You can help someone else

It is often said in business that givers gain. Just as you can refer a recruiter to relevant people in your network, hopefully one day someone can do the same for you.

Talking to a recruiter, even when you are not actively looking, might be the best career decision you make this year!

Are you looking to make your next career move or do you need to hire specialist talent for your Medical Device company? Visit our website to find out more about comprehensive range of search & selection services or get in touch directly via +44 1904720040.

4 Secrets to Start-up Onboarding Success

Guided Solutions

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November 15, 2018

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4 Secrets to Start-up Onboarding Success

Adding a new employee to a fledgling start-up organisation is a cause for celebration. It’s a signifier of growth and a time to look forward to the impact this new element would have on the business. But apart from the obvious upsides, there is a new dimension and personality to manage and integrate. And if you are going to reap the rewards, you need to do this well.

Getting this new relationship off on the right foot has a lot to do with creating a robust and engaging onboarding process that immerses your new employee in the company culture from the word go.

There are countless tools and tactics start-ups employ to make new team members feel at home, but we recommend you bear these 4 concepts in mind when devising your own onboarding strategy.

1. Make it a bilateral introduction

Although your new hire is the priority, don’t neglect the fact that each member of your existing team is also getting a new colleague, too. Ensure that everyone in the organisation has the chance to introduce themselves to one another within a social setting where people will have the time and freedom to express their personalities.

2. Make sure support is maintained

Once the pleasantries and niceties have been exchanged it can feel natural to simply let the new employee get on with their job. This is particularly the case if their role is autonomous or breaking ground on a new area for the business. Whilst it’s great to give new employees freedom to operate in their own way, don’t let this translate into isolation. Check-in with them regularly and, if you lack the time, make sure to assign a dedicated buddy they can go to with day-to-day queries and questions.

3. Scale up the process logically

Day one in a new job is often a blur. With so many new elements washing over your new employee it’s pointless to use this moment for anything more than a light orientation, i.e. meeting the team and beginning to observe the ebb and flow of the work environment. Days 2-7 and 7-14, depending on the nature of the role, should focus on the steady transition from ‘learning’ to ‘learning and doing’, to ‘doing (with guidance)’.

4. Reaffirm their importance in the future, and set out some structure

Between the end of the interview and the start date a couple months could have passed, with a natural dissipation of some of the zeal experienced at the interviewing and offer acceptance stage. On day one (or two) make sure you fire up the enthusiasm with a one-to-one. Depending on the nature of the role this is a good time to set out your vision for the first 90 days in the company, as well as go over some of the minutiae of their first few weeks and the onboarding activities your new hire can look forward to.

At Guided Solutions we are passionate about helping medical device businesses realise their potential through improved talent acquisition and retention.

Contact us to discuss a new hiring project or find out how our unique selection of search and consulting services could impact your business.

CE Mark or FDA Approval?

Guided Solutions

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November 5, 2018

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The answer is a resounding “well, it depends…”

It depends on many factors including the specific circumstance, position, timelines and ambitions you have for your device and your company. This article summarises some of the key differences, positives and negatives in order to augment your pathway selection processes.

Some Key Differences

FDA approval always requires bespoke clinical trial data. In comparison, CE mark can be obtained following utilisation and application of successful clinical evaluations of equivalent pre-existing devices and a subsequent post-market study.
CE mark requires proof of the safety of the device usage. FDA approval, on the other hand, requires proof of the safety and efficacy of the device. It must be noted here that CE marked devices will necessarily then be required to provide proof of efficacy on a country-by-country basis to achieve reimbursement, although the acquisition of these proofs is expedited by successful CE marking.
Federal oversight of the Food and Drug Administration Agency and subsequent nationwide reimbursement processes (i.e. Medicare) mean that FDA efficacy proofs are much less open to interpretation and variation than those obtained in the EU (currently comprising 28 nations and sets of regulations). As mentioned, devices in the EU must satisfy multiple country-specific efficacy requirements whilst FDA efficacy supersedes state law and (theoretically) provides successful applicants with instant access to the world’s largest market for Medical Devices.
One of the key predicates of venture capital funding is the ability of a business to demonstrate a workable strategy to obtain a tandem accreditation, where both FDA and CE marking are pursued concurrently. Tandem accreditation may require the most substantial resources, but it does the most to minimise risk and delay.
On average, CE marking processes tend to be faster and cheaper than FDA.

The Processes

The Class III CE Marking process (Class I and II are even shorter):

Identification and implementation of a valid conformity assessment procedure:
- Notified body studies technical design versus the legislative instruments (directives) which apply to it (Module B)
- Full QA and design dossier examination by notified body (Module H)

Technical file submission
Device manufacturer declares conformity and appoints an authorised representative
Proper packaging and labelling of the newly accredited device
Post-market surveillance

The FDA Process:

If the manufacturer is claiming substantial equivalence to a pre-existing device the process can begin with a 510k pre-market notification. This requires the manufacturer to prove deep technological, design and performance-related similarity to the equivalent device. Without sufficient proof of equivalence, the device falls into Class III and requires pre-market approval (PMA).
Appropriate classification of the device.
If a device is classified as lower than Class III it falls within the ambit of 510k submission requiring proof of substantial equivalence. Devices categorised as Class III will require pre-market approval.
If a manufacturer is unable to prove substantial equivalence to an existing device, the FDA can continually request data until satisfied, or where it feels that equivalence cannot be proven it can categorise the device as Class III by default and it must then pass through the PMA instead.
Clinical trials are an essential element of the clearance process. As a general rule, these trials should take place within the US. A company can obtain investigational device exemption (IDE) for trials conducted outside the US in support of a PMA on the condition that it complies with IDE regulation. Additonally, IDE may only support and not replace in-US clinical trials.

Summary

It’s difficult to draw too many conclusions on this topic without venturing into the realms of over-simplification and generalisation. Still, the following truths are self-evident:

If you want your device to become commercially available, you will need to obtain a regulatory approval. Depending on your company’s location and your market penetration strategy, you will start with either FDA or CE Mark, but ultimately, if your technology has the potential to disrupt clinical practice on a global scale, you will need both.
Making informed decisions about getting marketing authorisation, especially within the context of ever-tightening regulatory parameters, requires expert knowledge, experience and, more often than not, a strong industry network.

Guided Solutions has been identifying and delivering transformative talent to growth-led, technology-driven Medical Device SMEs for nearly 20 years. If you need to get proven regulatory affairs expertise on board to make a successful next step in your product’s lifecycle, don’t hesitate to get in touch for an exploratory discussion.

Our seasoned team of international consultants and continually expanding global network of 120,000+ medtech professionals will deliver the right fit for your team.

Chief Technical Officer Intensive Therapy – Norway

Guided Solutions

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November 5, 2018

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Chief Technical Officer Intensive Therapy – Norway

The Context

Guided Solutions were contacted by a young pre-commercialisation stage start-up Medical Device company based out of a relatively remote location in Norway. The company had developed a disruptive technology for use in ICU.

With further funding to obtain, trials to pass and regulatory hoops to jump through, the company were looking to find an individual who would relish the challenges presented by the market conditions and the ambitious timelines the company had set for reaching evolving milestones.

The Campaign

The primary function of the role was to develop where possible the usability of the core technology, overcome production scale-up difficulties, and work with regulatory bodies to ensure that the product could enter the market smoothly. The search for an individual with the knowledge of technological development, regulatory procedure and fitting cultural outlook to work within a highly specific entrepreneurial environment proved to be challenging and rewarding in equal measure.

After a measured process, two candidates emerged with the blended skill-set necessary. At the final interview stage, one candidate edged the other through their consistent presentation of a deep desire to affect the client company and a value-adding strategic plan for achieving this.

Our core Executive Search service helps Medical Device businesses to access and retain impactful, growth-leading talent at each key stage of the company lifecycle.

Click here to learn more or contact us directly for an exploratory discussion.

VP Business Development Cardiology – France

Guided Solutions

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October 31, 2018

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VP Business Development Cardiology – France

The Context

Guided Solutions had identified a company and technology within the cardiology market which was nearing a phase of existence where robust business development would soon be required. The company were looking for a VP Business Development to commence European commercial activity for their 18 month old project. The company gained some traction for their product within relevant clinical circles. The benefits of the new technology, if they could be brought to market, were highly sought after.

The Campaign

The VP Business Development needed to solidify these links with KOL’s across the EMEA, and create partnerships within 3rd party distribution channels. To be successful in this endeavour the successful applicant had to at once be capable of displaying clinical know-how as well as the commercial gravitas to drive change through established markets.

Ultimately we were able to successfully identify an individual with the clinical prowess, who had driven sales in new markets and had done so with a combination of sophistication and drive. The company have now acquired CE mark and are continuing their growth through the channels established by the successful candidate.

Since 2000, Guided Solutions have been helping the most innovative Medical Device companies in the world identify and retain the finest leadership talent in the market.

Learn more about our Executive Search capacity or contact us directly to explore further.

VP Global Sales Radiation Oncology – Denmark

Guided Solutions

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October 26, 2018

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VP Global Sales Radiation Oncology – Denmark

The Context

Our client, a leading source of cutting-edge innovation within the field of Radiation Oncology and Medical Imaging had historically focused their commercial activities on the US market. The recruitment of a Vice President Global Sales was a definite step towards the penetration of the APAC and EMEA markets, which up until that point had been largely untapped. The potential scale of the role related almost entirely to the vision and skill of the chosen candidate. In very real terms the future prosperity of the business depended on our ability to carry out such a meticulous recruitment process that we deliver the optimum hiring result for our client.

The Campaign

To ensure the need for speed was met we utilised our continually expanding network of 120,000+ Medical Device industry leaders and experts. The company was branching out into a new and exciting territory and this expansion required a very deliberate alignment and management of purpose to ensure an effective transition. The new VP would be tasked with plotting and overseeing the execution of a strategic vision for the global sales function, cultivating and leveraging a broad KOL network, and rolling out best practice across the entire global sales team.

Within our vast and uniquely specialised global talent network, we were able to identify three candidates to be assessed by the company, each of whom had experience spearheading similarly scaled operations. One candidate in particular demonstrated the strength of character needed to issue directives, leverage a viable KOL network and hit the ground running with the vision to understand where and when future augmentations and investments should be made.

Our multilingual team of seasoned Executive Search consultants connect Medical Device businesses to top-tier industry talent at each key stage of the company lifecycle.

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